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full study rank 61393 study protocol section identification module n c t id NCT04837053 org study id info org study id Value-based TKR organization org full name Technische Universität Dresden org class OTHER brief title Implementation of Indication Criteria for Total Knee Replacement in Osteoarthritis (Value-based TKR) official title An Individualized Decision Aid for Physicians and Patients for Total Knee Replacement in Osteoarthritis (Value-based TKR): Study Protocol for a Multi-center, Stepped Wedge, Cluster Randomized Controlled Trial status module status verified date August 2021 overall status Recruiting expanded access info has expanded access No start date struct start date June 1, 2021 start date type Actual primary completion date struct primary completion date October 31, 2022 primary completion date type Anticipated completion date struct completion date October 31, 2023 completion date type Anticipated study first submit date February 22, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date August 20, 2021 last update post date struct last update post date August 23, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Technische Universität Dresden lead sponsor class OTHER collaborator list collaborator collaborator name Innovation Fund of the Joint Federal Committee (Gemeinsamer Bundesausschuss, G-BA), Germany collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this trial is to investigate the effect of a medical decision aid (EKIT-Tool) on decision quality for knee arthroplasty. detailed description The tool will guide the SDM process and support the consultation, providing a systematic presentation of individual patient and disease-specific information and the fulfilment of indication criteria. Furthermore, it will present health information about knee replacement to empower the patient. To investigate the effect of the tool on decision quality, we choose a prospective multi-center, stepped wedge, cluster randomized controlled trial (SW-RCT) design. conditions module condition list condition Knee Osteoarthritis Arthroplasty, Replacement, Knee design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Sequential Assignment design intervention model description Pragmatic Multicenter Cluster Randomized Controlled Trial with stepped wedged design design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 1080 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intervention cluster arm group type Experimental arm group description EKIT tool arm group intervention list arm group intervention name Other: Digital decision aid for physicians and patients arm group label Control Cluster arm group type Active Comparator arm group description routine care arm group intervention list arm group intervention name Other: Routine care intervention list intervention intervention type Other intervention name Digital decision aid for physicians and patients intervention description The intervention consists of three parts: (1) the EKIT tool provides a systematic presentation of individual patient and disease-specific information; (2) it visualizes the fulfilment of the indication criteria recommanded in corresponding german guideline; (3) it presents health information about total knee replacement. intervention arm group label list intervention arm group label Intervention cluster intervention type Other intervention name Routine care intervention description Care as usual within the included study sites. intervention arm group label list intervention arm group label Control Cluster outcomes module primary outcome list primary outcome primary outcome measure Decision quality primary outcome description Decision quality measured by DQI-Knee Osteoarthritis v2.0 primary outcome time frame immediately after the intervention/procedure/surgery secondary outcome list secondary outcome secondary outcome measure Fulfillment of patient expectations secondary outcome description Fulfillment of patient expectations measured by a 5-point Likert-scale (not at all, no, unsure, yes partially, yes completely) secondary outcome time frame 12 months secondary outcome measure Oxford Knee Score (OKS) secondary outcome description Oxford Knee Score (0 worst to 48 best) secondary outcome time frame 12 month eligibility module eligibility criteria Inclusion Criteria:
patient with knee osteoarthritis who are candidates for knee replacement
capacity to consent
understanding of the German language (written and oral)
age of 18 years or older
informed consent
Exclusion criteria:
meeting not all inclusion criteria healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Franziska Beyer central contact role Contact central contact phone +49 351 458 14173 central contact e mail Franziska.Beyer@uniklinikum-dresden.de overall official list overall official overall official name Jörg Lützner, MD overall official affiliation TU Dresden overall official role Principal Investigator location list location location facility University Center of Orthopedics, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, Technische Universität Dresden location status Recruiting location city Dresden location state Saxony location zip 01307 location country Germany location contact list location contact location contact name Jörg Lützner, MD location contact role Contact references module reference list reference reference p m i d 34511058 reference type derived reference citation Lange T, Deckert S, Beyer F, Hahn W, Einhart N, Roessler M, Sedlmayr M, Schmitt J, Lützner J. An individualized decision aid for physicians and patients for total knee replacement in osteoarthritis (Value-based TKR study): study protocol for a multi-center, stepped wedge, cluster randomized controlled trial. BMC Musculoskelet Disord. 2021 Sep 12;22(1):783. doi: 10.1186/s12891-021-04546-5. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010003 condition mesh term Osteoarthritis condition mesh id D000020370 condition mesh term Osteoarthritis, Knee condition ancestor list condition ancestor condition ancestor id D000001168 condition ancestor term Arthritis condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition ancestor id D000012216 condition ancestor term Rheumatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M12078 condition browse leaf name Osteoarthritis condition browse leaf as found Osteoarthritis condition browse leaf relevance high condition browse leaf id M21321 condition browse leaf name Osteoarthritis, Knee condition browse leaf as found Knee Osteoarthritis condition browse leaf relevance high condition browse leaf id M3628 condition browse leaf name Arthritis condition browse leaf relevance low condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse leaf id M14197 condition browse leaf name Rheumatic Diseases condition browse leaf relevance low condition browse leaf id M5475 condition browse leaf name Collagen Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases | NCT04837053 | [
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full study rank 61379 study protocol section identification module n c t id NCT04837235 org study id info org study id HM005PS1S04 organization org full name Ganzhou Hemay Pharmaceutical Co., Ltd org class INDUSTRY brief title Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects official title Clinical Study of Safety, Tolerability, and Pharmacokinetics of Hemay005 Tablets in Single and Multiple Doses in Healthy Subjects acronym Hemay005 status module status verified date October 2021 overall status Active, not recruiting expanded access info has expanded access No start date struct start date April 29, 2021 start date type Actual primary completion date struct primary completion date October 2021 primary completion date type Anticipated completion date struct completion date November 2021 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 12, 2021 last update post date struct last update post date October 20, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Tianjin Hemay Pharmaceutical Co., Ltd lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. There were 3 dose cohorts (75mg, 90mg, 105mg) with 12 healthy subjects in each cohorts (6 males and 6 females). This study includes an 11-day Screening Period, a 1-day single dose and 7-days multiple doses Treatment Period. conditions module condition list condition Psoriasis design module study type Interventional phase list phase Phase 1 design info design allocation Non-Randomized design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 12 enrollment type Actual arms interventions module arm group list arm group arm group label 75mg group arm group type Experimental arm group description 15mg/tablet. Five tablets (75mg) each time. Participants will receive a single dose of Hemay005 tablet in Day 1 followed by twice a day of Hemay005 tablet in Day 3~Day8 and single dose in Day9. arm group intervention list arm group intervention name Drug: Hemay005 arm group label 90mg group arm group type Experimental arm group description 15mg/tablet. Six tablets (90mg) each time. Participants will receive a single dose of Hemay005 tablet in Day 1 followed by twice a day of Hemay005 tablet in Day 3~Day8 and single dose in Day9. arm group intervention list arm group intervention name Drug: Hemay005 arm group label 105mg group arm group type Experimental arm group description 15mg/tablet. Seven tablets (105mg) each time. Participants will receive a single dose of Hemay005 tablet in Day 1 followed by twice a day of Hemay005 tablet in Day 3~Day8 and single dose in Day9. arm group intervention list arm group intervention name Drug: Hemay005 intervention list intervention intervention type Drug intervention name Hemay005 intervention description oral intervention arm group label list intervention arm group label 105mg group 75mg group 90mg group outcomes module primary outcome list primary outcome primary outcome measure Number of adverse events (AEs), related AEs and serious AEs (SAEs) primary outcome description All subjects who receive the drug will be analyzed for safety, and the safety evaluation will refer to CTCAE 5.0 standard. primary outcome time frame From Day 1 to Day 11 eligibility module eligibility criteria Inclusion Criteria:
healthy subjects aged 18 to 60 years, The ratio of male to female is 1:1
male Bodyweight（BW）≥ 50kg, female Bodyweight（BW）≥ 45kg, Body mass index (BMI) in 18-28 (including upper and lower limit of the range);
All male subjects must agree and commit to the use of a reliable contraceptive regimen(including vasoligation, abstinence, using a condom) for the duration of the study(from screening until 6 months after the last dose), Female participants with a negative pregnancy test (serum) at both the screening visit and at Day-1, Female subjects and female partners of male subjects must agree and commit to the use of a reliable contraceptive regimen ( oral contraceptive medications or non-oral contraceptive medications) for the duration of the study(from screening until 6 months after the last dose);
Ability to understand and be willing to sign a written informed consent before study entry;
Subjects would have good communication with the investigator and could comply with protocol.
Exclusion Criteria:
A history of clinically severe gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders;
Have a known history of hypersensitivity to any medicine or food, or allergy to the test article or any of the excipient of the test article;
Those who have or are suffering from gastrointestinal, liver and kidney diseases that affect drug absorption or metabolism
A history of chronic infection (ie, tuberculosis);
A medical history of any clinically significant medical disease or surgery within 4 weeks of the screening
Clinically significant laboratory abnormal results at screening or prior to the first dose of study drug;
Clinically significant abnormal 12-lead ECG or vital signs
Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, hepatitis C virus antibody or Treponema pallidum antibody at screening;
Within 1 year before study enrollment of frequent alcohol consumption, defined by average intake of greater than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of spirits with 40% alcohol content, or 150 mL wine), Participants who are unable to abstain from smoking during the study or quitting smoking for less than 3 months;
Positive urine screen for drug and cigarettes, positive breath test for alcohol;
Subjects who use soft drugs (ie marijuana )within 3 months of the screening and entire study duration or hard drugs (ie cocaine, phencyclidine ) within 1 year of the screening and entire study duration;
Dietary habits or food intolerances which will interfere with the requirements for participants to consume a standardised diet whilst confined to the clinical unit;
Participants who eat special food (Including grapefruit and/or Xanthine diet) for 14 days prior to dosing or any caffeine containing food or drinks, i.e. chocolate for 48 hours prior to dosing or drinking alcohol for 24 hours prior to dosing and not will stop to intake above food and drinks;
Use of any drug that inhibits or induces hepatic metabolism of drugs within 30 days of planned study drug administration and entire study duration (e.g. inducers: barbiturates, carbamazepine, rifampicin, phenytoin, glucocorticoid and omeprazole; inhibitors-SSRI（Selective serotonin reuptake inhibitors） antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives and hypnotics, verapamil, fluoroquinolones and antihistamines);
Participant who received any medicine within 14 days of the initial dose of study drug;
Have received other clinical trials treatment within 3 months prior to study;
Participants who have donated of blood (>400 mL) within 4 weeks of the study, or plan to donate of blood during of the study and 4 weeks after the study;
Subjects cannot complete the study due to other reasons or by the investigator's judgment;
Pregnancy or lactating females healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 60 Years std age list std age Adult contacts locations module location list location location facility Sun Yat-sen Memorial Hospital of Sun Yat-sen University location city Guangzhou location country China derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011565 condition mesh term Psoriasis condition ancestor list condition ancestor condition ancestor id D000017444 condition ancestor term Skin Diseases, Papulosquamous condition ancestor id D000012871 condition ancestor term Skin Diseases condition browse leaf list condition browse leaf condition browse leaf id M13574 condition browse leaf name Psoriasis condition browse leaf as found Psoriasis condition browse leaf relevance high condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse leaf id M18865 condition browse leaf name Skin Diseases, Papulosquamous condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id C000628605 intervention mesh term Hemay005 intervention ancestor list intervention ancestor intervention ancestor id D000003879 intervention ancestor term Dermatologic Agents intervention ancestor id D000058988 intervention ancestor term Phosphodiesterase 4 Inhibitors intervention ancestor id D000010726 intervention ancestor term Phosphodiesterase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention browse leaf list intervention browse leaf intervention browse leaf id M261516 intervention browse leaf name Hemay005 intervention browse leaf as found DW-MRI intervention browse leaf relevance high intervention browse leaf id M6226 intervention browse leaf name Dermatologic Agents intervention browse leaf relevance low intervention browse leaf id M28487 intervention browse leaf name Phosphodiesterase 4 Inhibitors intervention browse leaf relevance low intervention browse leaf id M12781 intervention browse leaf name Phosphodiesterase Inhibitors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Derm intervention browse branch name Dermatologic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04837235 | [
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full study rank 61539 study protocol section identification module n c t id NCT04835155 org study id info org study id Hasan Kalyoncu University organization org full name Hasan Kalyoncu University org class OTHER brief title The Effect of The Premature Infant Oral Motorınterventıon on Suckıng Capacıty in Preterm Infants official title Faculty Member at Hasan Kalyoncu University status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date May 1, 2019 start date type Actual primary completion date struct primary completion date March 30, 2020 primary completion date type Actual completion date struct completion date June 15, 2020 completion date type Actual study first submit date March 25, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Selver Güler responsible party investigator title Dr. Asst.Prof. responsible party investigator affiliation Hasan Kalyoncu University lead sponsor lead sponsor name Hasan Kalyoncu University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary ABSTRACT Objective: To test the effect of the Premature Infant Oral Motor Intervention (PIOMI) at 29-30 weeks post-menstrual age on the development of oral-motor function and sucking capacity.
Study Design: This study was a single-blind randomized controlled experimental design. The sample consisted of 60 preterm babies from two Neonatal Intensive Care Units in Gaziantep, Turkey between May 2019 and March 2020, with 30 each in the control and experimental groups. The PIOMI was applied to the experimental group for five minutes a day for 14 consecutive days. Sucking capacity, growth, feeding outcomes, and length of hospital stay (LOS) were measured. The Yakut Manometer Measuring Suction Power (PCT/TR2019/050678) was developed specifically for this study and tested for the first time. detailed description METHODS The data were obtained for 11 months between May 2019 and March 2020 in the NICUs of two different hospitals in the Gaziantep province of Turkey using a single-blind randomized controlled experimental design.
Eligibilty was determined by the neonatologist based on the following inclusion criteria: 1) babies born at 26-30 weeks PMA, 2) stable clinical condition, 3) vital signs stable for at least 24 hours, 4) able to have PIOMI by the 29th or 30th week PMA, 5) required respiratory support limited to an oxyhood, Continuous Positive Airway Pressure (CPAP) and/or nasal cannula up to 2L flow, 6) APGAR scores at 1- and 5-minutes of 4 and above, 7) any race or ethnicity, 8) intraventricular hemmorhage limited to level 1 or 2; and 9) had no birth defects including facial anomolies that would impact feeding.
Sample The sample consisted of a total of 60 preterm infants all born after 26 weeks PMA with 30 each in the experimental and control group. Subjects were enrolled when they reached 29 or 30 weeks PMA and met inclusion criteria, and whose parents gave written consent.
Random assignment to groups was performed by a research assistant, who was not involved in the research but worked in the same unit as the researchers, using the online software at https://www.randomizer.org. The primary nurses were blinded to groups, and the parents stepped out during therapy to assist in blinding.
Two subjects were lost during the research period. Subject number 15 in the experimental group died on the 11th day after enrollment of causes unrelated to the intervention. Subject number 31 in the control group was intubated on the 7th day after enrollment thus became ineligable. After a subject dropped out, the next subject enrolled replaced that subject and the study was continued with the same sample size.
Data Collection Tools The data were recorded on a Data Collection Form, a Follow-up Form for Daily Procedures Applied to the Infant, a Sucking Capacity Monitoring Form. The outcome measurements required preterm baby bottles and pacifiers, measuring tape for growth measurements, a scale, a bottle and pacifier sterilization machine, a labeling machine, and preterm baby silicone bottle nipples. Sucking capacity was measured by the Yakut Manometer Measuring Suction Power (Figure 1), a pressure manometer embedded into a silicone nipple developed specifically for this study by Prof. Dr. Yavuz Yakut (International Patent Number PCT/TR2019/050678). The PIOMI intervention required a stopwatch and infant monitors and no other equipment.
Ethical Approval Approval for this research was obtained and dated 9.03.2019 from Hasan Kalyoncu University Faculty of Health Sciences, Research Ethics Committee(2019/29). To ensure correct performance of the PIOMI, the researcher trained with Dr. Brenda Lessen Knoll, the founder of PIOMI, and competency was evaluated via review of a video-recording of the researcher doing PIOMI on a preterm baby (with written consent from the parents) using the Reliability Rating Tool (13) to ensure intervention fidelity. Written permission was received from Dr. Yakut to use his manometer for measuring sucking power in this study. Written informed consent was obtained from the parents of all subjects.
Test-Retest Reliability of the Manometer Measuring Suction Power To asses the reliability of the newly developed Yakut Manometer Measuring Suction Power it was tested on 10 preterm babies who had transitioned to full oral feedings and who had written consent from the parents and who were approved by a neonatologist. Each baby sucked on the manometer nipple for a minimum of one minute of successful sucking on two separate occcasions with a 5-minute interval in between. During both measurements, the highest value the infant could reach within the first minute after the baby began to suck was documented. The average sucking power at the 1st measure was 102±22.38 mmHg, and 104.5±13.83 mmHg at the 2nd measure. The test re-test reliability coefficient between the two applications was calculated by the Intraclass Correlation Coefficient (ICC) (2.1) and found to be 0.912. An ICC value of 0.75 indicates good reliability, and above .90 is excellent (33). The obtained ICC value of above 0.90 showed that the manometer was suitable / acceptable for use in clinical measurements (34).
Application Phase The PIOMI was applied only by the trained researcher, and blind to the nursing staff in charge of care and feeding. No information about the PIOMI was shared with the general staff working in the NICU, and it was performed in the absence of the mothers, although no formal curtain was used for additional blinding. Day 1 of the study was considered the 1st day that the babies received PIOMI. The researcher applied PIOMI to the experimental group for 5 minutes per day for 14 consecutive days, 15-20 minutes before a sheduled feeding at either the 09:00 or 12:00 feeding. On the first day, the baseline sucking capacity of babies in both groups was measured before any intervention. On the following 8th, 11th and 14th days, the measures of sucking capacity were repeated and followed by oral feeding trials. Growth measures were collected on the 1st and 14th days and the day of disharge (CONSORT Flow Diagram). A separate manometer nipple was used for each baby and labeled with names and surnames. Before each use, the bottle nipple was sterilized with a bottle and pacifier sterilization machine. Routine hand-washing was excercised before and after any patient or equipment contact. Babies were monitored during both the PIOMI application and the evaluation of the sucking capacity for any negative physiological/ behavioral cues of intolerance (apnea, bradycardia, desaturation below 90%, crying, tachycardia, facial color change). If one negative cue was observed, the procedure was suspended until the baby returned to normal, and was documented. The intervention would then be conitnued the following day. conditions module condition list condition Feeding Behavior Premature Birth Sucking Behavior keyword list keyword Preterm Infant Sucking Capacity Premature Infant Oral Motor Intervention Feeding Oral Stimulation design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Sample The sample consisted of a total of 60 preterm infants all born after 26 weeks PMA with 30 each in the experimental and control group. Subjects were enrolled when they reached 29 or 30 weeks PMA and met inclusion criteria, and whose parents gave written consent.
Random assignment to groups was performed by a research assistant, who was not involved in the research but worked in the same unit as the researchers, using the online software at https://www.randomizer.org. The primary nurses were blinded to groups, and the parents stepped out during therapy to assist in blinding. design primary purpose Supportive Care design masking info design masking Double design masking description The PIOMI was applied only by the trained researcher, and blind to the nursing staff in charge of care and feeding. No information about the PIOMI was shared with the general staff working in the NICU, and it was performed in the absence of the mothers, although no formal curtain was used for additional blinding. design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 60 enrollment type Actual arms interventions module arm group list arm group arm group label experimental group arm group type Experimental arm group description The researcher applied Premature Infant Oral Motor Intervention to the experimental group for 5 minutes per day for 14 consecutive days, 15-20 minutes before a sheduled feeding at either the 09:00 or 12:00 feeding. On the first day, the baseline sucking capacity of babies in experimental group was measured before any intervention. On the following 8th, 11th and 14th days, the measures of sucking capacity were repeated and followed by oral feeding trials. Growth measures were collected on the 1st and 14th days and the day of disharge. arm group intervention list arm group intervention name Procedure: Premature Infant Oral Motor Intervention (PIOMI) arm group label control grup arm group type No Intervention arm group description The researcher did not apply any intervention. On the first day, the baseline sucking capacity of babies in control group was measured before any intervention. On the following 8th, 11th and 14th days, the measures of sucking capacity were repeated and followed by oral feeding trials. intervention list intervention intervention type Procedure intervention name Premature Infant Oral Motor Intervention (PIOMI) intervention description The Premature Infant Oral Motor Intervention (PIOMI), developed by Dr. Brenda Lessen Knoll, was chosen for this study because it is the only oral motor program designed specifically for preterm babies as young as 29 weeks post menstrual age (PMA) and is the only program with a standardized training method and published intervention fidelity. The 5 minute therapy offers assisted movement to activate muscle contraction and movement against resistance to build strength in the perioral structures. The PIOMI has 8 steps where a provider uses a pinky finger to provide gentle stroking and pressure on the cheeks, lips, tongue, gums and palate to strengthen the oral sensory-motor functions and improve feeding efficiency. PIOMI ends with 2 minutes of NNS. NNS and oral stimulation have been found to mature the oral motor sensory system, and improve not only bottle feeding, but also breastfeeding. intervention arm group label list intervention arm group label experimental group outcomes module primary outcome list primary outcome primary outcome measure Baby's sucking power primary outcome description The suction power of the baby was measured in mmHg with the Manometer measuring the Sucking Power. primary outcome time frame The sucking power of the baby included in the study was measured up to 32 weeks. primary outcome measure Baby's sucking before releasing the bottle primary outcome description The baby's sucking time without leaving the bottle was calculated in seconds. primary outcome time frame The sucking time without leaving the bottle of the baby included in the study was measured up to 32 weeks. primary outcome measure Baby's total sucking time primary outcome description The baby's total sucking time was calculated in seconds. primary outcome time frame The total sucking time of the baby included in the study was measured up to 32 weeks. primary outcome measure Baby's sucking amount primary outcome description The baby's sucking amount was calculated in milliliters. primary outcome time frame The sucking amount of the baby included in the study was measured up to 32 weeks. secondary outcome list secondary outcome secondary outcome measure Baby's body weight secondary outcome description Baby's body weight was measured in grams. height and head circumference. secondary outcome time frame The baby's body weight was measured for up to 40 weeks. secondary outcome measure Baby's height secondary outcome description Baby's height was measured in centimeters. secondary outcome time frame Baby's height was measured for up to 40 weeks. secondary outcome measure Baby's head circumference secondary outcome description Head circumference of the baby was measured in centimeters. secondary outcome time frame Baby's head circumference was measured for up to 40 weeks. secondary outcome measure First day of oral feeding time secondary outcome description From the day the baby was included in the study, the day he sucked his mother was calculated. The average was calculated as 31 days in the experimental group and 41 days in the control group. secondary outcome time frame The day when the baby was able to have the first oral feeding was measured up to 40 weeks. secondary outcome measure Discharge time secondary outcome description The total number of days the baby stayed in the hospital from the day he was included in the study was calculated. secondary outcome time frame Up to 40 weeks were measured on the day of discharge. eligibility module eligibility criteria Inclusion Criteria:
Eligibilty was determined by the neonatologist based on the following inclusion criteria:
babies born at 26-30 weeks PMA,
stable clinical condition,
vital signs stable for at least 24 hours,
able to have PIOMI by the 29th or 30th week PMA,
required respiratory support limited to an oxyhood, Continuous Positive Airway Pressure (CPAP) and/or nasal cannula up to 2L flow,
APGAR scores at 1- and 5-minutes of 4 and above,
any race or ethnicity,
intraventricular hemmorhage limited to level 1 or 2; and
had no birth defects including facial anomolies that would impact feeding.
Exclusion Criteria:
Whose gestational age at birth was less than 26 weeks,
had congenital disorder or birth trauma,
had NEC,
had RDS,
were diagnosed with severe asphyxia,
had intraventricular bleeding,
had Newborn Withdrawal Syndrome,
had Fetal Alcohol Syndrome,
were receiving ventilator support,
were receiving Extracorporeal Membrane Oxygenation,
developed any complications during the follow-up period in the intervention group, whose balance status deteriorated,
whose written and verbal permissions were obtained from their parents. healthy volunteers No gender All minimum age 29 Weeks maximum age 30 Weeks std age list std age Child contacts locations module overall official list overall official overall official name Selver GÜLER, PhD overall official affiliation https://www.hku.edu.tr/ overall official role Principal Investigator location list location location facility Hasan Kalyoncu University, Faculty of Health Sciences, Department of Nursing location city Gaziantep location state Şahinbey location zip 27412 location country Turkey references module reference list reference reference p m i d 26252313 reference type result reference citation Tian X, Yi LJ, Zhang L, Zhou JG, Ma L, Ou YX, Shuai T, Zeng Z, Song GM. Oral Motor Intervention Improved the Oral Feeding in Preterm Infants: Evidence Based on a Meta-Analysis With Trial Sequential Analysis. Medicine (Baltimore). 2015 Aug;94(31):e1310. doi: 10.1097/MD.0000000000001310. reference p m i d 30721652 reference type result reference citation Lessen Knoll BS, Daramas T, Drake V. Randomized Controlled Trial of a Prefeeding Oral Motor Therapy and Its Effect on Feeding Improvement in a Thai NICU. J Obstet Gynecol Neonatal Nurs. 2019 Mar;48(2):176-188. doi: 10.1016/j.jogn.2019.01.003. Epub 2019 Feb 2. reference p m i d 12183719 reference type result reference citation Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731. Erratum In: J Pediatr 2002 Nov;141(5):743. reference p m i d 21730902 reference type result reference citation Lessen BS. Effect of the premature infant oral motor intervention on feeding progression and length of stay in preterm infants. Adv Neonatal Care. 2011 Apr;11(2):129-39. doi: 10.1097/ANC.0b013e3182115a2a. reference p m i d 26803089 reference type result reference citation Lessen BS, Morello CA, Williams LJ. Establishing Intervention Fidelity of an Oral Motor Intervention for Preterm Infants. Neonatal Netw. 2015;34(2):72-82. doi: 10.1891/0730-0832.34.2.72. reference p m i d 28376549 reference type result reference citation Kamitsuka MD, Nervik PA, Nielsen SL, Clark RH. Incidence of Nasogastric and Gastrostomy Tube at Discharge Is Reduced after Implementing an Oral Feeding Protocol in Premature (< 30 weeks) Infants. Am J Perinatol. 2017 May;34(6):606-613. doi: 10.1055/s-0037-1601443. Epub 2017 Apr 4. reference p m i d 31013539 reference type result reference citation Li XL, Liu Y, Liu M, Yang CY, Yang QZ. Early Premature Infant Oral Motor Intervention Improved Oral Feeding and Prognosis by Promoting Neurodevelopment. Am J Perinatol. 2020 May;37(6):626-632. doi: 10.1055/s-0039-1685448. Epub 2019 Apr 23. reference p m i d 30851536 reference type result reference citation Ghomi H, Yadegari F, Soleimani F, Knoll BL, Noroozi M, Mazouri A. The effects of premature infant oral motor intervention (PIOMI) on oral feeding of preterm infants: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2019 May;120:202-209. doi: 10.1016/j.ijporl.2019.02.005. Epub 2019 Feb 5. see also link list see also link see also link label Oral motor intervention improved the oral feeding in preterm infants: Evidence based on a meta-analysis with trial sequential analysis. see also link u r l http://ncbi.nlm.nih.gov/pmc/articles/PMC4616601/ see also link label Randomized controlled trial of a prefeeding oral motor therapy and ıts effect on feeding ımprovement in a Thai NICU. see also link u r l https://www.sciencedirect.com/science/article/abs/pii/S0884217519300048 see also link label Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. see also link u r l https://www.sciencedirect.com/science/article/pii/S0022347602000732 see also link label Effect of the premature infant oral motor intervention on feeding progression and length of stay in preterm infants. see also link u r l https://journals.lww.com/advancesinneonatalcare/Abstract/2011/04000/Effect_of_the_Premature_Infant_Oral_Motor.12.aspx see also link label Incidence of nasogastric and gastrostomy tube at discharge is reduced after implementing an oral feeding protocol in preterm (<30 weeks) infants. see also link u r l https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0037-1601443 see also link label Early premature infant Oral motor intervention improved oral feeding and prognosis by promoting neurodevelopment. see also link u r l https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0039-1685448 see also link label he effects of Premature Infant Oral Motor İntervention (PIOMI) on oral feeding of preterm infants: A randomized clinical trial. see also link u r l https://www.sciencedirect.com/science/article/pii/S0165587619300709 i p d sharing statement module i p d sharing No i p d sharing description We plan to share it after it is ready for publication. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000047928 condition mesh term Premature Birth condition ancestor list condition ancestor condition ancestor id D000007752 condition ancestor term Obstetric Labor, Premature condition ancestor id D000007744 condition ancestor term Obstetric Labor Complications condition ancestor id D000011248 condition ancestor term Pregnancy Complications condition browse leaf list condition browse leaf condition browse leaf id M25022 condition browse leaf name Premature Birth condition browse leaf as found Premature Birth condition browse leaf relevance high condition browse leaf id M9924 condition browse leaf name Obstetric Labor, Premature condition browse leaf relevance low condition browse leaf id M9916 condition browse leaf name Obstetric Labor Complications condition browse leaf relevance low condition browse leaf id M13279 condition browse leaf name Pregnancy Complications condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions | NCT04835155 | [
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1103,
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1987,
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1103,
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4567,
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4989,
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119,
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1108,
1460,
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1987,
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1204,
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1111,
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1540,
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119,
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9635,
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3836,
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5960,
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9635,
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1103,
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1127,
4092,
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170,
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10024,
8844,
119,
2994,
2963,
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1103,
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1111,
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5867,
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2517,
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2265,
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2767,
184,
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5266,
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170,
126,
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119,
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117,
1103,
2439,
2860,
1103,
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1439,
1103,
1148,
2517,
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1103,
2963,
1310,
1106,
13054,
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8510,
119,
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1540,
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1103,
2198,
4929,
1108,
9081,
28168,
20581,
119,
3383,
2608,
3048,
1403,
117,
1105,
9377,
119,
126,
28168,
17668,
119,
6032,
2608,
3048,
1403,
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1103,
2518,
4929,
119,
1109,
2774,
1231,
118,
2774,
17104,
21130,
1206,
1103,
1160,
4683,
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10056,
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1103,
1130,
4487,
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3836,
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3078,
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1103,
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7300,
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22491,
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3666,
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1103,
3972,
11325,
117,
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1106,
1103,
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2546,
1107,
2965,
1104,
1920,
1105,
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119,
1302,
1869,
1164,
1103,
153,
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14038,
1108,
3416,
1114,
1103,
1704,
2546,
1684,
1107,
1103,
151,
9741,
2591,
117,
1105,
1122,
1108,
1982,
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1103,
5884,
1104,
1103,
12694,
117,
1780,
1185,
4698,
12354,
1108,
1215,
1111,
2509,
22350,
119,
2295,
122,
1104,
1103,
2025,
1108,
1737,
1103,
2198,
1285,
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1103,
12237,
1460,
153,
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14038,
119,
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11325,
3666,
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1106,
1103,
6700,
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118,
1406,
1904,
1196,
170,
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8722,
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1719,
1103,
4925,
131,
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1137,
1367,
131,
3135,
8453,
119,
1212,
1103,
1148,
1285,
117,
1103,
2259,
2568,
14571,
3211,
1104,
12237,
1107,
1241,
2114,
1108,
7140,
1196,
1251,
9108,
119,
1212,
1103,
1378,
5192,
117,
5573,
1105,
5740,
1552,
117,
1103,
5252,
1104,
14571,
3211,
1127,
4892,
1105,
1723,
1118,
9619,
8453,
7356,
119,
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5252,
1127,
4465,
1113,
1103,
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1105,
5740,
1552,
1105,
1103,
1285,
1104,
10478,
1813,
2176,
113,
18732,
12412,
9565,
1942,
25549,
12120,
8517,
4515,
114,
119,
138,
2767,
1299,
20182,
15070,
1108,
1215,
1111,
1296,
2963,
1105,
12893,
1114,
2666,
1105,
12239,
1116,
119,
2577,
1296,
1329,
117,
1103,
5346,
15070,
1108,
188,
2083,
15892,
1114,
170,
5346,
1105,
185,
7409,
17792,
188,
2083,
15100,
3395,
119,
155,
3554,
2042,
1289,
118,
13445,
1108,
4252,
14840,
14636,
1181,
1196,
1105,
1170,
1251,
5351,
1137,
3204,
3232,
119,
18757,
16751,
1127,
19232,
1219,
1241,
1103,
153,
19368,
14038,
4048,
1105,
1103,
10540,
1104,
1103,
14571,
3211,
1111,
1251,
4366,
23292,
120,
18560,
26602,
1104,
1154,
2879,
3923,
113,
170,
1643,
25362,
117,
12418,
3810,
10542,
1465,
117,
3532,
2980,
23022,
2071,
3078,
110,
117,
6675,
117,
27629,
8992,
10542,
1465,
117,
14078,
2942,
1849,
114,
119,
1409,
1141,
4366,
18780,
1108,
4379,
117,
1103,
7791,
1108,
6232,
1235,
1103,
2963,
1608,
1106,
2999,
117,
1105,
1108,
8510,
119,
1109,
9108,
1156,
1173,
1129,
14255,
2875,
14787,
1174,
1103,
1378,
1285,
119,
2975,
13196,
3879,
2190,
3879,
11907,
17141,
4108,
2328,
17564,
11689,
21943,
3313,
20729,
15463,
12944,
4108,
2328,
17564,
2501,
12565,
2190,
2501,
12565,
11689,
2083,
1306,
1130,
26636,
15463,
12944,
17212,
19905,
11689,
21943,
3313,
1130,
26636,
26925,
8226,
11300,
21987,
11907,
17141,
26925,
1457,
4060,
6856,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
9108,
2235,
6136,
2687,
7136,
1109,
6876,
4227,
1104,
170,
1703,
1104,
2539,
3073,
2083,
1306,
20186,
1155,
1255,
1170,
1744,
2277,
14123,
1592,
1114,
1476,
1296,
1107,
1103,
6700,
1105,
1654,
1372,
119,
12859,
26394,
1127,
7945,
1165,
1152,
1680,
1853,
1137,
1476,
2277,
14123,
1592,
1105,
1899,
10838,
9173,
117,
1105,
2133,
2153,
1522,
1637,
9635,
119,
19441,
8641,
1106,
2114,
1108,
1982,
1118,
170,
1844,
3109,
117,
1150,
1108,
1136,
2017,
1107,
1103,
1844,
1133,
1589,
1107,
1103,
1269,
2587,
1112,
1103,
6962,
117,
1606,
1103,
3294,
3594,
1120,
18630,
131,
120,
120,
7001,
119,
7091,
17260,
119,
8916,
119,
1109,
2425,
13318,
1127,
24255,
1106,
2114,
117,
1105,
1103,
2153,
2843,
1149,
1219,
7606,
1106,
6043,
1107,
22350,
119,
1902,
2425,
3007,
8704,
2109,
8396,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8543,
1902,
7739,
1158,
6136,
1109,
153,
19368,
14038,
1108,
3666,
1178,
1118,
1103,
3972,
11325,
117,
1105,
7198,
1106,
1103,
11138,
2546,
1107,
2965,
1104,
1920,
1105,
8453,
119,
1302,
1869,
1164,
1103,
153,
19368,
14038,
1108,
3416,
1114,
1103,
1704,
2546,
1684,
1107,
1103,
151,
9741,
2591,
117,
1105,
1122,
1108,
1982,
1107,
1103,
5884,
1104,
1103,
12694,
117,
1780,
1185,
4698,
12354,
1108,
1215,
1111,
2509,
22350,
119,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
4539,
27989,
10224,
1204,
3929,
19191,
1116,
1249,
8830,
21484,
10803,
23992,
10803,
5099,
2539,
10803,
2076,
2173,
4746,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
6700,
1372,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1109,
11325,
3666,
11689,
21943,
3313,
1130,
26636,
26925,
8226,
11300,
21987,
1106,
1103,
6700,
1372,
1111,
126,
1904,
1679,
1285,
1111,
1489,
4776,
1552,
117,
1405,
118,
1406,
1904,
1196,
170,
8478,
8722,
1181,
8453,
1120,
1719,
1103,
4925,
131,
3135,
1137,
1367,
131,
3135,
8453,
119,
1212,
1103,
1148,
1285,
117,
1103,
2259,
2568,
14571,
3211,
1104,
12237,
1107,
6700,
1372,
1108,
7140,
1196,
1251,
9108,
119,
1212,
1103,
1378,
5192,
117,
5573,
1105,
5740,
1552,
117,
1103,
5252,
1104,
14571,
3211,
1127,
4892,
1105,
1723,
1118,
9619,
8453,
7356,
119,
20227,
5252,
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4465,
1113,
1103,
2198,
1105,
5740,
1552,
1105,
1103,
1285,
1104,
10478,
1813,
2176,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
5096,
9650,
3313,
131,
11689,
21943,
3313,
1130,
26636,
26925,
8226,
11300,
21987,
113,
153,
19368,
14038,
114,
1981,
1372,
3107,
1654,
176,
20910,
1981,
1372,
2076,
1302,
11300,
21987,
1981,
1372,
6136,
1109,
11325,
1225,
1136,
6058,
1251,
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119,
1212,
1103,
1148,
1285,
117,
1103,
2259,
2568,
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1271,
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21943,
3313,
1130,
26636,
26925,
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21987,
113,
153,
19368,
14038,
114,
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1109,
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21943,
3313,
1130,
26636,
26925,
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21987,
113,
153,
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14038,
114,
117,
1872,
1118,
1987,
119,
16400,
13568,
1424,
148,
2728,
2339,
117,
1108,
3468,
1111,
1142,
2025,
1272,
1122,
1110,
1103,
1178,
9619,
5968,
1788,
2011,
4418,
1111,
3073,
2083,
1306,
12237,
1112,
1685,
1112,
1853,
2277,
2112,
1441,
2050,
5082,
1348,
1425,
113,
14123,
1592,
114,
1105,
1110,
1103,
1178,
1788,
1114,
170,
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2013,
3442,
1105,
1502,
9108,
20497,
18860,
119,
1109,
126,
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6842,
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1106,
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24827,
1105,
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1222,
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1106,
3076,
3220,
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1348,
4413,
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1144,
129,
3343,
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170,
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2745,
170,
5325,
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117,
3661,
117,
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185,
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8096,
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3769,
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123,
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151,
12412,
119,
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1103,
2268,
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1103,
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12944,
3794,
119,
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1103,
2963,
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2277,
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112,
188,
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10056,
1107,
6159,
18575,
5759,
119,
2425,
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1109,
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1104,
1103,
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1529,
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1103,
2025,
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1146,
1106,
2724,
2277,
119,
3718,
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2190,
3718,
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3718,
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4929,
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112,
188,
1404,
2841,
3718,
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112,
188,
1404,
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1107,
25293,
119,
3976,
1105,
1246,
172,
3161,
19172,
16792,
119,
3718,
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1159,
4207,
1109,
2963,
112,
188,
1404,
2841,
1108,
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1111,
1146,
1106,
1969,
2277,
119,
3718,
9386,
4929,
6008,
112,
188,
3976,
3718,
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6136,
6008,
112,
188,
3976,
1108,
7140,
1107,
19567,
119,
3718,
9386,
1159,
4207,
6008,
112,
188,
3976,
1108,
7140,
1111,
1146,
1106,
1969,
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119,
3718,
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4929,
6008,
112,
188,
1246,
172,
3161,
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16792,
3718,
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1246,
172,
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1969,
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119,
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9386,
4929,
1752,
1285,
1104,
9619,
8453,
1159,
3718,
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1622,
1103,
1285,
1103,
2963,
1108,
1529,
1107,
1103,
2025,
117,
1103,
1285,
1119,
8286,
1117,
1534,
1108,
10056,
119,
1109,
1903,
1108,
10056,
1112,
1955,
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1103,
6700,
1372,
1105,
3746,
1552,
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1103,
1654,
1372,
119,
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1285,
1165,
1103,
2963,
1108,
1682,
1106,
1138,
1103,
1148,
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1108,
7140,
1146,
1106,
1969,
2277,
119,
3718,
9386,
4929,
14856,
7111,
2176,
1159,
3718,
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6136,
1109,
1703,
1295,
1104,
1552,
1103,
2963,
3523,
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1103,
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1103,
2025,
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10056,
119,
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1159,
4207,
3725,
1106,
1969,
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1113,
1103,
1285,
1104,
12398,
119,
11768,
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11768,
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3561,
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3464,
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5389,
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10024,
8844,
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1103,
1378,
10838,
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131,
12237,
1255,
1120,
1744,
118,
1476,
2277,
14123,
1592,
117,
6111,
7300,
3879,
117,
9301,
5300,
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1111,
1120,
1655,
1572,
2005,
117,
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1106,
1138,
153,
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14038,
1118,
1103,
17333,
1137,
13631,
1989,
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1592,
117,
2320,
19192,
1619,
2609,
1106,
1126,
184,
16844,
5914,
117,
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6105,
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22472,
1806,
2787,
2544,
3313,
113,
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123,
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7432,
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122,
118,
1105,
126,
118,
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1104,
125,
1105,
1807,
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1251,
1886,
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21052,
117,
1107,
4487,
14850,
4907,
5552,
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26271,
19911,
2609,
1106,
1634,
122,
1137,
123,
132,
1105,
1125,
1185,
3485,
20705,
1259,
14078,
1126,
18445,
7875,
1115,
1156,
3772,
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119,
16409,
1665,
17855,
140,
10587,
3464,
131,
2627,
2217,
176,
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3485,
14780,
117,
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26546,
1658,
117,
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155,
13675,
117,
1127,
11534,
1114,
5199,
1112,
22192,
19767,
117,
1125,
1107,
4487,
14850,
4907,
5552,
9793,
117,
1125,
1203,
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1556,
7412,
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156,
5730,
12743,
117,
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11907,
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2528,
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156,
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117,
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2772,
1619,
117,
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4172,
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1348,
2508,
12913,
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152,
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4915,
1891,
117,
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1251,
13522,
1219,
1103,
2812,
118,
1146,
1669,
1107,
1103,
9108,
1372,
117,
2133,
5233,
2781,
21959,
117,
2133,
1637,
1105,
14093,
6156,
1116,
1127,
3836,
1121,
1147,
2153,
119,
8071,
8118,
1302,
5772,
1398,
5867,
1425,
1853,
23519,
4177,
1425,
1476,
23519,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
6405,
10492,
4541,
13196,
2905,
2078,
2190,
2905,
2078,
2905,
2078,
1271,
22087,
23534,
1197,
144,
28196,
17516,
2069,
117,
7735,
2905,
2078,
13494,
18630,
131,
120,
120,
7001,
119,
177,
4786,
119,
5048,
1358,
119,
189,
1197,
120,
2905,
2078,
1648,
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1130,
5710,
3121,
25524,
1766,
2450,
2190,
2450,
2450,
3695,
18892,
14812,
1193,
1320,
10182,
1239,
117,
6694,
1104,
3225,
4052,
117,
1951,
1104,
15192,
2450,
1331,
144,
19888,
14626,
1643,
2450,
1352,
320,
22332,
1179,
18503,
2450,
195,
9717,
1765,
25892,
1477,
2450,
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4439,
7732,
13196,
3835,
2190,
3835,
3835,
185,
182,
178,
173,
24280,
1571,
22737,
17668,
3835,
2076,
1871,
3835,
19548,
157,
1811,
161,
117,
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149,
4538,
117,
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149,
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15330,
147,
2349,
117,
7085,
149,
117,
152,
1358,
162,
3190,
117,
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3814,
157,
117,
18933,
1403,
163,
117,
3765,
14748,
119,
26925,
8226,
11300,
21987,
146,
8223,
16011,
1103,
26925,
11907,
17141,
1107,
11689,
2083,
1306,
1130,
26636,
1116,
131,
16573,
7457,
1113,
170,
19415,
1161,
118,
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1556,
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22087,
21967,
12504,
119,
5734,
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1955,
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174,
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7629,
7629,
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7629,
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22639,
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173,
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full study rank 61570 study protocol section identification module n c t id NCT04834752 org study id info org study id 2102-004-1192 organization org full name Seoul National University Hospital org class OTHER brief title Effect of H2 Receptor Antagonist and Proton Pump Inhibitor on the Positivity Rates and Clinical Outcomes of COVID-19 official title Effect of Histamine 2 Receptor Antagonist (H2RA) and Proton Pump Inhibitor (PPI) on the Positivity Rates and Clinical Outcomes of Coronavirus Disease-19 (COVID-19). status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 1, 2021 start date type Anticipated primary completion date struct primary completion date December 31, 2021 primary completion date type Anticipated completion date struct completion date December 31, 2021 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Soo-Jeong Cho responsible party investigator title Clinical associate professor responsible party investigator affiliation Seoul National University Hospital lead sponsor lead sponsor name Seoul National University Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Dong-A ST Co., Ltd. collaborator class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This retrospective cohort study aims to evaluate the effect of proton pump inhibitor (PPI) or histamine-2 receptor antagonist (H2RA) on the clinical outcomes and positivity rates of Coronavirus Disease-19 (COVID-19). detailed description Previous researches on the association between the use of PPI and H2RA and the treatment and prevention of COVID-19 have reported inconsistent findings. This study aimed to evaluate the effect of H2 receptor antagonists and proton pump inhibitors on the clinical outcomes and positivity rates of COVID-19 using the Korean National Health Insurance (NHI) data. This is a retrospective cohort study using the NHI COVID-19 dataset, which includes health insurance data of individuals who underwent COVID-19 PCR test in South Korea. This study aims to evaluate the effect of the use of PPI and H2RA on the positivity rates and clinical outcomes of COVID-19. conditions module condition list condition COVID-19 keyword list keyword COVID-19 Proton pump inhibitor H2 receptor antagonist design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 400000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patients tested for COVID-19 arm group description Patients who were tested for COVID-19 nasopharyngeal polymerase chain reaction (PCR) arm group intervention list arm group intervention name Other: No intervention (Retrospective Cohort Observational) intervention list intervention intervention type Other intervention name No intervention (Retrospective Cohort Observational) intervention description History of PPI and H2RA prescription of the participants who were tested for COVID-19 will be reviewed. intervention arm group label list intervention arm group label Patients tested for COVID-19 intervention other name list intervention other name PPI: Rabeprazole, Pantoprazole, Omeprazole, Esomeprazole, Lansoprazole, Dexlansoprazole H2RA: Famotidine, Cimetidine, Nizatidine, Ranitidine outcomes module primary outcome list primary outcome primary outcome measure COVID-19 test positivity primary outcome description Test positivity rates for COVID-19 nasopharyngeal polymerase chain reaction (PCR): number of participants diagnosed with COVID-19 compared to the number participants who were tested for COVID-19 primary outcome time frame Through test completion, an average of 1 day primary outcome measure Mortality primary outcome description Mortality of participants who died after diagnosis of COVID-19 (during the hospitalization or after discharge) primary outcome time frame 60 days secondary outcome list secondary outcome secondary outcome measure Intensive care unit admission rate secondary outcome description Intensive care unit admission rate of patients who were diagnosed with COVID-19 secondary outcome time frame 60 days secondary outcome measure Mechanical ventilator application rate secondary outcome description Mechanical ventilator application rate of patients who were diagnosed with COVID-19 secondary outcome time frame 60 days secondary outcome measure Oxygen apply rate (Nasal prong, Facial Mask, High flow nasal cannula) secondary outcome description Oxygen apply (Nasal prong, Facial Mask, High flow nasal cannula) rates of patients who were diagnosed with COVID-19 secondary outcome time frame 60 days secondary outcome measure Rates of vasopressor and inotrope use secondary outcome description Rates of vasopressor and inotrope use of patients who were diagnosed with COVID-19 secondary outcome time frame 60 days eligibility module eligibility criteria Inclusion Criteria:
Individuals who were tested for COVID-19 using real-time reverse transcriptase PCR assay of nasal and pharyngeal swabs
Exclusion Criteria:
Record of a new prescription of non-steroidal anti-inflammatory drugs (NSAID) within 1 month of the test date
Patients who died within 48 hours after test. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Individuals who were tested for COVID-19 using real-time reverse transcriptase PCR assay of nasal and pharyngeal swabs were included. Data were obtained from the Korean national health insurance claims-based database (COVID-19 research dataset). Individuals with a Record of a new prescription of NSAID within 1 month of the test date were excluded because NSAID users for early pneumonia symptoms may initiated for PPIs or H2 blockers. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Bokyung Kim, M.D. central contact role Contact central contact phone +82-2-2072-8112 central contact e mail lovebkim1119@naver.com central contact name Soo-Jeong Cho, M.D., Ph.D. central contact role Contact central contact phone 82-10-5297-3398 central contact e mail crystal522@daum.net location list location location facility Seoul National University Hospital location city Seoul location zip 03080 location country Korea, Republic of location contact list location contact location contact name Bokyung Kim, M.D. location contact role Contact location contact phone +82-2-2072-8112 location contact e mail lovebkim1119@naver.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id D000064098 intervention mesh term Esomeprazole intervention mesh id D000009853 intervention mesh term Omeprazole intervention mesh id D000064750 intervention mesh term Rabeprazole intervention mesh id D000077402 intervention mesh term Pantoprazole intervention mesh id D000064747 intervention mesh term Lansoprazole intervention mesh id D000064748 intervention mesh term Dexlansoprazole intervention mesh id D000015738 intervention mesh term Famotidine intervention mesh id D000011899 intervention mesh term Ranitidine intervention mesh id D000002927 intervention mesh term Cimetidine intervention mesh id D000016567 intervention mesh term Nizatidine intervention ancestor list intervention ancestor intervention ancestor id D000000897 intervention ancestor term Anti-Ulcer Agents intervention ancestor id D000005765 intervention ancestor term Gastrointestinal Agents intervention ancestor id D000054328 intervention ancestor term Proton Pump Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000006635 intervention ancestor term Histamine H2 Antagonists intervention ancestor id D000006633 intervention ancestor term Histamine Antagonists intervention ancestor id D000018494 intervention ancestor term Histamine Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000065609 intervention ancestor term Cytochrome P-450 CYP1A2 Inhibitors intervention ancestor id D000065607 intervention ancestor term Cytochrome P-450 Enzyme Inhibitors intervention browse leaf list intervention browse leaf intervention browse leaf id M11937 intervention browse leaf name Omeprazole intervention browse leaf as found Methotrexate intervention browse leaf relevance high intervention browse leaf id M29535 intervention browse leaf name Rabeprazole intervention browse leaf as found 2/day intervention browse leaf relevance high intervention browse leaf id M29357 intervention browse leaf name Esomeprazole intervention browse leaf as found Due intervention browse leaf relevance high intervention browse leaf id M1783 intervention browse leaf name Pantoprazole intervention browse leaf as found Eye drops intervention browse leaf relevance high intervention browse leaf id M26783 intervention browse leaf name Proton Pump Inhibitors intervention browse leaf relevance low intervention browse leaf id M17455 intervention browse leaf name Famotidine intervention browse leaf as found Indirect intervention browse leaf relevance high intervention browse leaf id M29532 intervention browse leaf name Lansoprazole intervention browse leaf as found Obtain intervention browse leaf relevance high intervention browse leaf id M29533 intervention browse leaf name Dexlansoprazole intervention browse leaf as found 37.5 intervention browse leaf relevance high intervention browse leaf id M5317 intervention browse leaf name Cimetidine intervention browse leaf as found GOS intervention browse leaf relevance high intervention browse leaf id M13897 intervention browse leaf name Ranitidine intervention browse leaf as found Sensitization intervention browse leaf relevance high intervention browse leaf id M251989 intervention browse leaf name Ranitidine bismuth citrate intervention browse leaf relevance low intervention browse leaf id M8863 intervention browse leaf name Histamine H2 Antagonists intervention browse leaf relevance low intervention browse leaf id M8860 intervention browse leaf name Histamine intervention browse leaf relevance low intervention browse leaf id M18108 intervention browse leaf name Nizatidine intervention browse leaf as found Holter monitoring intervention browse leaf relevance high intervention browse leaf id M212140 intervention browse leaf name Histamine phosphate intervention browse leaf relevance low intervention browse leaf id M3340 intervention browse leaf name Antacids intervention browse leaf relevance low intervention browse leaf id M3371 intervention browse leaf name Anti-Ulcer Agents intervention browse leaf relevance low intervention browse leaf id M8033 intervention browse leaf name Gastrointestinal Agents intervention browse leaf relevance low intervention browse leaf id M8861 intervention browse leaf name Histamine Antagonists intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse leaf id M29690 intervention browse leaf name Cytochrome P-450 Enzyme Inhibitors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04834752 | [
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full study rank 61206 study protocol section identification module n c t id NCT04839484 org study id info org study id CT001 organization org full name LifeSprout, Inc. org class INDUSTRY brief title LifeSprout Lumina™ Study in the Treatment of Nasolabial Folds official title A Prospective, Randomized, Controlled, Multi-center Study of the Safety and Effectiveness of Lumina™ in the Treatment of Nasolabial Folds status module status verified date August 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date March 2, 2021 start date type Actual primary completion date struct primary completion date September 4, 2022 primary completion date type Actual completion date struct completion date March 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date September 9, 2022 last update post date struct last update post date September 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name LifeSprout, Inc. lead sponsor class INDUSTRY collaborator list collaborator collaborator name Health Policy Associates collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is unapproved device Yes is u s export Yes description module brief summary The study will be a prospective, randomized, split-face, double blind, controlled, clinical trial to evaluate the safety and effectiveness of Lumina™ for the treatment of Nasolabial Folds (NLFs). Subjects will be randomized to receive treatment (Lumina™) in one NLF and control (Restylane® Defyne) in the contra-lateral NLF. 118 subjects will be treated. conditions module condition list condition Nasolabial Fold design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Parallel assignment to product to different sides of face, per randomization code. At 12 months subjects may be retreated only with study product (partial cross over potential) design primary purpose Other design masking info design masking Single design masking description A blinded evaluator at each site who does not know what patient was treated with what product (per side) scores the patient. Photographic reviewers are also blinded to treatment. design who masked list design who masked Outcomes Assessor enrollment info enrollment count 118 enrollment type Anticipated arms interventions module arm group list arm group arm group label Lumina arm group type Experimental arm group description Lumina Dermal Filler injected into 1 nasolabial fold. Optional Touch-up at 3 week visit with same. arm group intervention list arm group intervention name Device: Study Product arm group label Restylane Defyne arm group type Active Comparator arm group description Restylane Defyne Dermal Filler injected into 1 nasolabial fold. Optional Touch-up at 3 week visit with same. arm group intervention list arm group intervention name Device: Active Control intervention list intervention intervention type Device intervention name Study Product intervention description up to 2cc per injection of filler placed into nasolabial fold. intervention arm group label list intervention arm group label Lumina intervention other name list intervention other name Lumina intervention type Device intervention name Active Control intervention description up to 2cc per injection of filler placed into nasolabial fold. intervention arm group label list intervention arm group label Restylane Defyne intervention other name list intervention other name Restylane Defyne outcomes module primary outcome list primary outcome primary outcome measure primary effectiveness Wrinkle Severity Rating Scale (WSRS) primary outcome description The mean change from baseline of NLFs in the Lumina™ treatment arm will be compared to that of NLFs in the Restylane® Defyne control arm. (5 point scale with 1 being no visible NLF and 5 being extreme, deep and long NLFs) primary outcome time frame 6 month secondary outcome list secondary outcome secondary outcome measure WSRS other timepoint secondary outcome description Individual endpoints at each timepoint of other than 6 month for mean change from baseline on the WSRS scale, as determined by the live, masked evaluator secondary outcome time frame 6 weeks, 3, 9, and 12 months secondary outcome measure WSRS proportions secondary outcome description proportion of NLFs in the Lumina™ treatment arm compared to that of NLFs in the Restylane® Defyne control arm with ≥1 point improvement from baseline on the WSRS secondary outcome time frame 6 weeks, 3, 6, 9, and 12 months secondary outcome measure Global Aesthetics Improvement Scale (GAIS) - Masked Evaluator secondary outcome description Individual endpoints for each rater type, as rated by the live, masked evaluator (5 point scale with 1 being most improvement and 5 being worsened) secondary outcome time frame 6 weeks, 3, 6, 9, and 12 months secondary outcome measure GAIS Subject secondary outcome description Individual endpoints for each rater type, as rated by the study subject. secondary outcome time frame 6 weeks, 3, 6, 9, and 12 months secondary outcome measure GAIS Investigator secondary outcome description Individual endpoints for each rater type, as rated by treating investigator secondary outcome time frame 6 weeks, 3, 6, 9, and 12 months secondary outcome measure FACE-Q (standardized questionnaire developed by Memorial Sloan Kettering) Appraisal of Nasolabial Folds Questionnaire secondary outcome description change from baseline for Lumina™ and Restylane® Defyne on the Subject FACE-Q Appraisal of Nasolabial Folds Questionnaire secondary outcome time frame 6 weeks, 3, 6, 9, and 12 months secondary outcome measure Visual Analog Scale (VAS) Pain secondary outcome description pain assessment in NLFs treated with Lumina™ compared to NLFs treated with Restylane® Defyne at initial injection secondary outcome time frame injection secondary outcome measure WSRS Photographics secondary outcome description Individual endpoints at each timepoint of 6 weeks, 3, 6, 9, and 12 months for mean change from baseline on the WSRS scale for NLFs treated with Lumina™ compared to NLFs treated with Restylane® Defyne, as rated by a photographic reviewer. secondary outcome time frame 6 weeks, 3, 6, 9, and 12 months secondary outcome measure Proportion WSRS photographic secondary outcome description proportion of NLFs in the Lumina™ treatment arm compared to that of NLFs in the Restylane® Defyne control arm with ≥1 point improvement from baseline on the WSRS, as determined by a photographic reviewer secondary outcome time frame 6 weeks, 3, 6, 9, and 12 months other outcome list other outcome other outcome measure Safety Endpoint other outcome description to assess the rate and severity of adverse events from initial treatment through last study visit. other outcome time frame 13 month eligibility module eligibility criteria Inclusion Criteria:
Subject aged at least 22 years.
Subject has bilateral moderate or severe (grade 3 or 4) NLFs on the WSRS as scored by a live, masked evaluator.
Subject willing to abstain from other facial aesthetic procedures in the NLFs through the 12 month (13 month if retreatment at 12 months) follow-up visit which could interfere with treatment outcomes (e.g. facial fillers, skin laser and radiofrequency therapy such as Thermage, chemical re-surfacing, dermabrasion, Botox injections, aesthetic facial surgery, other facial treatments in the NLFs.
Subject understands and accepts the obligation to present for all scheduled follow-up visits and is logistically able to meet all study requirements.
Subject with facial hair which may obstruct the assessment of the treatment area, must be agreeable with non-laser removal of facial hair prior to assessment visits.
Subject willing to provide written informed consent for their participation in the study.
Exclusion Criteria:
Subject is a female of childbearing potential (e.g., not postmenopausal for at least one year or has not had a hysterectomy or tubal ligation) not using medically effective birth control (e.g., hormonal methods in use at least 30 days prior to injection or barrier methods such as condom and spermicide in use at least 14 days prior to injection) or is pregnant, lactating, or plans to become pregnant during the study.
Subject has participated in a clinical study in which an investigational device or drug was received in the 30 days prior to screening or plans to enroll in such a study during the course of the current study.
Subject is an employee or direct relative of an employee of the investigational site or study sponsor.
Subject who has received surgery in the NLFs.
Subject has a serious or progressive disease, which, in the investigator's judgment, puts the subject at undue risk (e.g. uncontrolled diabetes, autoimmune disease, cardiac pathologies).
Subject has an acute inflammatory process or infection, or history of chronic or recurrent infection or inflammation with the potential to interfere with the study results or increase the risk of adverse events.
Subject has a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
Subject has a history of precancerous lesions/skin malignancies.
Subject has had an active skin disease within the past 6 months.
Subject has scars, infection, rosacea, herpes, acne, blotches or other pathology in the NLFs.
Subject has facial hair covering the nasolabial folds that they are unwilling to remove for study assessments.
Subject has a past history of streptococcal disease or an active streptococcus infection.
Subject has a past history of allergy or hypersensitivity to gram positive bacterial proteins.
Subject is predisposed to keloidosis or hypertrophic scarring.
Subject has a known history of hyper- or hypo-pigmentation in the NLFs.
Subject with known allergy to poly (ε-caprolactone) microfibers, phosphate buffered saline, polyethylene glycol dithiol (PEG-SH), sodium-hyaluronate of bacterial origin, hyaluronic acid or streptococcal protein.
Subject has a known history of multiple allergies, allergic/anaphylactic reactions including hypersensitivity to lidocaine or anesthetics of the amide type.
Subject has a known bleeding disorder.
Subject has received within the past week or plans to receive up to 1 month after treatment high-dose Vitamin E, aspirin, anti-inflammatories, antiplatelets, thrombolytics or any other medication that could increase the risk of bleeding.
Subject has received any medication which, in the judgement of the investigator, may interfere with the study objectives.
Subject has received within the past 12 months or plans to receive during the study any injections outside of those in the study protocol including non-permanent fillers (e.g., hyaluronic acid, CaHA) or neurotoxin on the face below the orbital rim (forehead is acceptable).
Subject has received at any time or plans to receive during the study a permanent filler (e.g., polylactic acid, PMMA, silicone) on the face.
Subject has received within the past 2 weeks or plans to receive during the study dermal resurfacing procedures or non-invasive skin tightening on the face.
Subject has received in the past 2 weeks or plans to receive during the study prescription facial wrinkle therapies (RENOVA), topical steroids, skin irritating topical preparations, or self-tanning agents on the face.
Subject has a known history of rapid weight loss/gain or plans to begin a weight loss program during the study (5% of body weight). healthy volunteers Accepts Healthy Volunteers gender All minimum age 22 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Sashank Reddy, M.D. overall official affiliation LifeSprout, Inc. overall official role Study Director location list location location facility UZ Brussels - Brussels University Hosptal location city Brussel location country Belgium location facility FACCIA location city Lisboa location country Portugal location facility British Aesthetics location city London location country United Kingdom location facility PHP Aesthetic-PHP Wellness location city London location country United Kingdom i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 | NCT04839484 | [
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117,
17881,
1477,
1314,
11984,
2112,
2236,
188,
23055,
1314,
11984,
2112,
2236,
1347,
1275,
117,
17881,
1477,
1314,
11984,
2112,
2236,
2076,
2173,
4746,
10767,
24146,
13196,
2784,
1710,
2784,
1710,
2076,
156,
5674,
27035,
1197,
1730,
10767,
1730,
10767,
1271,
2583,
1708,
1643,
20885,
117,
3561,
119,
1730,
10767,
1705,
15969,
2137,
13329,
23313,
3663,
20715,
2190,
20715,
20715,
1271,
3225,
7037,
15264,
20715,
1705,
7414,
2428,
2249,
17056,
2249,
20051,
13196,
20051,
1144,
173,
182,
172,
1302,
1110,
175,
173,
170,
12521,
3850,
1302,
1110,
175,
173,
170,
12521,
4442,
2160,
1110,
8362,
11478,
1643,
16011,
4442,
2160,
1110,
190,
188,
10107,
2160,
6136,
13196,
4094,
14940,
1109,
2025,
1209,
1129,
170,
19916,
117,
7091,
2200,
117,
3325,
118,
1339,
117,
2702,
7198,
117,
4013,
117,
7300,
3443,
1106,
17459,
1103,
3429,
1105,
12949,
1104,
100,
1111,
1103,
3252,
1104,
11896,
24313,
23156,
1348,
143,
11015,
1116,
113,
21239,
2271,
1116,
114,
119,
12859,
26394,
1209,
1129,
7091,
2200,
1106,
3531,
3252,
113,
100,
114,
1107,
1141,
21239,
2271,
1105,
1654,
113,
20515,
22948,
1673,
28167,
3177,
13268,
1673,
114,
1107,
1103,
14255,
4487,
118,
11937,
21239,
2271,
119,
13176,
5174,
1209,
1129,
5165,
119,
2975,
13196,
3879,
2190,
3879,
11896,
24313,
23156,
1348,
143,
11015,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
9108,
2235,
6136,
23994,
4838,
1233,
8641,
1106,
3317,
1106,
1472,
3091,
1104,
1339,
117,
1679,
7091,
2734,
3463,
119,
1335,
1367,
1808,
5174,
1336,
1129,
11706,
1178,
1114,
2025,
3317,
113,
7597,
2771,
1166,
3209,
114,
1902,
2425,
3007,
2189,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8353,
1902,
7739,
1158,
6136,
138,
24255,
174,
7501,
6718,
2772,
1120,
1296,
1751,
1150,
1674,
1136,
1221,
1184,
5351,
1108,
5165,
1114,
1184,
3317,
113,
1679,
1334,
114,
7432,
1103,
5351,
119,
21906,
11293,
19475,
1132,
1145,
24255,
1106,
3252,
119,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
3929,
19191,
1116,
1249,
8830,
21484,
10803,
23992,
10803,
5099,
13176,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
14557,
14503,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
14557,
14503,
9682,
7435,
17355,
9860,
21881,
1154,
122,
9468,
24313,
23156,
1348,
11203,
119,
9126,
15937,
13637,
118,
1146,
1120,
124,
1989,
3143,
1114,
1269,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
15545,
2093,
131,
8690,
22249,
1981,
1372,
3107,
20515,
22948,
1673,
3177,
13268,
1673,
1981,
1372,
2076,
17244,
3291,
8223,
4626,
2772,
1981,
1372,
6136,
20515,
22948,
1673,
3177,
13268,
1673,
9682,
7435,
17355,
9860,
21881,
1154,
122,
9468,
24313,
23156,
1348,
11203,
119,
9126,
15937,
13637,
118,
1146,
1120,
124,
1989,
3143,
1114,
1269,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
15545,
2093,
131,
17244,
6342,
9108,
2190,
9108,
9108,
2076,
15545,
2093,
9108,
1271,
8690,
22249,
9108,
6136,
1146,
1106,
123,
19515,
1679,
14546,
1104,
5475,
1200,
1973,
1154,
9468,
24313,
23156,
1348,
11203,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
14557,
14503,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
14557,
14503,
9108,
2076,
15545,
2093,
9108,
1271,
17244,
6342,
9108,
6136,
1146,
1106,
123,
19515,
1679,
14546,
1104,
5475,
1200,
1973,
1154,
9468,
24313,
23156,
1348,
11203,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
20515,
22948,
1673,
3177,
13268,
1673,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
20515,
22948,
1673,
3177,
13268,
1673,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
2425,
12949,
160,
4854,
12767,
22087,
4121,
1785,
21632,
1158,
20334,
113,
160,
16396,
1708,
114,
2425,
9386,
6136,
1109,
1928,
1849,
1121,
2259,
2568,
1104,
21239,
2271,
1116,
1107,
1103,
100,
3252,
1981,
1209,
1129,
3402,
1106,
1115,
1104,
21239,
2271,
1116,
1107,
1103,
20515,
22948,
1673,
28167,
3177,
13268,
1673,
1654,
1981,
119,
113,
126,
1553,
3418,
1114,
122,
1217,
1185,
5085,
21239,
2271,
1105,
126,
1217,
6122,
117,
1996,
1105,
1263,
21239,
2271,
1116,
114,
2425,
9386,
1159,
4207,
127,
2370,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
160,
16396,
1708,
1168,
1159,
7587,
3718,
9386,
6136,
12265,
1322,
21521,
1120,
1296,
1159,
7587,
1104,
1168,
1190,
127,
2370,
1111,
1928,
1849,
1121,
2259,
2568,
1113,
1103,
160,
16396,
1708,
3418,
117,
1112,
3552,
1118,
1103,
1686,
117,
19970,
174,
7501,
6718,
2772,
3718,
9386,
1159,
4207,
127,
2277,
117,
124,
117,
130,
117,
1105,
1367,
1808,
3718,
9386,
4929,
160,
16396,
1708,
21136,
3718,
9386,
6136,
10807,
1104,
21239,
2271,
1116,
1107,
1103,
100,
3252,
1981,
3402,
1106,
1115,
1104,
21239,
2271,
1116,
1107,
1103,
20515,
22948,
1673,
28167,
3177,
13268,
1673,
1654,
1981,
1114,
864,
1475,
1553,
8331,
1121,
2259,
2568,
1113,
1103,
160,
16396,
1708,
3718,
9386,
1159,
4207,
127,
2277,
117,
124,
117,
127,
117,
130,
117,
1105,
1367,
1808,
3718,
9386,
4929,
5357,
138,
2556,
18994,
1116,
22053,
20334,
113,
20173,
6258,
114,
118,
23938,
1174,
9734,
7535,
6579,
3718,
9386,
6136,
12265,
1322,
21521,
1111,
1296,
2603,
1197,
2076,
117,
1112,
6317,
1118,
1103,
1686,
117,
19970,
174,
7501,
6718,
2772,
113,
126,
1553,
3418,
1114,
122,
1217,
1211,
8331,
1105,
126,
1217,
4146,
3540,
114,
3718,
9386,
1159,
4207,
127,
2277,
117,
124,
117,
127,
117,
130,
117,
1105,
1367,
1808,
3718,
9386,
4929,
20173,
6258,
12859,
16811,
3718,
9386,
6136,
12265,
1322,
21521,
1111,
1296,
2603,
1197,
2076,
117,
1112,
6317,
1118,
1103,
2025,
2548,
119,
3718,
9386,
1159,
4207,
127,
2277,
117,
124,
117,
127,
117,
130,
117,
1105,
1367,
1808,
3718,
9386,
4929,
20173,
6258,
1130,
5710,
3121,
25524,
1766,
3718,
9386,
6136,
12265,
1322,
21521,
1111,
1296,
2603,
1197,
2076,
117,
1112,
6317,
1118,
12770,
17805,
3718,
9386,
1159,
4207,
127,
2277,
117,
124,
117,
127,
117,
130,
117,
1105,
1367,
1808,
3718,
9386,
4929,
6820,
10954,
118,
154,
113,
18013,
2304,
24730,
1872,
1118,
4136,
20675,
26835,
20809,
114,
138,
8661,
14089,
11794,
1104,
11896,
24313,
23156,
1348,
143,
11015,
1116,
22171,
24730,
3718,
9386,
6136,
1849,
1121,
2259,
2568,
1111,
100,
1105,
20515,
22948,
1673,
28167,
3177,
13268,
1673,
1113,
1103,
12859,
16811,
6820,
10954,
118,
154,
138,
8661,
14089,
11794,
1104,
11896,
24313,
23156,
1348,
143,
11015,
1116,
22171,
24730,
3718,
9386,
1159,
4207,
127,
2277,
117,
124,
117,
127,
117,
130,
117,
1105,
1367,
1808,
3718,
9386,
4929,
12071,
9954,
13791,
20334,
113,
19497,
1708,
114,
13304,
3718,
9386,
6136,
2489,
8670,
1107,
21239,
2271,
1116,
5165,
1114,
100,
3402,
1106,
21239,
2271,
1116,
5165,
1114,
20515,
22948,
1673,
28167,
3177,
13268,
1673,
1120,
3288,
14546,
3718,
9386,
1159,
4207,
14546,
3718,
9386,
4929,
160,
16396,
1708,
21906,
11293,
1116,
3718,
9386,
6136,
12265,
1322,
21521,
1120,
1296,
1159,
7587,
1104,
127,
2277,
117,
124,
117,
127,
117,
130,
117,
1105,
1367,
1808,
1111,
1928,
1849,
1121,
2259,
2568,
1113,
1103,
160,
16396,
1708,
3418,
1111,
21239,
2271,
1116,
5165,
1114,
100,
3402,
1106,
21239,
2271,
1116,
5165,
1114,
20515,
22948,
1673,
28167,
3177,
13268,
1673,
117,
1112,
6317,
1118,
170,
15368,
12827,
119,
3718,
9386,
1159,
4207,
127,
2277,
117,
124,
117,
127,
117,
130,
117,
1105,
1367,
1808,
3718,
9386,
4929,
5096,
4342,
1988,
160,
16396,
1708,
15368,
3718,
9386,
6136,
10807,
1104,
21239,
2271,
1116,
1107,
1103,
100,
3252,
1981,
3402,
1106,
1115,
1104,
21239,
2271,
1116,
1107,
1103,
20515,
22948,
1673,
28167,
3177,
13268,
1673,
1654,
1981,
1114,
864,
1475,
1553,
8331,
1121,
2259,
2568,
1113,
1103,
160,
16396,
1708,
117,
1112,
3552,
1118,
170,
15368,
12827,
3718,
9386,
1159,
4207,
127,
2277,
117,
124,
117,
127,
117,
130,
117,
1105,
1367,
1808,
1168,
9386,
2190,
1168,
9386,
1168,
9386,
4929,
9218,
5135,
7587,
1168,
9386,
6136,
1106,
15187,
1103,
2603,
1105,
20997,
1104,
16798,
1958,
1121,
3288,
3252,
1194,
1314,
2025,
3143,
119,
1168,
9386,
1159,
4207,
1492,
2370,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
12859,
16811,
4079,
1120,
1655,
1659,
1201,
119,
12859,
16811,
1144,
20557,
8828,
1137,
5199,
113,
3654,
124,
1137,
125,
114,
21239,
2271,
1116,
1113,
1103,
160,
16396,
1708,
1112,
2297,
1118,
170,
1686,
117,
19970,
174,
7501,
6718,
2772,
119,
12859,
16811,
4988,
1106,
170,
4832,
11379,
1121,
1168,
14078,
13492,
8826,
1107,
1103,
21239,
2271,
1116,
1194,
1103,
1367,
2370,
113,
1492,
2370,
1191,
7826,
1880,
1120,
1367,
1808,
114,
2812,
118,
1146,
3143,
1134,
1180,
15891,
1114,
3252,
13950,
113,
174,
119,
176,
119,
14078,
5475,
1468,
117,
2241,
10221,
1105,
2070,
2087,
1874,
3530,
7232,
7606,
1216,
1112,
1109,
10841,
2176,
117,
5297,
1231,
118,
20114,
18715,
117,
4167,
1918,
6766,
8427,
117,
9326,
2430,
1775,
14546,
1116,
117,
13492,
14078,
6059,
117,
1168,
14078,
14115,
1107,
1103,
21239,
2271,
1116,
119,
12859,
16811,
21744,
1105,
13749,
1103,
16207,
1106,
1675,
1111,
1155,
4533,
2812,
118,
1146,
7508,
1105,
1110,
9366,
5562,
2716,
1682,
1106,
2283,
1155,
2025,
5420,
119,
12859,
16811,
1114,
14078,
1716,
1134,
1336,
184,
4832,
23055,
1103,
8670,
1104,
1103,
3252,
1298,
117,
1538,
1129,
5340,
1895,
1114,
1664,
118,
10221,
8116,
1104,
14078,
1716,
2988,
1106,
8670,
7508,
119,
12859,
16811,
4988,
1106,
2194,
1637,
6189,
9635,
1111,
1147,
6251,
1107,
1103,
2025,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
12859,
16811,
1110,
170,
2130,
1104,
2027,
3962,
10832,
3209,
113,
174,
119,
176,
119,
117,
1136,
2112,
2354,
4184,
25134,
1348,
1111,
1120,
1655,
1141,
1214,
1137,
1144,
1136,
1125,
170,
177,
21878,
10294,
18778,
1183,
1137,
15511,
1348,
181,
13499,
2116,
114,
1136,
1606,
2657,
1193,
3903,
3485,
1654,
113,
174,
119,
176,
119,
117,
16358,
26654,
1348,
4069,
1107,
1329,
1120,
1655,
1476,
1552,
2988,
1106,
14546,
1137,
9391,
4069,
1216,
1112,
23956,
1105,
20479,
24421,
1107,
1329,
1120,
1655,
1489,
1552,
2988,
1106,
14546,
114,
1137,
1110,
6391,
117,
2495,
5822,
3798,
117,
1137,
2714,
1106,
1561,
6391,
1219,
1103,
2025,
119,
12859,
16811,
1144,
3360,
1107,
170,
7300,
2025,
1107,
1134,
1126,
4449,
1348,
4442,
1137,
3850,
1108,
1460,
1107,
1103,
1476,
1552,
2988,
1106,
11954,
1137,
2714,
1106,
4035,
10747,
1107,
1216,
170,
2025,
1219,
1103,
1736,
1104,
1103,
1954,
2025,
119,
12859,
16811,
1110,
1126,
7775,
1137,
2904,
5236,
1104,
1126,
7775,
1104,
1103,
4449,
1348,
1751,
1137,
2025,
10767,
119,
12859,
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full study rank 61612 study protocol section identification module n c t id NCT04834206 org study id info org study id NPC-NDP-SGL arm organization org full name Affiliated Cancer Hospital & Institute of Guangzhou Medical University org class OTHER brief title Nedaplatin in Treatment for Nasopharyngeal Carcinoma official title Induction Chemotherapy With Nedaplatin, Docetaxel and 5-Fluorouracil Followed by Concurrent Nedaplatin and Radiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Single Arm, Open Label, Multicenter, Phase II Clinical Study. status module status verified date May 2022 overall status Completed expanded access info has expanded access No start date struct start date May 1, 2021 start date type Actual primary completion date struct primary completion date October 29, 2021 primary completion date type Actual completion date struct completion date May 1, 2022 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date May 6, 2022 last update post date struct last update post date May 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Jin-Quan Liu responsible party investigator title Section Chief responsible party investigator affiliation Affiliated Cancer Hospital & Institute of Guangzhou Medical University lead sponsor lead sponsor name Affiliated Cancer Hospital & Institute of Guangzhou Medical University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary To evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma. detailed description This is a prospective, phase II clinical trial to evaluate the efficacy and safety of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma patients. This is a multicenter study. All patients will be enrolled in endemic area. All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is objective response rate (ORR). conditions module condition list condition Nasopharyngeal Carcinoma keyword list keyword Induction chemotherapy Nedaplatin Concurrent chemoradiotherapy Nasopharyngeal Carcinoma design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 32 enrollment type Actual arms interventions module arm group list arm group arm group label DNF-N arm group type Other arm group description Induction chemotherapy:
three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks
Concurrent chemoradiotherapy:
three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy
Radiotherapy: radical intense modulated radiation therapy arm group intervention list arm group intervention name Drug: Docetaxel, nedaplatin, fluorouracil Radiation: IMRT Drug: Nedaplatin intervention list intervention intervention type Drug intervention name Docetaxel, nedaplatin, fluorouracil intervention description Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles. intervention arm group label list intervention arm group label DNF-N intervention other name list intervention other name DNF intervention type Radiation intervention name IMRT intervention description Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor. intervention arm group label list intervention arm group label DNF-N intervention other name list intervention other name RT intervention type Drug intervention name Nedaplatin intervention description Concurrent chemotherapy. nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy. intervention arm group label list intervention arm group label DNF-N intervention other name list intervention other name N outcomes module primary outcome list primary outcome primary outcome measure objective response rate (ORR) primary outcome description CR+PR primary outcome time frame at the end of radiotherapy(±1week） secondary outcome list secondary outcome secondary outcome measure Overall Survival(OS) secondary outcome description The OS was defined as the duration from the date of beginning of treatment to the date of death from any cause or censored at the date of the last follow-up. secondary outcome time frame 3 years secondary outcome measure Progress-Free Survival (PFS) secondary outcome description Progress-free survival is calculated from the date of beginning of treatment to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first. secondary outcome time frame 3 years secondary outcome measure Locoregional Relapse-Free Survival(LRRFS) secondary outcome description Relapse-free survival was defined as the time from beginning of treatment to local or regional relapse, or death from any cause. secondary outcome time frame 3 years secondary outcome measure Distant metastasis-Free Survival(DMFS) secondary outcome description Distant metastasis-free survival was defined as the time from beginning of treatment to distant metastasis, or death from any cause. secondary outcome time frame 3 years secondary outcome measure Quality of life (QoL) secondary outcome description Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for head and neck (EORTC QLQ-H&N35). The EORTC QLQ-H&N35 scale employs a 4-point response format ("not at all" to "very much"). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the functioning and the global QoL scale, a higher score indicates better health. For the symptom scales, a higher score indicates a higher level of symptom burden. Either English or Chinese version will be used according to patient's language habits. secondary outcome time frame 3 years eligibility module eligibility criteria Inclusion Criteria:
Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system
No evidence of distant metastasis (M0)
Age between 18-65
WBC≥4×10^9/ l, platelet ≥ 100×10^9/ l and hemoglobin ≥ 90g/l
With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)
With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)
Satisfactory performance status: KARNOFSKY scale (KPS) > 70
Patients must give signed informed consent
Exclusion Criteria:
Treatment with palliative intent
The primary tumor or lymph node has undergone chemotherapy or surgery (except operations for diagnostic purposes)
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes
History of previous radiotherapy
Pregnancy or lactation
Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Jinquan Liu, M.D overall official affiliation Affiliated Cancer Hospital & Institute of Guangzhou Medical University overall official role Study Director location list location location facility Department of radiotherapy(Section 5),Affiliated Cancer Hospital & Institute of Guangzhou Medical Universityedical University location city Guangzhou location state Guangdong location zip 510095 location country China i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000077274 condition mesh term Nasopharyngeal Carcinoma condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000009303 condition ancestor term Nasopharyngeal Neoplasms condition ancestor id D000010610 condition ancestor term Pharyngeal Neoplasms condition ancestor id D000010039 condition ancestor term Otorhinolaryngologic Neoplasms condition ancestor id D000006258 condition ancestor term Head and Neck Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009302 condition ancestor term Nasopharyngeal Diseases condition ancestor id D000010608 condition ancestor term Pharyngeal Diseases condition ancestor id D000009057 condition ancestor term Stomatognathic Diseases condition ancestor id D000010038 condition ancestor term Otorhinolaryngologic Diseases condition browse leaf list condition browse leaf condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf as found Carcinoma condition browse leaf relevance high condition browse leaf id M1730 condition browse leaf name Nasopharyngeal Carcinoma condition browse leaf as found Nasopharyngeal Carcinoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M11406 condition browse leaf name Nasopharyngeal Neoplasms condition browse leaf relevance low condition browse leaf id M12669 condition browse leaf name Pharyngeal Neoplasms condition browse leaf relevance low condition browse leaf id M12114 condition browse leaf name Otorhinolaryngologic Neoplasms condition browse leaf relevance low condition browse leaf id M8500 condition browse leaf name Head and Neck Neoplasms condition browse leaf relevance low condition browse leaf id M11405 condition browse leaf name Nasopharyngeal Diseases condition browse leaf relevance low condition browse leaf id M12667 condition browse leaf name Pharyngeal Diseases condition browse leaf relevance low condition browse leaf id M11169 condition browse leaf name Stomatognathic Diseases condition browse leaf relevance low condition browse leaf id M12113 condition browse leaf name Otorhinolaryngologic Diseases condition browse leaf relevance low condition browse leaf id T4047 condition browse leaf name Nasopharyngeal Carcinoma condition browse leaf as found Nasopharyngeal Carcinoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC07 condition browse branch name Mouth and Tooth Diseases condition browse branch abbrev BC09 condition browse branch name Ear, Nose, and Throat Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000077143 intervention mesh term Docetaxel intervention mesh id D000005472 intervention mesh term Fluorouracil intervention mesh id C000053989 intervention mesh term Nedaplatin intervention ancestor list intervention ancestor intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000050257 intervention ancestor term Tubulin Modulators intervention ancestor id D000050256 intervention ancestor term Antimitotic Agents intervention ancestor id D000050258 intervention ancestor term Mitosis Modulators intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000963 intervention ancestor term Antimetabolites intervention ancestor id D000000964 intervention ancestor term Antimetabolites, Antineoplastic intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M1668 intervention browse leaf name Docetaxel intervention browse leaf as found Three intervention browse leaf relevance high intervention browse leaf id M7752 intervention browse leaf name Fluorouracil intervention browse leaf as found Saline intervention browse leaf relevance high intervention browse leaf id M192523 intervention browse leaf name Nedaplatin intervention browse leaf as found 3 or 4 intervention browse leaf relevance high intervention browse leaf id M25350 intervention browse leaf name Tubulin Modulators intervention browse leaf relevance low intervention browse leaf id M25349 intervention browse leaf name Antimitotic Agents intervention browse leaf relevance low intervention browse leaf id M3433 intervention browse leaf name Antimetabolites intervention browse leaf relevance low intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04834206 | [
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1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
141,
28047,
118,
151,
1981,
1372,
2076,
2189,
1981,
1372,
6136,
1130,
11243,
22572,
5521,
20939,
131,
1210,
13874,
1104,
1107,
4487,
7912,
2285,
1202,
2093,
1777,
16056,
1233,
2539,
17713,
120,
6450,
1113,
1285,
122,
117,
1107,
4487,
7912,
2285,
24928,
1810,
1643,
16236,
1394,
2539,
17713,
120,
6450,
1113,
1285,
122,
117,
1105,
6803,
1107,
4487,
7912,
2285,
23896,
14824,
4084,
6617,
1233,
4372,
17713,
120,
6450,
1679,
1285,
1121,
1285,
122,
1106,
1285,
126,
117,
1451,
124,
2277,
16752,
21754,
22572,
5521,
6533,
13447,
8420,
11478,
1183,
131,
1210,
13874,
1104,
1620,
17713,
120,
6450,
24928,
1810,
1643,
16236,
1394,
1451,
124,
2277,
117,
18061,
1114,
7657,
118,
182,
5412,
8360,
2070,
8420,
11478,
1183,
2664,
8420,
11478,
1183,
131,
8276,
5827,
182,
5412,
8360,
8432,
7606,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
11387,
12405,
16056,
1233,
117,
24928,
1810,
1643,
16236,
1394,
117,
23896,
14824,
4084,
6617,
1233,
16890,
25971,
131,
146,
21148,
1942,
13982,
131,
13105,
11478,
16236,
1394,
9108,
2190,
9108,
9108,
2076,
13982,
9108,
1271,
11387,
12405,
16056,
1233,
117,
24928,
1810,
1643,
16236,
1394,
117,
23896,
14824,
4084,
6617,
1233,
9108,
6136,
1130,
11243,
22572,
5521,
20939,
119,
11387,
12405,
16056,
1233,
2539,
17713,
120,
182,
1477,
1107,
4487,
7912,
2285,
1285,
1475,
119,
13105,
11478,
16236,
1394,
2539,
17713,
120,
182,
1477,
1107,
4487,
7912,
2285,
1285,
1475,
119,
143,
7535,
14824,
4084,
6617,
1233,
11975,
17713,
120,
182,
1477,
6803,
1107,
4487,
7912,
2285,
1107,
17149,
5356,
2005,
1121,
1285,
1475,
119,
4081,
1626,
1552,
117,
124,
13874,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
141,
28047,
118,
151,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
141,
28047,
9108,
2076,
16890,
25971,
9108,
1271,
146,
21148,
1942,
9108,
6136,
1130,
23826,
1785,
182,
5412,
8360,
118,
2070,
8420,
11478,
1183,
113,
146,
21148,
1942,
114,
1110,
1549,
1112,
123,
119,
121,
118,
123,
119,
3081,
144,
1183,
1679,
13394,
1114,
1421,
3828,
13394,
1116,
1679,
1989,
1111,
127,
118,
128,
2277,
1106,
170,
1703,
13753,
1104,
5046,
144,
1183,
1137,
3407,
1106,
1103,
2425,
14601,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
141,
28047,
118,
151,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
155,
1942,
9108,
2076,
13982,
9108,
1271,
13105,
11478,
16236,
1394,
9108,
6136,
16752,
21754,
22572,
5521,
20939,
119,
24928,
1810,
1643,
16236,
1394,
1620,
17713,
120,
182,
1477,
1107,
4487,
7912,
2285,
1120,
1285,
1475,
117,
1659,
117,
3887,
1104,
2070,
8420,
11478,
1183,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
141,
28047,
118,
151,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
151,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
7649,
2593,
2603,
113,
23066,
2069,
114,
2425,
9386,
6136,
15531,
116,
11629,
2425,
9386,
1159,
4207,
1120,
1103,
1322,
1104,
2070,
8420,
11478,
1183,
113,
212,
1475,
21394,
1098,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
8007,
26849,
113,
11570,
114,
3718,
9386,
6136,
1109,
11570,
1108,
3393,
1112,
1103,
9355,
1121,
1103,
2236,
1104,
2150,
1104,
3252,
1106,
1103,
2236,
1104,
1473,
1121,
1251,
2612,
1137,
172,
5026,
13841,
1120,
1103,
2236,
1104,
1103,
1314,
2812,
118,
1146,
119,
3718,
9386,
1159,
4207,
124,
1201,
3718,
9386,
4929,
12798,
118,
4299,
26849,
113,
153,
17691,
114,
3718,
9386,
6136,
12798,
118,
1714,
8115,
1110,
10056,
1121,
1103,
2236,
1104,
2150,
1104,
3252,
1106,
1103,
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1104,
25338,
9475,
16680,
1348,
4290,
117,
6531,
4290,
117,
1137,
1473,
1121,
1251,
2612,
117,
1134,
17791,
3296,
1148,
119,
3718,
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1159,
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124,
1201,
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16680,
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118,
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113,
149,
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2069,
17691,
114,
3718,
9386,
6136,
11336,
16046,
2217,
118,
1714,
8115,
1108,
3393,
1112,
1103,
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1121,
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1104,
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1231,
16046,
2217,
117,
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1473,
1121,
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119,
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9386,
1159,
4207,
124,
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12120,
16566,
27154,
8419,
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118,
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113,
141,
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114,
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118,
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1103,
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8419,
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117,
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119,
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124,
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14801,
1104,
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113,
154,
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114,
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14801,
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113,
154,
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2162,
114,
1108,
14758,
1606,
1103,
1735,
6534,
1111,
2713,
1105,
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1104,
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14801,
1104,
2583,
22171,
24730,
13196,
1111,
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113,
142,
9565,
9481,
154,
2162,
4880,
118,
145,
111,
151,
19297,
114,
119,
1109,
142,
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9481,
154,
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4880,
118,
145,
111,
151,
19297,
3418,
13856,
170,
125,
118,
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2593,
3536,
113,
107,
1136,
1120,
1155,
107,
1106,
107,
1304,
1277,
107,
114,
119,
20334,
7432,
1132,
8272,
1106,
170,
3418,
1121,
121,
1106,
1620,
2452,
1106,
1103,
142,
9565,
9481,
3859,
9932,
119,
1370,
1103,
12641,
1105,
1103,
4265,
154,
1186,
2162,
3418,
117,
170,
2299,
2794,
6653,
1618,
2332,
119,
1370,
1103,
188,
17162,
6451,
4165,
9777,
117,
170,
2299,
2794,
6653,
170,
2299,
1634,
1104,
188,
17162,
6451,
4165,
11904,
119,
11940,
1483,
1137,
1922,
1683,
1209,
1129,
1215,
2452,
1106,
5351,
112,
188,
1846,
15640,
119,
3718,
9386,
1159,
4207,
124,
1201,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
7195,
24767,
1114,
3599,
1117,
2430,
7810,
1193,
3659,
1664,
118,
180,
5970,
6105,
4404,
9468,
7301,
20695,
15023,
2176,
1348,
1610,
16430,
7903,
117,
1259,
23750,
1563,
1137,
2684,
7267,
7300,
9645,
1112,
2684,
118,
4191,
1161,
113,
2589,
157,
1495,
118,
125,
2249,
1568,
114,
2452,
1106,
1103,
5192,
2596,
1237,
7885,
2341,
1113,
11558,
16772,
1449,
1302,
2554,
1104,
6531,
27154,
8419,
4863,
113,
150,
1568,
114,
4936,
1206,
1407,
118,
2625,
160,
9428,
28758,
1527,
28193,
10424,
167,
130,
120,
181,
117,
4885,
5765,
864,
1620,
28193,
10424,
167,
130,
120,
181,
1105,
23123,
8032,
2858,
7939,
864,
3078,
1403,
120,
181,
1556,
2999,
11911,
3053,
2774,
113,
157,
24963,
2162,
885,
18589,
1942,
885,
15278,
1942,
863,
123,
119,
126,
28193,
4654,
1179,
114,
1556,
2999,
1231,
7050,
3053,
2774,
113,
172,
11811,
6105,
2042,
863,
122,
119,
126,
28193,
4654,
1179,
1137,
14402,
1197,
864,
2539,
1306,
1233,
120,
11241,
114,
17784,
6620,
8057,
9363,
1183,
2099,
2781,
131,
148,
12426,
2249,
2346,
17691,
2428,
3663,
3418,
113,
148,
10197,
114,
135,
3102,
7195,
24767,
1538,
1660,
1878,
6189,
9635,
16409,
1665,
17855,
140,
10587,
3464,
131,
19165,
1114,
185,
5727,
1465,
3946,
7676,
1109,
2425,
14601,
1137,
181,
25698,
14372,
1144,
18369,
22572,
5521,
20939,
1137,
6059,
113,
2589,
2500,
1111,
20346,
4998,
114,
4602,
12477,
2646,
12149,
7232,
2589,
26449,
5165,
16361,
2765,
1137,
4816,
6718,
15852,
2765,
2241,
4182,
117,
1107,
3465,
1358,
172,
1200,
15901,
1348,
4182,
2892,
1104,
2166,
2070,
8420,
11478,
1183,
117,
22572,
5521,
20939,
117,
1137,
6059,
113,
2589,
20346,
114,
1106,
1103,
2425,
14601,
1137,
15029,
2892,
1104,
2166,
2070,
8420,
11478,
1183,
11689,
12149,
7232,
1137,
2495,
5822,
1891,
6291,
5199,
9455,
21754,
3653,
117,
1134,
1336,
2498,
24726,
3187,
1137,
6975,
1103,
14037,
1104,
1103,
3443,
117,
1111,
1859,
117,
15443,
17688,
3653,
8753,
3252,
117,
12104,
4252,
7954,
26281,
1891,
1104,
13306,
184,
4832,
23055,
2109,
26600,
3653,
1137,
1168,
19192,
6946,
8753,
10296,
1106,
2704,
117,
2327,
1119,
4163,
27659,
117,
1105,
4910,
19019,
119,
8071,
8118,
1302,
5772,
1398,
5867,
1425,
1407,
5848,
4177,
1425,
2625,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2905,
2078,
2190,
2905,
2078,
2905,
2078,
1271,
10922,
13284,
1179,
8411,
117,
150,
119,
141,
2905,
2078,
13494,
138,
3101,
21896,
11558,
3355,
111,
2024,
1104,
20272,
3875,
1239,
2905,
2078,
1648,
8690,
2524,
2450,
2190,
2450,
2450,
3695,
1951,
1104,
2070,
8420,
11478,
1183,
113,
6177,
126,
114,
117,
138,
3101,
21896,
11558,
3355,
111,
2024,
1104,
20272,
3875,
1239,
24506,
1348,
1239,
2450,
1331,
20272,
2450,
1352,
23488,
2450,
195,
9717,
26177,
1568,
1580,
1571,
2450,
1583,
1975,
178,
185,
173,
6303,
4195,
13196,
178,
185,
173,
6303,
1302,
4408,
2237,
1940,
1116,
1665,
23992,
13196,
1683,
10266,
1382,
5507,
117,
17881,
1477,
3879,
11424,
1162,
13196,
3879,
24000,
2190,
3879,
24000,
3879,
24000,
25021,
141,
7629,
7629,
1568,
20581,
1559,
1559,
3879,
24000,
1858,
8185,
16430,
7903,
3879,
24000,
25021,
141,
7629,
7629,
1559,
1559,
24458,
1527,
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24000,
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7629,
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7580,
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117,
144,
1931,
5552,
1105,
142,
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2916,
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141,
7629,
7629,
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full study rank 61856 study protocol section identification module n c t id NCT04831034 org study id info org study id FirstAHFujian7 organization org full name First Affiliated Hospital of Fujian Medical University org class OTHER brief title 68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease official title 68Ga-DOTA/NOTA-FAPI PET/CT in Patients With Various Fibrotic Disease status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Actual primary completion date struct primary completion date April 1, 2024 primary completion date type Anticipated completion date struct completion date April 1, 2024 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 1, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Weibing Miao, PhD responsible party investigator title Director, Department of Nuclear Medicine responsible party investigator affiliation First Affiliated Hospital of Fujian Medical University lead sponsor lead sponsor name First Affiliated Hospital of Fujian Medical University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/ computed tomography (PET/CT) for the diagnosis and prognosis in fibrotic disease detailed description Subjects with fibrotic disease underwent 68Ga-FAPI-04 PET/CT scanning. Fibrosis lesion uptake was quantified by the maximum standard uptake value (SUVmax). Subjects also received the conventional clinical assessment for liver fibrosis, such as magnetic resonance imaging(MRI) , biopsy and blood biochemical indexes (BBI) testing. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-FAPI-04 PET/CT, MRI and BBI were calculated and compared to evaluate the diagnostic efficacy. conditions module condition list condition Fibrosis Positron-Emission Tomography design module study type Interventional phase list phase Early Phase 1 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 500 enrollment type Anticipated arms interventions module arm group list arm group arm group label 68Ga-FAPI-04 arm group type Experimental arm group description Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time. arm group intervention list arm group intervention name Drug: 68Ga-FAPI-04 intervention list intervention intervention type Drug intervention name 68Ga-FAPI-04 intervention description Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time. intervention arm group label list intervention arm group label 68Ga-FAPI-04 outcomes module primary outcome list primary outcome primary outcome measure Standardized uptake value (SUV) primary outcome description Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject. primary outcome time frame 30 days secondary outcome list secondary outcome secondary outcome measure Diagnostic efficacy secondary outcome description The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated. secondary outcome time frame 30 days eligibility module eligibility criteria Inclusion Criteria:
adult patients (aged 18 years or order)
patients with suspected or new diagnosed fibrotic disease (supporting evidence may include , BBI, MRI, CT and pathology report)
patients who had scheduled 68Ga-FAPI-04 PET/CT scan
patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee
Exclusion Criteria:
patients with pregnancy
the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent healthy volunteers No gender All minimum age 18 Years maximum age 85 Years std age list std age Adult Older Adult contacts locations module location list location location facility Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University location status Recruiting location city Fuzhou location state Fujian location zip 350005 location country China location contact list location contact location contact name Weibing Miao, MD location contact role Contact location contact phone +86 591 87981618 location contact e mail miaoweibing@126.com location contact name Kaixian Lin, MD location contact role Contact location contact phone +86 591 87981619 location contact e mail kaysonlin@163.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000005355 condition mesh term Fibrosis condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M7637 condition browse leaf name Fibrosis condition browse leaf as found Fibrosis condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions | NCT04831034 | [
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full study rank 61280 study protocol section identification module n c t id NCT04838522 org study id info org study id TAK-555-4006 organization org full name Takeda org class INDUSTRY brief title A Study of Prucalopride in Breastfeeding Women With Constipation official title A Breast Milk Study in Lactating Women Who Have Been Prescribed Therapeutic Doses of MOTEGRITY® (Prucalopride) for Chronic Idiopathic Constipation to Evaluate Prucalopride Concentrations in Breast Milk, and to Collect Incidental Safety Data From the Nursing Infant status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 2, 2022 start date type Actual primary completion date struct primary completion date May 30, 2025 primary completion date type Anticipated completion date struct completion date May 30, 2025 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date August 2, 2022 last update post date struct last update post date August 5, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Takeda lead sponsor class INDUSTRY collaborator list collaborator collaborator name UC San Diego Human Milk Research Biorepository collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary Prucalopride is a medicine used to treat constipation. The main aim of the study is to measure prucalopride concentrations in breast milk. Other aims are to check the growth and development of babies breastfed by their mothers who took prucalopride and to check if the babies had any side effects.
During the study, participants will provide one set of milk samples over 24 hours using an electric breast pump. Breast milk samples will be collected at home and will be shipped to the laboratory.
Also, participants will be asked questions during telephone interviews every 2 months in the first year of their baby's life. They will also be asked to complete growth and development questionnaires about their baby. conditions module condition list condition Chronic Constipation keyword list keyword Prucalopride Motegrity Pharmacokinetics Lactation Breastfeeding Milk-only study Infant growth and development Infant neurodevelopment Infant outcomes design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective bio spec bio spec retention Samples With DNA bio spec description Breast milk enrollment info enrollment count 12 enrollment type Anticipated arms interventions module arm group list arm group arm group label All Study Participants arm group description Participants with chronic idiopathic constipation who are treated with prucalopride 2 milligrams (mg) oral tablets which was initiated prior to enrollment, and are breastfeeding their infant at the time of enrollment and sample collection will be observed prospectively. arm group intervention list arm group intervention name Other: No Intervention intervention list intervention intervention type Other intervention name No Intervention intervention description This is a non-interventional study. intervention arm group label list intervention arm group label All Study Participants outcomes module primary outcome list primary outcome primary outcome measure Area Under the Milk Concentration-time Curve (AUCmilk) of Prucalopride primary outcome description AUCmilk will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period for breast milk prucalopride concentrations. primary outcome time frame Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1 primary outcome measure Average Concentration of Prucalopride in Milk primary outcome description Average concentration will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period for breast milk prucalopride concentrations. primary outcome time frame Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1 primary outcome measure Area Under the Milk Concentration-time Curve from Time 0 to Time t Over the Dosing Interval [AUCmilk (0-t)] primary outcome description AUCmilk (0-t) will be derived from a series of 7 timed, full expression breast milk samples collected from a single breast using an electric breast pump over a 24-hour period for breast milk prucalopride concentrations. primary outcome time frame Pre-dose, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 1 secondary outcome list secondary outcome secondary outcome measure Number of Infant's With Adverse Events (AEs) Based on Maternal Report secondary outcome description Number of infant's with AEs while being breastfed by a mother who is taking prucalopride will be obtained by maternal report (by phone). secondary outcome time frame Up to 1 year of age secondary outcome measure Change in Length During the First Year of Life in Infant's secondary outcome description Growth changes in length in centimeters every 2 months during the first year of life in infant's breastfed by mothers taking prucalopride will be obtained by maternal report (by phone), medical records abstraction, and maternal responses to neurodevelopmental screening questionnaires. secondary outcome time frame Up to 1 year of age secondary outcome measure Change in Weight During the First Year of Life in Infant's secondary outcome description Growth changes in weight in grams every 2 months during the first year of life in infant's breastfed by mothers taking prucalopride will be obtained by maternal report (by phone), medical records abstraction, and maternal responses to neurodevelopmental screening questionnaires. secondary outcome time frame Up to 1 year of age secondary outcome measure Infant's Neurodevelopmental Performance Based on Ages and Stages Questionnaire-3 (ASQ-3) secondary outcome description Infant's neurodevelopmental progress at 4 and 12 months will be assessed by the ASQ-3 which will be completed by the mother. The ASQ-3 is a developmental screening instrument with 5 domains: (i) personal-social, (ii) gross motor, (iii) fine motor, (iv) problem solving, and (v) communication. Each domain has 6 questions, if the answer is Yes, score = 10, Sometimes = 5 and Not yet = 0. ASQ-3 average = average score of 5 aspects. secondary outcome time frame Up to 1 year of age eligibility module eligibility criteria Inclusion Criteria:
Participants cannot be enrolled before all inclusion criteria are confirmed.
Female participants with an ability to voluntarily provide verbal followed by written, signed, and dated (personally or via a legally authorized representative) informed consent as applicable to participate in the study.
Healthy female participants as determined by the investigator on the basis of enrollment evaluations.
Participants greater than or equal to (>=) 18 years of age at the time of consent. This inclusion criterion will only be assessed at the time of enrollment.
Participants who are currently breastfeeding a singleton infant who is between 10 days and 11 months 0 days.
Participants who are currently exclusively breastfeeding or breastfeeding with supplemental formula and/or solid food. Infants who are exclusively breastfed and do not eat solid food are preferred.
Participants who are currently treated as prescribed by their physician with prucalopride for functional constipation for at least 5 consecutive days at the time of taking the first breastmilk sample. All recommendations in the United States Prescribing Information (US PI) should be followed.
Participants who agree to the conditions and requirements of the study including the sample collection, interview schedule, completion of developmental questionnaires, and release of medical records.
Participants with an understanding, ability, and willingness to fully comply with study procedures and restrictions.
Exclusion Criteria:
The participant will be excluded from the study if any of the following exclusion criteria are met:
Participants who are breastfeeding an infant who: is hospitalized, has a major birth defect, or has a history of a disease that could affect absorption or drug disposition.
Participants who have used prucalopride while breastfeeding for a condition other than functional constipation.
Participants who are pregnant at the time of enrollment.
Participants who have started to wean their child from breast milk.
Participants with a history of any hematological, hepatic, respiratory, cardiovascular, renal, gall bladder removal, or other current or recurrent disease that could affect the action, absorption, or disposition of prucalopride. healthy volunteers No gender Female gender based Yes minimum age 18 Years std age list std age Adult Older Adult study population Female participants from United State (US), who are currently being treated with prucalopride for functional constipation and breastfeeding a single infant between the ages of 10 days and 11 months 0 days. Infants will be followed for up to 12 months 30 days of age. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Takeda Contact central contact role Contact central contact phone +1-877-825-3327 central contact e mail medinfoUS@takeda.com overall official list overall official overall official name Study Director overall official affiliation Takeda overall official role Study Director overall official name Study Director overall official affiliation UC San Diego Human Milk Research Biorepository overall official role Study Director location list location location facility University of California San Diego location status Recruiting location city La Jolla location state California location zip 92093 location country United States location contact list location contact location contact name Site Contact location contact role Contact location contact phone 858-246-1704 location contact e mail chchambers@health.ucsd.edu location contact name Christina Chambers, PhD, MPH location contact role Principal Investigator references module see also link list see also link see also link label To obtain more information on the study, click here/on this link see also link u r l https://clinicaltrials.takeda.com/study-detail/607462db688ad8001f42fb8e avail i p d list avail i p d avail i p d type Breast Milk At the Dawn of New Discoveries avail i p d u r l https://betterbeginnings.org/what-we-do/research/breast-milk/ i p d sharing statement module i p d sharing Yes i p d sharing description Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) i p d sharing access criteria IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement. i p d sharing u r l https://vivli.org/ourmember/takeda/ derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003248 condition mesh term Constipation condition ancestor list condition ancestor condition ancestor id D000012817 condition ancestor term Signs and Symptoms, Digestive condition browse leaf list condition browse leaf condition browse leaf id M5624 condition browse leaf name Constipation condition browse leaf as found Constipation condition browse leaf relevance high condition browse leaf id M14774 condition browse leaf name Signs and Symptoms, Digestive condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M275258 intervention browse leaf name Prucalopride intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04838522 | [
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8298,
6108,
118,
1159,
140,
2149,
2707,
113,
21646,
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3080,
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1104,
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7867,
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17731,
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2005,
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117,
122,
117,
123,
117,
125,
117,
129,
117,
1367,
117,
1105,
1572,
2005,
2112,
118,
13753,
1113,
2295,
122,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
7421,
1104,
1130,
26636,
112,
188,
1556,
24930,
10840,
17437,
113,
138,
27485,
114,
7457,
1113,
25702,
10449,
1348,
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3718,
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7421,
1104,
11551,
112,
188,
1114,
138,
27485,
1229,
1217,
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1118,
170,
1534,
1150,
1110,
1781,
185,
5082,
7867,
4184,
17731,
1209,
1129,
3836,
1118,
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2592,
113,
1118,
2179,
114,
119,
3718,
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4207,
3725,
1106,
122,
1214,
1104,
1425,
3718,
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4929,
9091,
1107,
16758,
1507,
1103,
1752,
2381,
1104,
2583,
1107,
1130,
26636,
112,
188,
3718,
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20227,
2607,
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2251,
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19567,
1451,
123,
1808,
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1214,
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5082,
7867,
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17731,
1209,
1129,
3836,
1118,
11476,
2592,
113,
1118,
2179,
114,
117,
2657,
3002,
11108,
1988,
117,
1105,
11476,
11317,
1106,
24928,
11955,
2007,
12559,
4184,
15595,
11954,
2304,
24730,
1116,
119,
3718,
9386,
1159,
4207,
3725,
1106,
122,
1214,
1104,
1425,
3718,
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4929,
9091,
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25589,
1507,
1103,
1752,
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2583,
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1130,
26636,
112,
188,
3718,
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2841,
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112,
188,
7209,
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5082,
7867,
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17731,
1209,
1129,
3836,
1118,
11476,
2592,
113,
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2179,
114,
117,
2657,
3002,
11108,
1988,
117,
1105,
11476,
11317,
1106,
24928,
11955,
2007,
12559,
4184,
15595,
11954,
2304,
24730,
1116,
119,
3718,
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1159,
4207,
3725,
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122,
1214,
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112,
188,
151,
8816,
13040,
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6724,
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9325,
1105,
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22171,
24730,
118,
124,
113,
15278,
4880,
118,
124,
114,
3718,
9386,
6136,
1130,
26636,
112,
188,
24928,
11955,
2007,
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4184,
15595,
5070,
1120,
125,
1105,
1367,
1808,
1209,
1129,
14758,
1118,
1103,
15278,
4880,
118,
124,
1134,
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2063,
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1103,
1534,
119,
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15278,
4880,
118,
124,
1110,
170,
16700,
11954,
6337,
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126,
13770,
131,
113,
178,
114,
2357,
118,
1934,
117,
113,
25550,
114,
10272,
5968,
117,
113,
25550,
1182,
114,
2503,
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117,
113,
178,
1964,
114,
2463,
15097,
117,
1105,
113,
191,
114,
4909,
119,
2994,
5777,
1144,
127,
3243,
117,
1191,
1103,
2590,
1110,
2160,
117,
2794,
134,
1275,
117,
5875,
134,
126,
1105,
1753,
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134,
121,
119,
15278,
4880,
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124,
1903,
134,
1903,
2794,
1104,
126,
5402,
119,
3718,
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3725,
1106,
122,
1214,
1104,
1425,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
4539,
27989,
21868,
2834,
1129,
7945,
1196,
1155,
10838,
9173,
1132,
3659,
119,
9714,
6635,
1114,
1126,
2912,
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14093,
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1878,
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1105,
5422,
113,
7572,
1137,
2258,
170,
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9320,
4702,
114,
6189,
9635,
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13036,
1106,
4868,
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1103,
2025,
119,
3225,
1183,
2130,
6635,
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3552,
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1103,
17805,
1113,
1103,
3142,
1104,
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10540,
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4539,
27989,
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3407,
1190,
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4463,
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135,
134,
114,
1407,
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1425,
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1104,
9635,
119,
1188,
10838,
26440,
1209,
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1129,
14758,
1120,
1103,
1159,
1104,
10803,
119,
4539,
27989,
21868,
1150,
1132,
1971,
7209,
8124,
17141,
170,
1423,
1633,
11551,
1150,
1110,
1206,
1275,
1552,
1105,
1429,
1808,
121,
1552,
119,
4539,
27989,
21868,
1150,
1132,
1971,
7097,
7209,
8124,
17141,
1137,
7209,
8124,
17141,
1114,
15491,
1348,
7893,
1105,
120,
1137,
4600,
2094,
119,
1130,
26636,
1116,
1150,
1132,
7097,
7209,
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1181,
1105,
1202,
1136,
3940,
4600,
2094,
1132,
6349,
119,
4539,
27989,
21868,
1150,
1132,
1971,
5165,
1112,
17421,
1118,
1147,
7454,
1114,
185,
5082,
7867,
4184,
17731,
1111,
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9717,
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126,
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1103,
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3080,
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6876,
119,
1398,
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1103,
1244,
1311,
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1116,
27362,
4219,
113,
1646,
153,
2240,
114,
1431,
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1723,
119,
4539,
27989,
21868,
1150,
5340,
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1103,
2975,
1105,
5420,
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1103,
2025,
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1103,
6876,
2436,
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3669,
6030,
117,
6026,
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2304,
24730,
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14616,
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8826,
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16409,
1665,
17855,
140,
10587,
3464,
131,
1109,
14031,
1209,
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9714,
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1971,
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7867,
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full study rank 61513 study protocol section identification module n c t id NCT04835493 org study id info org study id H-49672 organization org full name Baylor College of Medicine org class OTHER brief title Evaluating Telementoring for CHW-centered Diabetes Initiatives official title Evaluating Telementoring to Initiate a Multidimensional Diabetes Program for Latino(a)s in Community Clinics: A Randomized Clinical Trial status module status verified date September 2022 overall status Recruiting expanded access info has expanded access No start date struct start date September 1, 2022 start date type Actual primary completion date struct primary completion date July 31, 2026 primary completion date type Anticipated completion date struct completion date July 31, 2028 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date September 17, 2022 last update post date struct last update post date September 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Elizabeth Vaughan responsible party investigator title Associate Professor responsible party investigator affiliation Baylor College of Medicine lead sponsor lead sponsor name Baylor College of Medicine lead sponsor class OTHER collaborator list collaborator collaborator name University of Texas collaborator class OTHER collaborator name The University of Texas Health Science Center, Houston collaborator class OTHER collaborator name University of Houston collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Diabetes care is complex and requires a multidimensional approach, but interventional programs are difficult to initiate in low-income and minority populations. In the proposed study, investigators will mentor local clinics via telehealth to initiate our diabetes program, TIME (Telehealth-supported, Integrated CHWs, Medication-access, group visit Education), into their clinics. Mentoring local clinics to initiate TIME is a promising strategy to enhance sustainable diabetes care and reduce disparities in vulnerable minority populations. detailed description Diabetes is a major public health problem in Latino(a)s. There are escalating numbers of Latino(a)s diagnosed with diabetes and at disproportionate rates compared to other ethnicities. Numerous interventions have been initiated to improve minority healthcare including diabetes group visits, which have been valuable in improving education and glycemic control. In our group visit investigations, investigators initiated Community Health Workers (CHWs)-local community members who serve as culturally-sensitive patient liaisons to the healthcare system-as part of the multidisciplinary team. Investigators demonstrated that CHWs are vital team members and particularly helpful in identifying medication-access barriers. However, CHWs are frontline workers and often left unsupported and poorly supervised. Investigators used these data to pioneer the combination of four diabetes interventions in our TIME trial (Telehealth-supported, Integrated CHWs, Medication-access, group visit Education). The TIME trial showed that individuals randomized to TIME significantly improved glycemic control, blood pressure and adherence to American Diabetes Association standards compared to usual care. The study also showed that telehealth (mobile health (mHealth) and ZOOM video conferencing) was instrumental in supporting CHWs in their work and enhancing their communication with patients.
The COVID-19 pandemic has highlighted the expansive use of telehealth and its ability to improve healthcare. It has also underscored the pressing need to improve care for low-income minorities. Though diabetes programs are valuable in improving education and clinical outcomes, they are often difficult to initiate in low-income settings. Pragmatic implementation using telehealth to mentor local clinic teams of providers and CHWs is promising to address these barriers. Investigators have pilot data showing the feasibility of telementoring a local clinic to initiate TIME that has resulted in improved HbA1c levels but it needs to be tested within a larger sample. In the proposed study investigators will evaluate this approach in a randomized clinical trial (N=250; intervention=125) of low-income, adult Latino(a)s with type 2 diabetes randomized to TIME (intervention) versus usual care enhanced with education (EUC). Our research group will provide telementoring to local clinic teams to initiate TIME into their clinics. To evaluate efficacy, investigators will compare TIME versus EUC clinical changes including HbA1c (primary outcome), blood pressure, cholesterol, and body mass index from baseline to 12-months (AIM 1). To compare longitudinal data of study arms, investigators will follow these clinical measures until 36 months (AIM 2). Investigators will also provide TIME program acceptability and evaluation data for participants and clinic teams from baseline to 12-months (AIM 3). Investigators hypothesize that TIME participants will have superior and more sustainable clinical outcomes compared to EUC individuals and that the intervention will have high levels of acceptability and evaluation data. Investigators anticipate that the proposed study will provide justification of telementoring to initiate TIME and strong evidence to improve the longitudinal care of low-income Latino(a)s with diabetes. conditions module condition list condition Diabetes Mellitus, Type 2 design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design masking description Randomization will be achieved by blinded study staff using an automatic number generator that allows for stratification and blocking.
Individuals entering and obtaining study data will be blinded to study arm
Data will be collected prior to randomization for blinding purposes. Month-12 clinical data will be obtained in-person for both arms by nurses blinded to the study arm e.g., different nurses than those in the group visits, and chart review will be conducted for ADA measurements and for other clinical data if individuals from either study arm do not show.
Blinded research assistants will gather HbA1c, blood pressure, cholesterol, and BMI data for both arms quarterly until 36-months from baseline. design who masked list design who masked Outcomes Assessor enrollment info enrollment count 250 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intervention arm group type Experimental arm group description Intervention individuals will receive the 12-month diabetes TIME program arm group intervention list arm group intervention name Other: Intervention arm group label Enhanced Usual Care (EUC) arm group type Other arm group description We will define EUC as usual clinical care, which consists of diabetes management provider encounters (mean quarterly) plus monthly individual appointments with a pharm-Ds or nutritionists as clinically indicated. In addition, clinics offer multiple other individual and group opportunities. In addition for the EUC arm, we will provide three quarterly, 1-hour classes (nutrition medications, exercise). The classes will be led by a research-staff trained, bilingual healthcare professional e.g., nurse. EUC individuals will not have contact with CHWs. arm group intervention list arm group intervention name Other: Intervention intervention list intervention intervention type Other intervention name Intervention intervention description In the proposed study, we will conduct a randomized clinical trial of low-income, adult Latino(a)s with type 2 diabetes randomized at the individual level to TIME (Telehealth-supported, Integrated CHWs, Medication-access, group visit Education) (intervention) versus usual care enhanced with education (EUC). Our research team will provide telementoring to local clinic teams (providers and CHWs) to initiate the 12-month TIME program into their clinics. intervention arm group label list intervention arm group label Enhanced Usual Care (EUC) Intervention outcomes module primary outcome list primary outcome primary outcome measure HbA1c primary outcome description Compare TIME versus EUC HbA1c levels primary outcome time frame Baseline to 12-months secondary outcome list secondary outcome secondary outcome measure Blood pressure secondary outcome description Compare TIME versus blood pressure levels (systolic and diastolic) secondary outcome time frame Baseline to 12-months secondary outcome measure Body Mass Index (BMI) secondary outcome description Compare TIME versus EUC BMI levels secondary outcome time frame Baseline to 12-months secondary outcome measure Cholesterol secondary outcome description Compare TIME versus EUC cholesterol levels secondary outcome time frame Baseline to 12-months secondary outcome measure American Diabetes Association (ADA) adherence measures: Diabetes foot exam secondary outcome description Compare TIME versus EUC adherence to diabetes foot exams secondary outcome time frame Baseline to 12-months secondary outcome measure ADA adherence measures: B12 screening secondary outcome description Compare TIME versus EUC adherence to B12 screening secondary outcome time frame Baseline to 12-months secondary outcome measure ADA adherence measures: Diabetes eye exam secondary outcome description Compare TIME versus EUC adherence to diabetes eye exams secondary outcome time frame Baseline to 12-months secondary outcome measure ADA adherence measures: urine microalbumin screening secondary outcome description Compare TIME versus EUC adherence to urine microalbumin screening secondary outcome time frame Baseline to 12-months secondary outcome measure ADA adherence measures: flu vaccination secondary outcome description Compare TIME versus EUC adherence to flu vaccination secondary outcome time frame Baseline to 12-months secondary outcome measure ADA adherence measures: statin therapy secondary outcome description Compare TIME versus EUC adherence to statin therapy secondary outcome time frame Baseline to 12-months secondary outcome measure Sustainable clinical outcomes: HbA1c secondary outcome description Compared to EUC, TIME will have more sustainable HbA1c levels secondary outcome time frame baseline to 36-months secondary outcome measure Sustainable clinical outcomes: Blood pressure secondary outcome description Compared to EUC, TIME will have more sustainable blood pressure levels (systolic and diastolic) secondary outcome time frame baseline to 36-months secondary outcome measure Sustainable clinical outcomes: BMI secondary outcome description Compared to EUC, TIME will have more sustainable BMI levels secondary outcome time frame baseline to 36-months secondary outcome measure TIME satisfaction secondary outcome description Anticipate >/=80% patient satisfaction as demonstrated by our 12-question satisfaction survey questions (on Likert scales of 1 to 10 (n=5 questions) where 10 is very satisfied and 1 is not at all satisfied and from 1-4 (n=3 questions) where 4 is very satisfied and 1 is not satisfied). There are three open-ended questions. secondary outcome time frame 12-months secondary outcome measure Attrition secondary outcome description Rate of attrition for TIME participants secondary outcome time frame baseline to 12-months secondary outcome measure Community Health Worker (CHW) knowledge secondary outcome description At 12-months; Knowledge as measured the CHW posttest, which includes 24-questions from the Star Education Study diabetes knowledge test, which has shown validity and reliability in English and Spanish and our TIME 25-question diabetes medication test that has been previously published. Tests are multiple choice with 4 possible answers. secondary outcome time frame 12-months secondary outcome measure Telehealth Acceptibility secondary outcome description Acceptability as measured by the Telehealth Usability Questionnaire, a 21-question survey of telehealth accepatibilty. Items are ranked on a 5-item scale (1 not acceptable, 5 very acceptable) and divided into six subsections that have shown good to excellent internal consistency. secondary outcome time frame 12-months eligibility module eligibility criteria Inclusion Criteria:
self-identified Latino(a)
Spanish-speaking
>/=18 years
type 2 diabetes (T2D), e.g., HbA1c >/=6.5%, provider documented T2D, on oral anti-hyperglycemic
uninsured, <150% federal poverty level
Exclusion Criteria:
no show to all group visits
condition that may alter HbA1c levels, e.g., recent blood transfusion
patients at high-risk or not appropriate for care in a group setting e.g., pregnancy, severe cognitive impairment, frequent clinic appointments for labile glucose/medication titration e.g., insulin. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Baylor College of Medicine location status Recruiting location city Houston location state Texas location zip 77030 location country United States location contact list location contact location contact name Erika LeGross location contact role Contact location contact phone 409-266-9400 location contact e mail sponsored.research@utmb.edu i p d sharing statement module i p d sharing No i p d sharing description The NIH policy on data sharing does not apply to this protocol: (1) it is not basic research and involves human subjects, (2) it is anticipated that the data can be readily replicated as the purpose of the study is to train local clinics to conduct the program, (3) more than $500K in direct costs annually are not requested for any year of the protocol. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003920 condition mesh term Diabetes Mellitus condition mesh id D000003924 condition mesh term Diabetes Mellitus, Type 2 condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M6271 condition browse leaf name Diabetes Mellitus, Type 2 condition browse leaf as found Diabetes Mellitus, Type 2 condition browse leaf relevance high condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions | NCT04835493 | [
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1132,
7468,
1107,
9248,
1972,
1105,
7300,
13950,
117,
1152,
1132,
1510,
2846,
1106,
19687,
1107,
1822,
118,
2467,
11106,
119,
153,
20484,
10734,
7249,
1606,
21359,
1513,
13836,
6066,
1324,
1106,
11757,
1469,
12257,
1929,
1104,
12263,
1105,
24890,
2924,
1116,
1110,
10480,
1106,
4134,
1292,
14317,
119,
1130,
5710,
3121,
25524,
3864,
1138,
3955,
2233,
4000,
1103,
175,
14517,
7706,
1104,
21359,
20041,
17089,
170,
1469,
12257,
1106,
19687,
157,
13371,
2036,
1115,
1144,
3657,
1107,
4725,
145,
1830,
1592,
1475,
1665,
3001,
1133,
1122,
2993,
1106,
1129,
7289,
1439,
170,
2610,
6876,
119,
1130,
1103,
3000,
2025,
17718,
1209,
17459,
1142,
3136,
1107,
170,
7091,
2200,
7300,
3443,
113,
151,
134,
4805,
132,
9108,
134,
8347,
114,
1104,
1822,
118,
2467,
117,
4457,
6897,
113,
170,
114,
188,
1114,
2076,
123,
17972,
7091,
2200,
1106,
157,
13371,
2036,
113,
9108,
114,
6055,
4400,
1920,
9927,
1114,
1972,
113,
7270,
1658,
114,
119,
3458,
1844,
1372,
1209,
2194,
21359,
20041,
17089,
1106,
1469,
12257,
1929,
1106,
19687,
157,
13371,
2036,
1154,
1147,
20562,
119,
1706,
17459,
23891,
117,
17718,
1209,
14133,
157,
13371,
2036,
6055,
7270,
1658,
7300,
2607,
1259,
145,
1830,
1592,
1475,
1665,
113,
2425,
9386,
114,
117,
1892,
2997,
117,
22572,
9016,
4648,
4063,
117,
1105,
1404,
3367,
7448,
1121,
2259,
2568,
1106,
1367,
118,
1808,
113,
19016,
2107,
122,
114,
119,
1706,
14133,
23191,
2233,
1104,
2025,
1739,
117,
17718,
1209,
2812,
1292,
7300,
5252,
1235,
3164,
1808,
113,
19016,
2107,
123,
114,
119,
1130,
5710,
3121,
25524,
3864,
1209,
1145,
2194,
157,
13371,
2036,
1788,
4392,
6328,
1105,
10540,
2233,
1111,
6635,
1105,
12257,
1929,
1121,
2259,
2568,
1106,
1367,
118,
1808,
113,
19016,
2107,
124,
114,
119,
1130,
5710,
3121,
25524,
3864,
177,
1183,
11439,
16090,
3708,
1115,
157,
13371,
2036,
6635,
1209,
1138,
7298,
1105,
1167,
10940,
7300,
13950,
3402,
1106,
7270,
1658,
2833,
1105,
1115,
1103,
9108,
1209,
1138,
1344,
3001,
1104,
4392,
6328,
1105,
10540,
2233,
119,
1130,
5710,
3121,
25524,
3864,
2848,
6617,
16963,
1115,
1103,
3000,
2025,
1209,
2194,
22647,
1104,
21359,
20041,
17089,
1106,
19687,
157,
13371,
2036,
1105,
2012,
2554,
1106,
4607,
1103,
23191,
1920,
1104,
1822,
118,
2467,
6897,
113,
170,
114,
188,
1114,
17972,
119,
2975,
13196,
3879,
2190,
3879,
12120,
22377,
3052,
11637,
12888,
1361,
117,
6902,
123,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8353,
1902,
7739,
1158,
6136,
19441,
2734,
1209,
1129,
3890,
1118,
24255,
2025,
2546,
1606,
1126,
6973,
1295,
14622,
1115,
3643,
1111,
188,
4487,
3121,
11531,
1105,
11016,
119,
26381,
5273,
1105,
11621,
2025,
2233,
1209,
1129,
24255,
1106,
2025,
1981,
7154,
1209,
1129,
4465,
2988,
1106,
7091,
2734,
1111,
22350,
4998,
119,
17545,
118,
1367,
7300,
2233,
1209,
1129,
3836,
1107,
118,
1825,
1111,
1241,
1739,
1118,
13318,
24255,
1106,
1103,
2025,
1981,
174,
119,
176,
119,
117,
1472,
13318,
1190,
1343,
1107,
1103,
1372,
7508,
117,
1105,
3481,
3189,
1209,
1129,
3303,
1111,
5844,
1592,
12307,
1105,
1111,
1168,
7300,
2233,
1191,
2833,
1121,
1719,
2025,
1981,
1202,
1136,
1437,
119,
13955,
1174,
1844,
19902,
1209,
8422,
145,
1830,
1592,
1475,
1665,
117,
1892,
2997,
117,
22572,
9016,
4648,
4063,
117,
1105,
139,
14038,
2233,
1111,
1241,
1739,
21081,
1235,
3164,
118,
1808,
1121,
2259,
2568,
119,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
3929,
19191,
1116,
1249,
8830,
21484,
10803,
23992,
10803,
5099,
4805,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
11300,
21987,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
11300,
21987,
2833,
1209,
3531,
1103,
1367,
118,
2370,
17972,
157,
13371,
2036,
1788,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
11300,
21987,
1981,
1372,
3107,
13832,
3822,
9650,
11155,
4746,
8396,
113,
7270,
1658,
114,
1981,
1372,
2076,
2189,
1981,
1372,
6136,
1284,
1209,
9410,
7270,
1658,
1112,
4400,
7300,
1920,
117,
1134,
2923,
1104,
17972,
2635,
11482,
12270,
113,
1928,
21081,
114,
4882,
7868,
2510,
16323,
1114,
170,
185,
7111,
1306,
118,
141,
1116,
1137,
20121,
3681,
1112,
7300,
1193,
4668,
119,
1130,
1901,
117,
20562,
2906,
2967,
1168,
2510,
1105,
1372,
6305,
119,
1130,
1901,
1111,
1103,
7270,
1658,
1981,
117,
1195,
1209,
2194,
1210,
21081,
117,
122,
118,
2396,
3553,
113,
20121,
23897,
117,
6730,
114,
119,
1109,
3553,
1209,
1129,
1521,
1118,
170,
1844,
118,
2546,
3972,
117,
20959,
12520,
1848,
174,
119,
176,
119,
117,
7439,
119,
7270,
1658,
2833,
1209,
1136,
1138,
3232,
1114,
24890,
2924,
1116,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
11300,
21987,
9108,
2190,
9108,
9108,
2076,
2189,
9108,
1271,
11300,
21987,
9108,
6136,
1130,
1103,
3000,
2025,
117,
1195,
1209,
5880,
170,
7091,
2200,
7300,
3443,
1104,
1822,
118,
2467,
117,
4457,
6897,
113,
170,
114,
188,
1114,
2076,
123,
17972,
7091,
2200,
1120,
1103,
2510,
1634,
1106,
157,
13371,
2036,
113,
11341,
10486,
13003,
1582,
118,
2726,
117,
18926,
24890,
2924,
1116,
117,
2508,
13923,
118,
2469,
117,
1372,
3143,
2531,
114,
113,
9108,
114,
6055,
4400,
1920,
9927,
1114,
1972,
113,
7270,
1658,
114,
119,
3458,
1844,
1264,
1209,
2194,
21359,
20041,
17089,
1106,
1469,
12257,
1929,
113,
12263,
1105,
24890,
2924,
1116,
114,
1106,
19687,
1103,
1367,
118,
2370,
157,
13371,
2036,
1788,
1154,
1147,
20562,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
13832,
3822,
9650,
11155,
4746,
8396,
113,
7270,
1658,
114,
11300,
21987,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
145,
1830,
1592,
1475,
1665,
2425,
9386,
6136,
3291,
8223,
8836,
157,
13371,
2036,
6055,
7270,
1658,
145,
1830,
1592,
1475,
1665,
3001,
2425,
9386,
1159,
4207,
14562,
2042,
1106,
1367,
118,
1808,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
5657,
2997,
3718,
9386,
6136,
3291,
8223,
8836,
157,
13371,
2036,
6055,
1892,
2997,
3001,
113,
188,
6834,
2430,
8031,
1105,
4267,
12788,
14987,
114,
3718,
9386,
1159,
4207,
14562,
2042,
1106,
1367,
118,
1808,
3718,
9386,
4929,
10341,
8718,
10146,
113,
139,
14038,
114,
3718,
9386,
6136,
3291,
8223,
8836,
157,
13371,
2036,
6055,
7270,
1658,
139,
14038,
3001,
3718,
9386,
1159,
4207,
14562,
2042,
1106,
1367,
118,
1808,
3718,
9386,
4929,
22964,
2897,
25710,
1233,
3718,
9386,
6136,
3291,
8223,
8836,
157,
13371,
2036,
6055,
7270,
1658,
22572,
9016,
4648,
4063,
3001,
3718,
9386,
1159,
4207,
14562,
2042,
1106,
1367,
118,
1808,
3718,
9386,
4929,
1237,
12120,
22377,
3052,
1791,
113,
5844,
1592,
114,
8050,
21634,
5252,
131,
12120,
22377,
3052,
2555,
12211,
3718,
9386,
6136,
3291,
8223,
8836,
157,
13371,
2036,
6055,
7270,
1658,
8050,
21634,
1106,
17972,
2555,
15747,
3718,
9386,
1159,
4207,
14562,
2042,
1106,
1367,
118,
1808,
3718,
9386,
4929,
5844,
1592,
8050,
21634,
5252,
131,
139,
11964,
11954,
3718,
9386,
6136,
3291,
8223,
8836,
157,
13371,
2036,
6055,
7270,
1658,
8050,
21634,
1106,
139,
11964,
11954,
3718,
9386,
1159,
4207,
14562,
2042,
1106,
1367,
118,
1808,
3718,
9386,
4929,
5844,
1592,
8050,
21634,
5252,
131,
12120,
22377,
3052,
2552,
12211,
3718,
9386,
6136,
3291,
8223,
8836,
157,
13371,
2036,
6055,
7270,
1658,
8050,
21634,
1106,
17972,
2552,
15747,
3718,
9386,
1159,
4207,
14562,
2042,
1106,
1367,
118,
1808,
3718,
9386,
4929,
5844,
1592,
8050,
21634,
5252,
131,
19968,
17599,
1348,
7925,
7937,
11954,
3718,
9386,
6136,
3291,
8223,
8836,
157,
13371,
2036,
6055,
7270,
1658,
8050,
21634,
1106,
19968,
17599,
1348,
7925,
7937,
11954,
3718,
9386,
1159,
4207,
14562,
2042,
1106,
1367,
118,
1808,
3718,
9386,
4929,
5844,
1592,
8050,
21634,
5252,
131,
23896,
191,
7409,
16430,
1891,
3718,
9386,
6136,
3291,
8223,
8836,
157,
13371,
2036,
6055,
7270,
1658,
8050,
21634,
1106,
23896,
191,
7409,
16430,
1891,
3718,
9386,
1159,
4207,
14562,
2042,
1106,
1367,
118,
1808,
3718,
9386,
4929,
5844,
1592,
8050,
21634,
5252,
131,
188,
19756,
1394,
7606,
3718,
9386,
6136,
3291,
8223,
8836,
157,
13371,
2036,
6055,
7270,
1658,
8050,
21634,
1106,
188,
19756,
1394,
7606,
3718,
9386,
1159,
4207,
14562,
2042,
1106,
1367,
118,
1808,
3718,
9386,
4929,
21779,
7300,
13950,
131,
145,
1830,
1592,
1475,
1665,
3718,
9386,
6136,
22439,
1106,
7270,
1658,
117,
157,
13371,
2036,
1209,
1138,
1167,
10940,
145,
1830,
1592,
1475,
1665,
3001,
3718,
9386,
1159,
4207,
2259,
2568,
1106,
3164,
118,
1808,
3718,
9386,
4929,
21779,
7300,
13950,
131,
5657,
2997,
3718,
9386,
6136,
22439,
1106,
7270,
1658,
117,
157,
13371,
2036,
1209,
1138,
1167,
10940,
1892,
2997,
3001,
113,
188,
6834,
2430,
8031,
1105,
4267,
12788,
14987,
114,
3718,
9386,
1159,
4207,
2259,
2568,
1106,
3164,
118,
1808,
3718,
9386,
4929,
21779,
7300,
13950,
131,
139,
14038,
3718,
9386,
6136,
22439,
1106,
7270,
1658,
117,
157,
13371,
2036,
1209,
1138,
1167,
10940,
139,
14038,
3001,
3718,
9386,
1159,
4207,
2259,
2568,
1106,
3164,
118,
1808,
3718,
9386,
4929,
157,
13371,
2036,
10241,
3718,
9386,
6136,
8329,
6617,
16963,
135,
120,
134,
2908,
110,
5351,
10241,
1112,
7160,
1118,
1412,
1367,
118,
2304,
10241,
5980,
3243,
113,
1113,
2409,
3740,
9777,
1104,
122,
1106,
1275,
113,
183,
134,
126,
3243,
114,
1187,
1275,
1110,
1304,
8723,
1105,
122,
1110,
1136,
1120,
1155,
8723,
1105,
1121,
122,
118,
125,
113,
183,
134,
124,
3243,
114,
1187,
125,
1110,
1304,
8723,
1105,
122,
1110,
1136,
8723,
114,
119,
1247,
1132,
1210,
1501,
118,
2207,
3243,
119,
3718,
9386,
1159,
4207,
1367,
118,
1808,
3718,
9386,
4929,
1335,
19091,
2116,
3718,
9386,
6136,
24442,
1104,
1120,
19091,
2116,
1111,
157,
13371,
2036,
6635,
3718,
9386,
1159,
4207,
2259,
2568,
1106,
1367,
118,
1808,
3718,
9386,
4929,
3704,
3225,
26455,
113,
24890,
2924,
114,
3044,
3718,
9386,
6136,
1335,
1367,
118,
1808,
132,
14966,
1112,
7140,
1103,
24890,
2924,
2112,
13053,
117,
1134,
2075,
1572,
118,
3243,
1121,
1103,
2537,
2531,
8690,
17972,
3044,
2774,
117,
1134,
1144,
2602,
17782,
1105,
17104,
1107,
1483,
1105,
2124,
1105,
1412,
157,
13371,
2036,
1512,
118,
2304,
17972,
15683,
2774,
1115,
1144,
1151,
2331,
1502,
119,
21189,
1132,
2967,
3026,
1114,
125,
1936,
6615,
119,
3718,
9386,
1159,
4207,
1367,
118,
1808,
3718,
9386,
4929,
11341,
10486,
13003,
1582,
138,
19515,
15384,
7706,
3718,
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full study rank 61304 study protocol section identification module n c t id NCT04838210 org study id info org study id 202103142 organization org full name Washington University School of Medicine org class OTHER brief title Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care official title Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care acronym EleVATE GC status module status verified date November 2022 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date May 21, 2021 start date type Actual primary completion date struct primary completion date June 30, 2025 primary completion date type Anticipated completion date struct completion date June 30, 2025 completion date type Anticipated study first submit date March 18, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date November 22, 2022 last update post date struct last update post date November 23, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ebony Boyce Carter, MD, MPH responsible party investigator title Assistant Professor, Maternal Fetal Medicine responsible party investigator affiliation Washington University School of Medicine lead sponsor lead sponsor name Washington University School of Medicine lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This study will provide high-quality, representative data on the capacity of Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care (EleVATE GC) to reduce perinatal depression, preterm birth, and low birthweight in African-American women. If findings from this study indicate that EleVATE GC is feasible and effective, this model could be implemented nationwide to help achieve mental and obstetric health parity for low-income women of color in the United States. conditions module condition list condition Pregnancy Related Perinatal Depression design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized controlled trial design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 390 enrollment type Anticipated arms interventions module arm group list arm group arm group label Group Prenatal Care arm group type Experimental arm group description Group prenatal care model arm group intervention list arm group intervention name Behavioral: EleVATE Group Care arm group label Individual Prenatal Care arm group type Active Comparator arm group description Individual prenatal care arm group intervention list arm group intervention name Behavioral: Individual Prenatal Care intervention list intervention intervention type Behavioral intervention name EleVATE Group Care intervention description 10-session (2 hours per session) group prenatal care model following the prenatal visit schedule recommended by ACOG. In addition to pregnancy and infant-care related content, the EleVATE GC curriculum includes behavioral health strategies that can be used to manage depression and labor pain and navigate the daily frustrations and stress of life. Groups are facilitated by an obstetric clinician. intervention arm group label list intervention arm group label Group Prenatal Care intervention type Behavioral intervention name Individual Prenatal Care intervention description The dominant model of prenatal care in the United States, consisting of one-on-one encounters between a patient and obstetric clinician. Patients are seen for 10-15 mins every 4 weeks until 28 weeks gestation, every 2 weeks until 37 weeks or more by provider discretion), and weekly until delivery. Visits focus on routine screening tests and prenatal care. intervention arm group label list intervention arm group label Individual Prenatal Care outcomes module primary outcome list primary outcome primary outcome measure Perinatal Depression primary outcome description Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome) primary outcome time frame Baseline visit primary outcome measure Perinatal Depression primary outcome description Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome) primary outcome time frame 28-40 week visit primary outcome measure Perinatal Depression primary outcome description Major Depression (Edinburgh Postnatal Depression Scale Score, range: 0-30, higher scores are a worse outcome) primary outcome time frame 4-12 weeks Postpartum secondary outcome list secondary outcome secondary outcome measure Preterm Birth secondary outcome description Delivery at <37 weeks gestation secondary outcome time frame Delivery secondary outcome measure Small for Gestational Age secondary outcome description Birthweight <10th percentile on the Alexander growth curve secondary outcome time frame Delivery secondary outcome measure Perceived Stress secondary outcome description Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome secondary outcome time frame Baseline visit secondary outcome measure Perceived Stress secondary outcome description Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome secondary outcome time frame 28-40 week secondary outcome measure Perceived Stress secondary outcome description Perceived Stress Scale Total Scores, range: 0-40, higher scores are a worse outcome secondary outcome time frame 4-12 weeks Postpartum secondary outcome measure Anxiety secondary outcome description PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome secondary outcome time frame Baseline visit secondary outcome measure Anxiety secondary outcome description PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome secondary outcome time frame 28-40 week visit secondary outcome measure Anxiety secondary outcome description PROMIS Short Form Anxiety 8a T-Score, range: 37.1-83.1, higher scores are a worse outcome secondary outcome time frame 4-12 weeks Postpartum secondary outcome measure Post-Traumatic Stress Disorder (PTSD) secondary outcome description PTSD Checklist for DSM-V Total Symptom Severity Score, range 0-80, higher scores are a worse outcome secondary outcome time frame Baseline Visit secondary outcome measure Social Support secondary outcome description PROMIS Bank 2.0 Social Support (emotional support, instrumental support, informational support, and social isolation domains) T-Scores, range 23.7-76.9, higher scores are better outcomes for emotional support, instrumental support and informational support, higher scores are worse outcomes for social isolation secondary outcome time frame Baseline visit secondary outcome measure Social Support secondary outcome description PROMIS Bank 2.0 Social Support (emotional support, instrumental support, informational support, and social isolation domains) T-Scores, range 23.7-76.9, higher scores are better outcomes for emotional support, instrumental support and informational support, higher scores are worse outcomes for social isolation secondary outcome time frame 28-40 week visit secondary outcome measure Social Support secondary outcome description PROMIS Bank 2.0 Social Support (emotional support, instrumental support, informational support, and social isolation domains) T-Scores, range 23.7-76.9, higher scores are better outcomes for emotional support, instrumental support and informational support, higher scores are worse outcomes for social isolation secondary outcome time frame 4-12 weeks Postpartum secondary outcome measure Race-Related Stress secondary outcome description Index of Race Related Stress-Brief Version Total Score, range 0-22, higher scores are worse outcomes secondary outcome time frame Baseline visit secondary outcome measure Maternal Attachment (Antenatal) secondary outcome description Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes secondary outcome time frame Baseline visit secondary outcome measure Maternal Attachment (Antenatal) secondary outcome description Maternal Antenatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes secondary outcome time frame 28-40 week visit secondary outcome measure Maternal Attachment (Postnatal) secondary outcome description Maternal Postnatal Attachment Scale Total Score, range 19-95, higher scores are better outcomes secondary outcome time frame 4-12 Weeks Postpartum eligibility module eligibility criteria Inclusion Criteria:
English or Spanish speaking
≤18 weeks' gestation
Established prenatal care at EleVATE site
High-risk for postpartum depression by ≥1 risk factor (personal/family history, baseline EPDS≥10, low-income, 13-19 years old, single, history of physical/sexual abuse, unplanned/undesired pregnancy, history of pregnancy loss)
Ability to attend group prenatal visits at specified days/times
Willingness to be randomized
Ability to give informed consent
Any patient that has received prenatal care in a group setting previously
Exclusion Criteria:
Multiple gestation
Major fetal anomaly
Serious medical co-morbidity/psychiatric illness necessitating more care than can be safely provided in group setting
Serious medical co-morbidity necessitating more care than can be safely provided in group setting healthy volunteers No gender Female minimum age 13 Years std age list std age Child Adult Older Adult contacts locations module location list location location facility University of Missouri-Kansas City/Truman Health Centers-Kansas City location city Kansas City location state Missouri location zip 64108 location country United States location facility Affinia Healthcare location city Saint Louis location state Missouri location zip 63104 location country United States location facility Family Care Health Centers location city Saint Louis location state Missouri location zip 63111 location country United States location facility CareSTL Health location city Saint Louis location state Missouri location zip 63112 location country United States i p d sharing statement module i p d sharing Yes derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003863 condition mesh term Depression condition mesh id D000003866 condition mesh term Depressive Disorder condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition ancestor id D000019964 condition ancestor term Mood Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf as found Depression condition browse leaf relevance high condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse leaf id M20988 condition browse leaf name Mood Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions | NCT04838210 | [
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full study rank 61458 study protocol section identification module n c t id NCT04836208 org study id info org study id 2020-059 organization org full name Institut Pasteur org class INDUSTRY brief title Neonatal Acquisition of ESBL-PE in a Low-income Country - NeoLIC official title Neonatal Acquisition of ESBL-PE in a Low-income Country acronym NeoLIC status module status verified date September 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 30, 2021 start date type Actual primary completion date struct primary completion date May 2023 primary completion date type Anticipated completion date struct completion date May 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 6, 2022 last update post date struct last update post date October 7, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Institut Pasteur lead sponsor class INDUSTRY collaborator list collaborator collaborator name Institut Pasteur de Madagascar collaborator class OTHER collaborator name Centre hospitalier de référence du District de Moramanga collaborator class UNKNOWN oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Enterobacteriaceae, more specifically Escherichia coli and Klebsiella pneumoniae, are the bacteria most often responsible for neonatal infections in low-income countries. Infections caused by multidrug-resistant Enterobacteriaceae: Extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBL-E), are more often associated with an unfavorable outcome of the infection.
Enterobacteriaceae colonize the digestive tract which is the first step in developing a potential infection. Very few studies have been carried out at the community level. Colonization of the mother with ESBL-E is generally considered to be a major route of acquisition. The carrying of ESBL-E by other family members and other potential sources of transmission (food, objects and surfaces in contact with the newborn) have never been documented.
In addition, with a view to offering an intervention adapted to the local context, the local cultural determinants which govern the interactions of the newborn with his environment are important to understand. detailed description This is a single-center prospective cohort of all members living in the same household in which a newborn baby has just been born.
The study consists to:
recruit a cohort of all members of 60 households in which a newborn has just been born
carry out semi-structured interviews and direct participant observation.
This study is divided in two parts :
the epidemiological part : the documentation of colonization by E-ESBL by sampling the stools of the newborn, of all members of the household, and sampling of food given to the child, from surfaces in contact with it.
the anthropological part : Semi-structured interviews with key people in the structuring of the social and family environment of the newborn and participant direct observation of households. conditions module condition list condition Enterobacteriaceae Infections keyword list keyword new born intra-domiciliary transmission community Madagascar design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective bio spec bio spec retention Samples Without DNA bio spec description stool
milk for the mother of the new born enrollment info enrollment count 600 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure Number of acquisition events and the number of non-acquisition of E-ESBL in newborns for the epidemiological part primary outcome description Identification of bacterial strains from stool and sequencing of EBSL-E strains primary outcome time frame 2 years primary outcome measure Number of semi-structured interviews completed for the anthropological part primary outcome description 1 or 4 hours semi-structured interviews of participants at home done by investigators primary outcome time frame 2 years primary outcome measure Number of participant direct observation completed for the anthropological part primary outcome description observations of the participants at home done by investigators (2 to 4 hours in 3 to 4 sessions over 28 days) primary outcome time frame 2 years eligibility module eligibility criteria Inclusion Criteria:
For the epidemiological study :
All members of 60 households in which a newborn baby has just been born
Inclusion criteria for the mother at the time of childbirth, pregnant woman :
_ having a monofetal pregnancy
residing regularly in the study area OR planning to reside in the study area during the study period;
having been informed of the research and collection of biological samples on herself and her newborn;
having given its agreement to carry out the research and the associated collection of biological samples, and;
having signed the informed consent (or its witness if applicable).
Inclusion criteria for the live newborn at the time of childbirth, new born :
living after childbirth;
whose parents or legal representatives present:
reside regularly in the study area or plan to reside in the study area during the study period;
were informed of the research and the associated collection of biological samples on their newborn;
have given their agreement to carry out the research and the associated collection of biological samples,
Inclusion criteria for the household member, resident:
from the same household as the mother-child (ren) couple included
Residing at least 4 nights per week in this home
Having given its agreement to carry out the research and the associated collection of biological samples,
and having signed the consent of the study (or its witness, or its legal representative if applicable)
for the anthropological study with interviews : 16 homes will be selected from among the 60 homes included: 8 homes in which the child has not acquired an ESBL-E during the entire follow-up and 8 homes in which the child has acquired an ESBL-E at least once during its follow-up. Among these households, interviews will be carried out with: 16 mothers or first responsible for the child in the absence of the mother 4 people with a mothering role on the child (grandmother, aunts ...) 4 minors in the families to observe 4 fathers or father figures in families to observe
Also, interviews will be done with:
Health actors: medical (1 midwife and 1 neighborhood doctor) and traditional (1 matron and 1 traditional practitioner from the neighborhood), 1 community health worker 1 neighborhood chief
Inclusion criteria for semi-structured interviews :
people responding to the structuring functions of the child's social and family environment
Having given its agreement to carry out the research,
and having signed the consent of the study (or its witness, or its legal representative if applicable)
For health workers and district managers, inclusion criteria for semi-structured interviews :
people responding to the targeted functions
working in the district of homes included
Having given its agreement to carry out the research,
and having signed the consent of the study (or its witness, or its legal representative if applicable)
For the anthropological study with observations 4 households in total among the 16 initially selected for the interviews: 2 households in which the child did not acquire ESBL-E during all the follow-up and 2 households in which the child acquired at least once an BLSE-E during his follow-up Inclusion criteria for participating direct observations
Residents of the same household as the mother-child (ren) couple included
having agreed to participate in the study
Having given its agreement to carry out the research,
and having signed the consent of the study (or its witness, or its legal representative if applicable)
Exclusion Criteria:
For the epidemiological part:
Pregnant woman: non-monofetal pregnancy
Newborn: died during childbirth
Household resident: None
and 3) For the anthropological part: • Semi-structured interview:
For household members:
not responding to the structural family and social functions of the child's environment For health workers and district managers
people not meeting the targeted functions
not practicing in the district of homes included
• Participant direct observation:
Not living in the same household as the mother-child couple included healthy volunteers Accepts Healthy Volunteers gender All std age list std age Child Adult Older Adult study population epidemiological study
All members of 60 households in which a newborn baby has just been born
anthropological study with interviews
16 homes will be selected from among the 60 homes included: 8 homes (no ESBL-E) and 8 homes (ESBL-E). Interviews will be carried out with: 16 mothers 4 people with a mothering role on the child 4 minors in the families 4 fathers
Also, interviews will be done with:
Health actors: medical and traditional, 1 community health worker
1 neighborhood chief
3) anthropological study with observations 4 households in total among the 16 initially selected for the interviews: 2 households (no ESBL-E) and 2 households (ESBL-E) sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Bich-Tram Huynh, MD central contact role Contact central contact phone +33 1 45 68 83 01 central contact e mail bich-tram.huynh@pasteur.fr overall official list overall official overall official name Bich-Tram Huynh overall official affiliation Institut Pasteur overall official role Study Director location list location location facility Institut Pasteur de Madagascar location status Recruiting location city Antananarivo location country Madagascar location contact list location contact location contact name Aina HARIMANANA, MD location contact role Contact location contact e mail aharim@pasteur.mg location contact name Aina Rakotondrasoa, PhD location contact role Contact location contact phone +261 34 98 185 32 location contact e mail aina@pasteur.mg location contact name Aina HARIMANANA, MD location contact role Principal Investigator location contact name Aina Rakotondrasoa, PhD location contact role Principal Investigator location contact name Elliot Rakotomanana, Master location contact role Sub-Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004756 condition mesh term Enterobacteriaceae Infections condition ancestor list condition ancestor condition ancestor id D000016905 condition ancestor term Gram-Negative Bacterial Infections condition ancestor id D000001424 condition ancestor term Bacterial Infections condition ancestor id D000001423 condition ancestor term Bacterial Infections and Mycoses condition ancestor id D000007239 condition ancestor term Infections condition browse leaf list condition browse leaf condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M7070 condition browse leaf name Enterobacteriaceae Infections condition browse leaf as found Enterobacteriaceae Infections condition browse leaf relevance high condition browse leaf id M3874 condition browse leaf name Bacterial Infections condition browse leaf relevance low condition browse leaf id M18401 condition browse leaf name Gram-Negative Bacterial Infections condition browse leaf relevance low condition browse leaf id M11288 condition browse leaf name Mycoses condition browse leaf relevance low condition browse leaf id M3873 condition browse leaf name Bacterial Infections and Mycoses condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology | NCT04836208 | [
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full study rank 61175 study protocol section identification module n c t id NCT04839887 org study id info org study id NU21-09-00053 organization org full name Palacky University org class OTHER brief title Factors Affecting the Quality of Life After Ischemic Stroke in Young Adults official title Factors Affecting the Quality of Life After Ischemic Stroke in Young Adults: a Prospective Observational Study in Young Ischemic Stroke Patients Under 50 Years acronym FRAILTY status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 1, 2021 start date type Actual primary completion date struct primary completion date December 31, 2025 primary completion date type Anticipated completion date struct completion date December 31, 2026 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 20, 2022 last update post date struct last update post date April 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Elena Gurkova responsible party investigator title Associated professor responsible party investigator affiliation Palacky University lead sponsor lead sponsor name Elena Gurkova lead sponsor class OTHER collaborator list collaborator collaborator name University Hospital Olomouc collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Despite a generally favourable 3-month functional outcome and a very low mortality, young ischemic stroke (IS) patients face to reduced quality of life associated with a complexity of problems or "invisible dysfunctions" after IS. Better identification and understanding to these factors may improve stroke rehabilitation and stroke self-management programmes, wich will lead to better stroke recovery. The aim of the study is to assess the predictors of the health-related quality of life in young patients under 50 years after ischemic stroke, and to to evaluate specific changes in different dimensions of health-related quality of life during the first year of post-stroke recovery using a standardized battery of neuropsychological tools and stroke specific health-related quality of life measures. In the first phase of the study, 300 IS patients will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. In the second phase of study, 200 enrolled IS patients (100 young IS patients < 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In the third phase of study, twenty young IS patients < 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used. detailed description Despite a generally favourable 3-month functional outcome and a very low mortality, young ischemic stroke (IS) patients face to reduced quality of life associated with a complexity of problems or "invisible dysfunctions" after IS. Fatigue, cognitive impairment, anxiety, depression, sexual dysfunction, loss of employment, social isolation, lack of specialist support, reduction in mobility and life roles, negative body image, impaired self-efficacy and self-esteem are considered most relevant factors. Investigation of predictors of post-stroke quality of life in young-onset patients is needed to design, implement, and evaluate specific young stroke rehabilitation and stroke self-management programmes.
The aim of the study is to assess the predictors of the health-related quality of life in young patients under 50 years after ischemic stroke, and to evaluate specific changes in different dimensions of health-related quality of life during the first year of post-stroke recovery using a standardized battery of neuropsychological tools and stroke specific health-related quality of life measures. The aims of the study will be met by the triangulation of qualitative and quantitative research methods.
In the first phase of the study, 300 IS patients will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. The reliability and validity study will have a cross-sectional design. In the second phase of study, 200 enrolled IS patients (100 young IS patients < 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In all enrolled patients, the functional outcome, neuropsychological status and quality of life will be assessed using standardized scales and tools. In the third phase of study, twenty young IS patients < 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used. conditions module condition list condition Ischemic Stroke keyword list keyword Young Ischemic Stroke Stroke recovery Health-Related Quality of Life Life Change Events Life Experiences design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 520 enrollment type Anticipated arms interventions module arm group list arm group arm group label Validation study arm group description Three hundred patients with ischemic stroke (18-65 years) will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. The reliability and validity study will have a cross-sectional design. arm group label Prospective quantitative study arm group description Two hundred enrolled IS patients (100 young IS patients < 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In all enrolled patients, the functional outcome, neuropsychological status and quality of life will be assessed using standardized scales and tools. arm group label In-depth interview qualitative study arm group description twenty young IS patients < 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used. outcomes module primary outcome list primary outcome primary outcome measure Change in the Stroke Impact Scale (version 3.0) primary outcome description Assessment of the impact of stroke on eight domains relating to self-rated quality of life, self-perceived disability, and global recovery after stroke (i.e., strength, hand function, mobility, physical and instrumental activities of daily living, memory and thinking, communication, emotion, and social participation). Scores for each domain range from 0 to 100, and higher scores indicate a better health related quality of life primary outcome time frame three, six and 12 months after stroke secondary outcome list secondary outcome secondary outcome measure Change of the World Health Organization Quality of Life - BREF version (WHOQOL-BREF, self-reported) secondary outcome description Assessment of four domains relating to quality of life (Physical health, Psychological domain, Social relationships, Environment). The four domain scores are scaled in a positive direction with higher scores indicating a higher quality of life. The domain scores will be transformed in accordance with two transformation methods outlined in the WHOQOL-BREF scoring instructions. The domain scores will be transformed into scores ranging between 4 and 20 points (the first transformation method) or into a linear scale between 0 and 100 points (the second transformation method) secondary outcome time frame three, six and 12 months after stroke secondary outcome measure Change of the Barthel Index of Activities of Daily Living (self-reported) secondary outcome description Measure of performance in activities of daily living. Measure of performance in activities of daily living. Scores of 10 personal activities range from 0 to 100 points and higher score indicates greater independence. secondary outcome time frame three, six and 12 months after stroke secondary outcome measure Change of Modified Rankin Scale (self-reported) secondary outcome description Scale used for measuring the degree of disability or dependence in the daily activities in patients after stroke. Most widely used clinical outcome measure after stroke. Scale has six points and higher score means worse outcome; minimum is 0 points indicating no symptoms at all and maximum is 6 points indicating death. secondary outcome time frame three, six and 12 months after stroke secondary outcome measure Change of post-stroke depression and anxiety (self-reported) secondary outcome description Assessment of depressive and anxiety symptoms using Beck Depression Inventory II and Hospital Anxiety and Depression Scale. Higher total scores indicate more severe depressive symptoms. secondary outcome time frame three, six and 12 months after stroke secondary outcome measure Change of the Montreal Cognitive Assessment (MoCA) secondary outcome description Assessment of cognitive functions (cognitive test measuring specific cognitive domains). The MoCA generates a total score and six domain-specific index scores: Memory, Executive Functioning, Attention, Language, Visuospatial, and Orientation. MoCA score range between 0 and 30. Higher score indicates better cognitive functions. The following ranges are used to grade the severity of cognitive impairment: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment. secondary outcome time frame three, six and 12 months after stroke secondary outcome measure Change from 3-month the lived experience of ischemic stroke of young patients up to 50 years at 12 months. secondary outcome description Semi-structured interviews with stroke patients secondary outcome time frame three and 12 months after stroke secondary outcome measure Change in the NIH Stroke Scale (NIHSS) secondary outcome description NIHSS is used to objectively quantify the impairment caused by a stroke. Higher score indicates more severe neurological deficit. secondary outcome time frame three, six and 12 months after stroke other outcome list other outcome other outcome measure Change in the Fatigue Severity Scale other outcome description Assessment of post-stroke fatigue using Fatigue Severity Scale. A self-report scale of nine items about fatigue, its severity and how it affects certain activities. The minimum score is nine and the highest is 63 points. The higher score indicates more severe fatigue and greater affecting of the person's activities. other outcome time frame three, six and 12 months after stroke other outcome measure Change in the Brief Pain Inventory other outcome description Includes questions on site of pain, severity of pain, and how pain interfered with the patient's mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. These questions are rated on a scale of 0 to 10; a higher score indicates greater pain or greater interference with the daily activities. other outcome time frame three, six and 12 months after stroke other outcome measure Change in the Multi-dimensional Scale of Perceived Social Support other outcome description The Multi-dimensional Scale of Perceived Social Support (MSPSS) assesses different sources of support. The MSPSS is a brief 12-item, self-administered measurement tool with three subscales: Family, Friends, and Significant Others. A higher score indicates greater social support perceived by an individual; the total possible score ranges between 12 and 84 points. other outcome time frame three, six and 12 months after stroke eligibility module eligibility criteria Inclusion Criteria:
Acute ischemic stroke
Age 18-65 years
Exclusion Criteria:
Transient ischemic attack without progression to ischemic stroke
Haemorrhagic stroke
Severe cognitive impairment
Severe communication disorder (sensory aphasia with the inability to understand having been verified by a certified speech therapist)
Concomitant severe systemic illness
Impaired ability to understand the questionnaires gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult study population Participants will be recruited from individuals, diagnosed with ischemic stroke according to the ICD-10 classification who will be admitted to the stroke unit. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Elena Gurkova, PhD central contact role Contact central contact phone +420585632825 central contact e mail elena.gurkova@upol.cz central contact name Daniel Sanak, MD, PhD central contact role Contact central contact phone +420588442836 central contact e mail daniel.sanak@fnol.cz overall official list overall official overall official name Elena Gurkova, PhD overall official affiliation Palacky University, Faculty of Health Sciences, Department of Nursing overall official role Principal Investigator location list location location facility Palacky University, Faculty of Health Sciences location status Recruiting location city Olomouc location zip 77515 location country Czechia location contact list location contact location contact name Lenka Satekova, PhD location contact role Contact location contact phone +420585632821 location contact e mail lenka.satekova@upol.cz location contact name Daniel Sanak, MD, PhD location contact role Contact location contact phone +420588442836 location contact e mail daniel.sanak@fnol.cz references module reference list reference reference p m i d 24655479 reference type result reference citation Arntz RM, van Alebeek ME, Synhaeve NE, Brouwers PJ, van Dijk GW, Gons RA, den Heijer T, de Kort PL, de Laat KF, van Norden AG, Vermeer SE, van der Vlugt MJ, Kessels RP, van Dijk EJ, de Leeuw FE. 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J Stroke Cerebrovasc Dis. 2020 Aug;29(8):104875. doi: 10.1016/j.jstrokecerebrovasdis.2020.104875. 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full study rank 61187 study protocol section identification module n c t id NCT04839731 org study id info org study id IRB-19-691 organization org full name Carilion Clinic org class OTHER brief title Combination 5-FU / Calcipotriene Cream for SCCIS/SCC official title Combination Topical 5-fluorouracil 5% / Calcipotriene 0.005% Cream for Treatment of in Situ and Superficially Invasive Squamous Cell Carcinoma of the Skin status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 14, 2021 start date type Actual primary completion date struct primary completion date March 2022 primary completion date type Anticipated completion date struct completion date July 2022 completion date type Anticipated study first submit date March 2, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 26, 2021 last update post date struct last update post date April 27, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Carilion Clinic lead sponsor class OTHER oversight module is f d a regulated drug Yes is f d a regulated device No is u s export No description module brief summary The study will determine if calcipotriene and 5-fluorouracil (5-FU) creams when combined can treat SCCIS and superficially invasive SCC (but not deeply invasive or high-risk cutaneous SCC). 30 Patients will be divided into a 7 day treatment group (n=10), a 14 day treatment group (n=10), and a placebo group (n=10, divided into 7 and 14 days evenly). Following treatment with the topical chemotherapeutic medication, tumors would be completely excised according to standard of care, and specimens would be sent to pathology to determine if there was residual tumor/margin clearance. The potential benefit of this intervention would be the establishment of a non-invasive treatment that leads to minimal to no scarring or complications (akin to topical 5-FU alone) but would require a much shorter and more tolerable treatment duration (1-2 weeks) compared to available alternatives. detailed description Squamous cell carcinoma (SCC) of the skin is exceedingly common. For the most part, cutaneous SCC grows slowly and has a very high cure rate with excision for deep tumors or mechanical/chemical destruction for superficial tumors. While metastases are uncommon in the short-term, tumors can be very locally destructive; thus, their timely treatment is indicated. SCC develops through a stepwise progression from precancerous lesions known as actinic keratosis (AK)(less than full thickness epidermal involvement), then in-situ SCC (SCCIS) (full thickness epidermal involvement) and finally invasive SCC (full thickness epidermal involvement plus invasion/downward growth into the dermis).
For SCCIS, topical treatment with 5-fluorouracil (5-FU) cream (a topical antineoplastic agent) is an established, off-label treatment offering cure rates that are competitive but slightly inferior to surgical destruction or excision. The existing regimen requires patients to apply the medication twice daily for six weeks. The benefits of treatment with topical 5-FU is that the patient can treat a large-diameter lesion with minimal post-treatment scarring and an excellent cosmetic outcome. Alternatives to topical 5-FU include electrodessication and curettage (ED&C), an office-based procedure performed under local anesthetic in 10-15 minutes that includes 3 alternating cycles of curettage and desiccation with a hyfrecator device; this area is allowed to heal by secondary intention and usually heals with a broad, circular, hyperpigmented/red scar. The other alternative is wide local excision (WLE). Both invasive procedures carry some risk of complications, including infection, bleeding/hematoma formation (only with WLE), and wound dehiscence (only with WLE). The downside to topical 5-FU treatment is that it causes a temporary cutaneous reaction characterized by erythema, some burning and tenderness, and even some vesicle formation. This reaction is expected and reflective of the medication (and ensuing inflammatory reaction) taking effect, and it is explained to patients prior to starting the medication. This reaction is tolerable by most patients when used for the 2-3 weeks required to treat AKs, but it can in some cases become intolerable when patients are required to use the medication for the full 6 weeks to treat superficial skin cancers. However, the benefit to using the topical chemotherapeutic agent is that, after healing, the end result is excellent in terms of cosmesis (no or very little scarring).
While less often used for superficial SCC/SCCIS, topical 5-FU is routinely and ubiquitously employed in dermatology for treatment of actinic keratosis, which, as previously noted, are pre-cancerous lesions that ultimately progress to SCCIS. Histologically, AKs appear as partial thickness cellular atypia of the epidermis. Normally, patients need to treat a given area twice per day for 2-3 weeks in order to sufficiently treat an area with many AKs. A study published in 2017 discovered that combining topical calcipotriene 0.005% ointment (vitamin D analogue) with topical 5-FU 5% cream and using that combination twice per day for only 4 days was dramatically superior to using topical 5-FU alone (combined with petrolatum placebo).1 In the case of this study, the calcipotriene served to induce a molecule called "thymic stromal lymphopoietin" (TSLP), an epithelium-derived cytokine that serves as a potent inducer of antitumor immunity. Effectively, when used together, calcipotriene and 5-FU act synergistically to induce tumor apoptosis and generate an immune/inflammatory response to destroy the tumor cells.
The study would take the next logical step and expand/explore this combination of topical therapies to SCCIS and superficially invasive SCC (but not deeply invasive or high-risk cutaneous SCC), and do so without putting the patient at any increased risk for tumor recurrence. The study would be limited to tumors involving the trunk and upper extremities (excluding the hand). Following treatment with the topical chemotherapeutic medication, tumors would be completely excised according to standard of care, and specimens would be sent to pathology to determine if there was residual tumor/margin clearance. The potential benefit of this intervention would be the establishment of a non-invasive treatment that leads to minimal to no scarring or complications (akin to topical 5-FU alone) but would require a much shorter and more tolerable treatment duration (1-2 weeks) compared to available alternatives. conditions module condition list condition Squamous Cell Carcinoma keyword list keyword Calcipotriene Fluorouracil Squamous cell carcinoma design module study type Interventional phase list phase Early Phase 1 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description The three groups will include the following: Group 1 will be divided into 1- and 2-week treatment groups (5 patients in each group) and will apply placebo cream, Nourivan base cream from Pure Science Rx, twice per day for their designated time. Group 2 will apply combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream twice per day for 7 days, and Group 3 will apply combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream twice per day for 14 days. Patients will undergo randomization via an online randomization generator tool. design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label Placebo group arm group type Placebo Comparator arm group description 10 patients will be divided into 7 and 14 day treatment groups with 5 patients each. They will apply Nourivan base cream from Pure Science Rx, twice per day for their designated time. arm group intervention list arm group intervention name Drug: Nourivan Base Cream arm group label 7 day medication group arm group type Experimental arm group description The 7 day medication group will apply combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream twice per day for 7 days. arm group intervention list arm group intervention name Drug: Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream arm group label 14 day medication group arm group type Experimental arm group description The 14 day medication group will apply combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream twice per day for 14 days. arm group intervention list arm group intervention name Drug: Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream intervention list intervention intervention type Drug intervention name Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream intervention description Apply twice per day for allotted time intervention arm group label list intervention arm group label 14 day medication group 7 day medication group intervention type Drug intervention name Nourivan Base Cream intervention description Apply twice per day for allotted time intervention arm group label list intervention arm group label Placebo group outcomes module primary outcome list primary outcome primary outcome measure Cancer resolution on histopathology primary outcome description Histopathologic examination of resected tumor will be examined by pathology department. If tumor cells are remaining, that will be considered positive. The number of patients with positive tumor remaining will be reported. primary outcome time frame 6-8 wks secondary outcome list secondary outcome secondary outcome measure Final scar length secondary outcome description The final length of the surgical scar (in cm) will be measured. This will changed based on the size of the visible tumor seen after medication application secondary outcome time frame 6-8 wks secondary outcome measure Cosmetic appearance secondary outcome description Appearance of skin based on a physician clinical erythema scale from 0-10 (0 is normal skin, 10 is bright red) will be reported after medication application secondary outcome time frame 3-4 wks eligibility module eligibility criteria Inclusion Criteria:
Recruited patients will be limited to those with a biopsy-proven in situ or superficially invasive (does not invade past the papillary dermis) squamous cell carcinoma of the skin of the low risk or "L" areas. The tumor must measure 1.0-2.0cm in longest diameter dimension. Tumors must lack induration and/or nodularity. The tumor must also demonstrate positive margins on review of the original biopsy pathology (biopsy must be partial; there must be residual tumor that requires further treatment).
Patient has capacity to provide consent
Exclusion Criteria:
Immunocompromise or immunosuppression.
Contraindication to surgical excision.
Contraindication to use of topical medication(s) (e.g., history of allergic contact dermatitis to topical 5-fluorouracil)
Currently pregant, concerned could be pregnant, actively trying to conceive, or missed last menstrual period that is not explainable by birth control method (5-Fluorouracil is pregnancy category X)
Tumor is recurrent healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 100 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Kiley K Fagan, MD central contact role Contact central contact phone 5402245170 central contact e mail kkfagan@carilionclinic.org central contact name Joshua D Eikenberg, MD central contact role Contact central contact phone 5402245170 central contact e mail jdeikenberg@carilionclinic.org overall official list overall official overall official name Joshua D Eikenberg, MD overall official affiliation Carilion Clinic Dermatology overall official role Principal Investigator location list location location facility Carilion Clinic Dermatology and Mohs Surgery location status Recruiting location city Roanoke location state Virginia location zip 24016 location country United States location contact list location contact location contact name Kiley K Fagan, MD location contact role Contact location contact phone 540-224-5170 location contact e mail kkfagan@carilionclinic.org location contact name Joshua D Eikenberg, MD location contact role Contact location contact phone 5402245170 location contact e mail jdeikenberg@carilionclinic.org references module reference list reference reference p m i d 27869649 reference type background reference citation Cunningham TJ, Tabacchi M, Eliane JP, Tuchayi SM, Manivasagam S, Mirzaalian H, Turkoz A, Kopan R, Schaffer A, Saavedra AP, Wallendorf M, Cornelius LA, Demehri S. Randomized trial of calcipotriol combined with 5-fluorouracil for skin cancer precursor immunotherapy. J Clin Invest. 2017 Jan 3;127(1):106-116. doi: 10.1172/JCI89820. Epub 2016 Nov 21. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000002294 condition mesh term Carcinoma, Squamous Cell condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000018307 condition ancestor term Neoplasms, Squamous Cell condition browse leaf list condition browse leaf condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf as found Carcinoma condition browse leaf relevance high condition browse leaf id M4702 condition browse leaf name Carcinoma, Squamous Cell condition browse leaf as found Squamous Cell Carcinoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M19604 condition browse leaf name Neoplasms, Squamous Cell condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000005472 intervention mesh term Fluorouracil intervention mesh id C000055085 intervention mesh term Calcipotriene intervention ancestor list intervention ancestor intervention ancestor id D000000963 intervention ancestor term Antimetabolites intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000964 intervention ancestor term Antimetabolites, Antineoplastic intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000003879 intervention ancestor term Dermatologic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M7752 intervention browse leaf name Fluorouracil intervention browse leaf as found Saline intervention browse leaf relevance high intervention browse leaf id M347448 intervention browse leaf name Calcipotriene intervention browse leaf as found Fingolimod intervention browse leaf relevance high intervention browse leaf id M3433 intervention browse leaf name Antimetabolites intervention browse leaf relevance low intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse leaf id M6226 intervention browse leaf name Dermatologic Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Derm intervention browse branch name Dermatologic Agents | NCT04839731 | [
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1708,
117,
8366,
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126,
118,
143,
2591,
1110,
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190,
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1193,
4071,
1107,
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21943,
4807,
1111,
3252,
1104,
2496,
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1665,
180,
5970,
26156,
117,
1134,
117,
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117,
1132,
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118,
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119,
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117,
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1183,
15748,
1104,
1103,
174,
25786,
1200,
15394,
119,
17623,
117,
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170,
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1111,
123,
118,
124,
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13230,
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119,
138,
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8366,
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11439,
22500,
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121,
119,
3135,
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110,
184,
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1880,
113,
23971,
141,
26116,
114,
1114,
8366,
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126,
118,
143,
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126,
110,
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1111,
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125,
1552,
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7298,
1106,
1606,
8366,
1348,
126,
118,
143,
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2041,
113,
3490,
1114,
19847,
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1818,
1282,
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114,
119,
122,
1130,
1103,
1692,
1104,
1142,
2025,
117,
1103,
11019,
1233,
6617,
11439,
22500,
1162,
1462,
1106,
21497,
170,
14730,
1270,
107,
21153,
7257,
188,
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181,
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107,
113,
157,
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114,
117,
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174,
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118,
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172,
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21420,
1673,
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170,
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21497,
1197,
1104,
2848,
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17523,
119,
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13517,
117,
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117,
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11439,
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126,
118,
143,
2591,
2496,
188,
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1106,
21497,
14601,
170,
18299,
26156,
1105,
9509,
1126,
11650,
120,
22653,
2593,
1106,
5535,
1103,
14601,
3652,
119,
1109,
2025,
1156,
1321,
1103,
1397,
11730,
2585,
1105,
7380,
120,
8664,
1142,
4612,
1104,
8366,
1348,
1103,
14543,
1905,
1106,
9314,
19747,
1708,
1105,
26558,
1193,
19849,
9314,
1658,
113,
1133,
1136,
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19849,
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118,
3187,
2195,
13064,
9314,
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114,
117,
1105,
1202,
1177,
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1103,
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1111,
14601,
1231,
10182,
21629,
119,
1109,
2025,
1156,
1129,
2609,
1106,
24309,
5336,
1103,
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1105,
3105,
4252,
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9084,
1905,
113,
14243,
1103,
1289,
114,
119,
2485,
3252,
1114,
1103,
8366,
1348,
22572,
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5970,
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16065,
1665,
15683,
117,
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1129,
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2452,
1106,
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1920,
117,
1105,
9985,
1156,
1129,
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4807,
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1191,
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25399,
14601,
120,
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16443,
119,
1109,
3209,
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1104,
1142,
9108,
1156,
1129,
1103,
4544,
1104,
170,
1664,
118,
19849,
3252,
1115,
4501,
1106,
10298,
1106,
1185,
14161,
3384,
1137,
13522,
113,
21584,
1106,
8366,
1348,
126,
118,
143,
2591,
2041,
114,
1133,
1156,
4752,
170,
1277,
7681,
1105,
1167,
1106,
2879,
1895,
3252,
9355,
113,
122,
118,
123,
2277,
114,
3402,
1106,
1907,
18815,
119,
2975,
13196,
3879,
2190,
3879,
156,
13284,
15852,
17369,
8185,
16430,
7903,
2501,
12565,
2190,
2501,
12565,
11917,
6617,
11439,
22500,
1162,
143,
7535,
14824,
4084,
6617,
1233,
156,
13284,
15852,
2765,
1610,
16430,
7903,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
4503,
12278,
122,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
9108,
2235,
6136,
1109,
1210,
2114,
1209,
1511,
1103,
1378,
131,
1990,
122,
1209,
1129,
3233,
1154,
122,
118,
1105,
123,
118,
1989,
3252,
2114,
113,
126,
4420,
1107,
1296,
1372,
114,
1105,
1209,
6058,
1282,
4043,
7081,
117,
1302,
8212,
5242,
2259,
7081,
1121,
16665,
2444,
155,
1775,
117,
3059,
1679,
1285,
1111,
1147,
3574,
1159,
119,
1990,
123,
1209,
6058,
4612,
8366,
1348,
126,
118,
23896,
14824,
4084,
6617,
1233,
126,
110,
120,
11019,
1233,
6617,
11439,
22500,
1162,
121,
119,
3135,
1571,
110,
7081,
3059,
1679,
1285,
1111,
128,
1552,
117,
1105,
1990,
124,
1209,
6058,
4612,
8366,
1348,
126,
118,
23896,
14824,
4084,
6617,
1233,
126,
110,
120,
11019,
1233,
6617,
11439,
22500,
1162,
121,
119,
3135,
1571,
110,
7081,
3059,
1679,
1285,
1111,
1489,
1552,
119,
7195,
24767,
1209,
13971,
7091,
2734,
2258,
1126,
3294,
7091,
2734,
14622,
6806,
119,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8353,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
4539,
27989,
10224,
1204,
10803,
23992,
10803,
5099,
1476,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
5033,
4043,
1372,
1981,
1372,
2076,
5033,
4043,
3291,
8223,
4626,
2772,
1981,
1372,
6136,
1275,
4420,
1209,
1129,
3233,
1154,
128,
1105,
1489,
1285,
3252,
2114,
1114,
126,
4420,
1296,
119,
1220,
1209,
6058,
1302,
8212,
5242,
2259,
7081,
1121,
16665,
2444,
155,
1775,
117,
3059,
1679,
1285,
1111,
1147,
3574,
1159,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
1302,
8212,
5242,
5524,
24511,
1981,
1372,
3107,
128,
1285,
15683,
1372,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1109,
128,
1285,
15683,
1372,
1209,
6058,
4612,
8366,
1348,
126,
118,
23896,
14824,
4084,
6617,
1233,
126,
110,
120,
11019,
1233,
6617,
11439,
22500,
1162,
121,
119,
3135,
1571,
110,
7081,
3059,
1679,
1285,
1111,
128,
1552,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
3291,
12913,
9400,
8366,
1348,
126,
118,
23896,
14824,
4084,
6617,
1233,
126,
110,
120,
11019,
1233,
6617,
11439,
22500,
1162,
121,
119,
3135,
1571,
110,
7081,
1981,
1372,
3107,
1489,
1285,
15683,
1372,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1109,
1489,
1285,
15683,
1372,
1209,
6058,
4612,
8366,
1348,
126,
118,
23896,
14824,
4084,
6617,
1233,
126,
110,
120,
11019,
1233,
6617,
11439,
22500,
1162,
121,
119,
3135,
1571,
110,
7081,
3059,
1679,
1285,
1111,
1489,
1552,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
3291,
12913,
9400,
8366,
1348,
126,
118,
23896,
14824,
4084,
6617,
1233,
126,
110,
120,
11019,
1233,
6617,
11439,
22500,
1162,
121,
119,
3135,
1571,
110,
7081,
9108,
2190,
9108,
9108,
2076,
13982,
9108,
1271,
3291,
12913,
9400,
8366,
1348,
126,
118,
23896,
14824,
4084,
6617,
1233,
126,
110,
120,
11019,
1233,
6617,
11439,
22500,
1162,
121,
119,
3135,
1571,
110,
7081,
9108,
6136,
138,
8661,
1193,
3059,
1679,
1285,
1111,
27135,
1159,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
1489,
1285,
15683,
1372,
128,
1285,
15683,
1372,
9108,
2076,
13982,
9108,
1271,
1302,
8212,
5242,
5524,
24511,
9108,
6136,
138,
8661,
1193,
3059,
1679,
1285,
1111,
27135,
1159,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
5033,
4043,
1372,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
11558,
6021,
1113,
1117,
9870,
9779,
4807,
2425,
9386,
6136,
1230,
9870,
9779,
12805,
11007,
8179,
1104,
1231,
26338,
1174,
14601,
1209,
1129,
8600,
1118,
3507,
4807,
2853,
119,
1409,
14601,
3652,
1132,
2735,
117,
1115,
1209,
1129,
1737,
3112,
119,
1109,
1295,
1104,
4420,
1114,
3112,
14601,
2735,
1209,
1129,
2103,
119,
2425,
9386,
1159,
4207,
127,
118,
129,
192,
4616,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
3788,
14161,
2251,
3718,
9386,
6136,
1109,
1509,
2251,
1104,
1103,
13467,
14161,
113,
1107,
3975,
114,
1209,
1129,
7140,
119,
1188,
1209,
2014,
1359,
1113,
1103,
2060,
1104,
1103,
5085,
14601,
1562,
1170,
15683,
4048,
3718,
9386,
1159,
4207,
127,
118,
129,
192,
4616,
3718,
9386,
4929,
3291,
6602,
9265,
2468,
3718,
9386,
6136,
27717,
1104,
2241,
1359,
1113,
170,
7454,
7300,
14044,
25669,
15391,
1161,
3418,
1121,
121,
118,
1275,
113,
121,
1110,
2999,
2241,
117,
1275,
1110,
3999,
1894,
114,
1209,
1129,
2103,
1170,
15683,
4048,
3718,
9386,
1159,
4207,
124,
118,
125,
192,
4616,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
11336,
1665,
27975,
1174,
4420,
1209,
1129,
2609,
1106,
1343,
1114,
170,
25128,
12685,
118,
9893,
1107,
3465,
1358,
1137,
26558,
1193,
19849,
113,
1674,
1136,
20118,
1763,
1103,
185,
11478,
5878,
1616,
4167,
15394,
114,
4816,
6718,
15852,
2765,
1610,
16430,
7903,
1104,
1103,
2241,
1104,
1103,
1822,
3187,
1137,
107,
149,
107,
1877,
119,
1109,
14601,
1538,
4929,
122,
119,
121,
118,
123,
119,
121,
1665,
1306,
1107,
6119,
6211,
11025,
119,
17037,
26271,
1116,
1538,
2960,
1107,
7641,
6108,
1105,
120,
1137,
6873,
5552,
1785,
119,
1109,
14601,
1538,
1145,
10541,
3112,
18717,
1113,
3189,
1104,
1103,
1560,
25128,
12685,
3507,
4807,
113,
25128,
12685,
1538,
1129,
7597,
132,
1175,
1538,
1129,
25399,
14601,
1115,
5315,
1748,
3252,
114,
119,
7195,
9080,
1144,
3211,
1106,
2194,
9635,
16409,
1665,
17855,
140,
10587,
3464,
131,
146,
6262,
26761,
8178,
1643,
16071,
4862,
1137,
13280,
13601,
14226,
4455,
11135,
1988,
119,
16752,
4487,
24704,
4578,
2116,
1106,
13467,
4252,
16073,
119,
16752,
4487,
24704,
4578,
2116,
1106,
1329,
1104,
8366,
1348,
15683,
113,
188,
114,
113,
174,
119,
176,
119,
117,
1607,
1104,
1155,
26949,
3232,
4167,
21943,
10721,
1106,
8366,
1348,
126,
118,
23896,
14824,
4084,
6617,
1233,
114,
7199,
3073,
24581,
117,
4264,
1180,
1129,
6391,
117,
8525,
1774,
1106,
14255,
23566,
117,
1137,
4007,
1314,
1441,
2050,
5082,
1348,
1669,
1115,
1110,
1136,
4137,
1895,
1118,
3485,
1654,
3442,
113,
126,
118,
143,
7535,
14824,
4084,
6617,
1233,
1110,
10203,
4370,
161,
114,
17037,
26271,
1110,
1231,
21754,
8071,
8118,
138,
19515,
15384,
1116,
3225,
1183,
19340,
5772,
1398,
5867,
1425,
1407,
5848,
4177,
1425,
1620,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2129,
3232,
2190,
2129,
3232,
2129,
3232,
1271,
14477,
1926,
148,
143,
18323,
117,
9292,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
22120,
20581,
21336,
16770,
1568,
2129,
3232,
174,
6346,
180,
1377,
8057,
3820,
137,
1610,
18575,
1320,
1665,
21472,
1665,
119,
8916,
2129,
3232,
1271,
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141,
142,
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8904,
117,
9292,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
22120,
20581,
21336,
16770,
1568,
2129,
3232,
174,
6346,
179,
2007,
13012,
8904,
137,
1610,
18575,
1320,
1665,
21472,
1665,
119,
8916,
2905,
2078,
2190,
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2078,
2905,
2078,
1271,
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141,
142,
13012,
8904,
117,
9292,
2905,
2078,
13494,
8185,
18575,
1320,
18601,
9682,
21943,
4807,
2905,
2078,
1648,
8013,
1130,
5710,
3121,
25524,
1766,
2450,
2190,
2450,
2450,
3695,
8185,
18575,
1320,
18601,
9682,
21943,
4807,
1105,
12556,
9524,
17910,
2450,
2781,
11336,
1665,
27975,
1158,
2450,
1331,
155,
23516,
9143,
2450,
1352,
2550,
2450,
195,
9717,
11202,
16229,
2450,
1583,
1244,
1311,
2450,
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full study rank 61711 study protocol section identification module n c t id NCT04832919 org study id info org study id 3P30DA011041-23S1 org study id type U.S. NIH Grant/Contract org study id link https://reporter.nih.gov/quickSearch/3P30DA011041-23S1 organization org full name New York University org class OTHER brief title A Nurse-Community Health Worker-Family Partnership Model: Addressing Uptake of COVID-19 Testing and Control Measures official title A Nurse-Community Health Worker-Family Partnership Model to Increase COVID19 Testing in Urban Underserved and Vulnerable Communities status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 23, 2021 start date type Actual primary completion date struct primary completion date April 2023 primary completion date type Anticipated completion date struct completion date April 2023 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date July 13, 2022 last update post date struct last update post date July 15, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name New York University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Historically, health disparities in the US are concentrated among underserved communities and socially vulnerable populations. The disproportionate COVID-19 related morbidity and mortality in communities of color and socioeconomic disadvantage acutely highlight this persistent public health problem, drawing attention to the urgent need for more equitable reach of testing, prevention, and control measures. The proposed research addresses this need using a 2-arm randomized controlled trial (RCT) that will evaluate the effectiveness of the Nurse-Community Health Worker (CHW)-Family Partnership intervention in promoting COVID-19 testing uptake, adoption of COVID control measures, and mutual aid capacity at the household level in an underserved and vulnerable population disproportionately affected by COVID-19. Enrolled households will be randomly assigned to either the intervention group where families will receive the Nurse-CHW-Family Partnership intervention including the offer of in-home testing and referral to seasonal influenza vaccination services, or the treatment-as-usual control group, which will be used to measure actual testing rates among public housing residents in relation to participant and household characteristics. The study hypothesis is that the Nurse-CHW-Family Partnership intervention will improve household-level COVID-19 testing uptake, adoption of COVID control measures, and mutual aid capacity relative to the treatment-as-usual control. detailed description The investigators will recruit and follow a randomly-chosen sample of NYCHA public housing residents in the proposed target community who meet multiple criteria for being considered vulnerable or underserved. The current study will address knowledge gaps regarding COVID-19 testing, treatment, and household prevention strategies, and generate new knowledge related to the epidemiology of COVID-19 in these communities. Working with community partners, the investigators will create an acceptable and feasible intervention and testing infrastructure in advance of the influenza season, with a view toward designing best practices for sustainable COVID-19 testing, prevention, and preparedness for vaccination trials. The investigators will implement a 2-arm RCT that will evaluate the effectiveness of the Nurse-CHW-Family Partnership Intervention in promoting COVID testing uptake, adoption of COVID control measures, and household mutual aid capacity. The investigators will recruit members of randomly selected households in their homes using area sampling methods used with excellent results in the investigators' previous research in the target community. Participants will complete a baseline assessment and the entire household will be randomized to either the experimental or a treatment-as-usual control condition, which will be used to measure actual testing rates among public housing residents in relation to participant and household characteristics. The baseline sample will include 150 households, and 400 individual household members, randomized in a 2:1 ratio, intervention:control. Families will complete follow-up assessments at 6 and 9 months following the baseline. In-home testing and referral to seasonal influenza vaccination services will be offered to the intervention group; whereas the control group will receive treatment as usual at multiple NYC Department of Health COVID-19 testing sites that are within walking distance of each of the three housing complexes. Test acceptance will be recorded, and incentives will be paid for study visits, not for testing. conditions module condition list condition COVID-19 keyword list keyword SARS-CoV-2 COVID-19 COVID-19 testing Behavioral COVID-19 Mitigation Measures design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 400 enrollment type Anticipated arms interventions module arm group list arm group arm group label Nurse-Community Health Worker-Family Partnership arm group type Experimental arm group description The experimental arm will receive the Nurse-Community Health Worker-Family Partnership intervention arm group intervention list arm group intervention name Behavioral: Nurse-Community-Family Partnership Intervention arm group label Standard of Care arm group type No Intervention arm group description The control arm will receive standard access to NYC Department of Health COVID-19 testing sites and standard COVID-19 public health messaging intervention list intervention intervention type Behavioral intervention name Nurse-Community-Family Partnership Intervention intervention description Nurses conduct home visits on a monthly basis for the first five months post-baseline. During visits, nurses emphasize the importance of infection control measures and, jointly with household members, develop and follow-up on the implementation of an infection control plan tailored to the unique circumstances of the household. Nurses deliver training on infection control skills necessary for optimal implementation of the plan. Nurses offer at-home SARS-CoV-2 testing to all members of the household. Nurses conduct triage, medical case management, monitoring, and follow-up of individuals identified to have COVID-19 or any other acute health emergencies. CHWs conduct visits on a bi-weekly basis for the first five months post-baseline. CHWs deliver healthcare information and medical mistrust counseling in a culturally relevant and linguistically appropriate fashion; and provide social support, navigate household members to social welfare/vocational/economic/psychosocial services. intervention arm group label list intervention arm group label Nurse-Community Health Worker-Family Partnership outcomes module primary outcome list primary outcome primary outcome measure Household COVID-19 Testing Uptake primary outcome description All medical services delivered by nurses during home-visits (such as COVID-19 test administration) will be carefully documented by the investigative team. At the time of the assessment, the investigators will obtain self-reported information regarding COVID-19 testing uptake by study participants in the treatment and control groups. Respondents will be asked whether they have received COVID-19 testing in the past three months [Yes/No]. primary outcome time frame Delayed Follow-Up (9 Months) primary outcome measure COVID-19 Symptoms, Diagnoses, and Testing Scale primary outcome description An adapted version of the (PhenX Toolkit) COVID-19 Symptoms, Diagnoses, and Testing Scale will be used to measure COVID-19 symptoms, diagnoses, and testing. Participants will be asked questions regarding whether they are currently sick with an illness that might be related to COVID-19, any symptoms the participant experienced in the past three months [Check All That Apply], and the result of the participant's last COVID-19 test [Positive/Negative]. primary outcome time frame Delayed Follow-Up (9 Months) secondary outcome list secondary outcome secondary outcome measure COVID-19 Avoidant Behaviors Scale secondary outcome description An adapted version of the COVID-19 Avoidant Behaviors Scale (PhenX Toolkit) will be used to measure the secondary study outcome of COVID-19 control measure uptake. Respondents will be asked questions regarding their engagement in behaviors associated with COVID-19 exposure on a 5-point scale [Almost Never, Sometimes, a Moderate Amount of the Time, Most of the Time, Always]; with greater values indicating higher frequency of uptake of COVID-19 prevention behaviors in the past three months (e.g., "Had close contact (within 6 feet) with people who do not live with you. "Gone out to a bar, club, or other place where people gather) and questions regarding their uptake of COVID-19 control (e.g., "Worn a mask or other face covering." "Washed your hands with soap or used hand sanitizer several times per day"). secondary outcome time frame Delayed Follow-Up (9 Months) secondary outcome measure Vaccine Uptake secondary outcome description Referral to COVID-19 and seasonal influenza vaccination services by study nurses to intervention group participants will be carefully documented by the investigative team. At the time of the delayed assessment, the investigators will obtain self-reported information and documentation of COVID-19 and influenza vaccine uptake by study participants in the treatment as usual control group. For self-reported information, respondents will be asked if they received the flu shot in the past three months [Yes/No] and whether they received the COVID-19 vaccine [Yes/No], the type of vaccine, and the number of doses. secondary outcome time frame Delayed follow up (9 months) secondary outcome measure COVID-19 Improved Household & Family Mutual Aid secondary outcome description A set of measures will assess families' abilities to adjust to the COVID-19 pandemic, as evidenced by the reported overall impact of COVID-19 on family dynamics and relationships, psychological distress, food and housing insecurity, substance use, and sexual behavior in the past three months. secondary outcome time frame Delayed follow up (9 months) secondary outcome measure COVID-19 Household Environment Scale secondary outcome description An adapted version of the COVID-19 Household Environment Scale will be used to measure the secondary study outcome household/family mutual aid. The scale measures household conflict/togetherness. Participants are asked to rate, on a 5-point Likert scale, how much more or less conflict there was (as compared to before COVID-19) about 15 topics in the past three months (e.g., "Home maintenance;" "Decisions about visitors to the home"), with higher values indicating greater frequency of family conflict concerning the topic. secondary outcome time frame Delayed follow up (9 months) secondary outcome measure Household COVID-19 Testing Uptake secondary outcome description All medical services delivered by nurses during home-visits (such as COVID-19 test administration) will be carefully documented by the investigative team. At the time of the assessment, the investigators will obtain self-reported information regarding COVID-19 testing uptake by study participants in the treatment and control groups. Respondents will be asked whether they have received COVID-19 testing in the past six months [Yes/No]. secondary outcome time frame Immediate follow up (6 months) secondary outcome measure COVID-19 Symptoms, Diagnoses, and Testing Scale secondary outcome description An adapted version of the (PhenX Toolkit) COVID-19 Symptoms, Diagnoses, and Testing Scale will be used to measure COVID-19 symptoms, diagnoses, and testing. Participants will be asked questions regarding whether they are currently sick with an illness that might be related to COVID-19, any symptoms the participant experienced in the past six months [Check All That Apply], and the result of the participant's last COVID-19 test [Positive/Negative]. secondary outcome time frame Immediate follow up (6 months) secondary outcome measure COVID-19 Avoidant Behaviors Scale secondary outcome description An adapted version of the COVID-19 Avoidant Behaviors Scale (PhenX Toolkit) will be used to measure the secondary study outcome of COVID-19 control measure uptake. Respondents will be asked questions regarding their engagement in behaviors associated with COVID-19 exposure on a 5-point scale [Almost Never, Sometimes, a Moderate Amount of the Time, Most of the Time, Always]; with greater values indicating higher frequency of uptake of COVID-19 prevention behaviors in the past six months (e.g., "Had close contact (within 6 feet) with people who do not live with you. "Gone out to a bar, club, or other place where people gather) and questions regarding their uptake of COVID-19 control (e.g., "Worn a mask or other face covering." "Washed your hands with soap or used hand sanitizer several times per day"). secondary outcome time frame Immediate follow up (6 months) secondary outcome measure Vaccine Uptake secondary outcome description Referral to COVID-19 and seasonal influenza vaccination services by study nurses to intervention group participants will be carefully documented by the investigative team. At the time of the assessment, the investigators will obtain self-reported information and documentation of COVID-19 and influenza vaccine uptake by study participants in the treatment as usual control group. For self-reported information, respondents will be asked if they received the flu shot in the past six months [Yes/No] and whether they received the COVID-19 vaccine [Yes/No], the type of vaccine, and the number of doses. secondary outcome time frame Immediate follow up (6 months) secondary outcome measure COVID-19 Improved Household & Family Mutual Aid secondary outcome description A set of measures will assess families' abilities to adjust to the COVID-19 pandemic, as evidenced by the reported overall impact of COVID-19 on family dynamics and relationships, psychological distress, food and housing insecurity, substance use, and sexual behavior in the past six months. secondary outcome time frame Immediate follow up (6 months) secondary outcome measure COVID-19 Household Environment Scale secondary outcome description An adapted version of the COVID-19 Household Environment Scale will be used to measure the secondary study outcome household/family mutual aid. The scale measures household conflict/togetherness. Participants are asked to rate, on a 5-point Likert scale, how much more or less conflict there was (as compared to before COVID-19) about 15 topics in the past six months (e.g., "Home maintenance;" "Decisions about visitors to the home"), with higher values indicating greater frequency of family conflict concerning the topic. secondary outcome time frame Immediate follow up (6 months) eligibility module eligibility criteria Inclusion Criteria:
Residence in one of the public housing complexes in Mott Haven, South Bronx
English or Spanish-speaking
Age 10 years or older
Willing and able to provide informed consent or assent
Exclusion Criteria:
Non-resident of one of the public housing complexes in Mott Haven, South Bronx
Neither English nor Spanish speaker
Younger than 10 years old, unless household index case tests antigen positive. In this instance, all members of family will be included.
Unwilling or unable to provide informed consent or assent healthy volunteers Accepts Healthy Volunteers gender All minimum age 10 Years std age list std age Child Adult Older Adult contacts locations module central contact list central contact central contact name Vincent M Guilamo-Ramos, PhD central contact role Contact central contact phone 212-998-4306 central contact e mail vincent.ramos@nyu.edu central contact name Holly Hagan, PhD central contact role Contact central contact phone 212-998-5221 central contact e mail hh50@nyu.edu overall official list overall official overall official name Vincent M Guilamo-Ramos, PhD overall official affiliation New York University overall official role Principal Investigator overall official name Holly Hagan, PhD overall official affiliation New York University overall official role Principal Investigator location list location location facility New York University location status Recruiting location city New York location state New York location zip 10003 location country United States location contact list location contact location contact name Desiree Williams, MPH location contact role Contact location contact e mail dw2483@nyu.edu location contact name Adam Benzekri, MS location contact role Contact location contact phone 833-774-1799 location contact e mail ab7170@nyu.edu i p d sharing statement module i p d sharing Yes i p d sharing description The project team will share all individual participant data that underlie the results reported in any future published manuscript, after deidentification (text, tables, figures, and appendices). We will make available the study protocol and statistical analysis plan. The project team will make the data available beginning 3 months and ending 5 years following article publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Investigators will be approved to conduct analyses to achieve the aims in the proposal that they submit for approval by an independent review committee. Proposals should be directed to Dr. Holly Hagan (hh50@nyu.edu). To gain access, data requesters will need to sign a data access agreement. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) i p d sharing time frame The project team will make the data available beginning 3 months and ending 5 years following article publication. i p d sharing access criteria The project team will make the data available for investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. document section large document module large doc list large doc large doc type abbrev Prot large doc has protocol Yes large doc has s a p No large doc has i c f No large doc label Study Protocol large doc date July 12, 2022 large doc upload date 07/12/2022 19:54 large doc filename Prot_000.pdf large doc type abbrev SAP large doc has protocol No large doc has s a p Yes large doc has i c f No large doc label Statistical Analysis Plan large doc date July 12, 2022 large doc upload date 07/12/2022 19:54 large doc filename SAP_001.pdf derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology | NCT04832919 | [
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14056,
1942,
1568,
19203,
17101,
1580,
16382,
8916,
2025,
25021,
23992,
8916,
2025,
25021,
124,
2101,
13144,
11392,
24400,
10424,
25892,
118,
1695,
1708,
1475,
8916,
2025,
25021,
2076,
158,
119,
156,
119,
151,
2240,
3048,
4468,
120,
16752,
15017,
8916,
2025,
25021,
5088,
18630,
131,
120,
120,
6672,
119,
11437,
1324,
119,
1301,
1964,
120,
3613,
1708,
19386,
1732,
120,
124,
2101,
13144,
11392,
24400,
10424,
25892,
118,
1695,
1708,
1475,
2369,
8916,
1554,
1271,
1203,
1365,
1239,
8916,
1705,
152,
24162,
9637,
4094,
1641,
138,
17418,
118,
3704,
3225,
26455,
118,
3921,
17330,
6747,
131,
24930,
18380,
1158,
3725,
13482,
1104,
18732,
23314,
2137,
118,
1627,
27259,
1105,
6342,
2508,
27523,
2078,
1641,
138,
17418,
118,
3704,
3225,
26455,
118,
3921,
17330,
6747,
1106,
3561,
15691,
18732,
23314,
2137,
16382,
27259,
1107,
6972,
2831,
17886,
1181,
1105,
159,
4654,
2511,
1895,
21474,
2781,
13196,
2781,
22480,
2236,
1351,
17881,
1477,
2905,
2781,
11336,
1665,
27975,
1158,
3631,
2469,
23992,
1144,
3631,
2469,
1302,
1838,
2236,
188,
23055,
1838,
2236,
1351,
1695,
117,
17881,
1475,
1838,
2236,
2076,
2173,
4746,
2425,
6026,
2236,
188,
23055,
2425,
6026,
2236,
1364,
17881,
1495,
2425,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
6026,
2236,
188,
23055,
6026,
2236,
1364,
17881,
1495,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
2025,
1148,
12295,
2236,
1364,
123,
117,
17881,
1475,
2025,
1148,
12295,
186,
172,
2236,
1364,
123,
117,
17881,
1475,
2025,
1148,
2112,
2236,
188,
23055,
2025,
1148,
2112,
2236,
1364,
127,
117,
17881,
1475,
2025,
1148,
2112,
2236,
2076,
2173,
4746,
1314,
11984,
12295,
2236,
1351,
1492,
117,
17881,
1477,
1314,
11984,
2112,
2236,
188,
23055,
1314,
11984,
2112,
2236,
1351,
1405,
117,
17881,
1477,
1314,
11984,
2112,
2236,
2076,
2173,
4746,
10767,
24146,
13196,
2784,
1710,
2784,
1710,
2076,
156,
5674,
27035,
1197,
1730,
10767,
1730,
10767,
1271,
1203,
1365,
1239,
1730,
10767,
1705,
152,
24162,
9637,
20051,
13196,
20051,
1144,
173,
182,
172,
2160,
1110,
175,
173,
170,
12521,
3850,
1302,
1110,
175,
173,
170,
12521,
4442,
1302,
6136,
13196,
4094,
14940,
14630,
117,
2332,
4267,
20080,
7710,
4338,
1107,
1103,
1646,
1132,
7902,
1621,
1223,
17886,
1181,
3611,
1105,
15315,
8018,
6623,
119,
1109,
4267,
20080,
12736,
12148,
1988,
2193,
18732,
23314,
2137,
118,
1627,
2272,
182,
1766,
14598,
1785,
1105,
14471,
1107,
3611,
1104,
2942,
1105,
20650,
25726,
22611,
12104,
1193,
13426,
1142,
15970,
1470,
2332,
2463,
117,
4619,
2209,
1106,
1103,
14844,
1444,
1111,
1167,
174,
18276,
8637,
2519,
1104,
5193,
117,
13347,
117,
1105,
1654,
5252,
119,
1109,
3000,
1844,
11869,
1142,
1444,
1606,
170,
123,
118,
1981,
7091,
2200,
4013,
3443,
113,
25157,
1942,
114,
1115,
1209,
17459,
1103,
12949,
1104,
1103,
17418,
118,
3704,
3225,
26455,
113,
24890,
2924,
114,
118,
3921,
17330,
9108,
1107,
7495,
18732,
23314,
2137,
118,
1627,
5193,
1146,
13482,
117,
10156,
1104,
18732,
23314,
2137,
1654,
5252,
117,
1105,
9175,
4256,
3211,
1120,
1103,
3705,
1634,
1107,
1126,
1223,
17886,
1181,
1105,
8018,
1416,
4267,
20080,
12736,
12148,
1988,
16310,
4634,
1118,
18732,
23314,
2137,
118,
1627,
119,
13832,
10747,
1174,
3065,
1209,
1129,
19729,
3346,
1106,
1719,
1103,
9108,
1372,
1187,
2073,
1209,
3531,
1103,
17418,
118,
24890,
2924,
118,
3921,
17330,
9108,
1259,
1103,
2906,
1104,
1107,
118,
1313,
5193,
1105,
5991,
4412,
1106,
13286,
1107,
27206,
191,
7409,
16430,
1891,
1826,
117,
1137,
1103,
3252,
118,
1112,
118,
4400,
1654,
1372,
117,
1134,
1209,
1129,
1215,
1106,
4929,
4315,
5193,
5600,
1621,
1470,
3328,
3159,
1107,
6796,
1106,
14031,
1105,
3705,
5924,
119,
1109,
2025,
11066,
1110,
1115,
1103,
17418,
118,
24890,
2924,
118,
3921,
17330,
9108,
1209,
4607,
3705,
118,
1634,
18732,
23314,
2137,
118,
1627,
5193,
1146,
13482,
117,
10156,
1104,
18732,
23314,
2137,
1654,
5252,
117,
1105,
9175,
4256,
3211,
5236,
1106,
1103,
3252,
118,
1112,
118,
4400,
1654,
119,
6448,
6136,
1109,
17718,
1209,
14240,
1105,
2812,
170,
19729,
118,
3468,
6876,
1104,
17520,
11612,
1470,
3328,
3159,
1107,
1103,
3000,
4010,
1661,
1150,
2283,
2967,
9173,
1111,
1217,
1737,
8018,
1137,
1223,
17886,
1181,
119,
1109,
1954,
2025,
1209,
4134,
3044,
18249,
4423,
18732,
23314,
2137,
118,
1627,
5193,
117,
3252,
117,
1105,
3705,
13347,
10700,
117,
1105,
9509,
1207,
3044,
2272,
1106,
1103,
174,
25786,
5521,
17288,
1104,
18732,
23314,
2137,
118,
1627,
1107,
1292,
3611,
119,
9612,
1114,
1661,
6449,
117,
1103,
17718,
1209,
2561,
1126,
12095,
1105,
25667,
9108,
1105,
5193,
6557,
1107,
4657,
1104,
1103,
1107,
27206,
1265,
117,
1114,
170,
2458,
1755,
13795,
1436,
5660,
1111,
10940,
18732,
23314,
2137,
118,
1627,
5193,
117,
13347,
117,
1105,
4029,
1757,
1111,
191,
7409,
16430,
1891,
7356,
119,
1109,
17718,
1209,
10407,
170,
123,
118,
1981,
25157,
1942,
1115,
1209,
17459,
1103,
12949,
1104,
1103,
17418,
118,
24890,
2924,
118,
3921,
17330,
11300,
21987,
1107,
7495,
18732,
23314,
2137,
5193,
1146,
13482,
117,
10156,
1104,
18732,
23314,
2137,
1654,
5252,
117,
1105,
3705,
9175,
4256,
3211,
119,
1109,
17718,
1209,
14240,
1484,
1104,
19729,
2700,
3065,
1107,
1147,
4481,
1606,
1298,
18200,
4069,
1215,
1114,
6548,
2686,
1107,
1103,
17718,
112,
2166,
1844,
1107,
1103,
4010,
1661,
119,
4539,
27989,
21868,
1209,
2335,
170,
2259,
2568,
8670,
1105,
1103,
2072,
3705,
1209,
1129,
7091,
2200,
1106,
1719,
1103,
6700,
1137,
170,
3252,
118,
1112,
118,
4400,
1654,
3879,
117,
1134,
1209,
1129,
1215,
1106,
4929,
4315,
5193,
5600,
1621,
1470,
3328,
3159,
1107,
6796,
1106,
14031,
1105,
3705,
5924,
119,
1109,
2259,
2568,
6876,
1209,
1511,
4214,
3065,
117,
1105,
3434,
2510,
3705,
1484,
117,
7091,
2200,
1107,
170,
123,
131,
122,
6022,
117,
9108,
131,
1654,
119,
21860,
1209,
2335,
2812,
118,
1146,
25451,
1120,
127,
1105,
130,
1808,
1378,
1103,
2259,
2568,
119,
1130,
118,
1313,
5193,
1105,
5991,
4412,
1106,
13286,
1107,
27206,
191,
7409,
16430,
1891,
1826,
1209,
1129,
2356,
1106,
1103,
9108,
1372,
132,
6142,
1103,
1654,
1372,
1209,
3531,
3252,
1112,
4400,
1120,
2967,
17520,
1951,
1104,
3225,
18732,
23314,
2137,
118,
1627,
5193,
3911,
1115,
1132,
1439,
3179,
2462,
1104,
1296,
1104,
1103,
1210,
3328,
16575,
119,
5960,
10030,
1209,
1129,
1802,
117,
1105,
24273,
1209,
1129,
3004,
1111,
2025,
7508,
117,
1136,
1111,
5193,
119,
2975,
13196,
3879,
2190,
3879,
18732,
23314,
2137,
118,
1627,
2501,
12565,
2190,
2501,
12565,
13411,
8900,
118,
3291,
2559,
118,
123,
18732,
23314,
2137,
118,
1627,
18732,
23314,
2137,
118,
1627,
5193,
4108,
2328,
17564,
1348,
18732,
23314,
2137,
118,
1627,
12107,
3121,
10716,
2508,
27523,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
18461,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8353,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
3929,
19191,
1116,
1249,
8830,
21484,
10803,
23992,
10803,
5099,
3434,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
17418,
118,
3704,
3225,
26455,
118,
3921,
17330,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1109,
6700,
1981,
1209,
3531,
1103,
17418,
118,
3704,
3225,
26455,
118,
3921,
17330,
9108,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
17418,
118,
3704,
118,
3921,
17330,
11300,
21987,
1981,
1372,
3107,
6433,
1104,
8396,
1981,
1372,
2076,
1302,
11300,
21987,
1981,
1372,
6136,
1109,
1654,
1981,
1209,
3531,
2530,
2469,
1106,
17520,
1951,
1104,
3225,
18732,
23314,
2137,
118,
1627,
5193,
3911,
1105,
2530,
18732,
23314,
2137,
118,
1627,
1470,
2332,
6477,
10588,
9108,
2190,
9108,
9108,
2076,
4108,
2328,
17564,
1348,
9108,
1271,
17418,
118,
3704,
118,
3921,
17330,
11300,
21987,
9108,
6136,
17418,
1116,
5880,
1313,
7508,
1113,
170,
7868,
3142,
1111,
1103,
1148,
1421,
1808,
2112,
118,
2259,
2568,
119,
1507,
7508,
117,
13318,
19291,
1103,
4495,
1104,
8974,
1654,
5252,
1105,
117,
10824,
1114,
3705,
1484,
117,
3689,
1105,
2812,
118,
1146,
1113,
1103,
7249,
1104,
1126,
8974,
1654,
2197,
24423,
1106,
1103,
3527,
5607,
1104,
1103,
3705,
119,
17418,
1116,
7852,
2013,
1113,
8974,
1654,
4196,
3238,
1111,
17307,
7249,
1104,
1103,
2197,
119,
17418,
1116,
2906,
1120,
118,
1313,
13411,
8900,
118,
3291,
2559,
118,
123,
5193,
1106,
1155,
1484,
1104,
1103,
3705,
119,
17418,
1116,
5880,
189,
3464,
2176,
117,
2657,
1692,
2635,
117,
9437,
117,
1105,
2812,
118,
1146,
1104,
2833,
3626,
1106,
1138,
18732,
23314,
2137,
118,
1627,
1137,
1251,
1168,
12104,
2332,
12982,
9885,
119,
24890,
2924,
1116,
5880,
7508,
1113,
170,
16516,
118,
5392,
3142,
1111,
1103,
1148,
1421,
1808,
2112,
118,
2259,
2568,
119,
24890,
2924,
1116,
7852,
12520,
1869,
1105,
2657,
12791,
19604,
22138,
1107,
170,
23656,
7503,
1105,
13633,
2716,
5806,
4633,
132,
1105,
2194,
1934,
1619,
117,
24713,
3705,
1484,
1106,
1934,
9319,
120,
18341,
120,
2670,
120,
15604,
21155,
22354,
12562,
1826,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
17418,
118,
3704,
3225,
26455,
118,
3921,
17330,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
25705,
18732,
23314,
2137,
118,
1627,
27259,
3725,
13482,
2425,
9386,
6136,
1398,
2657,
1826,
4653,
1118,
13318,
1219,
1313,
118,
7508,
113,
1216,
1112,
18732,
23314,
2137,
118,
1627,
2774,
3469,
114,
1209,
1129,
4727,
8510,
1118,
1103,
19043,
1264,
119,
1335,
1103,
1159,
1104,
1103,
8670,
117,
1103,
17718,
1209,
6268,
2191,
118,
2103,
1869,
4423,
18732,
23314,
2137,
118,
1627,
5193,
1146,
13482,
1118,
2025,
6635,
1107,
1103,
3252,
1105,
1654,
2114,
119,
11336,
20080,
16838,
9857,
1209,
1129,
1455,
2480,
1152,
1138,
1460,
18732,
23314,
2137,
118,
1627,
5193,
1107,
1103,
1763,
1210,
1808,
164,
2160,
120,
1302,
166,
119,
2425,
9386,
1159,
4207,
9352,
4164,
1174,
19253,
118,
3725,
113,
130,
17545,
1116,
114,
2425,
9386,
4929,
18732,
23314,
2137,
118,
1627,
156,
17162,
6451,
17112,
117,
12120,
8517,
22583,
1116,
117,
1105,
27259,
20334,
2425,
9386,
6136,
1760,
5546,
1683,
1104,
1103,
113,
7642,
1424,
3190,
6466,
10493,
2875,
114,
18732,
23314,
2137,
118,
1627,
156,
17162,
6451,
17112,
117,
12120,
8517,
22583,
1116,
117,
1105,
27259,
20334,
1209,
1129,
1215,
1106,
4929,
18732,
23314,
2137,
118,
1627,
8006,
117,
4267,
8517,
22583,
1116,
117,
1105,
5193,
119,
4539,
27989,
21868,
1209,
1129,
1455,
3243,
4423,
2480,
1152,
1132,
1971,
4809,
1114,
1126,
6946,
1115,
1547,
1129,
2272,
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full study rank 61341 study protocol section identification module n c t id NCT04837729 org study id info org study id 701 organization org full name Mersin University org class OTHER brief title The Effect of Acupressure Applied to Menopausal Women on Menopausal Symptoms and Quality of Life official title The Effect of Acupressure Applied to Menopausal Women on Menopausal Symptoms and Quality of Life status module status verified date June 2022 overall status Completed expanded access info has expanded access No start date struct start date May 15, 2021 start date type Actual primary completion date struct primary completion date June 15, 2021 primary completion date type Actual completion date struct completion date November 15, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date June 3, 2022 last update post date struct last update post date June 7, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ahu AKSOY responsible party investigator title Research Assistant responsible party investigator affiliation Mersin University lead sponsor lead sponsor name Mersin University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary In this randomized controlled study, it was aimed to determine the effect of acupressure on menopausal symptoms and quality of life and the relationship between menopausal symptoms and quality of life. Three different hypothesis teams have been established for the study. These; H0: There is no significant difference between the menopause rating scores of the women in the study group in which acupressure was applied and the control group without acupressure.
H1: There is a significant difference between the menopause rating scores of the women in the study group in which acupressure was applied and the control group without acupressure.
H0: There is no significant difference between the quality of life scores of the women in the study group in which acupressure was applied and the control group without acupressure.
H1: There is a significant difference between the quality of life scores of the women in the study group in which acupressure was applied and the control group without acupressure.
H0: There is no relationship between menopause rating scores and quality of life scores of women in the study group in which acupressure was applied and in the control group without acupressure.
H1: There is a relationship between menopause rating scores and quality of life scores of women in the study group in which acupressure was applied and in the control group without acupressure. detailed description Parallel to the increase in life expectancy by years, the population of women living in the post-menopausal period is also increasing. In order to have a healthy menopause, which is an important part of women's life, it is thought that the acupressure without health risks by women may be effective in reducing the symptoms of menopause experienced by women and quality of life. In line with this information, it was aimed to determine the effect of acupressure on menopausal symptoms and quality of life and the relationship between menopausal symptoms and quality of life. The study will be carried out with menopausal women between the ages of 40-60 in Mersin province in Turkey. Therefore, in the study, 46 women in the menopausal period between the ages of 40-60 will be randomly assigned to acupressure and control groups. The study group (n = 23) will be applied to the determined points in a certain order. Sequence of application Large intestine 4th point (LI 4), Heart 7th point (HT 7), Triple warmer point 23 (TE 23), Stomach 36th point (ST 36), Spleen 6th point (SP 6) and Liver The 3rd point is (LV 3). Acupressure application for 20-25 minutes three times a week for four weeks will be applied individually to the study group. No intervention will be made to the control group for a period of four weeks. The primary expected outcome of the research is the effect of acupressure on menopausal symptoms of menopausal women. The second expected result of the study is to determine the effect of acupressure on quality of life. Results will be applied three times in total, before the study and control application, two weeks and 4 weeks later. conditions module condition list condition Menopausal Symptom Quality of Life keyword list keyword Acupressure Menopause Menopausal symptoms Quality of life Nursing design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Supportive Care design masking info design masking Single design who masked list design who masked Investigator enrollment info enrollment count 61 enrollment type Actual arms interventions module arm group list arm group arm group label Experimental (acupressure) group arm group type Experimental arm group description Acupressure (complementary and integrative medicine method) Acupressure will be applied individually to the experimental group for 20-25 minutes three times a week for four weeks. Data collection forms will be applied 3 times in total, before the intervention, in the second and the fourth week. arm group intervention list arm group intervention name Other: Acupressure arm group label Control group arm group type No Intervention arm group description No intervention will be made to women in the control group. However, data collection forms will be applied 3 times in total, before the intervention, in the second and the fourth week. intervention list intervention intervention type Other intervention name Acupressure intervention description acupressure is a non-pharmacological method originating from traditional Chinese medicine. According to the National Cancer Institute, acupressure is defined as pressure / massage applied to certain parts of the body to control symptoms such as pain or nausea. The main purpose of acupressure is to stimulate the regions associated with the specific organ by applying pressure with energy channels called meridians. intervention arm group label list intervention arm group label Experimental (acupressure) group outcomes module primary outcome list primary outcome primary outcome measure Menopause Rating Scale primary outcome description It was developed in German by Schneider et al. In 1992 to measure the severity of menopausal symptoms and was adapted to English in 1996. MRT was adapted to Turkish by Gürkan in our country in 2005. There are "0 = None", "1 = Mild", "2 = Moderate", "3 = Severe" and "4 = Very severe" options for each item in the Likert-type scale consisting of 11 items including menopausal complaints. The total score of the scale is calculated based on the scores given for each item. The lowest score that can be obtained from the scale is 0, the highest score is 44. primary outcome time frame change from before intervention, 2nd and 4th week of intervention secondary outcome list secondary outcome secondary outcome measure World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF) secondary outcome description Life of quality will be evaluated by using the WHOQOL-BREF-TR. This scale consists of 27 questions. There are a total of five areas in the scale: physical, mental, social, environmental and national environmental areas. Each area is evaluated within itself. The domain score is calculated with the score it gets from the questions that determine it. Field scores are evaluated between 4-20. Increasing score indicates goodness. Cronbach's alpha internal consistency coefficients of the scale; 0.83 in the physical area, 0.66 in the spiritual area, 0.53 in the social area, 0.73 in the environmental area and 0.73 in the national environmental area. secondary outcome time frame change from before intervention, 2nd and 4th week of intervention eligibility module eligibility criteria Inclusion Criteria:
Willing to participate in research,
Can read and write in Turkish,
Open to communication,
Those who are between the ages of 40-60 and do not experience menstruation for at least one year,
Experiencing at least one or more of the menopausal symptoms,
Do not use medication for the treatment of menopausal symptoms,
No chronic disease,
Body mass index <30 kg / m2,
Not applying regular acupressure,
Those who have not surgically entered menopause,
Women without psychiatric problems
Exclusion Criteria:
- who do not agree to participate in the research,
Can't read and write Turkish,
Communication is not possible,
Those who are younger than 40, older than 60, have experienced menstruation for at least one year,
Do not experience the symptoms of menopause,
Using medication for the treatment of menopausal symptoms,
Chronic illness,
Body mass index ≥30 kg / m2,
Regular acupressure is applied,
Surgically in menopause,
Women with psychiatric problems healthy volunteers Accepts Healthy Volunteers gender Female gender based Yes gender description Women aged 40-60 who are in menopause minimum age 40 Years maximum age 60 Years std age list std age Adult contacts locations module overall official list overall official overall official name Duygu VEFİKULUÇAY YILMAZ, Dr. overall official affiliation Mersin University Nursing Faculty overall official role Study Director location list location location facility Mersin University location city Mersi̇n location zip 33140 location country Turkey references module reference list reference reference p m i d 28504569 reference type background reference citation Kao YH, Huang YC, Chung UL, Hsu WN, Tang YT, Liao YH. Comparisons for Effectiveness of Aromatherapy and Acupressure Massage on Quality of Life in Career Women: A Randomized Controlled Trial. J Altern Complement Med. 2017 Jun;23(6):451-460. doi: 10.1089/acm.2016.0403. Epub 2017 May 15. reference p m i d 28584553 reference type background reference citation Ahmadinezhad M, Kargar M, Vizeshfar F, Hadianfard MJ. Comparison of the Effect of Acupressure and Pilates-Based Exercises on Sleep Quality of Postmenopausal Women: A Randomized Controlled Trial. Iran J Nurs Midwifery Res. 2017 Mar-Apr;22(2):140-146. doi: 10.4103/1735-9066.205954. see also link list see also link see also link label Effect of acupressure on early complications of menopause in women referring to selected health care centers see also link u r l https://www.ijnmrjournal.net/crossrefCitation.asp?doi=10.4103/1735-9066.208165 see also link label Effect of Auricular Acupressure on Peri- and Early Postmenopausal Women with Anxiety: A Double-Blinded, Randomized, and Controlled Pilot Study see also link u r l https://downloads.hindawi.com/journals/ecam/2012/567639.pdf i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf as found Quality of Life condition browse leaf relevance high condition browse leaf id T6036 condition browse leaf name Menopause condition browse leaf as found Menopausal condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions | NCT04837729 | [
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4746,
6026,
2236,
188,
23055,
6026,
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1379,
1405,
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1475,
6026,
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2236,
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127,
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186,
172,
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1364,
127,
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1475,
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188,
23055,
2025,
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129,
117,
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1475,
2025,
1148,
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2076,
2173,
4746,
1314,
11984,
12295,
2236,
1340,
124,
117,
17881,
1477,
1314,
11984,
2112,
2236,
188,
23055,
1314,
11984,
2112,
2236,
1340,
128,
117,
17881,
1477,
1314,
11984,
2112,
2236,
2076,
2173,
4746,
10767,
24146,
13196,
2784,
1710,
2784,
1710,
2076,
8013,
1130,
5710,
3121,
25524,
1766,
2784,
1710,
17805,
1554,
1271,
7066,
1358,
25808,
23161,
3663,
2784,
1710,
17805,
1641,
2713,
5414,
2784,
1710,
17805,
13494,
2508,
1733,
1394,
1239,
1730,
10767,
1730,
10767,
1271,
2508,
1733,
1394,
1239,
1730,
10767,
1705,
152,
24162,
9637,
20051,
13196,
20051,
1144,
173,
182,
172,
2160,
1110,
175,
173,
170,
12521,
3850,
1302,
1110,
175,
173,
170,
12521,
4442,
1302,
6136,
13196,
4094,
14940,
1130,
1142,
7091,
2200,
4013,
2025,
117,
1122,
1108,
5850,
1106,
4959,
1103,
2629,
1104,
170,
18637,
7370,
3313,
1113,
1441,
4184,
25134,
1348,
8006,
1105,
3068,
1104,
1297,
1105,
1103,
2398,
1206,
1441,
4184,
25134,
1348,
8006,
1105,
3068,
1104,
1297,
119,
2677,
1472,
11066,
1929,
1138,
1151,
1628,
1111,
1103,
2025,
119,
1636,
132,
145,
1568,
131,
1247,
1110,
1185,
2418,
3719,
1206,
1103,
1441,
4184,
25134,
1162,
5261,
7432,
1104,
1103,
1535,
1107,
1103,
2025,
1372,
1107,
1134,
170,
18637,
7370,
3313,
1108,
3666,
1105,
1103,
1654,
1372,
1443,
170,
18637,
7370,
3313,
119,
145,
1475,
131,
1247,
1110,
170,
2418,
3719,
1206,
1103,
1441,
4184,
25134,
1162,
5261,
7432,
1104,
1103,
1535,
1107,
1103,
2025,
1372,
1107,
1134,
170,
18637,
7370,
3313,
1108,
3666,
1105,
1103,
1654,
1372,
1443,
170,
18637,
7370,
3313,
119,
145,
1568,
131,
1247,
1110,
1185,
2418,
3719,
1206,
1103,
3068,
1104,
1297,
7432,
1104,
1103,
1535,
1107,
1103,
2025,
1372,
1107,
1134,
170,
18637,
7370,
3313,
1108,
3666,
1105,
1103,
1654,
1372,
1443,
170,
18637,
7370,
3313,
119,
145,
1475,
131,
1247,
1110,
170,
2418,
3719,
1206,
1103,
3068,
1104,
1297,
7432,
1104,
1103,
1535,
1107,
1103,
2025,
1372,
1107,
1134,
170,
18637,
7370,
3313,
1108,
3666,
1105,
1103,
1654,
1372,
1443,
170,
18637,
7370,
3313,
119,
145,
1568,
131,
1247,
1110,
1185,
2398,
1206,
1441,
4184,
25134,
1162,
5261,
7432,
1105,
3068,
1104,
1297,
7432,
1104,
1535,
1107,
1103,
2025,
1372,
1107,
1134,
170,
18637,
7370,
3313,
1108,
3666,
1105,
1107,
1103,
1654,
1372,
1443,
170,
18637,
7370,
3313,
119,
145,
1475,
131,
1247,
1110,
170,
2398,
1206,
1441,
4184,
25134,
1162,
5261,
7432,
1105,
3068,
1104,
1297,
7432,
1104,
1535,
1107,
1103,
2025,
1372,
1107,
1134,
170,
18637,
7370,
3313,
1108,
3666,
1105,
1107,
1103,
1654,
1372,
1443,
170,
18637,
7370,
3313,
119,
6448,
6136,
23994,
4838,
1233,
1106,
1103,
2773,
1107,
1297,
5363,
10413,
1118,
1201,
117,
1103,
1416,
1104,
1535,
1690,
1107,
1103,
2112,
118,
1441,
4184,
25134,
1348,
1669,
1110,
1145,
4138,
119,
1130,
1546,
1106,
1138,
170,
8071,
1441,
4184,
25134,
1162,
117,
1134,
1110,
1126,
1696,
1226,
1104,
1535,
112,
188,
1297,
117,
1122,
1110,
1354,
1115,
1103,
170,
18637,
7370,
3313,
1443,
2332,
11040,
1118,
1535,
1336,
1129,
3903,
1107,
7914,
1103,
8006,
1104,
1441,
4184,
25134,
1162,
4531,
1118,
1535,
1105,
3068,
1104,
1297,
119,
1130,
1413,
1114,
1142,
1869,
117,
1122,
1108,
5850,
1106,
4959,
1103,
2629,
1104,
170,
18637,
7370,
3313,
1113,
1441,
4184,
25134,
1348,
8006,
1105,
3068,
1104,
1297,
1105,
1103,
2398,
1206,
1441,
4184,
25134,
1348,
8006,
1105,
3068,
1104,
1297,
119,
1109,
2025,
1209,
1129,
2446,
1149,
1114,
1441,
4184,
25134,
1348,
1535,
1206,
1103,
6776,
1104,
1969,
118,
2539,
1107,
2508,
1733,
1394,
3199,
1107,
4439,
119,
6589,
117,
1107,
1103,
2025,
117,
3993,
1535,
1107,
1103,
1441,
4184,
25134,
1348,
1669,
1206,
1103,
6776,
1104,
1969,
118,
2539,
1209,
1129,
19729,
3346,
1106,
170,
18637,
7370,
3313,
1105,
1654,
2114,
119,
1109,
2025,
1372,
113,
183,
134,
1695,
114,
1209,
1129,
3666,
1106,
1103,
3552,
1827,
1107,
170,
2218,
1546,
119,
22087,
25113,
1104,
4048,
10236,
1107,
13053,
2042,
3492,
1553,
113,
149,
2240,
125,
114,
117,
4641,
4766,
1553,
113,
145,
1942,
128,
114,
117,
9457,
18153,
1553,
1695,
113,
157,
2036,
1695,
114,
117,
1457,
7903,
1732,
23646,
1553,
113,
23676,
3164,
114,
117,
156,
7136,
1424,
4584,
1553,
113,
16625,
127,
114,
1105,
3374,
1197,
1109,
2973,
1553,
1110,
113,
149,
2559,
124,
114,
119,
138,
18637,
7370,
3313,
4048,
1111,
1406,
118,
1512,
1904,
1210,
1551,
170,
1989,
1111,
1300,
2277,
1209,
1129,
3666,
15473,
1106,
1103,
2025,
1372,
119,
1302,
9108,
1209,
1129,
1189,
1106,
1103,
1654,
1372,
1111,
170,
1669,
1104,
1300,
2277,
119,
1109,
2425,
2637,
9386,
1104,
1103,
1844,
1110,
1103,
2629,
1104,
170,
18637,
7370,
3313,
1113,
1441,
4184,
25134,
1348,
8006,
1104,
1441,
4184,
25134,
1348,
1535,
119,
1109,
1248,
2637,
1871,
1104,
1103,
2025,
1110,
1106,
4959,
1103,
2629,
1104,
170,
18637,
7370,
3313,
1113,
3068,
1104,
1297,
119,
16005,
1209,
1129,
3666,
1210,
1551,
1107,
1703,
117,
1196,
1103,
2025,
1105,
1654,
4048,
117,
1160,
2277,
1105,
125,
2277,
1224,
119,
2975,
13196,
3879,
2190,
3879,
3401,
4184,
25134,
1348,
156,
17162,
6451,
4165,
14801,
1104,
2583,
2501,
12565,
2190,
2501,
12565,
138,
18637,
7370,
3313,
3401,
4184,
25134,
1162,
3401,
4184,
25134,
1348,
8006,
14801,
1104,
1297,
15192,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
8704,
2109,
8396,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8353,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
1130,
5710,
3121,
25524,
1766,
10803,
23992,
10803,
5099,
5391,
10803,
2076,
2173,
4746,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
17635,
113,
170,
18637,
7370,
3313,
114,
1372,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
138,
18637,
7370,
3313,
113,
24671,
1105,
1107,
1566,
14867,
3946,
5182,
3442,
114,
138,
18637,
7370,
3313,
1209,
1129,
3666,
15473,
1106,
1103,
6700,
1372,
1111,
1406,
118,
1512,
1904,
1210,
1551,
170,
1989,
1111,
1300,
2277,
119,
7154,
2436,
2769,
1209,
1129,
3666,
124,
1551,
1107,
1703,
117,
1196,
1103,
9108,
117,
1107,
1103,
1248,
1105,
1103,
2223,
1989,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
138,
18637,
7370,
3313,
1981,
1372,
3107,
6342,
1372,
1981,
1372,
2076,
1302,
11300,
21987,
1981,
1372,
6136,
1302,
9108,
1209,
1129,
1189,
1106,
1535,
1107,
1103,
1654,
1372,
119,
1438,
117,
2233,
2436,
2769,
1209,
1129,
3666,
124,
1551,
1107,
1703,
117,
1196,
1103,
9108,
117,
1107,
1103,
1248,
1105,
1103,
2223,
1989,
119,
9108,
2190,
9108,
9108,
2076,
2189,
9108,
1271,
138,
18637,
7370,
3313,
9108,
6136,
170,
18637,
7370,
3313,
1110,
170,
1664,
118,
185,
7111,
1918,
23388,
3442,
16394,
1121,
2361,
1922,
5182,
119,
1792,
1106,
1103,
1305,
11558,
2024,
117,
170,
18637,
7370,
3313,
1110,
3393,
1112,
2997,
120,
26088,
3666,
1106,
2218,
2192,
1104,
1103,
1404,
1106,
1654,
8006,
1216,
1112,
2489,
1137,
22882,
119,
1109,
1514,
3007,
1104,
170,
18637,
7370,
3313,
1110,
1106,
26225,
1103,
4001,
2628,
1114,
1103,
2747,
5677,
1118,
11892,
2997,
1114,
2308,
6412,
1270,
1143,
10132,
5895,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
17635,
113,
170,
18637,
7370,
3313,
114,
1372,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
3401,
4184,
25134,
1162,
21632,
1158,
20334,
2425,
9386,
6136,
1135,
1108,
1872,
1107,
1528,
1118,
15934,
3084,
2393,
119,
1130,
1924,
1106,
4929,
1103,
20997,
1104,
1441,
4184,
25134,
1348,
8006,
1105,
1108,
5546,
1106,
1483,
1107,
1820,
119,
25827,
1942,
1108,
5546,
1106,
4229,
1118,
144,
17176,
23870,
1179,
1107,
1412,
1583,
1107,
1478,
119,
1247,
1132,
107,
121,
134,
7330,
107,
117,
107,
122,
134,
12107,
5253,
107,
117,
107,
123,
134,
18390,
5498,
107,
117,
107,
124,
134,
22087,
25243,
107,
1105,
107,
125,
134,
6424,
5199,
107,
6665,
1111,
1296,
8926,
1107,
1103,
2409,
3740,
118,
2076,
3418,
4721,
1104,
1429,
4454,
1259,
1441,
4184,
25134,
1348,
11344,
119,
1109,
1703,
2794,
1104,
1103,
3418,
1110,
10056,
1359,
1113,
1103,
7432,
1549,
1111,
1296,
8926,
119,
1109,
6905,
2794,
1115,
1169,
1129,
3836,
1121,
1103,
3418,
1110,
121,
117,
1103,
2439,
2794,
1110,
3140,
119,
2425,
9386,
1159,
4207,
1849,
1121,
1196,
9108,
117,
2518,
1105,
3492,
1989,
1104,
9108,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
1291,
3225,
6534,
14801,
1104,
2583,
1130,
2050,
5697,
3452,
117,
6373,
15075,
113,
23750,
4880,
13901,
118,
26660,
14663,
114,
3718,
9386,
6136,
2583,
1104,
3068,
1209,
1129,
17428,
1118,
1606,
1103,
23750,
4880,
13901,
118,
26660,
14663,
118,
157,
2069,
119,
1188,
3418,
2923,
1104,
1765,
3243,
119,
1247,
1132,
170,
1703,
1104,
1421,
1877,
1107,
1103,
3418,
131,
2952,
117,
4910,
117,
1934,
117,
4801,
1105,
1569,
4801,
1877,
119,
2994,
1298,
1110,
17428,
1439,
2111,
119,
1109,
5777,
2794,
1110,
10056,
1114,
1103,
2794,
1122,
3370,
1121,
1103,
3243,
1115,
4959,
1122,
119,
3479,
7432,
1132,
17428,
1206,
125,
118,
1406,
119,
3561,
11811,
4253,
2794,
6653,
18023,
119,
140,
3484,
6396,
112,
188,
11164,
4422,
20904,
23795,
1104,
1103,
3418,
132,
121,
119,
6032,
1107,
1103,
2952,
1298,
117,
121,
119,
5046,
1107,
1103,
6170,
1298,
117,
121,
119,
4389,
1107,
1103,
1934,
1298,
117,
121,
119,
5766,
1107,
1103,
4801,
1298,
1105,
121,
119,
5766,
1107,
1103,
1569,
4801,
1298,
119,
3718,
9386,
1159,
4207,
1849,
1121,
1196,
9108,
117,
2518,
1105,
3492,
1989,
1104,
9108,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
3100,
1158,
1106,
4868,
1107,
1844,
117,
2825,
2373,
1105,
3593,
1107,
4229,
117,
3353,
1106,
4909,
117,
4435,
1150,
1132,
1206,
1103,
6776,
1104,
1969,
118,
2539,
1105,
1202,
1136,
2541,
1441,
2050,
5082,
1891,
1111,
1120,
1655,
1141,
1214,
117,
16409,
3365,
8584,
4869,
1120,
1655,
1141,
1137,
1167,
1104,
1103,
1441,
4184,
25134,
1348,
8006,
117,
2091,
1136,
1329,
15683,
1111,
1103,
3252,
1104,
1441,
4184,
25134,
1348,
8006,
117,
1302,
13306,
3653,
117,
10341,
3367,
7448,
133,
1476,
4023,
120,
182,
1477,
117,
1753,
11892,
2366,
170,
18637,
7370,
3313,
117,
4435,
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full study rank 61757 study protocol section identification module n c t id NCT04832321 org study id info org study id 2013P000395_1 organization org full name Massachusetts General Hospital org class OTHER brief title Measuring Beliefs and Norms About Persons With Alcohol Use Disorder official title Measuring Beliefs and Norms About Persons With Alcohol Use Disorder status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date February 19, 2021 start date type Actual primary completion date struct primary completion date December 31, 2021 primary completion date type Anticipated completion date struct completion date December 31, 2021 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Alexander Tsai responsible party investigator title Associate Professor of Psychiatry responsible party investigator affiliation Massachusetts General Hospital lead sponsor lead sponsor name Massachusetts General Hospital lead sponsor class OTHER collaborator list collaborator collaborator name Mbarara University of Science and Technology collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Survey experiment to estimate drivers of stigma toward people with alcohol use disorder detailed description Despite significant advances in scientific understanding of substance use disorders accompanied by significant advances in treatment and improvements in prognosis, substance use disorder remains highly stigmatized throughout the world. Previous studies suggest that portraying alcohol use disorder as treatable can reduce negative attitudes toward persons with alcohol use disorder. This randomized controlled trial compares the effects of exposing study participants to vignettes portraying persons with untreated and symptomatic alcohol use disorder vs. treated alcohol use disorder with complete response vs. treated alcohol use disorder with relapse, with and without adverse economic impacts. It is hypothesized, based on prior work, that study participants exposed to vignettes depicting treated alcohol use disorder with completed response would have the greatest effect on reducing negative attitudes toward persons with alcohol use disorder, followed by treated alcohol use disorder with relapse and untreated and symptomatic alcohol use disorder, and that adverse economic impacts will exacerbate negative attitudes toward persons with alcohol use disorder. conditions module condition list condition Alcohol Use Disorder (AUD) keyword list keyword Stigma design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Other design masking info design masking Double design masking description Study participants are randomly assigned to be read vignettes with slight changes in wording. Neither study participants nor outcomes assessors are provided with information about "treatment" assignment. design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 1553 enrollment type Anticipated arms interventions module arm group list arm group arm group label No intervention: V1: Control arm group type No Intervention arm group description This version of the survey questionnaire depicts a young man with no symptoms of alcohol use disorder arm group label Experimental: V2: Alcohol Use Disorder arm group type Experimental arm group description As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder. arm group intervention list arm group intervention name Other: Survey questionnaire arm group label Experimental: V3: Alcohol Use Disorder + Treatment with Response arm group type Experimental arm group description As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder who is successfully treated with complete response. arm group intervention list arm group intervention name Other: Survey questionnaire arm group label Experimental: V4: Alcohol Use Disorder + Treatment with Relapse arm group type Experimental arm group description As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder who is successfully treated with partial relapse. arm group intervention list arm group intervention name Other: Survey questionnaire arm group label Experimental: V5: Alcohol Use Disorder + Economic Impact arm group type Experimental arm group description As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder whose untreated alcohol use disorder negatively affects his family's finances. arm group intervention list arm group intervention name Other: Survey questionnaire arm group label Experimental: V6: Alcohol Use Disorder + Economic Impact + Treatment with Response arm group type Experimental arm group description As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder whose untreated alcohol use disorder negatively affects his family's finances, who is then successfully treated with complete response. arm group intervention list arm group intervention name Other: Survey questionnaire arm group label Experimental: V7: Alcohol Use Disorder + Economic Impact + Treatment with Relapse arm group type Experimental arm group description As this is a survey experiment, the "intervention" involves random assignment to a survey questionnaire with specific wording. This version of the survey questionnaire depicts a young man with symptomatic, untreated alcohol use disorder whose untreated alcohol use disorder negatively affects his family's finances, who is then successfully treated with partial relapse and continued negative economic impact. arm group intervention list arm group intervention name Other: Survey questionnaire intervention list intervention intervention type Other intervention name Survey questionnaire intervention description Each version of the questionnaire portrays a young Ugandan man with different profiles of illness severity, treatment, and treatment response. intervention arm group label list intervention arm group label Experimental: V2: Alcohol Use Disorder Experimental: V3: Alcohol Use Disorder + Treatment with Response Experimental: V4: Alcohol Use Disorder + Treatment with Relapse Experimental: V5: Alcohol Use Disorder + Economic Impact Experimental: V6: Alcohol Use Disorder + Economic Impact + Treatment with Response Experimental: V7: Alcohol Use Disorder + Economic Impact + Treatment with Relapse outcomes module primary outcome list primary outcome primary outcome measure Social Distance primary outcome description Willingness to have the man portrayed in the vignette to marry into the study participant's family (single item, culturally adapted instrument developed specifically for this study; response options yes/no) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate) primary outcome measure Perceived Norms about Social Distance primary outcome description Study participant's perception of the extent to which other people would be willing to have the man portrayed in the vignette to marry into their families (single item, culturally adapted instrument developed specifically for this study; response options on a Likert-type scale: 1=all or almost all; 2=more than half but less than all; 3=fewer than half but more than no one; 4=very few or no one) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate) primary outcome measure Negative Attitudes (Attribution) primary outcome description Personal belief that the symptoms of the man portrayed in the vignette represent divine punishment (single item, culturally adapted instrument developed specifically for this study; response options yes/no) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate) primary outcome measure Perceived Norms about Negative Attitudes (Attribution) primary outcome description Study participant's perception of the extent to which other people believe that the symptoms of the man portrayed in the vignette represent divine punishment (single item, culturally adapted instrument developed specifically for this study; response options on a Likert-type scale: 1=all or almost all; 2=more than half but less than all; 3=fewer than half but more than no one; 4=very few or no one) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate) primary outcome measure Negative Attitudes (Shame) primary outcome description Personal belief that the symptoms of the man portrayed in the vignette bring shame upon his family (single item, culturally adapted instrument developed specifically for this study; response options yes/no) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate) primary outcome measure Perceived Norms about Negative Attitudes (Shame) primary outcome description Study participant's perception of the extent to which other people believe that the symptoms of the man portrayed in the vignette bring shame upon his family (single item, culturally adapted instrument developed specifically for this study; response options on a Likert-type scale: 1=all or almost all; 2=more than half but less than all; 3=fewer than half but more than no one; 4=very few or no one) primary outcome time frame Baseline (The experimental manipulation in this study has to do with which version of the survey the study participant receives, so the time frame for assessment is immediate) eligibility module eligibility criteria Inclusion Criteria:
All adults who consider Nyakabare their primary place of residence and who are capable of providing consent
Exclusion Criteria:
Minors younger than 18 years of age, with the exception of emancipated minors
Persons who do not consider Nyakabare Parish their primary place of residence, e.g., persons who happen to be visiting Nyakabare at the time of the survey or who own a home in Nyakabare but spend most of their time outside the parish
Persons with psychosis, neurological damage, acute intoxication, or other cognitive impairment (all of which are determined informally in the field by non-clinical research staff in consultation with a supervisor) healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Alexander C Tsai, MD central contact role Contact central contact phone 617-724-1120 central contact e mail actsai@partners.org central contact name Emily Satinsky, MSc central contact role Contact central contact phone 617-724-1120 central contact e mail esatinsky@partners.org overall official list overall official overall official name Alexander C Tsai, MD overall official affiliation Massachusetts General Hospital overall official role Principal Investigator location list location location facility Mbarara University of Science and Technology location status Recruiting location city Mbarara location country Uganda location contact list location contact location contact name Bernard Kakuhikire, MBA location contact role Contact location contact phone 256-075-250-4030 location contact e mail baitwakaku@gmail.com location contact name Charles Baguma, MPH location contact role Contact location contact phone 256-077-564-1558 location contact e mail cbaguma@mustresearch.org i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000437 condition mesh term Alcoholism condition mesh id D000000428 condition mesh term Alcohol Drinking condition ancestor list condition ancestor condition ancestor id D000004327 condition ancestor term Drinking Behavior condition ancestor id D000019973 condition ancestor term Alcohol-Related Disorders condition ancestor id D000019966 condition ancestor term Substance-Related Disorders condition ancestor id D000064419 condition ancestor term Chemically-Induced Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M2926 condition browse leaf name Alcohol Drinking condition browse leaf as found Alcohol Use condition browse leaf relevance high condition browse leaf id M2935 condition browse leaf name Alcoholism condition browse leaf as found Alcohol Use Disorder condition browse leaf relevance high condition browse leaf id M6654 condition browse leaf name Drinking Behavior condition browse leaf relevance low condition browse leaf id M20995 condition browse leaf name Alcohol-Related Disorders condition browse leaf relevance low condition browse leaf id M20990 condition browse leaf name Substance-Related Disorders condition browse leaf relevance low condition browse leaf id M29455 condition browse leaf name Chemically-Induced Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC25 condition browse branch name Substance Related Disorders intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M2929 intervention browse leaf name Ethanol intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04832321 | [
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24730,
11268,
170,
1685,
1299,
1114,
188,
17162,
6451,
7903,
2941,
117,
8362,
7877,
2913,
6272,
1329,
8936,
1150,
1110,
4358,
5165,
1114,
7597,
1231,
16046,
2217,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
8157,
2304,
24730,
1981,
1372,
3107,
17635,
131,
159,
1571,
131,
2586,
2528,
14084,
11696,
12120,
21484,
2692,
116,
6051,
13788,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1249,
1142,
1110,
170,
5980,
7886,
117,
1103,
107,
9108,
107,
6808,
7091,
8641,
1106,
170,
5980,
2304,
24730,
1114,
2747,
1937,
1158,
119,
1188,
1683,
1104,
1103,
5980,
2304,
24730,
11268,
170,
1685,
1299,
1114,
188,
17162,
6451,
7903,
2941,
117,
8362,
7877,
2913,
6272,
1329,
8936,
2133,
8362,
7877,
2913,
6272,
1329,
8936,
21598,
13974,
1117,
1266,
112,
188,
18488,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
8157,
2304,
24730,
1981,
1372,
3107,
17635,
131,
159,
1545,
131,
2586,
2528,
14084,
11696,
12120,
21484,
2692,
116,
6051,
13788,
116,
19165,
1114,
24187,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1249,
1142,
1110,
170,
5980,
7886,
117,
1103,
107,
9108,
107,
6808,
7091,
8641,
1106,
170,
5980,
2304,
24730,
1114,
2747,
1937,
1158,
119,
1188,
1683,
1104,
1103,
5980,
2304,
24730,
11268,
170,
1685,
1299,
1114,
188,
17162,
6451,
7903,
2941,
117,
8362,
7877,
2913,
6272,
1329,
8936,
2133,
8362,
7877,
2913,
6272,
1329,
8936,
21598,
13974,
1117,
1266,
112,
188,
18488,
117,
1150,
1110,
1173,
4358,
5165,
1114,
2335,
2593,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
8157,
2304,
24730,
1981,
1372,
3107,
17635,
131,
159,
1559,
131,
2586,
2528,
14084,
11696,
12120,
21484,
2692,
116,
6051,
13788,
116,
19165,
1114,
11336,
16046,
2217,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1249,
1142,
1110,
170,
5980,
7886,
117,
1103,
107,
9108,
107,
6808,
7091,
8641,
1106,
170,
5980,
2304,
24730,
1114,
2747,
1937,
1158,
119,
1188,
1683,
1104,
1103,
5980,
2304,
24730,
11268,
170,
1685,
1299,
1114,
188,
17162,
6451,
7903,
2941,
117,
8362,
7877,
2913,
6272,
1329,
8936,
2133,
8362,
7877,
2913,
6272,
1329,
8936,
21598,
13974,
1117,
1266,
112,
188,
18488,
117,
1150,
1110,
1173,
4358,
5165,
1114,
7597,
1231,
16046,
2217,
1105,
1598,
4366,
2670,
3772,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
8157,
2304,
24730,
9108,
2190,
9108,
9108,
2076,
2189,
9108,
1271,
8157,
2304,
24730,
9108,
6136,
2994,
1683,
1104,
1103,
2304,
24730,
18801,
170,
1685,
9831,
1179,
1299,
1114,
1472,
21138,
1104,
6946,
20997,
117,
3252,
117,
1105,
3252,
2593,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
17635,
131,
159,
1477,
131,
2586,
2528,
14084,
11696,
12120,
21484,
2692,
17635,
131,
159,
1495,
131,
2586,
2528,
14084,
11696,
12120,
21484,
2692,
116,
19165,
1114,
24187,
17635,
131,
159,
1527,
131,
2586,
2528,
14084,
11696,
12120,
21484,
2692,
116,
19165,
1114,
11336,
16046,
2217,
17635,
131,
159,
1571,
131,
2586,
2528,
14084,
11696,
12120,
21484,
2692,
116,
6051,
13788,
17635,
131,
159,
1545,
131,
2586,
2528,
14084,
11696,
12120,
21484,
2692,
116,
6051,
13788,
116,
19165,
1114,
24187,
17635,
131,
159,
1559,
131,
2586,
2528,
14084,
11696,
12120,
21484,
2692,
116,
6051,
13788,
116,
19165,
1114,
11336,
16046,
2217,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
3563,
22694,
2425,
9386,
6136,
3100,
1158,
1757,
1106,
1138,
1103,
1299,
6313,
1107,
1103,
191,
11368,
6347,
1106,
5390,
1154,
1103,
2025,
14031,
112,
188,
1266,
113,
1423,
8926,
117,
23656,
5546,
6337,
1872,
4418,
1111,
1142,
2025,
132,
2593,
6665,
4208,
120,
1185,
114,
2425,
9386,
1159,
4207,
14562,
2042,
113,
1109,
6700,
18776,
1107,
1142,
2025,
1144,
1106,
1202,
1114,
1134,
1683,
1104,
1103,
5980,
1103,
2025,
14031,
7881,
117,
1177,
1103,
1159,
4207,
1111,
8670,
1110,
5670,
114,
2425,
9386,
4929,
14286,
21437,
16162,
4206,
1164,
3563,
22694,
2425,
9386,
6136,
8690,
14031,
112,
188,
11170,
1104,
1103,
6102,
1106,
1134,
1168,
1234,
1156,
1129,
4988,
1106,
1138,
1103,
1299,
6313,
1107,
1103,
191,
11368,
6347,
1106,
5390,
1154,
1147,
2073,
113,
1423,
8926,
117,
23656,
5546,
6337,
1872,
4418,
1111,
1142,
2025,
132,
2593,
6665,
1113,
170,
2409,
3740,
118,
2076,
3418,
131,
122,
134,
1155,
1137,
1593,
1155,
132,
123,
134,
1167,
1190,
1544,
1133,
1750,
1190,
1155,
132,
124,
134,
8307,
1190,
1544,
1133,
1167,
1190,
1185,
1141,
132,
125,
134,
1304,
1374,
1137,
1185,
1141,
114,
2425,
9386,
1159,
4207,
14562,
2042,
113,
1109,
6700,
18776,
1107,
1142,
2025,
1144,
1106,
1202,
1114,
1134,
1683,
1104,
1103,
5980,
1103,
2025,
14031,
7881,
117,
1177,
1103,
1159,
4207,
1111,
8670,
1110,
5670,
114,
2425,
9386,
4929,
151,
12606,
5838,
1335,
3121,
22764,
113,
1335,
14970,
114,
2425,
9386,
6136,
13907,
6369,
1115,
1103,
8006,
1104,
1103,
1299,
6313,
1107,
1103,
191,
11368,
6347,
4248,
10455,
7703,
113,
1423,
8926,
117,
23656,
5546,
6337,
1872,
4418,
1111,
1142,
2025,
132,
2593,
6665,
4208,
120,
1185,
114,
2425,
9386,
1159,
4207,
14562,
2042,
113,
1109,
6700,
18776,
1107,
1142,
2025,
1144,
1106,
1202,
1114,
1134,
1683,
1104,
1103,
5980,
1103,
2025,
14031,
7881,
117,
1177,
1103,
1159,
4207,
1111,
8670,
1110,
5670,
114,
2425,
9386,
4929,
14286,
21437,
16162,
4206,
1164,
151,
12606,
5838,
1335,
3121,
22764,
113,
1335,
14970,
114,
2425,
9386,
6136,
8690,
14031,
112,
188,
11170,
1104,
1103,
6102,
1106,
1134,
1168,
1234,
2059,
1115,
1103,
8006,
1104,
1103,
1299,
6313,
1107,
1103,
191,
11368,
6347,
4248,
10455,
7703,
113,
1423,
8926,
117,
23656,
5546,
6337,
1872,
4418,
1111,
1142,
2025,
132,
2593,
6665,
1113,
170,
2409,
3740,
118,
2076,
3418,
131,
122,
134,
1155,
1137,
1593,
1155,
132,
123,
134,
1167,
1190,
1544,
1133,
1750,
1190,
1155,
132,
124,
134,
8307,
1190,
1544,
1133,
1167,
1190,
1185,
1141,
132,
125,
134,
1304,
1374,
1137,
1185,
1141,
114,
2425,
9386,
1159,
4207,
14562,
2042,
113,
1109,
6700,
18776,
1107,
1142,
2025,
1144,
1106,
1202,
1114,
1134,
1683,
1104,
1103,
5980,
1103,
2025,
14031,
7881,
117,
1177,
1103,
1159,
4207,
1111,
8670,
1110,
5670,
114,
2425,
9386,
4929,
151,
12606,
5838,
1335,
3121,
22764,
113,
156,
25948,
114,
2425,
9386,
6136,
13907,
6369,
1115,
1103,
8006,
1104,
1103,
1299,
6313,
1107,
1103,
191,
11368,
6347,
2498,
10499,
1852,
1117,
1266,
113,
1423,
8926,
117,
23656,
5546,
6337,
1872,
4418,
1111,
1142,
2025,
132,
2593,
6665,
4208,
120,
1185,
114,
2425,
9386,
1159,
4207,
14562,
2042,
113,
1109,
6700,
18776,
1107,
1142,
2025,
1144,
1106,
1202,
1114,
1134,
1683,
1104,
1103,
5980,
1103,
2025,
14031,
7881,
117,
1177,
1103,
1159,
4207,
1111,
8670,
1110,
5670,
114,
2425,
9386,
4929,
14286,
21437,
16162,
4206,
1164,
151,
12606,
5838,
1335,
3121,
22764,
113,
156,
25948,
114,
2425,
9386,
6136,
8690,
14031,
112,
188,
11170,
1104,
1103,
6102,
1106,
1134,
1168,
1234,
2059,
1115,
1103,
8006,
1104,
1103,
1299,
6313,
1107,
1103,
191,
11368,
6347,
2498,
10499,
1852,
1117,
1266,
113,
1423,
8926,
117,
23656,
5546,
6337,
1872,
4418,
1111,
1142,
2025,
132,
2593,
6665,
1113,
170,
2409,
3740,
118,
2076,
3418,
131,
122,
134,
1155,
1137,
1593,
1155,
132,
123,
134,
1167,
1190,
1544,
1133,
1750,
1190,
1155,
132,
124,
134,
8307,
1190,
1544,
1133,
1167,
1190,
1185,
1141,
132,
125,
134,
1304,
1374,
1137,
1185,
1141,
114,
2425,
9386,
1159,
4207,
14562,
2042,
113,
1109,
6700,
18776,
1107,
1142,
2025,
1144,
1106,
1202,
1114,
1134,
1683,
1104,
1103,
5980,
1103,
2025,
14031,
7881,
117,
1177,
1103,
1159,
4207,
1111,
8670,
1110,
5670,
114,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
1398,
6323,
1150,
4615,
151,
2315,
1968,
6824,
1162,
1147,
2425,
1282,
1104,
4662,
1105,
1150,
1132,
4451,
1104,
3558,
9635,
16409,
1665,
17855,
140,
10587,
3464,
131,
8187,
1116,
3247,
1190,
1407,
1201,
1104,
1425,
117,
1114,
1103,
5856,
1104,
9712,
1389,
6617,
16963,
1181,
21675,
24113,
1150,
1202,
1136,
4615,
151,
2315,
1968,
6824,
1162,
6648,
1147,
2425,
1282,
1104,
4662,
117,
174,
119,
176,
119,
117,
4983,
1150,
3333,
1106,
1129,
5807,
151,
2315,
1968,
6824,
1162,
1120,
1103,
1159,
1104,
1103,
5980,
1137,
1150,
1319,
170,
1313,
1107,
151,
2315,
1968,
6824,
1162,
1133,
4511,
1211,
1104,
1147,
1159,
1796,
1103,
3363,
24113,
1114,
15604,
21155,
11776,
117,
24928,
11955,
7810,
3290,
117,
12104,
1154,
8745,
14520,
117,
1137,
1168,
12176,
24034,
8341,
1880,
113,
1155,
1104,
1134,
1132,
3552,
25355,
1107,
1103,
1768,
1118,
1664,
118,
7300,
1844,
2546,
1107,
18261,
1114,
170,
16014,
114,
8071,
8118,
138,
19515,
15384,
1116,
3225,
1183,
19340,
5772,
1398,
5867,
1425,
1407,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2129,
3232,
2190,
2129,
3232,
2129,
3232,
1271,
2792,
140,
157,
19021,
117,
9292,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
5391,
1559,
118,
5117,
1527,
118,
11150,
1568,
2129,
3232,
174,
6346,
4096,
3814,
137,
6449,
119,
8916,
2129,
3232,
1271,
5590,
17784,
6105,
4969,
117,
10978,
1665,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
5391,
1559,
118,
5117,
1527,
118,
11150,
1568,
2129,
3232,
174,
6346,
13936,
11745,
22226,
137,
6449,
119,
8916,
2905,
2078,
2190,
2905,
2078,
2905,
2078,
1271,
2792,
140,
157,
19021,
117,
9292,
2905,
2078,
13494,
3559,
1615,
3355,
2905,
2078,
1648,
8013,
1130,
5710,
3121,
25524,
1766,
2450,
2190,
2450,
2450,
3695,
150,
18228,
1611,
1239,
1104,
2444,
1105,
3529,
2450,
2781,
11336,
1665,
27975,
1158,
2450,
1331,
150,
18228,
1611,
2450,
1583,
9831,
2450,
3232,
2190,
2450,
3232,
2450,
3232,
1271,
6190,
14812,
4786,
3031,
2293,
1874,
117,
16079,
2450,
3232,
1648,
24367,
2450,
3232,
2179,
18440,
118,
5004,
1571,
118,
4805,
118,
1969,
13144,
2450,
3232,
174,
6346,
21012,
3624,
1968,
4786,
137,
176,
14746,
119,
3254,
2450,
3232,
1271,
1889,
18757,
19524,
1161,
117,
5478,
3048,
2450,
3232,
1648,
24367,
2450,
3232,
2179,
18440,
118,
5004,
1559,
118,
4376,
1527,
118,
14691,
1604,
2450,
3232,
174,
6346,
172,
17097,
10161,
137,
1538,
4894,
19386,
1732,
119,
8916,
178,
185,
173,
6303,
4195,
13196,
178,
185,
173,
6303,
1302,
4408,
2237,
1940,
1116,
1665,
23992,
13196,
1683,
10266,
1382,
5507,
117,
17881,
1477,
3879,
11424,
1162,
13196,
3879,
24000,
2190,
3879,
24000,
3879,
24000,
25021,
141,
7629,
7629,
7629,
25631,
1559,
3879,
24000,
1858,
2586,
2528,
14084,
1863,
3879,
24000,
25021,
141,
7629,
7629,
7629,
23117,
1604,
3879,
24000,
1858,
2586,
2528,
14084,
1987,
10223,
1158,
3879,
13596,
2190,
3879,
13596,
3879,
13596,
25021,
141,
7629,
7629,
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full study rank 61228 study protocol section identification module n c t id NCT04839198 org study id info org study id HSC-SPH-20-1159 secondary id info list secondary id info secondary id R00DA046564 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/R00DA046564 organization org full name The University of Texas Health Science Center, Houston org class OTHER brief title Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation official title Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation status module status verified date September 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date November 1, 2021 start date type Anticipated primary completion date struct primary completion date August 31, 2022 primary completion date type Anticipated completion date struct completion date November 30, 2023 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date September 27, 2021 last update post date struct last update post date September 28, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Emily Hebert responsible party investigator title Assistant Professor responsible party investigator affiliation The University of Texas Health Science Center, Houston lead sponsor lead sponsor name The University of Texas Health Science Center, Houston lead sponsor class OTHER collaborator list collaborator collaborator name National Institute on Drug Abuse (NIDA) collaborator class NIH oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to evaluate the feasibility and preliminary effectiveness of delivering a personalized, just-in-time adaptive intervention driven by machine learning prediction of smoking lapse risk in real time. conditions module condition list condition Smoking Cessation keyword list keyword Nicotine patch design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Adaptive Treatment plus usual care arm group type Experimental arm group intervention list arm group intervention name Behavioral: Android Wear smartwatch Behavioral: Adaptive Treatment Drug: Nicotine Patch Behavioral: interviewing-based counseling arm group label Usual care arm group type Active Comparator arm group intervention list arm group intervention name Behavioral: Android Wear smartwatch Drug: Nicotine Patch Behavioral: interviewing-based counseling intervention list intervention intervention type Behavioral intervention name Android Wear smartwatch intervention description All participants will wear an Android Wear smartwatch, and will complete ecological momentary assessments (EMA). intervention arm group label list intervention arm group label Adaptive Treatment plus usual care Usual care intervention type Behavioral intervention name Adaptive Treatment intervention description Participants will have access to a "Dashboard" button in the InsightTM app that displays personalized statistics based on their progress and patterns in the study.The dashboard will update as more data is collected about the participant's smoking habits, starting in the pre-quit period and continuing through the post-quit period. Second, in the post-quit period, participants will receive treatment messages when the machine learning algorithm determines that they are at high risk for lapse.At the follow-up visit, participants will complete a survey to evaluate what they liked and disliked about the intervention, how accurate they thought the app was in predicting their risk, and how useful they found the dashboard. intervention arm group label list intervention arm group label Adaptive Treatment plus usual care intervention type Drug intervention name Nicotine Patch intervention description At Visit 2, participants will be asked to begin their attempt to quit smoking and will receive a 12-week supply of nicotine replacement therapy (i.e., nicotine patches and gum) intervention arm group label list intervention arm group label Adaptive Treatment plus usual care Usual care intervention type Behavioral intervention name interviewing-based counseling intervention description At Visit 2, participants will be asked to begin their attempt to quit smoking and meet with a Tobacco Treatment Specialist, who will provide motivational interviewing-based counseling, help the participants develop a quit plan, and discuss relapse prevention. During the 6-weeks of the study, participants will have the option of attending up to 6 counseling sessions with the Tobacco Treatment Specialist, either in-person or via phone or web. intervention arm group label list intervention arm group label Adaptive Treatment plus usual care Usual care outcomes module primary outcome list primary outcome primary outcome measure Number of patients who quit smoking as confirmed by absence of salivary cotinine primary outcome time frame 4-weeks after quit day eligibility module eligibility criteria Inclusion Criteria:
a score greater than or equal to 4 on the Rapid Estimate of Adult Literacy in Medicine Short Form (REALM-SF),12
willingness to quit smoking 14 days after the baseline visit
no contraindications to using Nicotine replacement therapy (NRT).
If participants would like to use their own phone to complete the EMAs, they must additionally have an Android smartphone (Android 5.2 or higher), and be willing to install the InsightTM mHealth app on their phone.
Exclusion Criteria:
currently smoking less than 5 cigarettes per day healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Emily Hebert, DrPH central contact role Contact central contact phone (512) 391-1351 central contact e mail Emily.T.Hebert@uth.tmc.edu overall official list overall official overall official name Emily Hebert, DrPH overall official affiliation The University of Texas Health Science Center, Houston overall official role Principal Investigator location list location location facility The University of Texas Health Science Center at Houston location city Houston location state Texas location zip 77030 location country United States location contact list location contact location contact name Emily Hebert, DrPH location contact role Contact location contact phone 512-391-1351 location contact e mail Emily.T.Hebert@uth.tmc.edu i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 intervention browse module intervention mesh list intervention mesh intervention mesh id D000009538 intervention mesh term Nicotine intervention ancestor list intervention ancestor intervention ancestor id D000005731 intervention ancestor term Ganglionic Stimulants intervention ancestor id D000001337 intervention ancestor term Autonomic Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018722 intervention ancestor term Nicotinic Agonists intervention ancestor id D000018679 intervention ancestor term Cholinergic Agonists intervention ancestor id D000018678 intervention ancestor term Cholinergic Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention browse leaf list intervention browse leaf intervention browse leaf id M11630 intervention browse leaf name Nicotine intervention browse leaf as found Inhibitor intervention browse leaf relevance high intervention browse leaf id M3181 intervention browse leaf name Central Nervous System Stimulants intervention browse leaf relevance low intervention browse leaf id M19949 intervention browse leaf name Nicotinic Agonists intervention browse leaf relevance low intervention browse leaf id M19911 intervention browse leaf name Cholinergic Agents intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev CNSSti intervention browse branch name Central Nervous System Stimulants | NCT04839198 | [
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full study rank 61750 study protocol section identification module n c t id NCT04832412 org study id info org study id AFCRO-126 organization org full name Microphyt org class INDUSTRY brief title A Randomised, Double-blind, Placebo-controlled, Parallel Study of the Effect of BrainPhyt on Cognitive Function in Healthy Older Subjects official title A Randomised, Double-blind, Placebo-controlled, Parallel Study of the Effect of BrainPhyt on Cognitive Function in Healthy Older Subjects acronym BrainPhyt-one status module status verified date June 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 12, 2021 start date type Actual primary completion date struct primary completion date January 30, 2022 primary completion date type Anticipated completion date struct completion date January 30, 2022 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date June 16, 2021 last update post date struct last update post date June 22, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Microphyt lead sponsor class INDUSTRY collaborator list collaborator collaborator name Atlantia Food Clinical Trials collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary In developed countries, the acceleration of the general population ageing has been widely described for decades, involving changes in public health policies. Among the health issues arising from this demographic change, the maintenance of cognitive function will be a major challenge in the next years, both in societal and economic terms. In this regard, some pharmacological and behavioural (e.g. physical activity, social involvement, intellectually demanding activities) preventive approaches have been evaluated to improve cognitive function with ageing. Among them, dietary interventions showed a potential interest to prevent cognitive decline during ageing. In this sense, there is a growing interest to find ecological solutions and to meet major societal challenge the use of microalgae as molecule of interest sources is a recent promising approach. Marine environments harbour a huge biological diversity of microalgae that represents a large source of almost untapped bioactive compounds. This biodiversity comprises 200,000 to 2 million species with about 35,000 which are described and 15,000 maintained in culture collections. Microalgae are able to produce bioactive molecules, such as pigments, fatty acids, peptides and sterols. Some of these compounds are unique and specifically found in the marine environment and they could be increasingly used as natural bioactive products for targeted applications. Fucoxanthin is one of the major carotenoid found in microalgae well known for its neuroprotective effect but to our knowledge no human studies were realized.
Thus the objective is to evaluate, in healthy older adults, the effect of a 24-week period of daily supplementation of high and low BrainPhyt, doses on cognitive function parameters (Spatial Working Memory scores, Attention and vigilance, episodic memory, executive function), stress, mood, sleep quality and biomarkers. conditions module condition list condition Healthy Aging Dietary Supplement Fucoxanthin Cognitive Impairment Neuroprotection Mood Stress Sleep design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 144 enrollment type Anticipated arms interventions module arm group list arm group arm group label BrainPhyt Low dose arm group type Experimental arm group description 220 mg BrainPhyt and 500 mg 100 % sunflower oil for 4 weeks, followed by 220 mg for 20 weeks arm group intervention list arm group intervention name Dietary Supplement: BrainPhyt arm group label BrainPhyt high dose arm group type Experimental arm group description 440 mg BrainPhyt for 4 weeks, followed by 500 mg 100 % sunflower oil for 20 weeks arm group intervention list arm group intervention name Dietary Supplement: BrainPhyt arm group label Placebo arm group type Placebo Comparator arm group description 1000 mg 100 % sunflower oil for 4 weeks, followed by 500 mg 100 % sunflower oil for 20 weeks arm group intervention list arm group intervention name Dietary Supplement: 100 % sunflower oil intervention list intervention intervention type Dietary Supplement intervention name BrainPhyt intervention description Low and high doses BrainPhyt supplementation during 24 months intervention arm group label list intervention arm group label BrainPhyt Low dose BrainPhyt high dose intervention type Dietary Supplement intervention name 100 % sunflower oil intervention description 100 % sunflower oil intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Spatial working memory primary outcome description Change in spatial working memory scores - COMPASS cognitive assessment system primary outcome time frame From week 0 to week 24 secondary outcome list secondary outcome secondary outcome measure Spatial working memory secondary outcome description Change in spatial working memory scores - COMPASS cognitive assessment system secondary outcome time frame From week 0 to week 4 secondary outcome measure Attention and vigilance secondary outcome description Change in spatial working memory scores - COMPASS cognitive assessment system secondary outcome time frame From week 0 to week 24 secondary outcome measure Attention and vigilance secondary outcome description Change in spatial working memory scores - COMPASS cognitive assessment system (Choice reaction time and digit vigilance tasks) secondary outcome time frame From week 0 to week 4 secondary outcome measure Executive function secondary outcome description Change in Executive function scores - COMPASS cognitive assessment system (Stroop task) secondary outcome time frame From week 0 to week 24 secondary outcome measure Executive function secondary outcome description Change in Executive function scores - COMPASS cognitive assessment system (Stroop task) secondary outcome time frame From week 0 to week 4 secondary outcome measure Episodic memory secondary outcome description Change in Episodic memory scores - COMPASS cognitive assessment system (Picture and word recognition tasks) secondary outcome time frame From week 0 to week 4 secondary outcome measure Episodic memory secondary outcome description Change in Episodic memory scores - COMPASS cognitive assessment system (Picture and word recognition tasks) secondary outcome time frame From week 0 to week 24 secondary outcome measure Sleep quality secondary outcome description Change in Leeds sleep evaluation questionnaire score secondary outcome time frame From week 0 to week 24 secondary outcome measure Sleep quality secondary outcome description Change in Leeds sleep evaluation questionnaire score secondary outcome time frame From week 0 to week 4 secondary outcome measure Mood state secondary outcome description Change in Bond-Lader Mood Rating scale score secondary outcome time frame From week 0 to week 24 secondary outcome measure Mood state secondary outcome description Change in Bond-Lader Mood Rating scale score secondary outcome time frame From week 0 to week 4 secondary outcome measure Stress state secondary outcome description Change in Cohen's Perceived stress scale score secondary outcome time frame From week 0 to week 24 secondary outcome measure Stress state secondary outcome description Change in Cohen's Perceived stress scale score secondary outcome time frame From week 0 to week 4 secondary outcome measure Blood TNFa level (pg/ml) secondary outcome description Change in blood TNFa compared to baseline secondary outcome time frame From week 0 to week 4 and week 24 secondary outcome measure Blood IFN level (pg/ml) secondary outcome description Change in blood IFN compared to baseline secondary outcome time frame From week 0 to week 4 and week 24 secondary outcome measure Blood CRP level (pg/ml) secondary outcome description Change in blood CRP compared to baseline secondary outcome time frame From week 0 to week 4 and week 24 secondary outcome measure Blood IL6 level (pg/ml) secondary outcome description Change in blood IL6 compared to baseline secondary outcome time frame From week 0 to week 4 and week 24 secondary outcome measure Blood Insulin level (mUI/l) secondary outcome description Change in blood Insulin compared to baseline secondary outcome time frame From week 0 to week 4 and week 24 secondary outcome measure Blood HbA1C level (%) secondary outcome description Change in blood HbA1C compared to baseline secondary outcome time frame From week 0 to week 4 and week 24 eligibility module eligibility criteria Inclusion Criteria:
Be able to give written informed consent and to consume the investigational product daily for the duration of the study.
Healthy males and females aged ≥ 55 and ≤ 75 years old.
Is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance).
Have age-related mild cognitive decline, defined as:
Absence of dementia as determined by a score of ≥24 on the Mini Mental State Examination (MMSE).
A score on the MAC-Q of ≥25.
Have a self-reported memory complaint.
Have an AD8 Dementia Screening Score of <2 (normal cognition).
Have a Hospital Anxiety and Depression Scale (HADS) score of ≤7 for both anxiety and depression.
Is in general good health, as determined by the investigator
Ability to comply with study protocol and complete computerised cognitive testing.
Willing to maintain their habitual diet and exercise routines.
Willing to maintain consistent sleep duration the evening before study visits.
Exclusion Criteria:
Women who are pregnant, breastfeeding, or wish to become pregnant during the study.
Female participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:
Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
sexual partner(s) is/are exclusively female.
Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g. male condom, female diaphragm) or contraceptive pill. The participant must be using this method for at least 1 week following the end of the study.
Use of any non-hormonal intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1 % per year. The participant must have the device inserted at least 2 weeks prior to the first Screening Visit, throughout the study, and 2 weeks following the end of the study.
Individuals with dementia or mild cognitive impairment defined as greater than or equal to one standard deviation below the mean for age-matched norms on a standardised memory test
Individuals taking the following supplements who are unwilling to undergo a 4-week washout period: Ginkgo biloba, Ginseng, Choline, Taurine, Huperizine A, Acetyl-L-Carnitine, DMAE (Dimethylaminoethanol), Lecithin, Phosphatidylcholine, Phosphatidylderine, DHEA (Dehydroepiandrosterene), Alpha lipoic acid, Bacopa (Brahmi), CDP-choline (Citicoline), Alpha-GPC, Green tea extract, L-Tyrosine, or L-Theanine
Chronic use of oral or injectable corticosteroids
Untreated psychotic or major depressive disorder
Uncontrolled hypertension/diabetes
A significant history of cardiovascular complaints (e.g., angina)
A significant neurological disease
Planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study.
History within previous 12 months of alcohol or substance abuse.
History of heavy smoking (>1 pack/day) within past 3 months.
History of heavy caffeinated beverage consumption (>400 mg caffeine/day) within past 2 weeks. healthy volunteers Accepts Healthy Volunteers gender All minimum age 55 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jonathan MAURY, PhD central contact role Contact central contact phone 0611150394 central contact e mail jonathan.maury@microphyt.eu central contact name Ilya Zhivkovich central contact role Contact central contact e mail ilya.zhivkovich@microphyt.eu overall official list overall official overall official name Timothy Dinan, Professor overall official affiliation Atlantia Clinical Food Trials overall official role Principal Investigator location list location location facility Atlantia Clinical Food trial location status Recruiting location city Cork location country Ireland location contact list location contact location contact name Jonathan Maury, PhD location contact role Contact location contact phone 0611150394 location contact e mail jonathan.maury@microphyt.eu i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000060825 condition mesh term Cognitive Dysfunction condition ancestor list condition ancestor condition ancestor id D000003072 condition ancestor term Cognition Disorders condition ancestor id D000019965 condition ancestor term Neurocognitive Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M28858 condition browse leaf name Cognitive Dysfunction condition browse leaf as found Cognitive Impairment condition browse leaf relevance high condition browse leaf id M5453 condition browse leaf name Cognition Disorders condition browse leaf relevance low condition browse leaf id M20989 condition browse leaf name Neurocognitive Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id T305 intervention browse leaf name Sunflower intervention browse leaf as found Grip intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev HB intervention browse branch name Herbal and Botanical intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04832412 | [
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12859,
26394,
2078,
1641,
138,
19441,
3673,
117,
8543,
118,
7198,
117,
5033,
4043,
118,
4013,
117,
23994,
4838,
1233,
8690,
1104,
1103,
27007,
1104,
15240,
2101,
7889,
1204,
1113,
3291,
22152,
3946,
16068,
5796,
1107,
3225,
1183,
26694,
12859,
26394,
22478,
15240,
2101,
7889,
1204,
118,
1141,
2781,
13196,
2781,
22480,
2236,
1340,
17881,
1475,
2905,
2781,
11336,
1665,
27975,
1158,
3631,
2469,
23992,
1144,
3631,
2469,
1302,
1838,
2236,
188,
23055,
1838,
2236,
1364,
1367,
117,
17881,
1475,
1838,
2236,
2076,
2173,
4746,
2425,
6026,
2236,
188,
23055,
2425,
6026,
2236,
1356,
1476,
117,
17881,
1477,
2425,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
6026,
2236,
188,
23055,
6026,
2236,
1356,
1476,
117,
17881,
1477,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
2025,
1148,
12295,
2236,
1364,
123,
117,
17881,
1475,
2025,
1148,
12295,
186,
172,
2236,
1364,
123,
117,
17881,
1475,
2025,
1148,
2112,
2236,
188,
23055,
2025,
1148,
2112,
2236,
1364,
126,
117,
17881,
1475,
2025,
1148,
2112,
2236,
2076,
2173,
4746,
1314,
11984,
12295,
2236,
1340,
1479,
117,
17881,
1475,
1314,
11984,
2112,
2236,
188,
23055,
1314,
11984,
2112,
2236,
1340,
1659,
117,
17881,
1475,
1314,
11984,
2112,
2236,
2076,
2173,
4746,
10767,
24146,
13196,
2784,
1710,
2784,
1710,
2076,
156,
5674,
27035,
1197,
1730,
10767,
1730,
10767,
1271,
27730,
22192,
1204,
1730,
10767,
1705,
15969,
2137,
13329,
23313,
3663,
20715,
2190,
20715,
20715,
1271,
1335,
9180,
1465,
6702,
15961,
21373,
20715,
1705,
15969,
2137,
13329,
23313,
3663,
20051,
13196,
20051,
1144,
173,
182,
172,
1302,
1110,
175,
173,
170,
12521,
3850,
1302,
1110,
175,
173,
170,
12521,
4442,
1302,
6136,
13196,
4094,
14940,
1130,
1872,
2182,
117,
1103,
18383,
1104,
1103,
1704,
1416,
1425,
1158,
1144,
1151,
3409,
1758,
1111,
4397,
117,
5336,
2607,
1107,
1470,
2332,
5502,
119,
3841,
1103,
2332,
2492,
19528,
1121,
1142,
17898,
1849,
117,
1103,
5972,
1104,
12176,
3053,
1209,
1129,
170,
1558,
4506,
1107,
1103,
1397,
1201,
117,
1241,
1107,
27266,
1105,
2670,
2538,
119,
1130,
1142,
7328,
117,
1199,
185,
7111,
1918,
23388,
1105,
9151,
1348,
113,
174,
119,
176,
119,
2952,
3246,
117,
1934,
6083,
117,
8066,
1193,
9504,
2619,
114,
3843,
2109,
8015,
1138,
1151,
17428,
1106,
4607,
12176,
3053,
1114,
1425,
1158,
119,
3841,
1172,
117,
10211,
3113,
22496,
2799,
170,
3209,
2199,
1106,
3843,
12176,
6246,
1219,
1425,
1158,
119,
1130,
1142,
2305,
117,
1175,
1110,
170,
2898,
2199,
1106,
1525,
14769,
7995,
1105,
1106,
2283,
1558,
27266,
4506,
1103,
1329,
1104,
17599,
1348,
2571,
1162,
1112,
14730,
1104,
2199,
3509,
1110,
170,
2793,
10480,
3136,
119,
4620,
10152,
11614,
170,
3321,
7269,
9531,
1104,
17599,
1348,
2571,
1162,
1115,
5149,
170,
1415,
2674,
1104,
1593,
8362,
1777,
10438,
25128,
19667,
10071,
119,
1188,
23797,
8302,
2363,
117,
1288,
1106,
123,
1550,
1530,
1114,
1164,
2588,
117,
1288,
1134,
1132,
1758,
1105,
1405,
117,
1288,
4441,
1107,
2754,
6286,
119,
27730,
1348,
2571,
1162,
1132,
1682,
1106,
3133,
25128,
19667,
10799,
117,
1216,
1112,
13407,
4385,
117,
24862,
13087,
117,
185,
27105,
1116,
1105,
188,
25710,
3447,
119,
1789,
1104,
1292,
10071,
1132,
3527,
1105,
4418,
1276,
1107,
1103,
5243,
3750,
1105,
1152,
1180,
1129,
5672,
1215,
1112,
2379,
25128,
19667,
2982,
1111,
9271,
4683,
119,
14763,
2528,
20192,
2227,
8265,
1110,
1141,
1104,
1103,
1558,
1610,
11860,
2728,
2386,
1276,
1107,
17599,
1348,
2571,
1162,
1218,
1227,
1111,
1157,
24928,
11955,
1643,
21020,
13851,
2629,
1133,
1106,
1412,
3044,
1185,
1769,
2527,
1127,
2788,
119,
4516,
1103,
7649,
1110,
1106,
17459,
117,
1107,
8071,
2214,
6323,
117,
1103,
2629,
1104,
170,
1572,
118,
1989,
1669,
1104,
3828,
15491,
1891,
1104,
1344,
1105,
1822,
15240,
2101,
7889,
1204,
117,
24429,
1113,
12176,
3053,
11934,
113,
23665,
16764,
9612,
14500,
7432,
117,
1335,
5208,
2116,
1105,
191,
24874,
13831,
117,
174,
19093,
5412,
1596,
2962,
117,
3275,
3053,
114,
117,
6600,
117,
6601,
117,
2946,
3068,
1105,
25128,
8519,
1468,
119,
2975,
13196,
3879,
2190,
3879,
3225,
1183,
138,
3375,
22327,
3113,
15463,
8661,
20041,
14763,
2528,
20192,
2227,
8265,
3291,
22152,
3946,
146,
8223,
8341,
1880,
151,
8816,
4184,
21020,
5796,
12556,
5412,
1457,
7370,
15153,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
18461,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
154,
18413,
20910,
1513,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
4539,
27989,
10224,
1204,
8396,
5096,
22650,
1197,
1130,
5710,
3121,
25524,
1766,
3929,
19191,
1116,
1249,
8830,
21484,
10803,
23992,
10803,
5099,
15373,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
15240,
2101,
7889,
1204,
8274,
13753,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
10423,
17713,
15240,
2101,
7889,
1204,
1105,
2260,
17713,
1620,
110,
3336,
15055,
2949,
1111,
125,
2277,
117,
1723,
1118,
10423,
17713,
1111,
1406,
2277,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
22327,
3113,
15463,
8661,
20041,
131,
15240,
2101,
7889,
1204,
1981,
1372,
3107,
15240,
2101,
7889,
1204,
1344,
13753,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
18629,
17713,
15240,
2101,
7889,
1204,
1111,
125,
2277,
117,
1723,
1118,
2260,
17713,
1620,
110,
3336,
15055,
2949,
1111,
1406,
2277,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
22327,
3113,
15463,
8661,
20041,
131,
15240,
2101,
7889,
1204,
1981,
1372,
3107,
5033,
4043,
1981,
1372,
2076,
5033,
4043,
3291,
8223,
4626,
2772,
1981,
1372,
6136,
6087,
17713,
1620,
110,
3336,
15055,
2949,
1111,
125,
2277,
117,
1723,
1118,
2260,
17713,
1620,
110,
3336,
15055,
2949,
1111,
1406,
2277,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
22327,
3113,
15463,
8661,
20041,
131,
1620,
110,
3336,
15055,
2949,
9108,
2190,
9108,
9108,
2076,
22327,
3113,
15463,
8661,
20041,
9108,
1271,
15240,
2101,
7889,
1204,
9108,
6136,
8274,
1105,
1344,
24429,
15240,
2101,
7889,
1204,
15491,
1891,
1219,
1572,
1808,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
15240,
2101,
7889,
1204,
8274,
13753,
15240,
2101,
7889,
1204,
1344,
13753,
9108,
2076,
22327,
3113,
15463,
8661,
20041,
9108,
1271,
1620,
110,
3336,
15055,
2949,
9108,
6136,
1620,
110,
3336,
15055,
2949,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
5033,
4043,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
23665,
16764,
1684,
2962,
2425,
9386,
6136,
9091,
1107,
15442,
1684,
2962,
7432,
118,
18732,
12347,
10719,
1708,
12176,
8670,
1449,
2425,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
1572,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
23665,
16764,
1684,
2962,
3718,
9386,
6136,
9091,
1107,
15442,
1684,
2962,
7432,
118,
18732,
12347,
10719,
1708,
12176,
8670,
1449,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
125,
3718,
9386,
4929,
1335,
5208,
2116,
1105,
191,
24874,
13831,
3718,
9386,
6136,
9091,
1107,
15442,
1684,
2962,
7432,
118,
18732,
12347,
10719,
1708,
12176,
8670,
1449,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
1572,
3718,
9386,
4929,
1335,
5208,
2116,
1105,
191,
24874,
13831,
3718,
9386,
6136,
9091,
1107,
15442,
1684,
2962,
7432,
118,
18732,
12347,
10719,
1708,
12176,
8670,
1449,
113,
10373,
3943,
1159,
1105,
16521,
191,
24874,
13831,
8249,
114,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
125,
3718,
9386,
4929,
4183,
3053,
3718,
9386,
6136,
9091,
1107,
4183,
3053,
7432,
118,
18732,
12347,
10719,
1708,
12176,
8670,
1449,
113,
1457,
24886,
1643,
4579,
114,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
1572,
3718,
9386,
4929,
4183,
3053,
3718,
9386,
6136,
9091,
1107,
4183,
3053,
7432,
118,
18732,
12347,
10719,
1708,
12176,
8670,
1449,
113,
1457,
24886,
1643,
4579,
114,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
125,
3718,
9386,
4929,
142,
19093,
5412,
1596,
2962,
3718,
9386,
6136,
9091,
1107,
142,
19093,
5412,
1596,
2962,
7432,
118,
18732,
12347,
10719,
1708,
12176,
8670,
1449,
113,
10041,
1105,
1937,
4453,
8249,
114,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
125,
3718,
9386,
4929,
142,
19093,
5412,
1596,
2962,
3718,
9386,
6136,
9091,
1107,
142,
19093,
5412,
1596,
2962,
7432,
118,
18732,
12347,
10719,
1708,
12176,
8670,
1449,
113,
10041,
1105,
1937,
4453,
8249,
114,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
1572,
3718,
9386,
4929,
15153,
3068,
3718,
9386,
6136,
9091,
1107,
7383,
2946,
10540,
2304,
24730,
2794,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
1572,
3718,
9386,
4929,
15153,
3068,
3718,
9386,
6136,
9091,
1107,
7383,
2946,
10540,
2304,
24730,
2794,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
125,
3718,
9386,
4929,
12556,
5412,
1352,
3718,
9386,
6136,
9091,
1107,
8211,
118,
2001,
2692,
12556,
5412,
21632,
1158,
3418,
2794,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
1572,
3718,
9386,
4929,
12556,
5412,
1352,
3718,
9386,
6136,
9091,
1107,
8211,
118,
2001,
2692,
12556,
5412,
21632,
1158,
3418,
2794,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
125,
3718,
9386,
4929,
1457,
7370,
1352,
3718,
9386,
6136,
9091,
1107,
9735,
112,
188,
14286,
21437,
6600,
3418,
2794,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
1572,
3718,
9386,
4929,
1457,
7370,
1352,
3718,
9386,
6136,
9091,
1107,
9735,
112,
188,
14286,
21437,
6600,
3418,
2794,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
125,
3718,
9386,
4929,
5657,
157,
28047,
1161,
1634,
113,
185,
1403,
120,
182,
1233,
114,
3718,
9386,
6136,
9091,
1107,
1892,
157,
28047,
1161,
3402,
1106,
2259,
2568,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
125,
1105,
1989,
1572,
3718,
9386,
4929,
5657,
13729,
2249,
1634,
113,
185,
1403,
120,
182,
1233,
114,
3718,
9386,
6136,
9091,
1107,
1892,
13729,
2249,
3402,
1106,
2259,
2568,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
125,
1105,
1989,
1572,
3718,
9386,
4929,
5657,
15531,
2101,
1634,
113,
185,
1403,
120,
182,
1233,
114,
3718,
9386,
6136,
9091,
1107,
1892,
15531,
2101,
3402,
1106,
2259,
2568,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
125,
1105,
1989,
1572,
3718,
9386,
4929,
5657,
15393,
1545,
1634,
113,
185,
1403,
120,
182,
1233,
114,
3718,
9386,
6136,
9091,
1107,
1892,
15393,
1545,
3402,
1106,
2259,
2568,
3718,
9386,
1159,
4207,
1622,
1989,
121,
1106,
1989,
125,
1105,
1989,
1572,
3718,
9386,
4929,
5657,
1130,
24661,
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] |
full study rank 61895 study protocol section identification module n c t id NCT04830514 org study id info org study id 262424 organization org full name University of Arkansas org class OTHER brief title Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics official title Maximizing the Dietary Pattern of Older Adults: the Effects of Protein Intake on Protein Kinetics status module status verified date March 2022 overall status Completed expanded access info has expanded access No start date struct start date May 27, 2021 start date type Actual primary completion date struct primary completion date March 15, 2022 primary completion date type Actual completion date struct completion date March 15, 2022 completion date type Actual study first submit date March 31, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date March 17, 2022 last update post date struct last update post date March 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Arkansas lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary A randomized study to demonstrate how animal-based protein-rich food sources can be used by older adults to increase protein intake within pre-existing dietary patterns. detailed description Current dietary patterns of older Americans will be augmented by readily available quality protein sources. Investigators will observe the effects of recommended and common protein intakes on the maintenance of whole-body protein balance and potential for muscle protein anabolism.
3 groups of 10 older subjects will be studied during daily protein intakes. Study duration per subject will be about 2 weeks. conditions module condition list condition Sarcopenia keyword list keyword muscle loss protein animal-based protein design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 44 enrollment type Actual arms interventions module arm group list arm group arm group label Recommended dietary allowance (RDA) for protein arm group type Experimental arm group description (RDA; 0.8g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. arm group intervention list arm group intervention name Other: Recommended Dietary Allowance of Protein arm group label Habitual protein intake consistent with population level norms arm group type Experimental arm group description (NHANES; 1.0g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. arm group intervention list arm group intervention name Other: Habitual protein intake arm group label Optimal protein intake (OPI) arm group type Experimental arm group description (OPI; 1.5g/kg/day) Protein intakes will be structured within two meals per day. A 2-day dietary lead-in will precede each dietary intervention. Study duration per subject will last about two weeks. arm group intervention list arm group intervention name Other: Optimal Protein Intake intervention list intervention intervention type Other intervention name Recommended Dietary Allowance of Protein intervention description 0.8 g/kg/day protein intake intervention arm group label list intervention arm group label Recommended dietary allowance (RDA) for protein intervention other name list intervention other name RDA intervention type Other intervention name Habitual protein intake intervention description 1.0 g/kg/day protein intake intervention arm group label list intervention arm group label Habitual protein intake consistent with population level norms intervention other name list intervention other name NHANES intervention type Other intervention name Optimal Protein Intake intervention description 1.5 g/kg/day protein intake intervention arm group label list intervention arm group label Optimal protein intake (OPI) intervention other name list intervention other name OPI outcomes module primary outcome list primary outcome primary outcome measure Whole Body Protein Turnover primary outcome description Isotope Tracer primary outcome time frame 24 hour eligibility module eligibility criteria Inclusion Criteria:
BMI ≤ 35 kg/m2
Capable of providing informed consent
COVID-19 negative and/or asymptomatic
Exclusion Criteria:
Subject who does not/will not eat animal protein sources.
Body mass index > 35.
History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
Use of insulin to control blood sugar level.
Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
Currently using prescription blood thinning medications.
Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3.
Unwilling to avoid using protein or amino-acid supplements during participation. healthy volunteers Accepts Healthy Volunteers gender All minimum age 50 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Arny A Ferrando, PhD overall official affiliation University of Arkansas overall official role Principal Investigator location list location location facility University of Arkansas for Medical Sciences location city Little Rock location state Arkansas location zip 72205 location country United States derived section misc info module version holder December 02, 2022 submission tracking submission info list submission info submission release date October 5, 2022 condition browse module condition mesh list condition mesh condition mesh id D000055948 condition mesh term Sarcopenia condition ancestor list condition ancestor condition ancestor id D000009133 condition ancestor term Muscular Atrophy condition ancestor id D000020879 condition ancestor term Neuromuscular Manifestations condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000001284 condition ancestor term Atrophy condition ancestor id D000020763 condition ancestor term Pathological Conditions, Anatomical condition browse leaf list condition browse leaf condition browse leaf id M27549 condition browse leaf name Sarcopenia condition browse leaf as found Sarcopenia condition browse leaf relevance high condition browse leaf id M11242 condition browse leaf name Muscular Atrophy condition browse leaf relevance low condition browse leaf id M3741 condition browse leaf name Atrophy condition browse leaf relevance low condition browse leaf id M21772 condition browse leaf name Neuromuscular Manifestations condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M21672 condition browse leaf name Pathological Conditions, Anatomical condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions | NCT04830514 | [
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full study rank 61243 study protocol section identification module n c t id NCT04839003 org study id info org study id AC-018-IT organization org full name IRCCS Policlinico S. Matteo org class OTHER brief title A Registry of AL Amyloidosis (ReAL) official title A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL) acronym ReAL status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date February 27, 2020 start date type Actual primary completion date struct primary completion date May 2025 primary completion date type Anticipated completion date struct completion date May 2025 completion date type Anticipated study first submit date March 22, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date May 4, 2022 last update post date struct last update post date May 5, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name GIOVANNI PALLADINI responsible party investigator title Principal Investigator responsible party investigator affiliation IRCCS Policlinico S. Matteo lead sponsor lead sponsor name IRCCS Policlinico S. Matteo lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this protocol is to generate a large registry of patients with AL amyloidosis. detailed description Thanks to this registry, it will be possible to collect data at diagnosis and during follow up, in order to be able to describe the natural history of AL amyloidosis in a real-world setting and to define and validate prognostic models, response and relapse criteria applicable at any point of the disease. conditions module condition list condition AL Amyloidosis keyword list keyword amyloidosis prognosis registry design module study type Observational patient registry Yes target duration 5 Years design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective bio spec bio spec retention Samples Without DNA bio spec description It will be generated a biobank of body fluids (serum, plasma, urine) and relevant cellular (bone marrow and peripheral blood mononuclear cells) and tissue samples (bone marrow, periumbilical fat, possibly other biopsied organs) from patients with AL amyloidosis. We will obtain research samples from diagnostic leftovers of consenting patients at diagnosis and at each subsequent visit. enrollment info enrollment count 5000 enrollment type Anticipated outcomes module primary outcome list primary outcome primary outcome measure Creation of a registry of patients with AL amyloidosis primary outcome time frame 5 years eligibility module eligibility criteria Inclusion Criteria:
diagnosis of systemic AL amyloidosis;
treatment-naïve (pre-treatment data collected at participating center available for retrospective part);
age ≥18 years;
ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted);
planned (or ongoing) follow-up at participating center.
Exclusion Criteria:
non-AL amyloidosis;
previous treatment for AL amyloidosis. healthy volunteers No gender All minimum age 18 Years maximum age 99 Years std age list std age Adult Older Adult study population Patients will be entered the database pending on expressing an informed consent of the use of their data for research purposes. sampling method Non-Probability Sample contacts locations module location list location location facility Fondazione IRCCS Policlinico San Matteo location status Recruiting location city Pavia location zip 27100 location country Italy location contact list location contact location contact name Giovanni Palladini, MD location contact role Contact location contact phone +390382502994 location contact e mail giovanni.palladini@unipv.it derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000075363 condition mesh term Immunoglobulin Light-chain Amyloidosis condition mesh id D000000686 condition mesh term Amyloidosis condition ancestor list condition ancestor condition ancestor id D000057165 condition ancestor term Proteostasis Deficiencies condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000054219 condition ancestor term Neoplasms, Plasma Cell condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition ancestor id D000010265 condition ancestor term Paraproteinemias condition browse leaf list condition browse leaf condition browse leaf id M3173 condition browse leaf name Amyloidosis condition browse leaf as found Amyloidosis condition browse leaf relevance high condition browse leaf id M19712 condition browse leaf name Disease Progression condition browse leaf relevance low condition browse leaf id M1483 condition browse leaf name Immunoglobulin Light-chain Amyloidosis condition browse leaf as found AL Amyloidosis condition browse leaf relevance high condition browse leaf id M27900 condition browse leaf name Proteostasis Deficiencies condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M26741 condition browse leaf name Neoplasms, Plasma Cell condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id M12330 condition browse leaf name Paraproteinemias condition browse leaf relevance low condition browse leaf id T254 condition browse leaf name AL Amyloidosis condition browse leaf as found AL Amyloidosis condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases | NCT04839003 | [
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full study rank 61495 study protocol section identification module n c t id NCT04835727 org study id info org study id Si 063/2020 organization org full name Mahidol University org class OTHER brief title Effect of Semi-vegetarian Diet in Inflammatory Bowel Disease Patients With Clinical Remission official title Effect of Semi-vegetarian Diet in Inflammatory Bowel Disease Patients With Clinical Remission status module status verified date May 2022 overall status Completed expanded access info has expanded access No start date struct start date January 21, 2020 start date type Actual primary completion date struct primary completion date October 1, 2021 primary completion date type Actual completion date struct completion date October 1, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date May 23, 2022 last update post date struct last update post date May 24, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Julajak Limsrivilai responsible party investigator title Assistant Professor responsible party investigator affiliation Mahidol University lead sponsor lead sponsor name Mahidol University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary In the 21st century, the incidence of inflammatory bowel disease (IBD) globally increases. Higher incidence of IBD development may implicate that environmental factors played essential roles in IBD pathogenesis. One of the environmental factors is a westernized diet that contains a high amount of animal protein and a low amount of dietary fiber. This kind of diet can lead to gut microbial dysbiosis and increase susceptibility to IBD. A microbial dysbiosis pattern in IBD is a decrease in microbial diversity and the inversed ratio of local protective and pathologic bacteria. High animal protein was associated with an increased risk of IBD and increased risk of disease relapse meanwhile dietary fiber was associated with IBD risk reduction. A semi-vegetarian diet is a diet with high fiber and low red meat and processed food that may reduce inflammatory activity in IBD. The study in the semi-vegetarian diet in IBD activity is still limited.
This study aimed to evaluate a semi-vegetarian diet's effect in maintaining IBD remission in disease quiescence patients. detailed description This study is a prospective interventional cohort in clinically quiescence IBD patients in Siriraj Hospital, Mahidol University, Bangkok, Thailand. At enrollment, clinical information, dietary intake, inflammatory markers, and fecal microbiota will be recorded. Dietary intake will be assessed by an experienced nutritionist using pictures of food, a dietary questionnaire, and patient interviewing. The nutritionist advises the participants to consume a semi-vegetarian diet which includes high dietary fiber consumption and low red meat and processed food consumption. All patients will be required to send all pictures of food intake three days in 1 week before every visit, including two weekdays and one weekend. The dietary component will be analyzed using Nutrient calculation computer software INMUCAL-Nutrient V3 database NB1 (Institute of Nutrition, Mahidol University. Nakornpathom. 2013). The study will take 1 year including 6 visits (including baseline, 6th weeks, 18th week, 30th week, 42nd week, 54th week) for each patient. The primary outcome is the effect of increasing fiber diets and decreasing red meat and processed food on maintaining clinical remission in IBD. Secondary outcomes are the effect of modifying diet on change of inflammatory markers, microbiota, and quality of life. conditions module condition list condition Inflammatory Bowel Diseases Calprotectin Fecal Microbiota Vegetarian Diet keyword list keyword Vegetarian diet inflammatory bowel diseases design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design intervention model description This is a prospective interventional cohort study in patients with clinically quiescent IBD. At enrollment, clinical information, dietary intake, inflammatory markers, and fecal microbiota were recorded. Dietary intake was assessed by an experienced nutritionist using pictures of food, a dietary questionnaire, and patient interviewing. The nutritionist advised the participants to intake a semi-vegetarian diet and increase dietary fiber consumption. The changes in clinical symptoms, dietary intake, inflammatory markers, and fecal microbiota were recorded in each visit for 1 year. design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 60 enrollment type Actual arms interventions module arm group list arm group arm group label Semi-vegetarian diet arm group type Experimental arm group description All patients in this study will be advised by an experienced nutritionist to intake high fiber diets with a low intake of red meat and processed food. arm group intervention list arm group intervention name Other: Semi-vegetarian diet and increase fiber consumption intervention list intervention intervention type Other intervention name Semi-vegetarian diet and increase fiber consumption intervention description All patients in this study will be advised by an experienced nutritionist to intake high fiber diets with a low intake of red meat and processed food. intervention arm group label list intervention arm group label Semi-vegetarian diet outcomes module primary outcome list primary outcome primary outcome measure Rate of participants with clinical relapses primary outcome description Effect of semi-vegetarian food consumption on the rate of participants with clinical relapses assessed by Crohn's disease activity index for Crohn's disease and the clinical Mayo Score or partial Mayo Score for ulcerative colitis. The Crohn's disease activity index ranges from 0 to 1100, a higher score means a worse outcome, and clinical relapse is defined if the score is at least 150 points. The clinical Mayo Score for ulcerative colitis ranges from 0 to 9, a higher score means a worse outcome, and clinical relapse is defined if the score is at least 2 points. primary outcome time frame 1 year secondary outcome list secondary outcome secondary outcome measure C-Reactive Protein (CRP) secondary outcome description Effect of semi-vegetarian food consumption on inflammatory markers levels including serum CRP secondary outcome time frame 1 year secondary outcome measure fecal calprotectin level secondary outcome description Effect of semi-vegetarian food consumption on inflammatory markers levels including fecal calprotectin level secondary outcome time frame 1 year secondary outcome measure Fecal microbiota secondary outcome description Effect of semi-vegetarian food consumption on changing of fecal microbiota composition and diversity (Shannon's diversity index) secondary outcome time frame 1 year secondary outcome measure Quality of life score of SIBDQ secondary outcome description Effect of semi-vegetarian food consumption on quality of life: SIBDQ secondary outcome time frame 1 year secondary outcome measure Quality of life score of EQ5D3L secondary outcome description Effect of semi-vegetarian food consumption on quality of life: EQ5D3L secondary outcome time frame 1 year eligibility module eligibility criteria Inclusion Criteria:
Patients with Crohn's disease or Ulcerative colitis
Age ≥ 18 years old
Disease in remission at least 2weeks by following criteria Crohn's disease: Crohn's Disease Activity Index(CDAI) < 150 Ulcerative colitis: Mayo Ulcerative Colitis Subscore ≤ 2
Prednisolone ≤ 15 mg/day for at least 1 month
Stable immunomodulator dosage at least 1 month
Stable biologic agent at least 2 months
Exclusion Criteria:
Patients with Ulcerative colitis with a history of proctocolectomy
Patients with Crohn's disease with bowel stricture
Patients with recently antibiotic usage within 1 month
Pregnant patients healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Gastroenterology division, Faculty of Medicine, Siriraj Hospital, Mahidol University location city Bangkok location zip 10700 location country Thailand derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007410 condition mesh term Intestinal Diseases condition mesh id D000015212 condition mesh term Inflammatory Bowel Diseases condition ancestor list condition ancestor condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005759 condition ancestor term Gastroenteritis condition browse leaf list condition browse leaf condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf as found Bowel Disease condition browse leaf relevance high condition browse leaf id M17069 condition browse leaf name Inflammatory Bowel Diseases condition browse leaf as found Inflammatory Bowel Disease condition browse leaf relevance high condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M8027 condition browse leaf name Gastroenteritis condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions | NCT04835727 | [
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full study rank 61865 study protocol section identification module n c t id NCT04830917 org study id info org study id SVMC 17-328 organization org full name Orthopaedic Specialty Group PC, Fairfield org class OTHER brief title Conservative Treatment of Mallet Finger Injury official title Prospective Randomized Clinical Trial Comparing Kinesiotape and Oval 8 to Quick Cast for Conservative Treatment of Mallet Finger Injury status module status verified date April 2022 overall status Completed expanded access info has expanded access No start date struct start date April 24, 2017 start date type Actual primary completion date struct primary completion date April 28, 2021 primary completion date type Actual completion date struct completion date April 28, 2021 completion date type Actual study first submit date March 30, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 19, 2022 last update post date struct last update post date April 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Lori Algar responsible party investigator title Hand therapist/occupational therapist responsible party investigator affiliation Orthopaedic Specialty Group PC, Fairfield lead sponsor lead sponsor name Orthopaedic Specialty Group PC, Fairfield lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Comparing outcomes of individuals treated with Kinesiotape and oval 8 versus quick cast for a conservatively managed mallet finger injury. Outcomes include DIP joint extension lag, patient satisfaction and function via the MHQ. conditions module condition list condition Conservatively Treated Mallet Finger Injury design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 70 enrollment type Actual arms interventions module arm group list arm group arm group label Treatment with Kinesiotape and Oval 8 arm group type Experimental arm group intervention list arm group intervention name Other: Immobilization type for mallet injury arm group label Treatment with quick cast arm group type Experimental arm group intervention list arm group intervention name Other: Immobilization type for mallet injury intervention list intervention intervention type Other intervention name Immobilization type for mallet injury intervention description Method to hold the DIP joint in full extension to allow healing of terminal tendon injury/mallet injury intervention arm group label list intervention arm group label Treatment with Kinesiotape and Oval 8 Treatment with quick cast outcomes module primary outcome list primary outcome primary outcome measure Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit primary outcome time frame 12 weeks from injury secondary outcome list secondary outcome secondary outcome measure Goniometric measurement of range of motion for distal interphalangeal joint extension lag at the involved digit secondary outcome time frame 6 months post injury secondary outcome measure Brief Michigan Hand Outcome Questionnaire secondary outcome time frame 12 weeks from injury secondary outcome measure Brief Michigan Hand Outcome Questionnaire secondary outcome time frame 6 months post injury secondary outcome measure Satisfaction on a visual analog scale (0-10) secondary outcome time frame 12 weeks from injury secondary outcome measure Satisfaction on a visual analog scale (0-10) secondary outcome time frame 6 months post injury secondary outcome measure Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit secondary outcome time frame 12 week post injury secondary outcome measure Goniometric measurement of range of motion deficit for distal interphalangeal joint flexion for involved digit secondary outcome time frame 6 months post injury secondary outcome measure Pain according to a numeric pain rating scale (0-10/10) secondary outcome time frame 12 weeks after injury secondary outcome measure Pain according to a numeric pain rating scale (0-10/10) secondary outcome time frame 6 months post injury eligibility module eligibility criteria Inclusion Criteria:
determined by a physician to require conservative treatment for a mallet finger injury, at least 18 years of age
Exclusion Criteria:
previous injury to the involved digit impacting ROM healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Orthopaedic Specialty Group PC location city Fairfield location state Connecticut location zip 06825 location country United States i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000014947 condition mesh term Wounds and Injuries condition mesh id D000005383 condition mesh term Finger Injuries condition ancestor list condition ancestor condition ancestor id D000006230 condition ancestor term Hand Injuries condition browse leaf list condition browse leaf condition browse leaf id M7665 condition browse leaf name Finger Injuries condition browse leaf as found Finger Injuries condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf as found Injury condition browse leaf relevance high condition browse leaf id M8474 condition browse leaf name Hand Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions | NCT04830917 | [
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] |
full study rank 61254 study protocol section identification module n c t id NCT04838860 org study id info org study id EUSA SYL 0002 organization org full name EusaPharma (UK) Limited org class INDUSTRY brief title Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease official title A Phase 2 Study of Intrapatient Siltuximab Dose Escalation in Patients With Idiopathic Multicentric Castleman Disease That Has Progressed After Prior Siltuximab Treatment acronym SISREMCAD status module status verified date March 2021 overall status Terminated why stopped Internal Company Decision expanded access info has expanded access No start date struct start date March 31, 2021 start date type Actual primary completion date struct primary completion date April 1, 2021 primary completion date type Actual completion date struct completion date April 1, 2021 completion date type Actual study first submit date February 25, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 15, 2021 last update post date struct last update post date April 19, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name EusaPharma (UK) Limited lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary Phase 2 study to investigate the safety, tolerability, and efficacy of administering increased siltuximab doses to patients with iMCD detailed description This is an open-label, two-stage, Phase 2 study to investigate the safety, tolerability, and efficacy of administering increased siltuximab doses to patients with iMCD who progressed with elevated and rising serum C reactive protein (CRP) levels after prior treatment with siltuximab 11 mg/kg every 3 weeks (q3w) without unacceptable toxicity, and is primarily designed to leverage opportunities for intrapatient dose escalation with available clinical, nonclinical, and PK justification as a means to restore or enable disease control.
Enrolling in Stage 1a and Stage 1b of this study in parallel will be up to 6 patients each with siltuximab-relapsed or refractory IL-6-driven iMCD and TAFRO-iMCD patients, respectively, who will undergo intrapatient dose escalation of siltuximab beginning with 22 mg/kg q3w, then possibly dose escalating to 33 mg/kg q3w then 44 mg/kg q3w if clinically indicated in the absence of DLT. The justifications for escalating siltuximab doses up to 44 mg/kg q3w will be based on intrapatient dose escalation and DLT assessments as described below. conditions module condition list condition Idiopathic Multicentric Castleman's Disease design module study type Interventional phase list phase Phase 2 design info design allocation Non-Randomized design intervention model Parallel Assignment design intervention model description Enrolling in Stage 1a and Stage 1b of this study in parallel will be up to 6 patients each with siltuximab-relapsed or refractory IL-6-driven iMCD and TAFRO-iMCD patients, respectively, who will undergo intrapatient dose escalation of siltuximab beginning with 22 mg/kg q3w, then possibly dose escalating to 33 mg/kg q3w then 44 mg/kg q3w if clinically indicated in the absence of DLT. The justifications for escalating siltuximab doses up to 44 mg/kg q3w will be based on intrapatient dose escalation and DLT assessments as described below. design primary purpose Treatment design masking info design masking None (Open Label) design masking description No masking enrollment info enrollment count 22 enrollment type Actual arms interventions module arm group list arm group arm group label Parallel Arm of iMCD Patients arm group type Active Comparator arm group description Enrolling in Stage 1a of this study in parallel will be up to 6 patients each with siltuximab-relapsed or refractory IL-6-driven iMCD patients, respectively, who will undergo intrapatient dose escalation of siltuximab beginning with 22 mg/kg q3w, then possibly dose escalating to 33 mg/kg q3w then 44 mg/kg q3w if clinically indicated in the absence of DLT. The justifications for escalating siltuximab doses up to 44 mg/kg q3w will be based on intrapatient dose escalation and DLT assessments as described below. arm group intervention list arm group intervention name Drug: Siltuximab arm group label Parallel Arm of TAFRO-iMCD Patients arm group type Active Comparator arm group description Enrolling in Stage 1b of this study in parallel will be up to 6 patients each with siltuximab-relapsed or refractory IL-6-driven TAFRO-iMCD patients, respectively, who will undergo intrapatient dose escalation of siltuximab beginning with 22 mg/kg q3w, then possibly dose escalating to 33 mg/kg q3w then 44 mg/kg q3w if clinically indicated in the absence of DLT. The justifications for escalating siltuximab doses up to 44 mg/kg q3w will be based on intrapatient dose escalation and DLT assessments as described below. arm group intervention list arm group intervention name Drug: Siltuximab intervention list intervention intervention type Drug intervention name Siltuximab intervention description Participants will receive intravenous (IV) infusion of siltuximab 22 mg/kg over 2 hours every 3 weeks, then possibly dose escalating to 33 mg/kg IV over 3 hours +/- 44 mg/kg IV over 4 hours every 3 weeks if clinically indicated in the absence of dose-limiting toxicity. intervention arm group label list intervention arm group label Parallel Arm of TAFRO-iMCD Patients Parallel Arm of iMCD Patients intervention other name list intervention other name Sylvant outcomes module primary outcome list primary outcome primary outcome measure Assess the Clinical Benefit Response (CBR) of Siltuximab primary outcome description Assess the clinical benefit response (CBR) of increased siltuximab doses in patients with IL-6-driven (C-reactive protein [CRP]-elevated and rising) idiopathic multicentric Castleman disease (iMCD) after disease progression on the standard siltuximab dose schedule. CBR defined as complete response (CR), partial response (PR), or stable disease (SD) lasting ≥12 weeks per Castleman Disease Collaborative Network Response Criteria (CDCNRC). primary outcome time frame 12 Weeks secondary outcome list secondary outcome secondary outcome measure To evaluate the safety and tolerability of increased Siltuximab doses secondary outcome description Incidence of Adverse Events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), incidence of abnormal laboratory test results incidence of dose-limiting toxicities (DLTs) secondary outcome time frame 12 Weeks secondary outcome measure Pharmacokinetics (Vd) secondary outcome description To test the patient's drug propensity secondary outcome time frame 12 Weeks secondary outcome measure Pharmacokinetics (CL) secondary outcome description To test the volume of plasma cleared of drug per unit time secondary outcome time frame 12 Weeks secondary outcome measure Pharmacokinetics (AUC) secondary outcome description To test the extent of exposure to a drug and its clearance rate from the body secondary outcome time frame 12 Weeks secondary outcome measure Pharmacokinetics (Cmin / Cmax) secondary outcome description To test the minimum (Cmin) and the maximum (Cmax) blood plasma concentration secondary outcome time frame 12 Weeks secondary outcome measure Pharmacokinetics (Ctrough) secondary outcome description To test the minimum drug concentration after a dose secondary outcome time frame 12 Weeks secondary outcome measure Pharmacokinetics (Tmax) secondary outcome description To test the time taken to reach Cmax secondary outcome time frame 12 Weeks secondary outcome measure Evaluate the efficacy of increased siltuximab doses after disease progression on prior siltuximab treatment. secondary outcome description The primary efficacy endpoint is CBR defined as CR, PR, or SD lasting ≥12 weeks per CDCNRC based on evaluation of biochemical, lymph node, and symptom response secondary outcome time frame 12 Weeks secondary outcome measure Evaluate the immunogenicity of increased siltuximab doses after disease progression on prior siltuximab treatment. secondary outcome description Immunogenicity will be assessed through the detection of antibodies against siltuximab, and will be conducted via immunoassay ± serum IL-6 levels on Day 1 of Cycle 1, 3, 6 and every 4 cycles thereafter, before administration of siltuximab. secondary outcome time frame 12 Weeks secondary outcome measure To evaluate the patient-reported outcomes (PROs) using the EQ-5D Instrument secondary outcome description The secondary outcome measures will include the health status measures of the EuroQuality of Life Five Dimensions (EQ-5D) has the following dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the 5 dimensions secondary outcome time frame 12 Weeks secondary outcome measure To evaluate the patient-reported outcomes (PROs) using the MCD-SS Instrument secondary outcome description The Multicentric Castleman disease symptom score (MCD-SS) lists 10 symptoms which are graded on a scale: Did not experience (0); Very mild (2); Mild (4); Moderate (6); Severe (8); Very Severe (10). The mean score of the ten items is calculated and a higher score indicates more severe symptoms. secondary outcome time frame 12 Weeks eligibility module eligibility criteria Inclusion Criteria:
Documented history of consensus histologic, laboratory, and clinical diagnostic criteria of iMCD.
Archival and/or baseline incisional/excisional biopsy for retrospective central histologic confirmation of iMCD.
CDCNRC-defined disease progression on or after prior treatment with siltuximab at 11 mg/kg q3w without unacceptable toxicity within 12 weeks between the last dose of siltuximab and the date of signed patient informed consent form (ICF).
At least 1 measurable abnormal lymph node mass that is ≥1 cm in its longest transverse diameter as assessed by computerized tomography (CT) scan that has not been previously irradiated.
Elevated (>10 mg/L) and rising serum CRP in the absence of additional iMCD treatment.
Evidence of at least an additional one of the following laboratory or clinical signs of iMCD per international, evidence-based consensus diagnostic criteria for HIV or HHV 8-negative iMCD:
Anemia, thrombocytopenia, hypoalbuminemia, renal dysfunction, or polyclonal hypergammaglobulinemia.
Constitutional symptoms (night sweats, fever (>38°C), weight loss, or fatigue (CTCAE lymphoma B-symptoms score ≥2), large spleen and/or liver, fluid accumulation, eruptive cherry hemangiomatosis/violaceous papules, or lymphocytic interstitial pneumonitis.
Adequate clinical laboratory measurements within 3 weeks prior to study entry in all parameters below:
Absolute neutrophil count ≥1.0 × 109/L, hemoglobin <17 g/dL, and platelets ≥50 × 109/L without transfusion, hematopoietic growth factors, or both for >7 days prior to measurement.
AST, ALT, total bilirubin, and alkaline phosphatase ≤5 × ULN.
Fasting cholesterol <300 mg/dL and fasting triglyceride <400 mg/dL.
Age ≥12 years.
Exclusion Criteria:
Documentation of HIV or HHV-8 infection or presence of other infection-related disorders that resemble clinical or histological features of iMCD
Diagnosis of any malignant/benign lymphoproliferative disorders
Diagnosis of autoimmune/autoinflammatory disease
Treatment with corticosteroids (prednisone dose-equivalent >1 mg/kg/day) within 7 days prior to study entry.
History of solid organ transplant, allogeneic bone marrow transplant, or allogeneic peripheral blood stem cell transplant.
Previous malignancy with the following exceptions:
Past malignancy with treatment that was completed at least 2 years before signing informed consent and the patient has no evidence of disease, or
Concurrent malignancy that is clinically stable and does not require tumor-directed treatment (eg, nonmelanoma skin cancer and carcinoma in situ) healthy volunteers No gender All minimum age 12 Years std age list std age Child Adult Older Adult contacts locations module overall official list overall official overall official name Chris Keuker, MD overall official affiliation Syneos Health overall official role Study Director location list location location facility Edward W. Sparrow Hospital location city Lansing location state Michigan location zip 48912 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000005871 condition mesh term Castleman Disease condition ancestor list condition ancestor condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000008206 condition ancestor term Lymphatic Diseases condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M8135 condition browse leaf name Castleman Disease condition browse leaf as found Castleman Disease condition browse leaf relevance high condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M10355 condition browse leaf name Lymphatic Diseases condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T991 condition browse leaf name Castleman Disease condition browse leaf as found Castleman Disease condition browse leaf relevance high condition browse leaf id T5791 condition browse leaf name Unicentric Castleman Disease condition browse leaf as found Castleman Disease condition browse leaf relevance high condition browse leaf id T3921 condition browse leaf name Multicentric Castleman Disease condition browse leaf as found Multicentric Castleman's Disease condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id C000504234 intervention mesh term Siltuximab intervention ancestor list intervention ancestor intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M341662 intervention browse leaf name Siltuximab intervention browse leaf as found Rheumatic Diseases intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04838860 | [
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1830,
2091,
2217,
142,
26996,
6840,
1107,
7195,
24767,
1556,
146,
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21745,
18447,
24684,
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1399,
20012,
1337,
10736,
12798,
1174,
1258,
4602,
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22478,
156,
6258,
16941,
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2137,
2781,
13196,
2781,
22480,
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1475,
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16868,
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188,
23055,
1838,
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117,
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188,
23055,
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122,
117,
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188,
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122,
117,
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186,
172,
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127,
117,
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130,
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156,
5674,
27035,
1197,
1730,
10767,
1730,
10767,
1271,
142,
11700,
2101,
7111,
1918,
113,
1993,
114,
5975,
1730,
10767,
1705,
15969,
2137,
13329,
23313,
3663,
20051,
13196,
20051,
1144,
173,
182,
172,
1302,
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175,
173,
170,
12521,
3850,
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175,
173,
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123,
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1103,
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117,
1106,
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117,
1105,
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27466,
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24429,
1106,
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178,
10044,
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117,
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118,
2016,
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124,
2277,
113,
186,
1495,
2246,
114,
1443,
24726,
25954,
117,
1105,
1110,
3120,
2011,
1106,
24228,
6305,
1111,
1107,
4487,
27420,
13753,
13936,
7867,
1891,
1114,
1907,
7300,
117,
1664,
1665,
21472,
7867,
117,
1105,
153,
2428,
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170,
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1137,
9396,
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119,
13832,
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122,
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118,
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118,
127,
118,
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157,
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178,
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117,
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117,
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120,
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120,
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186,
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1191,
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1107,
1103,
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1104,
26624,
1942,
119,
1109,
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1116,
1111,
13936,
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3140,
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120,
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186,
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1129,
1359,
1113,
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4487,
27420,
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13936,
7867,
1891,
1105,
26624,
1942,
25451,
1112,
1758,
2071,
119,
2975,
13196,
3879,
2190,
3879,
146,
13447,
21745,
18447,
24684,
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112,
188,
20012,
1902,
13196,
2025,
2076,
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21987,
1348,
4065,
2190,
4065,
12278,
123,
1902,
23992,
1902,
18205,
7922,
118,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
9108,
2235,
6136,
13832,
10747,
1158,
1107,
6160,
122,
1161,
1105,
6160,
122,
1830,
1104,
1142,
2025,
1107,
5504,
1209,
1129,
1146,
1106,
127,
4420,
1296,
1114,
27466,
6066,
5025,
8628,
1830,
118,
1231,
16046,
5591,
1137,
1231,
27476,
9363,
1183,
15393,
118,
127,
118,
4940,
178,
10044,
2137,
1105,
157,
12303,
21564,
118,
178,
10044,
2137,
4420,
117,
3569,
117,
1150,
1209,
13971,
1107,
4487,
27420,
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13936,
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1114,
1659,
17713,
120,
4023,
186,
1495,
2246,
117,
1173,
3566,
13753,
13936,
7867,
3798,
1106,
3081,
17713,
120,
4023,
186,
1495,
2246,
1173,
3140,
17713,
120,
4023,
186,
1495,
2246,
1191,
7300,
1193,
4668,
1107,
1103,
5884,
1104,
26624,
1942,
119,
1109,
22647,
1116,
1111,
13936,
7867,
3798,
27466,
6066,
5025,
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24429,
1146,
1106,
3140,
17713,
120,
4023,
186,
1495,
2246,
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1129,
1359,
1113,
1107,
4487,
27420,
13753,
13936,
7867,
1891,
1105,
26624,
1942,
25451,
1112,
1758,
2071,
119,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
7330,
113,
3353,
20943,
114,
1902,
7739,
1158,
6136,
1302,
7739,
1158,
10803,
23992,
10803,
5099,
1659,
10803,
2076,
2173,
4746,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
23994,
4838,
1233,
24446,
1104,
178,
10044,
2137,
7195,
24767,
1981,
1372,
2076,
17244,
3291,
8223,
4626,
2772,
1981,
1372,
6136,
13832,
10747,
1158,
1107,
6160,
122,
1161,
1104,
1142,
2025,
1107,
5504,
1209,
1129,
1146,
1106,
127,
4420,
1296,
1114,
27466,
6066,
5025,
8628,
1830,
118,
1231,
16046,
5591,
1137,
1231,
27476,
9363,
1183,
15393,
118,
127,
118,
4940,
178,
10044,
2137,
4420,
117,
3569,
117,
1150,
1209,
13971,
1107,
4487,
27420,
13753,
13936,
7867,
1891,
1104,
27466,
6066,
5025,
8628,
1830,
2150,
1114,
1659,
17713,
120,
4023,
186,
1495,
2246,
117,
1173,
3566,
13753,
13936,
7867,
3798,
1106,
3081,
17713,
120,
4023,
186,
1495,
2246,
1173,
3140,
17713,
120,
4023,
186,
1495,
2246,
1191,
7300,
1193,
4668,
1107,
1103,
5884,
1104,
26624,
1942,
119,
1109,
22647,
1116,
1111,
13936,
7867,
3798,
27466,
6066,
5025,
8628,
1830,
24429,
1146,
1106,
3140,
17713,
120,
4023,
186,
1495,
2246,
1209,
1129,
1359,
1113,
1107,
4487,
27420,
13753,
13936,
7867,
1891,
1105,
26624,
1942,
25451,
1112,
1758,
2071,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
14159,
6066,
5025,
8628,
1830,
1981,
1372,
3107,
23994,
4838,
1233,
24446,
1104,
157,
12303,
21564,
118,
178,
10044,
2137,
7195,
24767,
1981,
1372,
2076,
17244,
3291,
8223,
4626,
2772,
1981,
1372,
6136,
13832,
10747,
1158,
1107,
6160,
122,
1830,
1104,
1142,
2025,
1107,
5504,
1209,
1129,
1146,
1106,
127,
4420,
1296,
1114,
27466,
6066,
5025,
8628,
1830,
118,
1231,
16046,
5591,
1137,
1231,
27476,
9363,
1183,
15393,
118,
127,
118,
4940,
157,
12303,
21564,
118,
178,
10044,
2137,
4420,
117,
3569,
117,
1150,
1209,
13971,
1107,
4487,
27420,
13753,
13936,
7867,
1891,
1104,
27466,
6066,
5025,
8628,
1830,
2150,
1114,
1659,
17713,
120,
4023,
186,
1495,
2246,
117,
1173,
3566,
13753,
13936,
7867,
3798,
1106,
3081,
17713,
120,
4023,
186,
1495,
2246,
1173,
3140,
17713,
120,
4023,
186,
1495,
2246,
1191,
7300,
1193,
4668,
1107,
1103,
5884,
1104,
26624,
1942,
119,
1109,
22647,
1116,
1111,
13936,
7867,
3798,
27466,
6066,
5025,
8628,
1830,
24429,
1146,
1106,
3140,
17713,
120,
4023,
186,
1495,
2246,
1209,
1129,
1359,
1113,
1107,
4487,
27420,
13753,
13936,
7867,
1891,
1105,
26624,
1942,
25451,
1112,
1758,
2071,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
14159,
6066,
5025,
8628,
1830,
9108,
2190,
9108,
9108,
2076,
13982,
9108,
1271,
14159,
6066,
5025,
8628,
1830,
9108,
6136,
4539,
27989,
21868,
1209,
3531,
1107,
4487,
7912,
2285,
113,
4191,
114,
1107,
17149,
1104,
27466,
6066,
5025,
8628,
1830,
1659,
17713,
120,
4023,
1166,
123,
2005,
1451,
124,
2277,
117,
1173,
3566,
13753,
13936,
7867,
3798,
1106,
3081,
17713,
120,
4023,
4191,
1166,
124,
2005,
116,
120,
118,
3140,
17713,
120,
4023,
4191,
1166,
125,
2005,
1451,
124,
2277,
1191,
7300,
1193,
4668,
1107,
1103,
5884,
1104,
13753,
118,
15816,
25954,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
23994,
4838,
1233,
24446,
1104,
157,
12303,
21564,
118,
178,
10044,
2137,
7195,
24767,
23994,
4838,
1233,
24446,
1104,
178,
10044,
2137,
7195,
24767,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
156,
7777,
14194,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
1249,
8830,
1116,
1103,
15961,
3096,
11470,
2875,
24187,
113,
18893,
2069,
114,
1104,
14159,
6066,
5025,
8628,
1830,
2425,
9386,
6136,
1249,
8830,
1116,
1103,
7300,
5257,
2593,
113,
18893,
2069,
114,
1104,
2569,
27466,
6066,
5025,
8628,
1830,
24429,
1107,
4420,
1114,
15393,
118,
127,
118,
4940,
113,
140,
118,
26844,
4592,
164,
15531,
2101,
166,
118,
8208,
1105,
4703,
114,
25021,
2660,
21745,
4321,
24684,
3856,
1399,
3653,
113,
178,
10044,
2137,
114,
1170,
3653,
16147,
1113,
1103,
2530,
27466,
6066,
5025,
8628,
1830,
13753,
6030,
119,
18893,
2069,
3393,
1112,
2335,
2593,
113,
15531,
114,
117,
7597,
2593,
113,
11629,
114,
117,
1137,
6111,
3653,
113,
19416,
114,
9810,
864,
11964,
2277,
1679,
3856,
1399,
20012,
9518,
1742,
12207,
5838,
3998,
24187,
140,
10587,
3464,
113,
2891,
1658,
16107,
1658,
114,
119,
2425,
9386,
1159,
4207,
1367,
23519,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
1706,
17459,
1103,
3429,
1105,
1106,
2879,
6328,
1104,
2569,
14159,
6066,
5025,
8628,
1830,
24429,
3718,
9386,
6136,
3561,
26859,
2093,
1104,
24930,
10840,
17437,
113,
138,
27485,
114,
117,
3021,
16798,
1958,
113,
13411,
27485,
114,
117,
6321,
9334,
3021,
16798,
9535,
113,
156,
13329,
12426,
1116,
114,
117,
21014,
1104,
22832,
8087,
2774,
2686,
21014,
1104,
13753,
118,
15816,
12844,
4233,
113,
26624,
1942,
1116,
114,
3718,
9386,
1159,
4207,
1367,
23519,
3718,
9386,
4929,
7642,
24275,
2528,
4314,
22259,
113,
159,
1181,
114,
3718,
9386,
6136,
1706,
2774,
1103,
5351,
112,
188,
3850,
21146,
5026,
1785,
3718,
9386,
1159,
4207,
1367,
23519,
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9386,
4929,
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24275,
2528,
4314,
22259,
113,
140,
2162,
114,
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6136,
1706,
2774,
1103,
3884,
1104,
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5323,
1104,
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1679,
2587,
1159,
3718,
9386,
1159,
4207,
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24275,
2528,
4314,
22259,
113,
21646,
1658,
114,
3718,
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1706,
2774,
1103,
6102,
1104,
7401,
1106,
170,
3850,
1105,
1157,
16443,
2603,
1121,
1103,
1404,
3718,
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1159,
4207,
1367,
23519,
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24275,
2528,
4314,
22259,
113,
140,
7937,
120,
140,
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114,
3718,
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6136,
1706,
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1103,
5867,
113,
140,
7937,
114,
1105,
1103,
4177,
113,
140,
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114,
1892,
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6256,
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1159,
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23519,
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24275,
2528,
4314,
22259,
113,
140,
8005,
6289,
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full study rank 61818 study protocol section identification module n c t id NCT04831528 org study id info org study id FDZL-ctDNA organization org full name Fudan University org class OTHER brief title Decision-making of ctDNA in Patients With mCRC After Failure of First-line Treatment Containing Cetuximab - a Single-center, Phase II Clinical Study official title The Role of Circulating Tumor DNA in Decision-making of Patients With Metastatic Colorectal Cancer After Failure of First-line Treatment Containing Cetuximab - a Single-center, Phase II Clinical Study status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 10, 2021 start date type Anticipated primary completion date struct primary completion date June 30, 2025 primary completion date type Anticipated completion date struct completion date June 30, 2026 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Fudan University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This study aimis at detecting the genomic changes of ctDNA in patients of RAS and BRAF wild-type mCRC, who failed after first line treatment containing cetuximab. According to the results of ctDNA detection, individualized second-line targeted therapy strategies were developed to explore the disease control rate and prognostic significance of ctDNA-guided treatment for metastatic colorectal cancer. conditions module condition list condition Metastatic Colorectal Cancer design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label No secondary changes of drug resistance arm group intervention list arm group intervention name Drug: Cetuximab Ab; Bevacizumab; Vermofenib + cetuximab;Trastuzumab+lapatinib or trastuzumab+pertuzumab; others arm group label Secondary mutations of RAS arm group intervention list arm group intervention name Drug: Cetuximab Ab; Bevacizumab; Vermofenib + cetuximab;Trastuzumab+lapatinib or trastuzumab+pertuzumab; others arm group label Secondary mutation of BRAF arm group intervention list arm group intervention name Drug: Cetuximab Ab; Bevacizumab; Vermofenib + cetuximab;Trastuzumab+lapatinib or trastuzumab+pertuzumab; others arm group label HER2 amplification arm group intervention list arm group intervention name Drug: Cetuximab Ab; Bevacizumab; Vermofenib + cetuximab;Trastuzumab+lapatinib or trastuzumab+pertuzumab; others arm group label Other secondary mutations arm group intervention list arm group intervention name Drug: Cetuximab Ab; Bevacizumab; Vermofenib + cetuximab;Trastuzumab+lapatinib or trastuzumab+pertuzumab; others intervention list intervention intervention type Drug intervention name Cetuximab Ab; Bevacizumab; Vermofenib + cetuximab;Trastuzumab+lapatinib or trastuzumab+pertuzumab; others intervention description After PD, patients received ctDNA testing, and different research protocols were selected according to different gene states of ctDNA, as follows: 1.No secondary changes related to drug resistance were found. Cetuximab cross-line + second-line chemotherapy (FOLFOX/FOLFIRI/ Irinotecan monotherapy, etc.) was used.2. If there is a RAS secondary mutation, change of beacizumab bead sheet resistance + second-line chemotherapy (FOLFOX/XELOX/stand for kang single-agent FOLFIRI mXEIRI/Iraq, etc.);3. If BRAF secondary mutation occurs, replace it with vimofenib + cetuximab + irinotecan;4. If HER2 amplification occurs, replace it with trastuzumab + lapatinib or trastuzumab + pertuzumab;5. In case of other secondary mutations, bevacizumab plus second-line chemotherapy should be replaced. intervention arm group label list intervention arm group label HER2 amplification No secondary changes of drug resistance Other secondary mutations Secondary mutation of BRAF Secondary mutations of RAS outcomes module primary outcome list primary outcome primary outcome measure Objective response rate primary outcome description The percentage of patients whose tumors shrink by a certain amount and remain so for a certain amount of time, including patients with CR and PR.Objective tumor response was assessed using the Response Assessment Criterion for Solid Tumors (RECIST 1.1). primary outcome time frame April 10,2021-June 30,2021 secondary outcome list secondary outcome secondary outcome measure overall survival secondary outcome description Time from enrollment to death from any cause.Lost visitors to the last follow-up time. secondary outcome time frame April 10,2021-June 30,2021 secondary outcome measure progress free survival secondary outcome description Patients were randomized to solstice for any recorded time of tumor progression or death from any cause. secondary outcome time frame April 10,2021-June 30,2021 secondary outcome measure Safety and tolerability secondary outcome description NCI -- CTC AE 4.0 will be used to evaluate the clinical safety of the treatment in the study.The incidence of adverse events in the subjects should be assessed at each clinical visit. secondary outcome time frame April 10,2021-June 30,2021 secondary outcome measure duration of response secondary outcome description This is the time between the first assessment of a tumor as CR or PR and the first assessment as PD or death from any cause. secondary outcome time frame April 10,2021-June 30,2021 eligibility module eligibility criteria Inclusion Criteria:
Age ≥18, gender unlimited;
Proven histologically by colorectal adenocarcinoma, local lesions can not be radical resection or metastatic colorectal cancer;
Patients with RAS and BRAF wild-type tissue genetic testing, receiving first-line treatment containing cetuximab, and radiographic evaluation of disease progression;
Eastern Cooperative Oncology Group (ECOG) physical condition score (PS) 0 ~ 2;
Expected survival of more than 3 months;
Within 7 days before screening (including 7 days), laboratory test data requirements were as follows: neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥90g/L (no blood transfusion within 14 days), serum total bilirubin ≤1.25 times the upper normal limit (ULN);ALT and AST≤ 2.5 x ULN (≤5x ULN in patients with liver metastasis);Serum creatinine ≤1.0 x ULN and creatinine clearance rate ≥60 mL /min;Left ventricular ejection fraction in ultrasound examination >55%;
At least one measurable lesion (RECIST 1.1 criteria);
Subjects (or their legal representative/guardian) must sign the informed consent indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study.
Exclusion Criteria:
Those who have one or more of the following will not be included in the study:
Have received any experimental drugs or anti-tumor drugs within 4 weeks before enrollment;
A history of other tumors in the past five years, except for cervix cancer or basal cell carcinoma of the skin that has been cured;
Patients with obvious intracranial hypertension or neuropsychiatric symptoms due to uncontrolled primary brain tumor or central nerve metastatic tumor
Pregnant or lactating women;Those who are fertile but do not take adequate contraceptive measures;
Alcoholism or drug addiction;
with pleural effusion or ascites, causing respiratory syndrome (≥CTCAE2 grade dyspnea), requiring local treatment;
Patients with the following serious or uncontrolled diseases: severe heart disease, unstable condition after treatment, myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment;Definite neuropathy or psychosis, including dementia or seizures;Severe or uncontrolled infections;Patients with active and disseminated intravascular coagulation and significant bleeding tendency
known hypersensitivity or anaphylaxis to any component of the study drug to be applied.
The function of important organs is obviously impaired
Other circumstances under which the investigator considers that the patient should not participate in the study healthy volunteers No gender All gender based Yes gender description ≥18y minimum age 18 Years std age list std age Adult Older Adult study population Patients who met the entry criteria, failed after receiving first-line treatment containing cetuximab, and were judged to have progressive disease (PD) by imaging evaluation were eligible for inclusion. sampling method Probability Sample contacts locations module central contact list central contact central contact name Zhiyu Chen, Professor central contact role Contact central contact phone 021-64175590 central contact e mail chanhj75@aliyun.com derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000015179 condition mesh term Colorectal Neoplasms condition ancestor list condition ancestor condition ancestor id D000007414 condition ancestor term Intestinal Neoplasms condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000003108 condition ancestor term Colonic Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000012002 condition ancestor term Rectal Diseases condition browse leaf list condition browse leaf condition browse leaf id M17042 condition browse leaf name Colorectal Neoplasms condition browse leaf as found Colorectal Cancer condition browse leaf relevance high condition browse leaf id M9600 condition browse leaf name Intestinal Neoplasms condition browse leaf relevance low condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M5488 condition browse leaf name Colonic Diseases condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M13996 condition browse leaf name Rectal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000068258 intervention mesh term Bevacizumab intervention mesh id D000068878 intervention mesh term Trastuzumab intervention mesh id D000068818 intervention mesh term Cetuximab intervention mesh id C000485206 intervention mesh term Pertuzumab intervention mesh id D000077341 intervention mesh term Lapatinib intervention ancestor list intervention ancestor intervention ancestor id D000074322 intervention ancestor term Antineoplastic Agents, Immunological intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000020533 intervention ancestor term Angiogenesis Inhibitors intervention ancestor id D000043924 intervention ancestor term Angiogenesis Modulating Agents intervention ancestor id D000006133 intervention ancestor term Growth Substances intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000006131 intervention ancestor term Growth Inhibitors intervention ancestor id D000047428 intervention ancestor term Protein Kinase Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention browse leaf list intervention browse leaf intervention browse leaf id M325 intervention browse leaf name Trastuzumab intervention browse leaf as found Breast Cancer intervention browse leaf relevance high intervention browse leaf id M246 intervention browse leaf name Bevacizumab intervention browse leaf as found Sessions intervention browse leaf relevance high intervention browse leaf id M315 intervention browse leaf name Cetuximab intervention browse leaf as found Dexamethasone intervention browse leaf relevance high intervention browse leaf id M1671 intervention browse leaf name Irinotecan intervention browse leaf relevance low intervention browse leaf id M289255 intervention browse leaf name Pertuzumab intervention browse leaf as found Knee Arthroplasty intervention browse leaf relevance high intervention browse leaf id M1778 intervention browse leaf name Lapatinib intervention browse leaf as found Cetuximab intervention browse leaf relevance high intervention browse leaf id M1346 intervention browse leaf name Antineoplastic Agents, Immunological intervention browse leaf relevance low intervention browse leaf id M21471 intervention browse leaf name Angiogenesis Inhibitors intervention browse leaf relevance low intervention browse leaf id M24973 intervention browse leaf name Protein Kinase Inhibitors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04831528 | [
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full study rank 61472 study protocol section identification module n c t id NCT04836026 org study id info org study id HF20 Registry organization org full name Children's Hospital Medical Center, Cincinnati org class OTHER brief title Registry for HF20 for Pediatric CRRT Under Emergency Use Authorization official title Evaluation of the HF20™ Filter for Pediatric Continuous Renal Replacement Therapy (CRRT) status module status verified date July 2022 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date January 27, 2021 start date type Actual primary completion date struct primary completion date November 30, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 18, 2022 last update post date struct last update post date July 20, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Stuart Goldstein, MD responsible party investigator title Director, Center for Acute Care Nephrology responsible party investigator affiliation Children's Hospital Medical Center, Cincinnati lead sponsor lead sponsor name Children's Hospital Medical Center, Cincinnati lead sponsor class OTHER collaborator list collaborator collaborator name Baxter Healthcare Corporation collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device Yes is u s export No description module brief summary Historically, innovations for acute kidney injury (AKI) and continuous renal replacement therapy (CRRT) have centered around an adult population. However, research has shown that over 10% of pediatric patients develop severe AKI within the first week in an intensive care unit (ICU). When a pediatric patient requires renal replacement therapy for AKI in the ICU, CRRT is usually the modality of choice. The HF20™ is indicated for supporting patients weighing 8 to 20 kilograms, addressing a critical clinical need for critically ill children who require CRRT. Current US Food and Drug Administration (FDA) approved CRRT filters are designed for patients weighing more than 20 kg or less than 10 kg, leaving a gap in appropriately designed filters for pediatric patients.
A previous trial in the US showed that the HF20™ is safe and effective, however the membrane composition of the HF20™ used in that trial is different than what is currently manufacturer and available. Baxter Healthcare Corporation has received an Emergency Use Authorization (EUA) for the currently available HF20™ to be used in the era of the COVID-19 pandemic, however participants do not need to be infected with the SAR-CoV-2 virus in order to be treated. The EUA for the HF20™ allows for treatment for any children weighing between 8 and 20 kilograms in need of CRRT. This registry will collect clinical data related to the safety and efficacy of the HF20™ filter for CRRT in pediatric patients weighing 8 to 20 kilograms at participating institutions, however participation in this registry is not a requirement in order to be treated with the HF20™ filter. conditions module condition list condition Pediatric Kidney Disease Acute Kidney Injury keyword list keyword HF20 design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label HF20™ for Pediatric CRRT arm group description Pediatric patients in an intensive care unit requiring CRRT for acute kidney injury (AKI) arm group intervention list arm group intervention name Device: HF20™ intervention list intervention intervention type Device intervention name HF20™ intervention description HF20™ will be used for CRRT intervention arm group label list intervention arm group label HF20™ for Pediatric CRRT outcomes module primary outcome list primary outcome primary outcome measure Change in Blood Urea Nitrogen (BUN) primary outcome time frame After 24 hours of CRRT with the HF20™ filter as compared to baseline secondary outcome list secondary outcome secondary outcome measure Change in Serum Creatinine secondary outcome time frame After 24 hours of CRRT with the HF20™ filter as compared to baseline secondary outcome measure Change in Serum Bicarbonate/Carbon Dioxide secondary outcome time frame After 24 hours of CRRT with the HF20™ filter as compared to baseline eligibility module eligibility criteria Inclusion Criteria:
Receiving or plan to receive CRRT with the HF20™ filter as standard of care
Acute kidney injury (AKI) or fluid overload as defined as one of the two below:
AKI defined as Kidney Disease Improving Global Outcomes (KDIGO) Stage 1 or higher by either:
Serum creatinine criteria (0.3 mg/dL increase over baseline in 48 hours, or a 50 percent increase within the previous 7 days) or
Urine output criteria (less than 0.5 mL/kg/hr for 6 or more hours)
Severe fluid overload defined as greater than 10 percent fluid accumulation based on ICU admission weight
Exclusion Criteria:
Weight less than 8 kilograms
Weight more than 20 kilograms
Patient not expected to survive more than 48 hours
Received renal replacement therapy in the previous 5 days healthy volunteers No gender All std age list std age Child Adult Older Adult study population Patients receiving CRRT with the HF20™ filter as their standard care for AKI or fluid overload in an intensive care unit at a participating institution. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Stuart L Goldstein, MD overall official affiliation Children's Hospital Medical Center, Cincinnati overall official role Principal Investigator location list location location facility Cincinnati Children's Hospital Medical Center location city Cincinnati location state Ohio location zip 45229 location country United States location facility Seattle Children's location city Seattle location state Washington location zip 98105 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007674 condition mesh term Kidney Diseases condition mesh id D000058186 condition mesh term Acute Kidney Injury condition ancestor list condition ancestor condition ancestor id D000014570 condition ancestor term Urologic Diseases condition ancestor id D000051437 condition ancestor term Renal Insufficiency condition browse leaf list condition browse leaf condition browse leaf id M6948 condition browse leaf name Emergencies condition browse leaf relevance low condition browse leaf id M9850 condition browse leaf name Kidney Diseases condition browse leaf as found Kidney Disease condition browse leaf relevance high condition browse leaf id M28151 condition browse leaf name Acute Kidney Injury condition browse leaf as found Acute Kidney Injury condition browse leaf relevance high condition browse leaf id M16471 condition browse leaf name Urologic Diseases condition browse leaf relevance low condition browse leaf id M25871 condition browse leaf name Renal Insufficiency condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases | NCT04836026 | [
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] |
full study rank 61430 study protocol section identification module n c t id NCT04836572 org study id info org study id SQI-09-01 organization org full name SQ Innovation, Inc. org class INDUSTRY brief title An Open-label, Non Significant Risk, Adhesive Wear Validation Study for the On Body Drug Delivery Device Component of the SQIN-01 Furosemide Infusor (Infusor Device) official title An Open-label, Non Significant Risk, Adhesive Wear Validation Study for the On Body Drug Delivery Device Component of the SQIN-01 Furosemide Infusor (Infusor Device) status module status verified date July 2021 overall status Completed expanded access info has expanded access No start date struct start date January 20, 2021 start date type Actual primary completion date struct primary completion date March 4, 2021 primary completion date type Actual completion date struct completion date March 4, 2021 completion date type Actual study first submit date March 31, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 14, 2021 last update post date struct last update post date July 21, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name SQ Innovation, Inc. lead sponsor class INDUSTRY collaborator list collaborator collaborator name Community Clinical Research Network collaborator class UNKNOWN oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of the present study is to test the adequacy, performance and skin reactivity of the adhesive tape to be utilized in the to-be-marketed Device.
The present study will examine adhesive hold performance, re-use protection (i.e. adhesive re-application) and skin reactivity/tolerability of the proposed commercial adhesive tape (i.e. within the Test Infusor Device; TID). As the purpose of the study is to assess adhesive performance which does not require activation of the device. Hence in this study no canula will be deployed (no skin penetration) and no delivery of the drug or other fluids. detailed description An open-label, non significant risk, adhesive wear validation study with 60 adult subjects.
Group A (30 subjects): Wearing of the Infusor for 5-9hrs followed by assessment and subsequent removal of the Infusor by study staff with photographic recording prior to and after removal.
Group B (30 subjects): Wearing of the Infusor for 5-9hrs followed by assessment and photographic recording of the Infusor by study staff after which the subject will return home and removal of the Infusor by subject or caregiver approximately 12hrs after placement (± 1hr), when another photograph will be taken. The subject must return the device to the site and transfer the photograph in accordance with the instructions.
Until enrollment for Group B is complete, study candidates will be asked if prefer group A or B. Additional inclusion criteria apply for participation in group B.
Consent, screening and enrollment may be performed on the same day (Day 1) Screening must be performed within 7 days of the Wear phase.
Following signing of the ICF (A or B) each subject will complete Screening activities (height, weight, brief medical history). If the subject meets all inclusion criteria an none of the exclusion criteria the subject may enroll.
The Wear Phase consists of one (1) wear period of five to twelve (5-12) hours. conditions module condition list condition Healthy Volunteer Study keyword list keyword Adhesive Attachment duarability Assess possible skin reactions Erythema Edema design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 60 enrollment type Actual arms interventions module arm group list arm group arm group label Wear Period arm group type Other arm group intervention list arm group intervention name Other: 3M 1529 Adhesive Tape intervention list intervention intervention type Other intervention name 3M 1529 Adhesive Tape intervention description 5-12 hour adhesive wear intervention arm group label list intervention arm group label Wear Period outcomes module primary outcome list primary outcome primary outcome measure Adhesion primary outcome description Number of participants with failed adhesion (Adhesion Score of 3 or 4 - Appendix A) 5-9 hours after placement as determined by study staff and documented by photography. primary outcome time frame 5-9 hours primary outcome measure Re-adhesion primary outcome description Number of participants with successful re-adhesion - score of 0, 1 or 2 as per Appendix A at 5 minutes after adhesion at the opposite side of the upper abdomen after a completed simulated wear period of no less than 5 hours primary outcome time frame > 5 hours secondary outcome list secondary outcome secondary outcome measure Comfort of Wear secondary outcome description Overall average comfort of wear score of the test device using a 10-point Visual Analogue Scale (VAS). The scores are values 0-10, with 0 being very comfortable, and 10 being intolerable discomfort. secondary outcome time frame 5-12 hours secondary outcome measure Interference secondary outcome description Overall average scoring of interference with important routine activities of daily living such as use of the bathroom, walking, and climbing stairs using a 10-point Visual Analogue Scale (VAS). The scores are values are 0-10, with 0 being no interference, and 10 being great interference. secondary outcome time frame 5-12 hours secondary outcome measure Irritation secondary outcome description Overall average irritation score for erythema and edema (on a 5-point scale) after wear(Appendix C). The scores are values 0-4 with 0 being no erythema/edema, and 4 being severe erythema/edema. secondary outcome time frame 5-12 hours eligibility module eligibility criteria Inclusion Criteria:
Subjects will be considered for inclusion only if they meet all of the following criteria:
An Institutional Review Board (IRB)-approved informed consent is signed and dated prior to any study-related activities.
Male and female subjects ≥40 and ≤80 years of age
Body mass index (BMI) <38 kg/m2.
Females will be non-pregnant and non-lactating.
Able to participate in the study in the opinion of the Investigator.
Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
Exclusion Criteria:
Subjects will be excluded from participation if they meet any of the following criteria:
Systolic blood pressure (SBP) <90 mmHg.
Temperature ≥38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment.
History of COVID-19 infection or recent exposure to someone with COVID-19 or who is currently in quarantine for COVID-19 exposure.
Presence of signs or symptoms of possible COVID-19 infection, including cough, shortness of breath, or temperature ≥ 38°C.
Previous abdominal surgery resulting in presence of a scar or malformation in upper abdominal area.
Presence of skin disorder or abnormality in upper abdominal area.
Known or suspected allergy to acylate adhesives or other materials present in the device.
Significant comorbidities or health issues which in the opinion of the investigator may interfere with study participation or study assessments.
Major surgery within 30 days prior to Screening.
Administration of an investigational drug or implantation of investigational device, or participation in another interventional trial, within 30 days prior to Screening. healthy volunteers Accepts Healthy Volunteers gender All minimum age 40 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Kyle Magner, RN overall official affiliation Community Clinical Research Network overall official role Principal Investigator location list location location facility Community Clinical Research Network location city Marlborough location state Massachusetts location zip 01752 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M6809 condition browse leaf name Edema condition browse leaf relevance low condition browse leaf id M7196 condition browse leaf name Erythema condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M7936 intervention browse leaf name Furosemide intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev NaAg intervention browse branch name Natriuretic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04836572 | [
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2548,
1538,
1862,
1103,
4442,
1106,
1103,
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1105,
4036,
1103,
10110,
1107,
10274,
1114,
1103,
7953,
119,
5226,
10803,
1111,
1990,
139,
1110,
2335,
117,
2025,
4765,
1209,
1129,
1455,
1191,
9353,
1372,
138,
1137,
139,
119,
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10838,
9173,
6058,
1111,
6251,
1107,
1372,
139,
119,
16752,
27408,
117,
11954,
1105,
10803,
1336,
1129,
1982,
1113,
1103,
1269,
1285,
113,
2295,
122,
114,
15652,
1158,
1538,
1129,
1982,
1439,
128,
1552,
1104,
1103,
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1813,
4065,
119,
2485,
6086,
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1103,
146,
27783,
113,
138,
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139,
114,
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113,
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117,
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117,
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114,
119,
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1103,
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10838,
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1126,
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1103,
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119,
1109,
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1813,
12278,
2923,
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113,
122,
114,
4330,
1669,
1104,
1421,
1106,
4030,
113,
126,
118,
1367,
114,
2005,
119,
2975,
13196,
3879,
2190,
3879,
3225,
1183,
12744,
8690,
2501,
12565,
2190,
2501,
12565,
24930,
23838,
1335,
1777,
1732,
1880,
3840,
4626,
5474,
1249,
8830,
1116,
1936,
2241,
9535,
142,
1616,
25962,
1161,
5316,
14494,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
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138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
151,
120,
138,
1902,
9108,
2235,
8353,
1990,
1249,
19638,
1880,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
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113,
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114,
10803,
23992,
10803,
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2076,
2173,
4746,
1739,
22496,
13196,
1981,
1372,
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1981,
1372,
1981,
1372,
3107,
1284,
1813,
16477,
1981,
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2076,
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1981,
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1981,
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1271,
2189,
131,
124,
2107,
15722,
1580,
24930,
23838,
22515,
3186,
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9108,
2076,
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124,
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23838,
22515,
3186,
9108,
6136,
126,
118,
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1981,
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9108,
1981,
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3107,
1284,
1813,
16477,
13950,
13196,
2425,
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2190,
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1104,
124,
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125,
118,
138,
20564,
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1775,
138,
114,
126,
118,
130,
2005,
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6427,
119,
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118,
130,
2005,
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11336,
118,
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2425,
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6635,
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118,
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118,
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121,
117,
122,
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123,
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1679,
138,
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138,
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126,
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1120,
1103,
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1104,
1103,
3105,
14701,
1170,
170,
2063,
27210,
4330,
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1104,
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1750,
1190,
126,
2005,
2425,
9386,
1159,
4207,
135,
126,
2005,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
3291,
1306,
11088,
1104,
1284,
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118,
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113,
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118,
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117,
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119,
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126,
118,
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2005,
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117,
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117,
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170,
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118,
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113,
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114,
119,
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121,
118,
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117,
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121,
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117,
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11364,
119,
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1159,
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126,
118,
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2005,
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9386,
4929,
146,
14791,
7984,
3718,
9386,
6136,
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1903,
19380,
2794,
1111,
14044,
25669,
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1105,
5048,
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113,
1113,
170,
126,
118,
1553,
3418,
114,
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138,
20564,
12090,
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140,
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119,
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7432,
1132,
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118,
125,
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1185,
14044,
25669,
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120,
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117,
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125,
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15391,
1161,
120,
5048,
14494,
119,
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1159,
4207,
126,
118,
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2005,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
12859,
26394,
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1103,
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2793,
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1106,
1800,
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118,
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1971,
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18732,
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2137,
118,
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119,
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1936,
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117,
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1197,
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156,
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170,
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170,
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1874,
1964,
1398,
9108,
11424,
1162,
3392,
1271,
1398,
26500,
1105,
10957,
1116,
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] |
full study rank 61419 study protocol section identification module n c t id NCT04836715 org study id info org study id IRB202100649 organization org full name University of Florida org class OTHER brief title Prevalence of Visual Dysfunction in Neurological Disorders official title Prevalence of Visual Dysfunction in Persons With Parkinson's Disease and Other Neurological Disorders status module status verified date July 2021 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date August 2021 start date type Anticipated primary completion date struct primary completion date March 2022 primary completion date type Anticipated completion date struct completion date March 2023 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 8, 2021 last update post date struct last update post date July 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University of Florida lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The objective is to determine the prevalence of visual dysfunction in People with Parkinson's Disease (PwP). The investigators will administer the: Visual Impairment in Parkinson's Disease Screen and Revised-Self-Report Assessment of Functional Visual Performance. Patients seen at Fixel Institute and their caregivers will be invited to participate. Responses to the 2 questionnaires will help determine prevalence rates of visual dysfunction in PwP compared to those both with and without other neurological conditions. detailed description The purpose of this study is to identify the prevalence of visual dysfunction among Persons with Parkinson's Disease, compared to other neurological conditions and controls without neurological conditions.
Data will be collected anonymously via RedCap. Patients seen at the Fixel Institute that have consented to be contacted regarding research opportunities will be recruited via blast email and advertisement in our Institute's monthly newsletter, the Movement Messenger. The email and newsletter will contain a link for participation in surveys within RedCap so the surveys can be completed anonymously at home. Participation will be completely voluntary and responses will be recorded anonymously. Data will include responses to the following: screening questions, the VIPDQ (Visual Impairment in PD Questionnaire), and the R-SRAFVP (Revised-Self-Report Assessment of Functional Visual Performance).
The investigators will calculate the prevalence of visual impairment (from the VIPDQ) and dysfunction in performance of daily activities (from the R-SRAFVP) for PwP and compare this to the prevalence occurring in other neurological populations as well as the population without any neurological conditions. Other data are collected so the investigators can then evaluate potential confounds or covariates. To ensure statistical methods are accurate, a statistician will be consulted. conditions module condition list condition Parkinson Disease Other Neurological Disorders Healthy design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Other enrollment info enrollment count 10000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Parkinson's Disease arm group description Individuals with idiopathic Parkinson's Disease and no other neurological disease arm group label Other Neurological Disorders arm group description Individuals with one neurological disorder other than Parkinson's Disease (e.g. Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Parkinsonism) arm group label Healthy arm group description Individuals without any neurological disorder outcomes module primary outcome list primary outcome primary outcome measure Visual Dysfunction primary outcome description Determined from VIPDQ: (with the highest and lowest scores on the VIPD-Q Score). Answers are given on a 4-point Likert scale ranging from "never have problems" to "daily problems" primary outcome time frame 1 day primary outcome measure Functional Visual Performance primary outcome description Determined from R-SRA FVP: SRAFVP % primary outcome time frame 1 day other outcome list other outcome other outcome measure Correlations between Visual Dysfunction and Functional Visual Performance other outcome description Correlation Coefficient: VIPDQ score and SRAFVP % will be analyzed statistically to report correlation coefficient other outcome time frame 1 day eligibility module eligibility criteria Inclusion Criteria:
Persons with Parkinson's Disease: Confirmed diagnosis of Parkinson's Disease without presence of any other neurological condition.
Persons without Parkinson's Disease (Controls): No previous diagnosis of any neurological condition
Persons with a single other neurological disorder (Neuro Controls): Confirmed diagnosis of other neurological condition (e.g. ALS, multiple sclerosis, essential tremor, ataxia, etc).
Exclusion Criteria:
Children (ages younger than 18 years of age)
Persons with more than one diagnosed neurological condition. gender All minimum age 18 Years std age list std age Adult Older Adult study population Persons with Parkinson's Disease
Persons without a Neurological Condition (Controls)
Persons with Other Neurological Conditions (e.g. ALS, TBI, MS, CBT/CBS, MSA, PSP, MCI, etc). sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Nicole J Tester, PhD, MOT, OTR/L, MSCS overall official affiliation University of Florida/UF Health Rehab overall official role Principal Investigator location list location location facility UF Health Rehab - Fixel Institute location city Gainesville location state Florida location zip 32608 location country United States location facility University of Florida location city Gainesville location state Florida location zip 32608 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010300 condition mesh term Parkinson Disease condition mesh id D000009422 condition mesh term Nervous System Diseases condition mesh id D000014786 condition mesh term Vision Disorders condition ancestor list condition ancestor condition ancestor id D000020734 condition ancestor term Parkinsonian Disorders condition ancestor id D000001480 condition ancestor term Basal Ganglia Diseases condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009069 condition ancestor term Movement Disorders condition ancestor id D000080874 condition ancestor term Synucleinopathies condition ancestor id D000019636 condition ancestor term Neurodegenerative Diseases condition ancestor id D000012678 condition ancestor term Sensation Disorders condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000005128 condition ancestor term Eye Diseases condition browse leaf list condition browse leaf condition browse leaf id M12365 condition browse leaf name Parkinson Disease condition browse leaf as found Parkinson's Disease condition browse leaf relevance high condition browse leaf id M16682 condition browse leaf name Vision Disorders condition browse leaf as found Visual Dysfunction condition browse leaf relevance high condition browse leaf id M21647 condition browse leaf name Parkinsonian Disorders condition browse leaf relevance low condition browse leaf id M24756 condition browse leaf name Ganglion Cysts condition browse leaf relevance low condition browse leaf id M15510 condition browse leaf name Synovial Cyst condition browse leaf relevance low condition browse leaf id M3926 condition browse leaf name Basal Ganglia Diseases condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M11181 condition browse leaf name Movement Disorders condition browse leaf relevance low condition browse leaf id M2217 condition browse leaf name Synucleinopathies condition browse leaf relevance low condition browse leaf id M20711 condition browse leaf name Neurodegenerative Diseases condition browse leaf relevance low condition browse leaf id M14642 condition browse leaf name Sensation Disorders condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases | NCT04836715 | [
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] |
full study rank 61530 study protocol section identification module n c t id NCT04835272 org study id info org study id songlu20210320 organization org full name Fu Xing Hospital, Capital Medical University org class OTHER brief title Comparison of the Decannulation Protocol With Suctioning and Capping in Severe Acquired Brain Injury Patients official title Tracheostomy Decannulation in Severe Acquired Brain Injury: a Decannulation Protocol With Suctioning or Capping? status module status verified date October 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date November 1, 2021 start date type Anticipated primary completion date struct primary completion date March 30, 2023 primary completion date type Anticipated completion date struct completion date October 30, 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 9, 2021 last update post date struct last update post date October 18, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Song Lu responsible party investigator title Attending doctor responsible party investigator affiliation Fu Xing Hospital, Capital Medical University lead sponsor lead sponsor name Fu Xing Hospital, Capital Medical University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Single-center randomized trail focused on tracheostomized patients with severe acquired brain injury , comparing two different decannulation protocols:
an assessment of readiness for decannulation that was based on suctioning frequency
an assessment that was based on tracheostomy capping conditions module condition list condition Tracheostomy Decannulation Acquired Brain Injury keyword list keyword Tracheostomy Decannulation without capping Airway patency assessment design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 104 enrollment type Anticipated arms interventions module arm group list arm group arm group label control group arm group type No Intervention arm group description In the control group, the decision to decannulate was based on a 48-hour capping trial. arm group label intervention group arm group type Experimental arm group description In the intervention group, the decision to decannulate was based on suctioning frequency. arm group intervention list arm group intervention name Procedure: the Decannulation Protocol With Suctioning intervention list intervention intervention type Procedure intervention name the Decannulation Protocol With Suctioning intervention description In the intervention group, the decision to decannulate was based on suctioning frequency. Patients underwent decannulation when they had had no more than two aspirations every 8 hours during during a 24-hour period. Patients in this group did not undergo capping trials. intervention arm group label list intervention arm group label intervention group intervention other name list intervention other name the Decannulation Protocol With Capping outcomes module primary outcome list primary outcome primary outcome measure the time to decannulation primary outcome description the time from randomization to actual decannulation primary outcome time frame From the date of randomization to decannulation, and the patients will be followed for the duration of hospital stay, an expected average of 3 months secondary outcome list secondary outcome secondary outcome measure Rate of decannulation failure secondary outcome description reintubation within 1 week after decannulation secondary outcome time frame within 1 week after decannulation secondary outcome measure high dependency unit length of stay secondary outcome description the time from high dependency unit admission to rehabilitation ward secondary outcome time frame From the date of high dependency unit admission to transferring to rehabilitation ward, and the patients will be followed for the duration of high dependency unit stay, an expected average of 2 months secondary outcome measure Rate of respiratory infections secondary outcome description post decannulation respiratory infections rate in each study group secondary outcome time frame From the date of high dependency unit admission to hospital discharge, and the patients will be followed for the duration of hospital stay, an expected average of 3 months secondary outcome measure Glasgow Outcome Scale(GOS) six months after the acute brain injury secondary outcome description The GOS is a brief descriptive outcome scale(from 0 point to 29 points, higher score means worse outcome). GOS six months after discharge to asess the prognosis of the patient secondary outcome time frame follow-up six months after discharge secondary outcome measure Functional Independence Measure(FIM) six months after the acute brain injury secondary outcome description The FIM is an 18-item ordinal scale, is viewed as most useful for assessment of progress during inpatient rehabilitation（from 18 points to 126 points, higher score means better outcome）. secondary outcome time frame follow up six months after discharge eligibility module eligibility criteria Inclusion Criteria:
Within three months of onset
Age≥18 years old
GCS≥8
Clinical stability( defined as the absence of fever, sepsis, or active infection and hemodynamic stability)
Without massive pooling or silent aspiration of saliva, more than one efficient swallow per minute, adequate cough reflex were tested by gently touching the aryepiglottic region with the tip of the endoscope.
Passing a tracheostomy-tube de-cuff test(de-cuff the tube for 3 days without pulmonary complications.
Without significant airway stenosis.
Exclusion Criteria:
Patients with pending diagnostic or therapeutic procedures and were considered by the clinicians to be at risk for neurologic deterioration
Medical history of severe respiratory system or heart disease
Neuromuscular disease other than ICU-acquired weakness, or tracheostomy for airway control
Don't get informed consent from patient or guardian healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Lu Song central contact role Contact central contact phone +86 15010852973 central contact e mail songlu@ccmu.edu.cn overall official list overall official overall official name Yong Wang overall official affiliation Rehabilitation medicine center, Fuxing hospital, capital medical university overall official role Study Chair location list location location facility Fuxing hospital, capital medical university location city Beijing location country China location contact list location contact location contact name Yong Wang location contact role Contact location contact phone 010-88062907 location contact e mail wyrehabil@ccmu.edu.cn i p d sharing statement module i p d sharing Yes i p d sharing description all IPD that underlie results in a publication are to be shared i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) i p d sharing time frame 1 year after publication derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001930 condition mesh term Brain Injuries condition mesh id D000014947 condition mesh term Wounds and Injuries condition ancestor list condition ancestor condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000006259 condition ancestor term Craniocerebral Trauma condition ancestor id D000020196 condition ancestor term Trauma, Nervous System condition browse leaf list condition browse leaf condition browse leaf id M4359 condition browse leaf name Brain Injuries condition browse leaf as found Brain Injury condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf as found Injury condition browse leaf relevance high condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M8501 condition browse leaf name Craniocerebral Trauma condition browse leaf relevance low condition browse leaf id M21176 condition browse leaf name Trauma, Nervous System condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions | NCT04835272 | [
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full study rank 61619 study protocol section identification module n c t id NCT04834115 org study id info org study id PINV20-387 organization org full name Universidad Nacional de Asunción org class OTHER brief title Efficacy of Ivermectin in Outpatients With Non-severe COVID-19 official title Efficacy of Ivermectin in Outpatients With Non-severe COVID-19: A Randomized Controlled Trial status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date November 17, 2020 start date type Actual primary completion date struct primary completion date April 30, 2021 primary completion date type Anticipated completion date struct completion date May 30, 2021 completion date type Anticipated study first submit date March 28, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 4, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Universidad Nacional de Asunción lead sponsor class OTHER collaborator list collaborator collaborator name Consejo Nacional de Ciencias y Tecnologia, Paraguay collaborator class UNKNOWN collaborator name Ministerio de Salud Pública y Bienestar Social, Paraguay collaborator class UNKNOWN collaborator name Centro de información y recursos para el desarrollo, Paraguay collaborator class UNKNOWN collaborator name Centro para el Desarrollo de la Investigación Científica, CEDIC, Paraguay collaborator class UNKNOWN collaborator name Instituto Desarrollo, Paraguay collaborator class UNKNOWN oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This is a randomized controlled trial to evaluate the efficacy of ivermectin in reducing the risk of progression to severe disease and hospitalizations in COVID-19 patients. detailed description This is a randomized controlled trial to evaluate the efficacy of ivermectin in COVID-19 outpatients reducing the risk of progression to severe disease.
Patients with COVID-19 infection are randomized to receive a single dose of 200mcg/kg of ivermectin or a placebo.
The randomization code is generated by the trial statistician. The allocation is made after fulfilment of both inclusion and exclusion criteria. conditions module condition list condition Covid19 Coronavirus Infection keyword list keyword Ivermectin Communicable Diseases Respiratory Tract Infections design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design intervention model description This is a double blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing hospitalization in outpatients with COVID-19. design primary purpose Treatment design masking info design masking Triple design masking description Triple (Participant, Investigator, Outcomes Assessor) design who masked list design who masked Participant Investigator Outcomes Assessor enrollment info enrollment count 400 enrollment type Anticipated arms interventions module arm group list arm group arm group label Ivermectin arm group type Experimental arm group description Ivermectin 200mcg/kg single dose, maximum dose 18mg arm group intervention list arm group intervention name Drug: Ivermectin Tablets arm group label Placebo arm group type Placebo Comparator arm group description Inactive medication tablets indistinguishable from ivermectin tablets arm group intervention list arm group intervention name Other: Placebo intervention list intervention intervention type Drug intervention name Ivermectin Tablets intervention description Oral ivermectin at a one time dose intervention arm group label list intervention arm group label Ivermectin intervention type Other intervention name Placebo intervention description Oral placebo at a one time dose intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Proportion of patients with hospitalization criteria primary outcome description Proportion of patients with hospitalization criteria at day 30 primary outcome time frame 30 days secondary outcome list secondary outcome secondary outcome measure Proportion of patients with COVID-19 signs and symptoms secondary outcome description Proportion of patients with COVID-19 signs and symptoms up to day 14 secondary outcome time frame 14 days secondary outcome measure Proportion of cohabitants who had COVID-19 after the index case secondary outcome description Proportion of cohabitants who had COVID-19 after the index case up to day 30 secondary outcome time frame 30 days secondary outcome measure Drug-related adverse events secondary outcome description Proportion of patients with ivermectin adverse events up to day 30 secondary outcome time frame 30 days secondary outcome measure Levels of IgG for SARS-CoV-2 secondary outcome description Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay secondary outcome time frame 30-60 days eligibility module eligibility criteria Inclusion Criteria:
Positive diagnostic RT-qPCR or antigen test for SARS-CoV-2
Symptomatic patients with up to 8 days from the onset of symptoms, and asymptomatic cases with up to 5 days of positive test for SARS-CoV-2.
Patients who agree to participate in the study by signing the informed consent.
Exclusion Criteria:
Patients with severity criteria defined in the Coronavirus Disease Epidemiological and Laboratory Surveillance Guide (Version 3/11/2020)
Pregnant or breastfeeding women
Women of childbearing age and without commitment to use contraceptive methods during the study time.
Inability to complete the study
Current treatment with drugs known to interact with ivermectin
Known intolerance to ivermectin, its derivate or any of its excipients.
Patients with known Child-Pugh C liver disease
Patients with prior ivermectin consumption in the 10 days prior to study entry. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Gabriela Avila, MD, MSc, PhD central contact role Contact central contact phone +59521683930 central contact phone ext 324 central contact e mail mavila@med.una.py location list location location facility Facultad de Ciencias Médicas - Universidad Nacional de Asunción location status Recruiting location city Asunción location zip 111421 location country Paraguay location contact list location contact location contact name Gabriela Avila, MD, MSc, PhD location contact role Contact location contact phone +59521683930 location contact e mail mavila@med.una.py references module reference list reference reference p m i d 33662102 reference type background reference citation López-Medina E, López P, Hurtado IC, Dávalos DM, Ramirez O, Martínez E, Díazgranados JA, Oñate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendaño AC, Toro DF, Torres M, Lesmes MC, Rios CA, Caicedo I. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1426-1435. doi: 10.1001/jama.2021.3071. reference p m i d 32251768 reference type background reference citation Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3. reference p m i d 32513289 reference type background reference citation Chaccour C, Ruiz-Castillo P, Richardson MA, Moncunill G, Casellas A, Carmona-Torre F, Giráldez M, Mota JS, Yuste JR, Azanza JR, Fernández M, Reina G, Dobaño C, Brew J, Sadaba B, Hammann F, Rabinovich R. The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset: A structured summary of a study protocol for a randomized control pilot trial. Trials. 2020 Jun 8;21(1):498. doi: 10.1186/s13063-020-04421-z. i p d sharing statement module i p d sharing No i p d sharing description The investigators will publish the results to compare data with other studies with ivermectin and SARS-CoV-2 infection. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000018352 condition mesh term Coronavirus Infections condition ancestor list condition ancestor condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf as found Coronavirus Infection condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention mesh list intervention mesh intervention mesh id D000007559 intervention mesh term Ivermectin intervention ancestor list intervention ancestor intervention ancestor id D000000977 intervention ancestor term Antiparasitic Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M9742 intervention browse leaf name Ivermectin intervention browse leaf as found Vincristine intervention browse leaf relevance high intervention browse leaf id M3446 intervention browse leaf name Antiparasitic Agents intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04834115 | [
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full study rank 61473 study protocol section identification module n c t id NCT04836013 org study id info org study id 52265 organization org full name Università degli Studi dell'Insubria org class OTHER brief title Combined Lactobacilli (Reuteri LMG P-27481 and GG ATCC 53103) to Prevent Antibiotic Associated Symptoms in Children official title Multicenter Randomized Trial of a Combined Probiotic (Lactobacillus Reuteri LMG P-27481 and Lactobacillus Rhamnosus GG (ATCC 53103) for the Prevention of Antibiotic-Associated Diarrhea and Gastrointestinal Symptoms in Children status module status verified date May 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 13, 2021 start date type Anticipated primary completion date struct primary completion date November 30, 2021 primary completion date type Anticipated completion date struct completion date April 13, 2022 completion date type Anticipated study first submit date March 20, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date May 1, 2021 last update post date struct last update post date May 4, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Silvia Salvatore responsible party investigator title Prof. MD responsible party investigator affiliation Università degli Studi dell'Insubria lead sponsor lead sponsor name Università degli Studi dell'Insubria lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a prospective multicenter pediatric double-blind, randomized placebo-controlled, parallel group clinical trial intended to evaluate the efficacy, safety and tolerability of a combined probiotic (LGG and L. reuteri LMG P-27481) in the prevention of antibiotic associated diarrhea and gastrointestinal symptoms in hospitalised children treated with antibiotics for proven or suspected bacterial infection. detailed description Eligible children will be randomly assigned to receive the combined probiotic study product (Noos, Roma, Italia)(BCCMTM Bacterial Collection of Ghent, Belgium, Italian Patent: 102016000011071, International Patent Request : PCT/IB 2017/053856), or placebo as additional treatment to the antibiotic therapy. Kind, dose and duration of antibiotic treatment will be decided by the local clinicians according to good medical practice and current recommendations. The first dose of probiotic will be started the same day of starting the antibiotic treatment, immediately after enrollment. Then, each oral stick will be administered orally once daily, in the morning, before breakfast, during the antibiotic treatment and prolonged for 30 days since starting.
Study product The combined probiotic is made by Lactobacillus reuteri LMG P-27481 and Lactobacillus rhamnosus GG (ATCC 53103), sucralose and isomalt as an oral stick formulation of 1.6 g with a concentration of probiotic of 2x1010 colony forming unit (CFU) per stick, launched in the Italian market with the name of Reuterin®GG (Noos, Roma, Italia).
The probiotic and placebo will be prepared centrally by the probiotic producer as identically appearing oral stick. The placebo will contain only sucralose and isomalt, 1.6 g per stick.
Randomization The allocation sequences and randomization lists has been generated by a online computer system. The probiotic -placebo allocation ratio will be of 1:1. To ensure allocation concealment, an independent subject prepared the randomization schedule and sealed envelopes to be sent to the participant centers. Each investigator will control the packaging and labels of trial treatments sent by the producer with a numerical code with no possible identification of the probiotic product compared to the placebo. The allocation will be consecutively assigned for all enrolled subjects. All investigators, participants, and statisticians will be blinded to the assigned treatment throughout the study and during the data analysis. After completing the analysis of the data or in case of sever adverse event the randomization code will be broken and information about the content of the product (probiotic or placebo) will be revealed by the producer, upon the investigator's request.
Monitoring and collection of data At enrollment a standardized form will record age, gender, anthropometric parameters, vital signs, refilling time, site of infection, laboratory tests, kind, dose and route of administration of antibiotic, diet, previous AAD or other gastrointestinal symptoms, comorbidity and associated treatment. Vesikary scale, anthropometric measures, vital signs, refilling time will be also recorded in each patient at enrollment and in case of occurrence of diarrhea. Bristol stool chart will be used to grade the consistency of stools.
Parents or care givers of each children will be instructed to fill in a diary to record the duration of antibiotic treatment and/or other treatment, the intake of the study product, the frequency of daily bowel movements, the consistency of stools (according to the Bristol stool scale), the frequency and intensity (according to a VAS scale, from 0 to 10) of abdominal pain, the presence and duration of fever, vomiting or any other symptoms they considered important, diet changes and general well being (according to a numerical 1-10 scale). The diary will be completed daily for the duration of the probiotic treatment and then weekly till the end of the study. After discharge from the hospital the absence from day care or school, the need of new antibiotic treatment or re-hospitalization will be also noted. In case of diarrhea, fever or other severe symptoms after hospital discharge parents will be instructed to contact the local pediatrician and investigator for clinical evaluation and stool analysis. A clinical visit will be scheduled in all recruited patients after 1, 3 and 6 months from enrollment.
Re-hospitalization will be required in case of severe infection, severe dehydration or whenever considered necessary by clinicians.
Scheduled investigations In all cases presenting diarrhea at least three stool samples will be collected and stool tests will be performed to detect viral, bacterial or C. difficile pathogens. Blood and urine test or radiologial investigations will be decided by the local clinician based on patient's clinical presentation and according to guidelines and good clinical practice.
One additional sample of stools will be collected, whenever possible, in each patient at enrollment, at 1, 3 and 6 months to evaluate fecal calprotectin to indirectly assess intestinal inflammation. In a subgroup of patients (the first 30 recruited in each arms) two other stool samples and a urine sample will be collected and stocked in freezer (-20° C) at the same study point for possible future additional explorative analysis of fecal inflammatory markers (lactoferrine, IgA, IL10 and TNF-α) and metabolomic profile (urine metabolites).
The probiotic producer (Noos S.r.L, Roma, Italia) will gift the probiotic product and placebo for the duration of the study for all children enrolled but has and will have no role in the design and conduct of the study; collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. The data of the enrolled subjects will be managed, stored and property of the clinical investigators of the participant centers and of the coordinator center and will be analysed and published anonymously and as aggregate, in the respect of the current legislation on privacy. conditions module condition list condition Diarrhea Caused by Drug Abdominal Pain keyword list keyword antibiotics diarrhea probiotics Lactobacillus children abdominal pain design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Double blind placebo controlled prospective trial design primary purpose Prevention design masking info design masking Quadruple design masking description Double blind trial design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 216 enrollment type Anticipated arms interventions module arm group list arm group arm group label Probiotic group arm group type Experimental arm group description Lactobacillus reuteri LMG P-27481 and Lactobacillus rhamnosus GG (ATCC 53103), sucralose and isomalt as an oral stick formulation of 1,6 g with a concentration of probiotic of 2x100bilion colony forming unit (CFU) per stick. arm group intervention list arm group intervention name Dietary Supplement: combined Lactobacilli arm group label Placebo group arm group type Placebo Comparator arm group description The placebo will contain 1.6 g per stick of sucralose and isomalt arm group intervention list arm group intervention name Other: Placebo intervention list intervention intervention type Dietary Supplement intervention name combined Lactobacilli intervention description 1 oral stick per day for 30 days starting the day of antibiotic treatment intervention arm group label list intervention arm group label Probiotic group intervention type Other intervention name Placebo intervention description 1 oral stick per day for 30 days starting the day of antibiotic treatment intervention arm group label list intervention arm group label Placebo group outcomes module primary outcome list primary outcome primary outcome measure Incidence of antibiotic-associated diarrhea, defined as episodes of otherwise unexplained diarrhea (≥3 loose or liquid stools per day with negative viral and bacterial stool tests), recorded by instructed parents in a structured daily diary. primary outcome description Both Intention to treat (ITT) and Multivariate linear regression models analysis taking into account age, sex, mode of antibiotic delivery, and the kind of antibiotics and comparison between the two groups will be performed.The relative risk (RR), 95% confidence interval (CI), and number needed to treat (NNT) will also be calculated. The difference between study groups will be considered significant when P-value <0.05 or when the 95% CI for RR will not exceed 1.0. primary outcome time frame From the second day after starting antibiotic treatment to 2 weeks after stopping antibiotics secondary outcome list secondary outcome secondary outcome measure Number of children with episodes of infective diarrhea; dehydration (by Vesikary scale), fever, abdominal pain, vomiting and constipation (by Bristol stool chart); general well being (by 1-10 scale) as assessed by patient's record form. secondary outcome description Instructed parents will record all the above parameters in a structured diary filled daily for the first month and weekly for 5 months. A follow-up evaluation will be done at one month, at 3 and 6 months from enrollment and in cases of diarrhea. The Student's t-test will be used to compare mean values of continuous variables approximating a normal distribution. For non-normally distributed variables, the Mann-Whitney U-test will be used. The chi-square test or Fisher exact test will be used, as appropriate, to compare percentages between the two groups of intervention. secondary outcome time frame 6 months from enrolling other outcome list other outcome other outcome measure Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 other outcome description Participant investigators will record in specific form any adverse event according to CTCAE v4.0 other outcome time frame From enrolling to all the period of intervention (1 month) other outcome measure Number of participants with abnormal fecal inflammatory markers (calprotectin, lactoferrine, IgA, IL10 and TNF-α) and urine metabolomic profile other outcome description In the first 30 patients recruited an additional stool and urine sample will be collected and stored in freezer (-20°C). Levels of lactoferrine, IgA, IL10 and TNF-α) and metabolomic profile (urine metabolites) will be measured and compared between the two groups. other outcome time frame The additional stool and urine sample will be collected at recruitment, after 1 month and after 6 months from enrollment. eligibility module eligibility criteria Inclusion Criteria (all of the following):
Children aged 12 months to 12 years
Proven or suspected bacterial infection
Inpatient children needed antibiotic treatment
Oral or intravenous or intramuscular antibiotic administration with at least 2 days of duration
Parental informed consent to the participation to the study
Exclusion Criteria:
Age below 12 months or above 12 years
Infections with no or only one day of antibiotic treatment
Sepsis or severe generalized infection
Pancreatitis
Known immunodeficiency or chronic gastrointestinal diseases or heart disease
Oncologic patients
Severe neurological impairment or lack of verbal expression
Enteral or parenteral nutrition
Gastrointestinal malformations or abdominal surgical interventions
Central line catheter
Acute or chronic diarrhea when starting antibiotics
Current or recent (in the last four weeks) use of any probiotic product
Antibiotic treatment started earlier than 24 hours before enrollment
Absence of parental consent healthy volunteers No gender All minimum age 12 Months maximum age 12 Years std age list std age Child contacts locations module location list location location facility Silvia Salvatore location city Varese location country Italy location contact list location contact location contact name Silvia Salvatore location contact role Contact location contact phone +39 0332 299247 location contact e mail silvia.salvatore@uninsubria.it i p d sharing statement module i p d sharing Yes i p d sharing description After publication of the results, upon motivated request i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) i p d sharing time frame From the publication of the study to 5 years i p d sharing access criteria Mailing to silvia.salvatore@uninsubria.it derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003967 condition mesh term Diarrhea condition mesh id D000015746 condition mesh term Abdominal Pain condition ancestor list condition ancestor condition ancestor id D000012817 condition ancestor term Signs and Symptoms, Digestive condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M17463 condition browse leaf name Abdominal Pain condition browse leaf as found Abdominal Pain condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M6311 condition browse leaf name Diarrhea condition browse leaf as found Diarrhea condition browse leaf relevance high condition browse leaf id M14774 condition browse leaf name Signs and Symptoms, Digestive condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3374 intervention browse leaf name Anti-Bacterial Agents intervention browse leaf relevance low intervention browse leaf id M3376 intervention browse leaf name Antibiotics, Antitubercular intervention browse leaf relevance low intervention browse leaf id T355 intervention browse leaf name Acidophilus intervention browse leaf as found Resistant intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Ot intervention browse branch name Other Dietary Supplements | NCT04836013 | [
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4184,
23930,
11934,
117,
9301,
5300,
117,
1231,
18591,
1158,
1159,
117,
1751,
1104,
8974,
117,
8087,
5715,
117,
1912,
117,
13753,
1105,
2438,
1104,
3469,
1104,
2848,
22400,
117,
10211,
117,
2166,
10419,
2137,
1137,
1168,
3245,
8005,
10879,
2556,
14196,
8006,
117,
3254,
1766,
14598,
1785,
1105,
2628,
3252,
119,
159,
18766,
6610,
1183,
3418,
117,
22904,
8167,
4184,
23930,
5252,
117,
9301,
5300,
117,
1231,
18591,
1158,
1159,
1209,
1129,
1145,
1802,
1107,
1296,
5351,
1120,
10803,
1105,
1107,
1692,
1104,
15299,
1104,
4267,
1813,
1197,
13836,
119,
6490,
15631,
3481,
1209,
1129,
1215,
1106,
3654,
1103,
20904,
1104,
15631,
1116,
119,
24261,
1137,
1920,
1660,
1733,
1104,
1296,
1482,
1209,
1129,
10154,
1106,
5475,
1107,
170,
12997,
1106,
1647,
1103,
9355,
1104,
2848,
22400,
3252,
1105,
120,
1137,
1168,
3252,
117,
1103,
14741,
1104,
1103,
2025,
3317,
117,
1103,
5625,
1104,
3828,
7125,
1883,
5172,
117,
1103,
20904,
1104,
15631,
1116,
113,
2452,
1106,
1103,
6490,
15631,
3418,
114,
117,
1103,
5625,
1105,
7657,
113,
2452,
1106,
170,
19497,
1708,
3418,
117,
1121,
121,
1106,
1275,
114,
1104,
24716,
2489,
117,
1103,
2915,
1105,
9355,
1104,
10880,
117,
26979,
1158,
1137,
1251,
1168,
8006,
1152,
1737,
1696,
117,
10211,
2607,
1105,
1704,
1218,
1217,
113,
2452,
1106,
170,
18294,
122,
118,
1275,
3418,
114,
119,
1109,
12997,
1209,
1129,
2063,
3828,
1111,
1103,
9355,
1104,
1103,
5250,
22400,
3252,
1105,
1173,
5392,
6174,
1103,
1322,
1104,
1103,
2025,
119,
1258,
12398,
1121,
1103,
2704,
1103,
5884,
1121,
1285,
1920,
1137,
1278,
117,
1103,
1444,
1104,
1207,
2848,
22400,
3252,
1137,
1231,
118,
2704,
2734,
1209,
1129,
1145,
2382,
119,
1130,
1692,
1104,
4267,
1813,
1197,
13836,
117,
10880,
1137,
1168,
5199,
8006,
1170,
2704,
12398,
2153,
1209,
1129,
10154,
1106,
3232,
1103,
1469,
185,
24795,
1811,
1105,
17805,
1111,
7300,
10540,
1105,
15631,
3622,
119,
138,
7300,
3143,
1209,
1129,
4533,
1107,
1155,
8443,
4420,
1170,
122,
117,
124,
1105,
127,
1808,
1121,
10803,
119,
11336,
118,
2704,
2734,
1209,
1129,
2320,
1107,
1692,
1104,
5199,
8974,
117,
5199,
1260,
7889,
7412,
2116,
1137,
7747,
1737,
3238,
1118,
12257,
5895,
119,
23070,
1181,
11041,
1130,
1155,
2740,
11124,
4267,
1813,
1197,
13836,
1120,
1655,
1210,
15631,
8025,
1209,
1129,
4465,
1105,
15631,
5715,
1209,
1129,
1982,
1106,
11552,
14837,
117,
19560,
1137,
140,
119,
4267,
3101,
27989,
1513,
3507,
19790,
1116,
119,
5657,
1105,
19968,
2774,
1137,
2070,
13791,
2916,
11041,
1209,
1129,
1879,
1118,
1103,
1469,
12257,
1811,
1359,
1113,
5351,
112,
188,
7300,
8685,
1105,
2452,
1106,
13112,
1105,
1363,
7300,
2415,
119,
1448,
2509,
6876,
1104,
15631,
1116,
1209,
1129,
4465,
117,
7747,
1936,
117,
1107,
1296,
5351,
1120,
10803,
117,
1120,
122,
117,
124,
1105,
127,
1808,
1106,
17459,
175,
25534,
1233,
11019,
1233,
1643,
21020,
5822,
1394,
1106,
18814,
15187,
1107,
13053,
14196,
24970,
119,
1130,
170,
23470,
1104,
4420,
113,
1103,
1148,
1476,
8443,
1107,
1296,
1739,
114,
1160,
1168,
15631,
8025,
1105,
170,
19968,
6876,
1209,
1129,
4465,
1105,
4482,
1174,
1107,
16020,
1197,
113,
118,
1406,
7259,
140,
114,
1120,
1103,
1269,
2025,
1553,
1111,
1936,
2174,
2509,
4252,
1643,
24171,
3946,
3622,
1104,
175,
25534,
1233,
22653,
18004,
113,
2495,
5822,
10008,
1200,
8643,
117,
146,
1403,
1592,
117,
15393,
10424,
1105,
157,
28047,
118,
418,
114,
1105,
27154,
15792,
18882,
1665,
6168,
113,
19968,
27154,
15792,
7571,
114,
119,
1109,
5250,
22400,
2451,
113,
1302,
2155,
156,
119,
187,
119,
149,
117,
13120,
117,
13399,
114,
1209,
5309,
1103,
5250,
22400,
3317,
1105,
1282,
4043,
1111,
1103,
9355,
1104,
1103,
2025,
1111,
1155,
1482,
7945,
1133,
1144,
1105,
1209,
1138,
1185,
1648,
1107,
1103,
1902,
1105,
5880,
1104,
1103,
2025,
132,
2436,
117,
2635,
117,
3622,
117,
1137,
7628,
1104,
1103,
2233,
132,
7288,
117,
3189,
117,
1137,
5684,
1104,
1103,
8323,
132,
1137,
1103,
2383,
1106,
12295,
1103,
8323,
1111,
4128,
119,
1109,
2233,
1104,
1103,
7945,
5174,
1209,
1129,
2374,
117,
7905,
1105,
2400,
1104,
1103,
7300,
17718,
1104,
1103,
14031,
6425,
1105,
1104,
1103,
13443,
2057,
1105,
1209,
1129,
24443,
6834,
1174,
1105,
1502,
12631,
1193,
1105,
1112,
9453,
117,
1107,
1103,
4161,
1104,
1103,
1954,
5626,
1113,
9909,
119,
2975,
13196,
3879,
2190,
3879,
12120,
1813,
1197,
13836,
20111,
1181,
1118,
13982,
22358,
18882,
7050,
13304,
2501,
12565,
2190,
2501,
12565,
2848,
25523,
4267,
1813,
1197,
13836,
5250,
25523,
23929,
2430,
2822,
6617,
24960,
1482,
24716,
2489,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
9108,
2235,
6136,
8543,
7198,
1282,
4043,
4013,
19916,
3443,
1902,
2425,
3007,
18461,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
154,
18413,
20910,
1513,
1902,
7739,
1158,
6136,
8543,
7198,
3443,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
4539,
27989,
10224,
1204,
8396,
5096,
22650,
1197,
1130,
5710,
3121,
25524,
1766,
3929,
19191,
1116,
1249,
8830,
21484,
10803,
23992,
10803,
5099,
22148,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
5096,
22400,
1372,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
23929,
2430,
2822,
6617,
24960,
1231,
18614,
1182,
149,
14666,
153,
118,
1765,
19203,
1475,
1105,
23929,
2430,
2822,
6617,
24960,
187,
2522,
14226,
1361,
144,
2349,
113,
13020,
12096,
4389,
10424,
1495,
114,
117,
28117,
1665,
4412,
6787,
1105,
1110,
7903,
6066,
1112,
1126,
9619,
6166,
22661,
1104,
122,
117,
127,
176,
1114,
170,
6256,
1104,
5250,
22400,
1104,
123,
1775,
20150,
15197,
1988,
6417,
5071,
2587,
113,
18802,
2591,
114,
1679,
6166,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
22327,
3113,
15463,
8661,
20041,
131,
3490,
23929,
2430,
2822,
6617,
6473,
1981,
1372,
3107,
5033,
4043,
1372,
1981,
1372,
2076,
5033,
4043,
3291,
8223,
4626,
2772,
1981,
1372,
6136,
1109,
1282,
4043,
1209,
4651,
122,
119,
127,
176,
1679,
6166,
1104,
28117,
1665,
4412,
6787,
1105,
1110,
7903,
6066,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
5033,
4043,
9108,
2190,
9108,
9108,
2076,
22327,
3113,
15463,
8661,
20041,
9108,
1271,
3490,
23929,
2430,
2822,
6617,
6473,
9108,
6136,
122,
9619,
6166,
1679,
1285,
1111,
1476,
1552,
2547,
1103,
1285,
1104,
2848,
22400,
3252,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
5096,
22400,
1372,
9108,
2076,
2189,
9108,
1271,
5033,
4043,
9108,
6136,
122,
9619,
6166,
1679,
1285,
1111,
1476,
1552,
2547,
1103,
1285,
1104,
2848,
22400,
3252,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
5033,
4043,
1372,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
3561,
26859,
2093,
1104,
2848,
22400,
118,
2628,
4267,
1813,
1197,
13836,
117,
3393,
1112,
3426,
1104,
4303,
25731,
1775,
18220,
1174,
4267,
1813,
1197,
13836,
113,
864,
1495,
5768,
1137,
6161,
15631,
1116,
1679,
1285,
1114,
4366,
14837,
1105,
19560,
15631,
5715,
114,
117,
1802,
1118,
10154,
2153,
1107,
170,
15695,
3828,
12997,
119,
2425,
9386,
6136,
2695,
1130,
5208,
2116,
1106,
7299,
113,
9686,
1942,
114,
1105,
18447,
8997,
15045,
7378,
1231,
24032,
3584,
3622,
1781,
1154,
3300,
1425,
117,
2673,
117,
5418,
1104,
2848,
22400,
6779,
117,
1105,
1103,
1912,
1104,
2848,
25523,
1105,
7577,
1206,
1103,
1160,
2114,
1209,
1129,
1982,
119,
1109,
5236,
3187,
113,
155,
2069,
114,
117,
4573,
110,
6595,
14235,
113,
140,
2240,
114,
117,
1105,
1295,
1834,
1106,
7299,
113,
151,
15681,
114,
1209,
1145,
1129,
10056,
119,
1109,
3719,
1206,
2025,
2114,
1209,
1129,
1737,
2418,
1165,
153,
118,
2860,
133,
121,
119,
4991,
1137,
1165,
1103,
4573,
110,
140,
2240,
1111,
155,
2069,
1209,
1136,
13908,
122,
119,
121,
119,
2425,
9386,
1159,
4207,
1622,
1103,
1248,
1285,
1170,
2547,
2848,
22400,
3252,
1106,
123,
2277,
1170,
7202,
2848,
25523,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
7421,
1104,
1482,
1114,
3426,
1104,
1107,
11916,
2109,
4267,
1813,
1197,
13836,
132,
1260,
7889,
7412,
2116,
113,
1118,
159,
18766,
6610,
1183,
3418,
114,
117,
10880,
117,
24716,
2489,
117,
26979,
1158,
1105,
14255,
2050,
9717,
1891,
113,
1118,
6490,
15631,
3481,
114,
132,
1704,
1218,
1217,
113,
1118,
122,
118,
1275,
3418,
114,
1112,
14758,
1118,
5351,
112,
188,
1647,
1532,
119,
3718,
9386,
6136,
1130,
2050,
5082,
8436,
2153,
1209,
1647,
1155,
1103,
1807,
11934,
1107,
170,
15695,
12997,
2709,
3828,
1111,
1103,
1148,
2370,
1105,
5392,
1111,
126,
1808,
119,
138,
2812,
118,
1146,
10540,
1209,
1129,
1694,
1120,
1141,
2370,
117,
1120,
124,
1105,
127,
1808,
1121,
10803,
1105,
1107,
2740,
1104,
4267,
1813,
1197,
13836,
119,
1109,
7646,
112,
188,
189,
118,
2774,
1209,
1129,
1215,
1106,
14133,
1928,
4718,
1104,
6803,
10986,
26403,
27182,
170,
2999,
3735,
119,
1370,
1664,
118,
5156,
4901,
10986,
117,
1103,
10852,
118,
9567,
158,
118,
2774,
1209,
1129,
1215,
119,
1109,
22572,
1182,
118,
1961,
2774,
1137,
8476,
6129,
2774,
1209,
1129,
1215,
117,
1112,
5806,
117,
1106,
14133,
6556,
1116,
1206,
1103,
1160,
2114,
1104,
9108,
119,
3718,
9386,
1159,
4207,
127,
1808,
1121,
4035,
10747,
1158,
1168,
9386,
2190,
1168,
9386,
1168,
9386,
4929,
7421,
1104,
6635,
1114,
3252,
118,
2272,
16798,
1958,
1112,
14758,
1118,
16899,
11356,
2036,
191,
1527,
119,
121,
1168,
9386,
6136,
4539,
27989,
10224,
1204,
17718,
1209,
1647,
1107,
2747,
1532,
1251,
16798,
1856,
2452,
1106,
16899,
11356,
2036,
191,
1527,
119,
121,
1168,
9386,
1159,
4207,
1622,
4035,
10747,
1158,
1106,
1155,
1103,
1669,
1104,
9108,
113,
122,
2370,
114,
1168,
9386,
4929,
7421,
1104,
6635,
1114,
22832,
175,
25534,
1233,
22653,
18004,
113,
11019,
1233,
1643,
21020,
5822,
1394,
117,
2495,
5822,
10008,
1200,
8643,
117,
146,
1403,
1592,
117,
15393,
10424,
1105,
157,
28047,
118,
418,
114,
1105,
19968,
27154,
15792,
18882,
1665,
6168,
1168,
9386,
6136,
1130,
1103,
1148,
1476,
4420,
8443,
1126,
2509,
15631,
1105,
19968,
6876,
1209,
1129,
4465,
1105,
7905,
1107,
16020,
1197,
113,
118,
1406,
7259,
1658,
114,
119,
9583,
1116,
1104,
2495,
5822,
10008,
1200,
8643,
117,
146,
1403,
1592,
117,
15393,
10424,
1105,
157,
28047,
118,
418,
114,
1105,
27154,
15792,
18882,
1665,
6168,
113,
19968,
27154,
15792,
7571,
114,
1209,
1129,
7140,
1105,
3402,
1206,
1103,
1160,
2114,
119,
1168,
9386,
1159,
4207,
1109,
2509,
15631,
1105,
19968,
6876,
1209,
1129,
4465,
1120,
17964,
117,
1170,
122,
2370,
1105,
1170,
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full study rank 61752 study protocol section identification module n c t id NCT04832386 org study id info org study id DokuzEU.Com.Garments organization org full name Dokuz Eylul University org class OTHER brief title COMPRESSION GARMENTS in BREAST CANCER-RELATED LYMPHEDEMA official title COMPLIANCE TO COMPRESSION GARMENTS AND RELATED FACTORS AMONG PATIENTS With BREAST CANCER-RELATED LYMPHEDEMA status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date March 30, 2019 start date type Actual primary completion date struct primary completion date August 29, 2019 primary completion date type Actual completion date struct completion date August 29, 2019 completion date type Actual study first submit date March 22, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Banu Dilek responsible party investigator title Principal investigator responsible party investigator affiliation Dokuz Eylul University lead sponsor lead sponsor name Dokuz Eylul University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Breast cancer is the most common cancer in women. It is an important health problem that has been increasingly encountered in recent years. With the advances in treatment, the survival time after breast cancer is prolonged, and as a result, many women face certain diseases during this period. One of these diseases, breast cancer-related lymphedema, is characterized by abnormal accumulation of protein-rich fluid in the interstitial tissue, which can occur at any time after breast cancer surgery or radiotherapy and is a major cause of morbidity. The aims of the treatment of lymphedema are to reduce edema, prevent the increase of edema, prevent infections, protect skin integrity, range of motion and limb functions. Complete Decongestive Therapy (CDT) is recommended by the International Society of Lymphology (ISL) as the international contemporary standard treatment for BCRL(breast cancer related lymphedema) treatment. CDT is a treatment method that includes manual lymph drainage (MLD), multilayer bandaging (Multilayer, short-stretch compression bandaging), exercise, skin care and compression garment. Compression garments, which are the most important component of the second phase of CDT, reduce the interstitial pressure of the extremity with the pressure they apply, and reduce capillary filtration and lymph production. Regular use of compression garments is very important during the treatment process. It is recommended that compression garments be worn during all waking hours. The success of compression garments is closely related to the patient's compliance with the treatment. Patients with lymphedema may need to wear compression garments for life. Wearing compression garments may have some difficulties for patients and this may affect compliance and adherence to treatment. The aim of this study is to investigate the compliance to compression garments and related factors among patients with breast cancer-related lymphedema. detailed description This study was planned as a cross-sectional study. Patients diagnosed with unilateral breast cancer-related lymphedema and recommended compression garments will be included in the study on a voluntary basis, after obtaining their written consent. Patients who have received a standard treatment and an education about the use of compression garments from a single center will be asked to answer our 28-question questionnaire about the use of compression garments. The patients will be asked whether compression garments were recommended or not, how long they have used compression garments, the type and model of the recommended compression garment, whether they can buy the recommended compression garment, how often it is changed, how long it is recommended to wear it during the day, whether it is used for the recommended time, how long wore during the day, the reasons for using and not using the garment. Compliance to compression garments and the factors affecting this will be questioned. Patients who use their garments for the recommended time and manner and those who do not will be compared in terms of these factors. Patients who used their garments for the recommended time and manner will be considered as compliant. conditions module condition list condition Breast Cancer Lymphedema design module study type Observational patient registry No design info design observational model list design observational model Other design time perspective list design time perspective Cross-Sectional enrollment info enrollment count 60 enrollment type Actual outcomes module primary outcome list primary outcome primary outcome measure 28-questionnaire about the use of compression garments primary outcome description Patients will be asked to answer our 28-questionnaire about the use of compression garments. Patients who used their garments for the recommended time and manner will be considered as compliant. primary outcome time frame baseline eligibility module eligibility criteria Inclusion Criteria:
Being over 18 years of age
Diagnosed with breast cancer related lymphedema
Having been prescribed compression garments
Exclusion Criteria:
cognitive and / or psychiatric illness
refusal to participate in the study healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Diagnosed with breast cancer releated lymphedema sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Banu Dilek overall official affiliation Dokuz Eylul University overall official role Study Director location list location location facility Dokuz Eylul University location city Izmir location zip 35340 location country Turkey references module reference list reference reference p m i d 35245100 reference type derived reference citation Erdinç Gündüz N, Şahin E, Dilek B, Ellidokuz H, Akalın E. Adherence to Compression Garment Wear and Associated Factors Among Patients with Breast Cancer-Related Lymphedema: A Pilot Study from a Turkish Tertiary Center. Lymphat Res Biol. 2022 Mar 3. doi: 10.1089/lrb.2021.0091. [Epub ahead of print] derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001943 condition mesh term Breast Neoplasms condition mesh id D000008209 condition mesh term Lymphedema condition mesh id D000072656 condition mesh term Breast Cancer Lymphedema condition ancestor list condition ancestor condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000001941 condition ancestor term Breast Diseases condition ancestor id D000012871 condition ancestor term Skin Diseases condition ancestor id D000008206 condition ancestor term Lymphatic Diseases condition ancestor id D000011183 condition ancestor term Postoperative Complications condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M4372 condition browse leaf name Breast Neoplasms condition browse leaf as found Breast Cancer condition browse leaf relevance high condition browse leaf id M10358 condition browse leaf name Lymphedema condition browse leaf as found Lymphedema condition browse leaf relevance high condition browse leaf id M1071 condition browse leaf name Breast Cancer Lymphedema condition browse leaf as found Breast Cancer Lymphedema condition browse leaf relevance high condition browse leaf id M4370 condition browse leaf name Breast Diseases condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse leaf id M10355 condition browse leaf name Lymphatic Diseases condition browse leaf relevance low condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology | NCT04832386 | [
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full study rank 61532 study protocol section identification module n c t id NCT04835246 org study id info org study id EFCNX002 organization org full name Endofotonics Pte Ltd org class INDUSTRY brief title Evaluating Diagnostic Performance of Spectra IMDx System for Detection of Gastric Cancer and Precancerous Lesions official title A Prospective, Single Centre Study Evaluating The Diagnostic Performance of Spectra IMDx System for The Detection of Gastric Cancer and Precancerous Lesions In Vivo status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date October 7, 2019 start date type Actual primary completion date struct primary completion date May 31, 2021 primary completion date type Anticipated completion date struct completion date July 31, 2021 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 12, 2021 last update post date struct last update post date April 15, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Endofotonics Pte Ltd lead sponsor class INDUSTRY collaborator list collaborator collaborator name Zhongshan Hospital Xiamen University collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of the study is to evaluate the diagnostic performance of a Raman spectroscopy analysis device - Spectra IMDx for the detection of gastric cancer and precancerous lesions in vivo. detailed description This is a prospective, single centre study to assess the diagnostic performance of Spectra IMDx system in detection of gastric cancer and precancerous lesions in subjects with suspected gastric intraepithelial neoplasia who are undergoing upper gastrointestinal endoscopic procedures.
The Spectra IMDx system comprises a laser system, a spectrometer, a computer with an analysis algorithm installed, and other ancillary parts. The Spectra IMDx system also comprises a Raman probe that can be connected with the main system. The Raman probe is an assembly of optical fibres and optical components arranged for maximal transmission of light energy. When in use, the laser system will emit a 785nm near infra-red laser that will be transmitted through the Raman probe to the distal end. When the laser is interrogated upon a tissue surface, the light energy is absorbed and reflected. The reflected energy is then collected from the distal end of the Raman probe, transmitted back to the main system, and passed through the spectrometer. The collected signal is then processed to obtain the clean Raman signal, which is then parsed through the analysis algorithm to evaluate its risk for cancer (high/low). Feedback will then be generated on the GUI in real time. conditions module condition list condition Gastric Cancer Gastric Precancerous Lesion design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 185 enrollment type Anticipated arms interventions module arm group list arm group arm group label Spectra IMDx arm group type Experimental arm group description The physician will be asked to give a diagnosis of the lesion under White light endoscopy (WLE) firstly and the endoscopic diagnosis result will be recorded on case report form. Then the physician will introduce the probe of Spectra IMDx system to contact and assess the lesion. The Spectra IMDx system will detect the scattering light signal from the lesion and assess the risk of the lesion being high-grade intraepithelial neoplasia or gastric cancer, and display the result on the Spectra IMDx screen. The Spectra IMDx assessment will be recorded on case report form. Both the patient and doctor will be blinded from the results from Spectra IMDx system.
After Spectra IMDx system examination, the physician takes biopsy sample(s) in suspected lesion for further histopathological diagnosis. arm group intervention list arm group intervention name Device: Spectra IMDx system intervention list intervention intervention type Device intervention name Spectra IMDx system intervention description The Spectra IMDx system is intended to be used in conjunction with conventional white light endoscopy in upper gastrointestinal endoscopic procedure to identify patients with high risk of developing and/or having gastric cancer and it is intended for use on patients above and equal to the age of 18. intervention arm group label list intervention arm group label Spectra IMDx outcomes module primary outcome list primary outcome primary outcome measure Sensitivity of Spectra IMDx system primary outcome description To assess the sensitivity of Spectra IMDx system for the detection of gastric cancer and precancerous lesions in vivo in the presence of using histological diagnosis as the gold standard.
Diagnostic measurements will be assessed in this trial. Using the histopathological diagnosis as the gold standard, true positives (TPs), true negatives (TNs), false positives (FPs) and false negatives (FNs) can be obtained for both Spectra IMDx (IMDx) system.
Sensitivity = TP/(TP + FN). primary outcome time frame During the procedure secondary outcome list secondary outcome secondary outcome measure Specificity of Spectra IMDx system secondary outcome description To assess the specificity and accuracy of Spectra IMDx system for the detection of gastric cancer and precancerous lesions in vivo in the presence of using histological diagnosis as the gold standard.
Specificity = TN/(TN + FP). secondary outcome time frame During the procedure secondary outcome measure Accuracy of Spectra IMDx system secondary outcome description To assess the accuracy of Spectra IMDx system for the detection of gastric cancer and precancerous lesions in vivo in the presence of using histological diagnosis as the gold standard.
Accuracy = (TP + TN)/(TP + TN + FP + FN). secondary outcome time frame During the procedure eligibility module eligibility criteria Inclusion Criteria:
The subject is older than 18 years of age.
The subject is undergoing upper GI endoscopy for suspected intraepithelial neoplasia or gastric cancer lesions (less than 20mm)
The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
The subject must be willing and able to comply with all study procedures.
Exclusion Criteria:
The subject has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.
The subject shows presence of active gastrointestinal bleeding or coagulopathy precluding biopsies.
The subject has rare gastric malignancies such as gastrointestinal stromal tumors (GISTs), lymphomas and neuroendocrine tumors （NETs）.
The subject is pregnant.
The subject with liver cirrhosis, impaired renal function, acute gastrointestinal (GI) bleeding, esophageal varices, jaundice, and GI post-surgery
The subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF), severe osteoarthritis (OA) and rheumatoid arthritis (RA) requiring long term non-steroidal anti-inflammatory drug (NSAID) therapy
The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study
The subject on regular anti-coagulant prophylaxis such as warfarin must be able to undergo a five-day washout period before gastroscopy. The subject on aspirin, ticlopidine and clopidogrel must be able to undergo a one-week washout period before gastroscopy. The subject's physician or study co-investigator will exercise their clinical judgement to ensure subject's safety.
The subject is unwilling or unable to provide signed informed consent. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Ying Wei, MD, PhD central contact role Contact central contact phone +65 69577585 central contact e mail contact@endofotonics.com overall official list overall official overall official name Hongzhi Xu, MD, PhD overall official affiliation Zhongshan Hospital Xiamen University overall official role Principal Investigator location list location location facility Zhongshan Hospital Xiamen University location status Recruiting location city Xiamen location state Fujian location zip 361004 location country China location contact list location contact location contact name Hongzhi Xu, MD, PhD location contact role Contact location contact phone +86 0592 2186786 location contact e mail xuhongzhi@xmu.edu.cn derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013274 condition mesh term Stomach Neoplasms condition ancestor list condition ancestor condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000013272 condition ancestor term Stomach Diseases condition browse leaf list condition browse leaf condition browse leaf id M15216 condition browse leaf name Stomach Neoplasms condition browse leaf as found Gastric Cancer condition browse leaf relevance high condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M15214 condition browse leaf name Stomach Diseases condition browse leaf relevance low condition browse leaf id T5486 condition browse leaf name Stomach Cancer condition browse leaf as found Gastric Cancer condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases | NCT04835246 | [
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7226,
119,
1109,
7226,
2308,
1110,
1173,
4465,
1121,
1103,
4267,
19760,
1322,
1104,
1103,
15078,
1179,
17357,
117,
12086,
1171,
1106,
1103,
1514,
1449,
117,
1105,
2085,
1194,
1103,
188,
26426,
11457,
2083,
119,
1109,
4465,
4344,
1110,
1173,
14659,
1106,
6268,
1103,
4044,
15078,
1179,
4344,
117,
1134,
1110,
1173,
14247,
5591,
1194,
1103,
3622,
9932,
1106,
17459,
1157,
3187,
1111,
4182,
113,
1344,
120,
1822,
114,
119,
11907,
1174,
4197,
1209,
1173,
1129,
6455,
1113,
1103,
144,
22054,
1107,
1842,
1159,
119,
2975,
13196,
3879,
2190,
3879,
12384,
11048,
11558,
12384,
11048,
11689,
7804,
14840,
2285,
5214,
1988,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
151,
120,
138,
1902,
9108,
2235,
8353,
1990,
1249,
19638,
1880,
1902,
2425,
3007,
12120,
8517,
14226,
2941,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
7330,
113,
3353,
20943,
114,
10803,
23992,
10803,
5099,
16183,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
156,
26426,
1611,
146,
18219,
1775,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1109,
7454,
1209,
1129,
1455,
1106,
1660,
170,
12645,
1104,
1103,
8241,
1988,
1223,
2061,
1609,
1322,
2155,
20739,
113,
160,
17516,
114,
22240,
1105,
1103,
1322,
2155,
22258,
12645,
1871,
1209,
1129,
1802,
1113,
1692,
2592,
1532,
119,
1599,
1103,
7454,
1209,
8698,
1103,
17357,
1104,
156,
26426,
1611,
146,
18219,
1775,
1449,
1106,
3232,
1105,
15187,
1103,
8241,
1988,
119,
1109,
156,
26426,
1611,
146,
18219,
1775,
1449,
1209,
11552,
1103,
19665,
1609,
4344,
1121,
1103,
8241,
1988,
1105,
15187,
1103,
3187,
1104,
1103,
8241,
1988,
1217,
1344,
118,
3654,
1107,
4487,
8043,
7088,
21091,
1348,
15242,
1643,
22992,
1137,
3245,
11048,
4182,
117,
1105,
3934,
1103,
1871,
1113,
1103,
156,
26426,
1611,
146,
18219,
1775,
3251,
119,
1109,
156,
26426,
1611,
146,
18219,
1775,
8670,
1209,
1129,
1802,
1113,
1692,
2592,
1532,
119,
2695,
1103,
5351,
1105,
3995,
1209,
1129,
24255,
1121,
1103,
2686,
1121,
156,
26426,
1611,
146,
18219,
1775,
1449,
119,
1258,
156,
26426,
1611,
146,
18219,
1775,
1449,
8179,
117,
1103,
7454,
2274,
25128,
12685,
6876,
113,
188,
114,
1107,
6321,
8241,
1988,
1111,
1748,
1117,
9870,
9779,
7542,
12645,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
15545,
2093,
131,
156,
26426,
1611,
146,
18219,
1775,
1449,
9108,
2190,
9108,
9108,
2076,
15545,
2093,
9108,
1271,
156,
26426,
1611,
146,
18219,
1775,
1449,
9108,
6136,
1109,
156,
26426,
1611,
146,
18219,
1775,
1449,
1110,
3005,
1106,
1129,
1215,
1107,
9342,
1114,
7228,
1653,
1609,
1322,
2155,
20739,
1107,
3105,
3245,
8005,
10879,
2556,
14196,
1322,
2155,
22258,
7791,
1106,
6183,
4420,
1114,
1344,
3187,
1104,
4297,
1105,
120,
1137,
1515,
3245,
11048,
4182,
1105,
1122,
1110,
3005,
1111,
1329,
1113,
4420,
1807,
1105,
4463,
1106,
1103,
1425,
1104,
1407,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
156,
26426,
1611,
146,
18219,
1775,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
14895,
5053,
3121,
14499,
1104,
156,
26426,
1611,
146,
18219,
1775,
1449,
2425,
9386,
6136,
1706,
15187,
1103,
15750,
1104,
156,
26426,
1611,
146,
18219,
1775,
1449,
1111,
1103,
11432,
1104,
3245,
11048,
4182,
1105,
3073,
7804,
14840,
2285,
26052,
1107,
191,
15435,
1107,
1103,
2915,
1104,
1606,
1117,
2430,
7810,
12645,
1112,
1103,
2284,
2530,
119,
12120,
8517,
14226,
2941,
12307,
1209,
1129,
14758,
1107,
1142,
3443,
119,
7993,
1103,
1117,
9870,
9779,
7542,
12645,
1112,
1103,
2284,
2530,
117,
2276,
3112,
1116,
113,
157,
17598,
114,
117,
2276,
4366,
1116,
113,
157,
2249,
1116,
114,
117,
6014,
3112,
1116,
113,
143,
17598,
114,
1105,
6014,
4366,
1116,
113,
143,
2249,
1116,
114,
1169,
1129,
3836,
1111,
1241,
156,
26426,
1611,
146,
18219,
1775,
113,
146,
18219,
1775,
114,
1449,
119,
14895,
5053,
3121,
14499,
134,
157,
2101,
120,
113,
157,
2101,
116,
143,
2249,
114,
119,
2425,
9386,
1159,
4207,
1507,
1103,
7791,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
156,
27934,
1785,
1104,
156,
26426,
1611,
146,
18219,
1775,
1449,
3718,
9386,
6136,
1706,
15187,
1103,
2747,
1785,
1105,
10893,
1104,
156,
26426,
1611,
146,
18219,
1775,
1449,
1111,
1103,
11432,
1104,
3245,
11048,
4182,
1105,
3073,
7804,
14840,
2285,
26052,
1107,
191,
15435,
1107,
1103,
2915,
1104,
1606,
1117,
2430,
7810,
12645,
1112,
1103,
2284,
2530,
119,
156,
27934,
1785,
134,
157,
2249,
120,
113,
157,
2249,
116,
143,
2101,
114,
119,
3718,
9386,
1159,
4207,
1507,
1103,
7791,
3718,
9386,
4929,
138,
19515,
4084,
3457,
1104,
156,
26426,
1611,
146,
18219,
1775,
1449,
3718,
9386,
6136,
1706,
15187,
1103,
10893,
1104,
156,
26426,
1611,
146,
18219,
1775,
1449,
1111,
1103,
11432,
1104,
3245,
11048,
4182,
1105,
3073,
7804,
14840,
2285,
26052,
1107,
191,
15435,
1107,
1103,
2915,
1104,
1606,
1117,
2430,
7810,
12645,
1112,
1103,
2284,
2530,
119,
138,
19515,
4084,
3457,
134,
113,
157,
2101,
116,
157,
2249,
114,
120,
113,
157,
2101,
116,
157,
2249,
116,
143,
2101,
116,
143,
2249,
114,
119,
3718,
9386,
1159,
4207,
1507,
1103,
7791,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
1109,
2548,
1110,
2214,
1190,
1407,
1201,
1104,
1425,
119,
1109,
2548,
1110,
15819,
3105,
144,
2240,
1322,
2155,
20739,
1111,
6321,
1107,
4487,
8043,
7088,
21091,
1348,
15242,
1643,
22992,
1137,
3245,
11048,
4182,
26052,
113,
1750,
1190,
1406,
6262,
114,
1109,
2548,
1538,
1138,
7572,
1878,
1105,
5422,
1103,
5351,
6189,
9635,
1532,
7713,
1115,
1119,
120,
1131,
1144,
1151,
6189,
1104,
1155,
1679,
24123,
5402,
1104,
1103,
2025,
119,
1109,
2548,
1538,
1129,
4988,
1105,
1682,
1106,
14616,
1114,
1155,
2025,
8826,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
1109,
2548,
1144,
9793,
11759,
117,
1216,
1112,
5871,
5521,
4184,
20473,
1465,
117,
1107,
2292,
25128,
3491,
1905,
1132,
14255,
4487,
24704,
4578,
1906,
119,
1109,
2548,
2196,
2915,
1104,
2327,
3245,
8005,
10879,
2556,
14196,
9793,
1137,
1884,
28026,
13200,
23610,
3073,
1665,
7535,
3408,
25128,
3491,
1905,
119,
1109,
2548,
1144,
4054,
3245,
11048,
12477,
2646,
12149,
9885,
1216,
1112,
3245,
8005,
10879,
2556,
14196,
188,
24655,
1348,
24309,
113,
144,
6258,
1942,
1116,
114,
117,
181,
25698,
7903,
1116,
1105,
24928,
11955,
6696,
13335,
8643,
24309,
1097,
26546,
1942,
1116,
1098,
119,
1109,
2548,
1110,
6391,
119,
1109,
2548,
1114,
11911,
172,
3161,
1197,
15342,
1548,
117,
20606,
1231,
7050,
3053,
117,
12104,
3245,
8005,
10879,
2556,
14196,
113,
144,
2240,
114,
9793,
117,
13936,
4184,
19911,
1348,
15661,
18117,
117,
179,
3984,
12090,
2093,
117,
1105,
144,
2240,
2112,
118,
6059,
1109,
2548,
1114,
5199,
1884,
118,
182,
1766,
14598,
6946,
117,
1216,
1112,
1322,
118,
2016,
1231,
7050,
4290,
113,
142,
16396,
2271,
114,
117,
14255,
7562,
3946,
17688,
4290,
113,
21362,
2271,
114,
117,
5199,
184,
13894,
19243,
1582,
7729,
1548,
113,
152,
1592,
114,
1105,
187,
4638,
10161,
2430,
2386,
1893,
8167,
10721,
113,
26547,
114,
8753,
1263,
1858,
1664,
118,
188,
25710,
13293,
2848,
118,
22653,
3850,
113,
27020,
9949,
114,
7606,
1109,
2548,
1144,
1168,
5199,
12104,
1137,
13306,
2657,
1137,
17123,
3879,
1137,
8087,
22832,
1785,
1115,
1336,
15891,
1114,
1103,
7628,
1104,
2025,
2686,
1105,
1107,
1103,
9228,
1104,
1103,
17805,
1156,
1294,
1103,
2548,
8362,
26841,
8637,
1111,
3990,
1154,
1103,
2025,
1109,
2548,
1113,
2366,
2848,
118,
1884,
28026,
9180,
21146,
18873,
7897,
1548,
1216,
1112,
1594,
21975,
1179,
1538,
1129,
1682,
1106,
13971,
170,
1421,
118,
1285,
10124,
3554,
1669,
1196,
3245,
8005,
11428,
5005,
119,
1109,
2548,
1113,
1112,
8508,
4854,
117,
189,
1596,
13200,
2386,
2042,
1105,
172,
13200,
12894,
1403,
9261,
1538,
1129,
1682,
1106,
13971,
170,
1141,
118,
1989,
10124,
3554,
1669,
1196,
3245,
8005,
11428,
5005,
119,
1109,
2548,
112,
188,
7454,
1137,
2025,
1884,
118,
17805,
1209,
6730,
1147,
7300,
21261,
1106,
4989,
2548,
112,
188,
3429,
119,
1109,
2548,
1110,
17026,
1137,
3372,
1106,
2194,
1878,
6189,
9635,
119,
8071,
8118,
1302,
5772,
1398,
5867,
1425,
1407,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2129,
3232,
2190,
2129,
3232,
2129,
3232,
1271,
26446,
12068,
117,
9292,
117,
7735,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
116,
2625,
5691,
1571,
1559,
26253,
1604,
1571,
2129,
3232,
174,
6346,
3232,
137,
1322,
10008,
12355,
21157,
119,
3254,
2905,
2078,
2190,
2905,
2078,
2905,
2078,
1271,
3475,
23239,
17584,
117,
9292,
117,
7735,
2905,
2078,
13494,
163,
15564,
10257,
3355,
20802,
16470,
1179,
1239,
2905,
2078,
1648,
8013,
1130,
5710,
3121,
25524,
1766,
2450,
2190,
2450,
2450,
3695,
163,
15564,
10257,
3355,
20802,
16470,
1179,
1239,
2450,
2781,
11336,
1665,
27975,
1158,
2450,
1331,
20802,
16470,
1179,
2450,
1352,
23219,
1389,
2450,
195,
9717,
3164,
20150,
1527,
2450,
1583,
1975,
2450,
3232,
2190,
2450,
3232,
2450,
3232,
1271,
3475,
23239,
17584,
117,
9292,
117,
7735,
2450,
3232,
1648,
24367,
2450,
3232,
2179,
116,
5942,
4991,
1580,
1477,
22723,
1545,
1559,
22392,
2450,
3232,
174,
6346,
193,
23698,
4553,
23239,
137,
193,
13601,
119,
5048,
1358,
119,
172,
1179,
4408,
2237,
1940,
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1162,
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full study rank 61913 study protocol section identification module n c t id NCT04830280 org study id info org study id 2021/03-11 organization org full name Zonguldak Bulent Ecevit University org class OTHER brief title Effect Posterior QLB on Atelectasis official title The Effect of Ultrasound-guided Posterior Quadratus Lumborum Block on Atelectasis in Pediatric Patients status module status verified date June 2021 overall status Recruiting expanded access info has expanded access No start date struct start date March 1, 2021 start date type Actual primary completion date struct primary completion date August 31, 2021 primary completion date type Anticipated completion date struct completion date September 30, 2021 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date June 1, 2021 last update post date struct last update post date June 2, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Çağdaş Baytar responsible party investigator title medical doctor responsible party investigator affiliation Zonguldak Bulent Ecevit University lead sponsor lead sponsor name Zonguldak Bulent Ecevit University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary We aimed to investigate the effect of posterior quadratus lumborum block on postoperative atelectasis in inguinal hernia surgery in pediatric patients. conditions module condition list condition Atelectasis Block Pediatrics Quadratus Lumborum Block keyword list keyword postoperative atelectasis ultrasound lung ultrasound score posterior QLB design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 2 enrollment type Anticipated arms interventions module arm group list arm group arm group label Posterior quadratus lumborum block arm group type Active Comparator arm group intervention list arm group intervention name Procedure: posterior quadratus lumborum block arm group label control group arm group type Sham Comparator arm group intervention list arm group intervention name Procedure: posterior quadratus lumborum block intervention list intervention intervention type Procedure intervention name posterior quadratus lumborum block intervention description administration local anesthetic solution between the middle layer of the thoracolumbar fascia and QL muscle at the posterior edge of the quadratus lumborum muscle intervention arm group label list intervention arm group label Posterior quadratus lumborum block control group outcomes module primary outcome list primary outcome primary outcome measure lung ultrasound score primary outcome description atelectasis primary outcome time frame up to 1 hour after surgery secondary outcome list secondary outcome secondary outcome measure pain scores secondary outcome description Flacc scores secondary outcome time frame up to 6 hour after surgery eligibility module eligibility criteria Inclusion Criteria:
under 2 years old,
ASA I-II risk group
Patients who underwent an inguinal hernia operation under general anesthesia, posterior quadratus lumborum block for postoperative analgesia or pain treatment with conventional method
Patients whose informed consent was read and approval was obtained from him and his guardian
Exclusion Criteria:
who do not want to participate in the study,
ASA III-IV-V patients healthy volunteers Accepts Healthy Volunteers gender All minimum age 0 Years maximum age 2 Years std age list std age Child contacts locations module location list location location facility Zonguldak Bülent Ecevit University Medicine Faculty location status Recruiting location city Zonguldak location state Kozlu location zip 67600 location country Turkey location contact list location contact location contact name murat can location contact role Contact location contact phone +90 372 261 20 01 location contact phone ext 2839 location contact e mail murat.can@beun.edu.tr i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001261 condition mesh term Pulmonary Atelectasis condition ancestor list condition ancestor condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M3719 condition browse leaf name Pulmonary Atelectasis condition browse leaf as found Atelectasis condition browse leaf relevance high condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M21013 intervention browse leaf name Pharmaceutical Solutions intervention browse leaf relevance low intervention browse leaf id M3261 intervention browse leaf name Anesthetics, Local intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions | NCT04830280 | [
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full study rank 61432 study protocol section identification module n c t id NCT04836546 org study id info org study id CTP-0039 organization org full name Senseonics, Inc. org class INDUSTRY brief title Eversense® Non-adjunctive Use Post Approval Study official title A Post Approval Study to Evaluate the Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System Used Non-adjunctively acronym NA-PAS status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 13, 2021 start date type Actual primary completion date struct primary completion date March 31, 2026 primary completion date type Anticipated completion date struct completion date March 31, 2026 completion date type Anticipated study first submit date March 30, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 10, 2022 last update post date struct last update post date November 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Senseonics, Inc. lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device Yes description module brief summary This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants with either Type 1 or Type 2 diabetes. Subjects will serve as their own control, with their baseline based on using SMBG to manage their diabetes for the first 6 months followed by using Eversense CGM System non-adjunctively for the second 6 months. Total follow-up duration is 12 months. The investigation will include both clinic visits and home use of Eversense CGM System. The nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. All care decisions specific to diabetes will be based on blood glucose (BG) values in the first phase and the Eversense CGM system values in the second phase. conditions module condition list condition Diabetes keyword list keyword Type 1 Diabetes Type 2 Diabetes design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 925 enrollment type Anticipated arms interventions module arm group list arm group arm group label Self monitoring of blood glucose, then CGM System arm group type Experimental arm group description All participants will first manage their diabetes with SMBG for 6 months followed by managing their diabetes with Eversense CGM system for the next 6 months arm group intervention list arm group intervention name Device: Blood glucose meter Device: Eversense CGM System intervention list intervention intervention type Device intervention name Blood glucose meter intervention description First phase: SMBG for 6 months intervention arm group label list intervention arm group label Self monitoring of blood glucose, then CGM System intervention type Device intervention name Eversense CGM System intervention description Second phase: CGM for 6 months intervention arm group label list intervention arm group label Self monitoring of blood glucose, then CGM System outcomes module primary outcome list primary outcome primary outcome measure Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events primary outcome description Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events with SMBG use for 6 months compared to Eversense CGM system used non-adjunctively for 6 months primary outcome time frame First 6 months (phase 1) compared to second 6 months (phase 2) eligibility module eligibility criteria Inclusion Criteria:
Subject has diabetes
Subject is ≥18 years of age
Subject has a smartphone that is internet enabled
Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion
Subjects is willing and able to provide written signed and dated informed consent
Exclusion Criteria:
Subject is critically ill or hospitalized
Prior use of CGM defined as:
No more than 1 week of continuous CGM use in the last 6 months, and
At least 4 weeks of continuous use of CGM in the last 12 months or 12 weeks total use in the past 3 years.
Subject has a known contraindication to dexamethasone or dexamethasone acetate
Subjects requiring intravenous mannitol or mannitol irrigation solutions
Subject is on dialysis at the time of enrollment
Female subjects who are pregnant, planning on becoming pregnant or nursing healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Pamela Mann, RN central contact role Contact central contact phone 240-778-6164 central contact e mail pamela.mann@senseonics.com central contact name Katherine Tweden, PhD central contact role Contact central contact e mail katherine.tweden@senseonics.com location list location location facility LA Universal Research Center, Inc. location status Recruiting location city Los Angeles location state California location zip 90057 location country United States location contact list location contact location contact name Maximo Tacuchi location contact role Contact location contact phone 213-359-9091 location contact e mail drmaxt@launiresearch.com location contact name Tatyana Palmer location contact role Contact location contact e mail TatyanaCRC10@launiresearch.com location contact name Bruce Torkan, MD location contact role Principal Investigator location facility Denver Endocrinology, Diabetes & Thyroid Center location status Recruiting location city Englewood location state Colorado location zip 80113 location country United States location contact list location contact location contact name Stacey Mitchell, CRC location contact role Contact location contact phone 303-321-2644 location contact e mail Stacey.Mitchell@denverendocenter.com location contact name Jessica Talan, CRC location contact role Contact location contact phone 3033212644 location contact phone ext 214 location contact e mail jtalan@Denverendocenter.com location contact name Lori Gerard, MD location contact role Principal Investigator location contact name Linda Buckley, MD location contact role Sub-Investigator location facility CMR of Greater New Haven location status Recruiting location city Hamden location state Connecticut location zip 06517 location country United States location contact list location contact location contact name Melissa Capasso location contact role Contact location contact phone 203-490-2077 location contact e mail mcapasso@chasemr.com location contact name Joseph Soufer, MD location contact role Principal Investigator location facility Chase Medical Research location status Recruiting location city Waterbury location state Connecticut location zip 06708 location country United States location contact list location contact location contact name Yassinia Deleon location contact role Contact location contact phone 203-419-4420 location contact phone ext 306 location contact e mail ydeleon@chasemr.com location contact name Joseph Soufer, MD location contact role Principal Investigator location facility The Center for Diabetes and Endocrine Care location status Recruiting location city Fort Lauderdale location state Florida location zip 33312 location country United States location contact list location contact location contact name Carrie-Ann Silvia location contact role Contact location contact phone 954-963-7191 location contact phone ext 243 location contact e mail csilvia@diabetes-endocare.com location contact name Maria Martin location contact role Contact location contact phone 954-963-7100 location contact phone ext 236 location contact e mail mmartin@diabetes-endocare.com location contact name Sam Lerman, MD location contact role Principal Investigator location facility Miami Lakes Clinical Trials INC location status Recruiting location city Miami Lakes location state Florida location zip 33014 location country United States location contact list location contact location contact name Nayribis Vargas, BS location contact role Contact location contact phone 305-621-8051 location contact e mail nvargas@sunctrials.com location contact name Barry M Kotler, MD location contact role Principal Investigator location facility MedCare Research location status Recruiting location city Miami location state Florida location zip 33165 location country United States location contact list location contact location contact name Daniela Urra location contact role Contact location contact e mail durra@medcareresearch.com location contact name Adalberto Aguilera, MD location contact role Principal Investigator location facility Atlanta Diabetes Associates location status Recruiting location city Atlanta location state Georgia location zip 30318 location country United States location contact list location contact location contact name Betsy Childs location contact role Contact location contact phone 404-355-4393 location contact e mail bchilds@atlantadiabetes.com location contact name Bruce Bode, MD location contact role Principal Investigator location facility Rocky Mountain Clinical Research location status Recruiting location city Idaho Falls location state Idaho location zip 83404 location country United States location contact list location contact location contact name William Hardee location contact role Contact location contact phone 208-522-6005 location contact e mail william.hardee@idahomed.com location contact name David Liljenquist, MD location contact role Principal Investigator location facility MODEL Clinical Research location status Withdrawn location city Baltimore location state Maryland location zip 21204 location country United States location facility Southern Maryland Medical Group location status Recruiting location city Camp Springs location state Maryland location zip 20746 location country United States location contact list location contact location contact name Iluyomade Adeusi location contact role Contact location contact phone 301-312-0575 location contact e mail luyomade@marylandresearchcenters.com location facility Metro Detroit Endocrinology location status Recruiting location city Dearborn location state Michigan location zip 48126 location country United States location contact list location contact location contact name Ahmad Ghamlouche, BS location contact role Contact location contact phone 313-203-5300 location contact phone ext 3050 location contact e mail Ahmad1mdec@gmail.com location contact name Ayman Elkadry, MD location contact role Principal Investigator location facility Diabetes and Endocinology Specialists, Inc. location status Recruiting location city Chesterfield location state Missouri location zip 63017 location country United States location contact list location contact location contact name Suzette Christopher, CRC location contact role Contact location contact phone 314-469-6224 location contact phone ext 226 location contact e mail metabnet@aol.com location contact name Ralph Oiknine, MD location contact role Principal Investigator location facility Southwest Family Medicine Associates location status Recruiting location city Dallas location state Texas location zip 75235 location country United States location contact list location contact location contact name Lashonda Brown location contact role Contact location contact phone 469-893-1242 location contact e mail lashonda@southwestfamilymed.com location contact name Chrisette Dharma, MD location contact role Principal Investigator location facility Javara, Inc location status Withdrawn location city Houston location state Texas location zip 77095 location country United States location facility Green Mountain Research Institute location status Recruiting location city Rutland location state Vermont location zip 05701 location country United States location contact list location contact location contact name Desiree Delgado Chamorro location contact role Contact location contact phone 802-855-8368 location contact e mail desiree@greenmountainresearch.org location contact name Hurtado, MD location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M6271 condition browse leaf name Diabetes Mellitus, Type 2 condition browse leaf relevance low condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M6269 condition browse leaf name Diabetes Mellitus, Type 1 condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases | NCT04836546 | [
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full study rank 61182 study protocol section identification module n c t id NCT04839796 org study id info org study id 201800289A3 organization org full name Chang Gung Memorial Hospital org class OTHER brief title Northeastern Taiwan Community Medicine Research Cohort official title A Cohort Study on Disease Prevention and Health Promotion in Northeastern Region of Taiwan acronym NTCMRC status module status verified date January 2021 overall status Recruiting expanded access info has expanded access No start date struct start date August 2013 start date type Actual primary completion date struct primary completion date August 2043 primary completion date type Anticipated completion date struct completion date August 2043 completion date type Anticipated study first submit date March 28, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 9, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Chang Gung Memorial Hospital lead sponsor class OTHER oversight module description module brief summary The cohort study on disease prevention and health promotion in the northeastern region of Taiwan is a trial dedicated to large-scale generational research in northeastern Taiwan beginning in the August of 2013. The program aims to develop a comprehensive and integrated approach to disease prevention and community health. The researcher's cohort organizes healthcare outreaches for participants over the age of 20 residing in 64 administrative areas in Keelung city and new Taipei city. The researcher's sessions include a comprehensive health examination, health-related questionnaires, and disease awareness seminars.
Biological samples, questionnaire information, and medical data obtained from researcher's participants are stored in researcher's core laboratory. Depersonalized data and samples are shared with partnering trials approved by the Chang Gung Memorial Hospital Institutional review board. The investigators are currently partnered with 18 clinical trials spanning across multiple disciplines such as urology, hepatology, metabolism, physical therapy, and psychology. detailed description The cohort study on disease prevention and health promotion in the northeastern region of Taiwan is a trial dedicated to large-scale generational research in northeastern Taiwan beginning in the August of 2013. The program aims to develop a comprehensive and integrated approach to disease prevention and community health. The researcher's cohort organizes healthcare outreaches for participants over the age in Keelung city and new Taipei city. The researcher's sessions include a comprehensive health examination, health-related questionnaires and disease awareness seminars.
Biological samples, questionnaire information, and medical data obtained from the researcher's participants are stored in the researcher's core laboratory. Depersonalized data and samples are shared with partnering trials approved by the Chang Gung Memorial Hospital Institutional review board. The investigators are currently partnered with 18 clinical trials spanning across multiple disciplines such as urology, hepatology, metabolism, physical therapy, and psychology.
The investigators are also a member of the national "Establish Multi-omics Database of Smart Healthcare for Obesity Therapeutics involving " joint project and the national "Remote Medical Monitoring System-Linking Healthcare Industrial Ecosystem-Taiwanese Novel Disease Monitoring Solution" initiative.
Introduction: This research is conducted in the form of community health care activities. Through regular community health household activities, community residents' awareness of health is improved, and various pathogenic factors are analyzed to strengthen health education, improve living habits, reduce risk factors, and promote the health of community residents.
Project purpose: In order to promote community fitness, The investigators will conduct long-term community medicine generation research. This research consists of a series of collaborative projects such as chronic kidney disease, chronic liver disease, metabolic syndrome, depression, dementia, obesity, exercise rehabilitation, etc.
In community health care activities, collect biological samples such as blood, urine, feces, etc., as well as questionnaire data. This project will link participants relevant health data to establish a database for the generation of Keelung Chang Gung community medicine research. These data will be provided for analysis of co-operative plans related to generations of research and long-term tracking of participants health. conditions module condition list condition Cohort Study keyword list keyword NTCMRC Maintenance Project Health Care Activities design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 20000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Participants residing in urban areas arm group description Urban residents enjoy convenient transportation, have access to abundant medical resources, have more job opportunities, and are on average younger but are also exposed to more air pollution. arm group label Participants residing in rural areas arm group description Rural residents have less access to transportation, medical resources, and job prospects comparatively and are comparatively older. However, Rural residents are exposed to less pollution in general. outcomes module primary outcome list primary outcome primary outcome measure Participant died during the observation period. primary outcome description Investigators keep in touch with participants and invite them to participate in healthcare outreaches every year. primary outcome time frame From 2013 Augus to Feb 2021 primary outcome measure Dementia primary outcome description The AD8 dementia screening interview is used to detect the early signs of dementia. Using the items in the form to check whether participants have similar symptoms, so as to detect and treat them as soon as possible. primary outcome time frame From 2013 Augus to Feb 2021 primary outcome measure Chronic Kidney Disease primary outcome description Chronic kidney disease is a type of kidney disease in which there is gradual loss of kidney function over a period of months to years. primary outcome time frame From 2013 Augus to Feb 2021 primary outcome measure Liver cancer primary outcome description Participant suffers from liver cancer primary outcome time frame From 2013 Augus to Feb 2021 eligibility module eligibility criteria Inclusion Criteria:
Residing in Keelung city and new Taipei city.
Mobile health and mental health
Participating in healthcare outreaches
Exclusion Criteria:
Under 20 years old
Participant without judgment
Participant has HIV gender All minimum age 20 Years std age list std age Adult Older Adult study population Participants who enroll in these community health activities and meet the following conditions:
Over the age of 20.
Residing in 64 administrative areas in Keelung city and new Taipei city. sampling method Probability Sample contacts locations module central contact list central contact central contact name Yu Chiau Shyu, PHD central contact role Contact central contact phone 02-24329292 central contact phone ext 3391 central contact e mail yuchiaushyu@gmail.com central contact name Rou Ling Cho, PHD central contact role Contact central contact phone 02-24329292 central contact phone ext 3391 central contact e mail royeariel760918@gmail.com overall official list overall official overall official name Yu Chiau Shyu, PHD overall official affiliation Community Medicine Research Center,Chang Gung Memorial Hospital,Keelung branch overall official role Principal Investigator location list location location facility Community Medicine Research Center Chang Gung Memorial Hospital Keelung,Taiwan,204 location status Recruiting location city Keelung location country Taiwan location contact list location contact location contact name Yu Chiau Shyu, PHD location contact role Contact location contact phone 02-24329292 location contact phone ext 3391 location contact e mail yuchiaushyu@gmail.com location contact name Rou Ling Cho, PHD location contact role Contact location contact phone 02-24329292 location contact phone ext 3391 location contact e mail royeariel760918@gmail.com references module reference list reference reference p m i d 35546525 reference type derived reference citation Wu IW, Tsai TH, Lo CJ, Chou YJ, Yeh CH, Cheng ML, Lai CC, Sytwu HK, Tsai TF. Discovery of a Biomarker Signature That Reveals a Molecular Mechanism Underlying Diabetic Kidney Disease via Organ Cross Talk. Diabetes Care. 2022 Jun 2;45(6):e102-e104. doi: 10.2337/dc22-0145. No abstract available. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 | NCT04839796 | [
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full study rank 61498 study protocol section identification module n c t id NCT04835688 org study id info org study id CG1-2021 organization org full name Zealand University Hospital org class OTHER brief title Ventilation Tube Insertion for Unilateral Menière's Disease official title Transmyringeal Ventilation Tube Insertion for Unilateral Menière's Disease: a Prospective, Sham-controlled, Double-blinded, Randomized, Clinical Trial status module status verified date September 2021 overall status Recruiting expanded access info has expanded access No start date struct start date September 20, 2021 start date type Actual primary completion date struct primary completion date January 1, 2024 primary completion date type Anticipated completion date struct completion date January 1, 2024 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 5, 2021 last update post date struct last update post date October 14, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Casper Grønlund Larsen responsible party investigator title MD, PhD-student responsible party investigator affiliation Zealand University Hospital lead sponsor lead sponsor name Casper Grønlund Larsen lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this trial is to assess the effects of transmyringeal ventilation tubes compared with sham-treatment which do not ventilate the middle ear, on the number of vertigo attacks lasting more than 20 minutes in participants with Menière's disease. detailed description Menière's disease is an inner ear disorder with recurrent attacks of vertigo, fluctuating sensorineural hearing loss, tinnitus, and aural fullness. The underlying pathogenetic mechanisms are not known. The pathologic-anatomic correlate of the disease is endolymphatic hydrops, i.e. distension of the endolymphatic spaces as seen at post-mortem microscopic examination of the temporal bone. Prevalence-figures are in the range between 0.1% to 0.5% in the population. In Denmark, the estimated prevalence of Menière's disease is 3500. The disease commonly begins in the fourth or fifth decade of life, and the prevalence increases with age.
There are a great number of different treatment options for Menière's disease including diuretics, sodium-restriction, beta-histidine, and psycho-supportive means, most of which are not validated. The only validated treatment for the vertigo attacks is chemical labyrinthectomy by intra-tympanic injections of the ototoxic antibiotic gentamicin for which two double-blind, placebo-controlled trials found a significant effect. Treatment with gentamicin is ablative, i.e. the goal of the treatment is to destroy the vestibular sensors of the affected ear. This carries a risk of long-standing unsteadiness alongside with permanent hearing loss in the treated ear. Still, no treatments seem to protect from the hearing loss associated with Menière's disease.
The first to advocate the use of transmyringeal ventilation tubes for Menière's disease was Tumarkin in 1966. Tumarkin et al. suggested that negative middle-ear pressure, due to poor tubal function, would lead to a relative over-pressure in the inner ear and that this might be one of the mechanisms behind Menière's disease. In addition, Tumarkin et al. presented several cases where treatment with transmyringeal tubes resulted in relief from vertigo attacks. Hall and Brackmann performed tympanometry in patients with Menière's disease and showed that some, but not all, patients had negative middle-ear pressure and they questioned Tumarkin's suggestions. conditions module condition list condition Meniere Disease keyword list keyword Ventilation tube insertion Grommet insertion Vertigo design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description A pro-spective, double-blinded, sham-controlled, randomized, clinical trial design primary purpose Treatment design masking info design masking Quadruple design masking description Participants, care providers, data collectors, outcome assessors, research personnel, and data analysts will be blinded to treatment allocation. However, the ENT-specialist performing the insertion of the ventilation tube or placebo-treatment will inevitably be aware of treatment allocation. design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 104 enrollment type Anticipated arms interventions module arm group list arm group arm group label Ventilation tube insertion arm group type Experimental arm group description Ventilation tube insertion into the tympanic membrane. arm group intervention list arm group intervention name Procedure: Transmyringeal ventilation tube insertion arm group label Sham-treatment arm group type Sham Comparator arm group description Sham-treatment. Manipulation of the tympanic membrane to simulate ventilation tube insertion without performing a ventilation tube insertion. arm group intervention list arm group intervention name Procedure: Sham-treatment intervention list intervention intervention type Procedure intervention name Transmyringeal ventilation tube insertion intervention description In both groups, the tympanic membrane will be anesthetized by local application of topical prilocaine (EMLA) or phenol or by infiltration anaesthesia of the outer ear canal. The choice of method is left to the discretion of the surgeon.
For the experimental group, insertion of a ventilation tube will be performed. An incision is performed, usually in the lower, anterior quadrant of the tympanic membrane and the transmyringeal tube is inserted. intervention arm group label list intervention arm group label Ventilation tube insertion intervention other name list intervention other name Ventilation tube insertion, grommet insertion intervention type Procedure intervention name Sham-treatment intervention description For the control group, the ENT-specialist will touch the tympanic membrane with an alligator ear forceps to simulate getting a paracentesis. In the same procedure, without having made a paracentesis, a ventilation tube is placed on the tympanic membrane and removed again afterwards. The reason for the above-mentioned is to simulate getting a paracentesis and insertion of a ventilation tube. intervention arm group label list intervention arm group label Sham-treatment outcomes module primary outcome list primary outcome primary outcome measure Number of vertigo attacks lasting more than 20 minutes primary outcome description Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire. primary outcome time frame 3 months primary outcome measure Number of vertigo attacks lasting more than 20 minutes primary outcome description Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire. primary outcome time frame 24 months secondary outcome list secondary outcome secondary outcome measure Pure-tone audiometry secondary outcome description 4 tone average of 500, 1000, 2000, and 3000 Hz (dB) and 3 tone average of 125, 250, and 500 Hz (dB). secondary outcome time frame 3 months secondary outcome measure AAO-HNS Functional Level Scale secondary outcome description Questionnaire with written descriptions of how Menière's disease affects the life of the patient, from no impact at all to totally handicapped and unable to work. secondary outcome time frame 3 months secondary outcome measure Hearing, tinnitus, unsteadiness and aural fullness secondary outcome description Patient-reported outcome by filling out a self-evaluation of symptoms-questionnaire. secondary outcome time frame 24 months secondary outcome measure Number of subjects leaving secondary outcome description To check for unsatisfied treatment. secondary outcome time frame 24 months secondary outcome measure Number of subjects satisfied secondary outcome description To check for satisfied treatment secondary outcome time frame 24 months secondary outcome measure Speech audiometry secondary outcome description Discrimination in %. secondary outcome time frame 3 months eligibility module eligibility criteria Inclusion Criteria:
Patients with definite or probable unilateral Menière's disease according to the diagnostic criteria formulated by the Classification Committee of the Bárány Society, The Japan Society for Equilibrium Research, the European Academy of Otology and Neurotology (EAONO), the Equilibrium Committee of the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS), and the Korean Balance Society:
Two or more spontaneous episodes of vertigo, each lasting 20 minutes to 12 hours
Audiometrically documented low- to medium-frequency sensorineural hearing loss in the affected ear on at least one occasion before, during or after one of the episodes of vertigo
Fluctuating aural symptoms (hearing, tinnitus or fullness) in the affected ear
Not better accounted for by another vestibular diagnosis
Exclusion Criteria:
Bilateral Menière's disease
Additional neurotological disorders (e.g. vestibular migraine, vertebrobasilar transient ischemic attack or acoustic neuroma)
Previous surgical therapy such as intratympanic gentamicin or endolymphatic sac surgery
Expected problems to adhere to the study protocol (dementia, non-fluent in Danish, substance abuse, etc.)
Previous treatment with transmyringeal ventilation tubes after childhood
A serious illness that might interfere with treatment or follow-up healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Casper Grønlund Larsen, MD central contact role Contact central contact phone 47 32 38 00 central contact e mail caslar@regionsjaelland.dk central contact name Bjarki Djurhuus, MD, PhD central contact role Contact central contact e mail bjdd@regionsjaelland.dk overall official list overall official overall official name Casper Grønlund Larsen, MD overall official affiliation Zealand University Hospital overall official role Principal Investigator location list location location facility Zealand University Hospital location status Recruiting location city Køge location zip 4600 location country Denmark location contact list location contact location contact name Casper Grønlund Larsen, MD location contact role Contact location contact phone 47323800 location contact e mail caslar@regionsjaelland.dk references module reference list reference reference p m i d 36253829 reference type derived reference citation Larsen CG, Karlberg M, Guldfred F, Devantier L, Maagaard M, Homøe P, Djurhuus BD. Transmyringeal ventilation tube insertion for unilateral Menière's disease: a protocol for a prospective, sham-controlled, double-blinded, randomized, clinical trial. Trials. 2022 Oct 17;23(1):877. doi: 10.1186/s13063-022-06777-w. i p d sharing statement module i p d sharing Yes i p d sharing description Individual patient data will be shared upon reasonable request i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code i p d sharing time frame 1/6-2024. i p d sharing access criteria Individual patient data will be shared upon reasonable request. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008575 condition mesh term Meniere Disease condition ancestor list condition ancestor condition ancestor id D000018159 condition ancestor term Endolymphatic Hydrops condition ancestor id D000007759 condition ancestor term Labyrinth Diseases condition ancestor id D000004427 condition ancestor term Ear Diseases condition ancestor id D000010038 condition ancestor term Otorhinolaryngologic Diseases condition browse leaf list condition browse leaf condition browse leaf id M16614 condition browse leaf name Vertigo condition browse leaf relevance low condition browse leaf id M6572 condition browse leaf name Dizziness condition browse leaf relevance low condition browse leaf id M10710 condition browse leaf name Meniere Disease condition browse leaf as found Meniere's Disease condition browse leaf relevance high condition browse leaf id M6809 condition browse leaf name Edema condition browse leaf relevance low condition browse leaf id M19457 condition browse leaf name Endolymphatic Hydrops condition browse leaf relevance low condition browse leaf id M9934 condition browse leaf name Labyrinthitis condition browse leaf relevance low condition browse leaf id M9931 condition browse leaf name Labyrinth Diseases condition browse leaf relevance low condition browse leaf id M6753 condition browse leaf name Ear Diseases condition browse leaf relevance low condition browse leaf id M12113 condition browse leaf name Otorhinolaryngologic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC09 condition browse branch name Ear, Nose, and Throat Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M13343 intervention browse leaf name Prilocaine intervention browse leaf relevance low intervention browse leaf id M20847 intervention browse leaf name Phenol intervention browse leaf relevance low intervention browse leaf id M1801 intervention browse leaf name Lidocaine, Prilocaine Drug Combination intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions | NCT04835688 | [
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1372,
6136,
159,
3452,
16230,
7159,
27914,
1154,
1103,
189,
17162,
10224,
1596,
10936,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
5096,
9650,
3313,
131,
13809,
4527,
3384,
13003,
22297,
7159,
27914,
1981,
1372,
3107,
156,
2522,
118,
3252,
1981,
1372,
2076,
156,
2522,
3291,
8223,
4626,
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1981,
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6136,
156,
2522,
118,
3252,
119,
2268,
9717,
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1103,
189,
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27466,
13601,
8052,
22297,
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27914,
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170,
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27914,
119,
1981,
1372,
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1981,
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131,
156,
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118,
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117,
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189,
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113,
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119,
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6700,
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117,
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170,
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1982,
119,
1760,
1107,
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1110,
1982,
117,
1932,
1107,
1103,
2211,
117,
16557,
186,
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6922,
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1103,
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119,
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1981,
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1981,
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159,
3452,
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2190,
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117,
176,
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1973,
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1981,
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1981,
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7404,
25319,
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] |
full study rank 61594 study protocol section identification module n c t id NCT04834440 org study id info org study id MF2467-2021-14 organization org full name Healthpoint Hospital org class OTHER brief title Ropivacaine Use in Femoral Nerve Block; What is the Minimal Effective Analgesic Concentration (MEAC 90) official title Ropivacaine Use in Femoral Nerve Block; What is the Minimal Effective Analgesic Concentration (MEAC 90) status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 1, 2021 start date type Anticipated primary completion date struct primary completion date September 30, 2021 primary completion date type Anticipated completion date struct completion date September 30, 2021 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ahmad Muhammad Taha responsible party investigator title Consultant of anesthesia responsible party investigator affiliation Healthpoint Hospital lead sponsor lead sponsor name Healthpoint Hospital lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary The aim of this study is to determine the minimal effective ropivacaine concentration required to provide adequate analgesic femoral nerve block in 90% of patients (MEAC90) detailed description Before induction of GA, all patients will receive sciatic, obturator, lateral femoral cutaneous and femoral nerve blocks.
The femoral nerve block will be performed using 15ml of ropivacaine which concentration relied on the response of the previous patient.
Based on biased-coin design up-down sequential method: when a patient has a negative response, the next patient will receive a concentration 0.01% w/v higher. However if he has a positive response, the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 0.01% w/v less.
Patients with pain free recovery will be considered to have positive response.
Patients' responses will be analyzed to calculate the MEAC90 conditions module condition list condition Postoperative Pain design module study type Interventional phase list phase Phase 4 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 45 enrollment type Anticipated arms interventions module intervention list intervention intervention type Drug intervention name Ropivacaine intervention description all patients will receive femoral nerve block using same volume of ropivacaine but in different concentrations outcomes module primary outcome list primary outcome primary outcome measure effective analgesic femoral nerve block primary outcome description postoperative pain. it will be assessed using numerical rating scale (NRS). NRS, 0 = no pain; 10 = worst pain imaginable; if NRS ≥ 3, pain (ineffective block) is considered, other wise a successful block will be considered. primary outcome time frame in recovery unit (one hour after surgery) eligibility module eligibility criteria Inclusion Criteria:
Patients, who are scheduled for knee ligament reconstruction
Exclusion Criteria:
<18 y,
ASA physical class greater >III
BMI >40 has any contraindication for medications or techniques used in the study healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Healthpoint Hospital location city Abu Dhabi location zip 112308 location country United Arab Emirates i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010149 condition mesh term Pain, Postoperative condition ancestor list condition ancestor condition ancestor id D000011183 condition ancestor term Postoperative Complications condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M12221 condition browse leaf name Pain, Postoperative condition browse leaf as found Postoperative Pain condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000077212 intervention mesh term Ropivacaine intervention ancestor list intervention ancestor intervention ancestor id D000000779 intervention ancestor term Anesthetics, Local intervention ancestor id D000000777 intervention ancestor term Anesthetics intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M1700 intervention browse leaf name Ropivacaine intervention browse leaf as found Intensity intervention browse leaf relevance high intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf relevance low intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M3261 intervention browse leaf name Anesthetics, Local intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Analg intervention browse branch name Analgesics | NCT04834440 | [
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full study rank 61189 study protocol section identification module n c t id NCT04839705 org study id info org study id CL11010-001 organization org full name Microvention-Terumo, Inc. org class INDUSTRY brief title Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device official title Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device acronym WEB PAS status module status verified date March 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date June 2022 start date type Anticipated primary completion date struct primary completion date August 2023 primary completion date type Anticipated completion date struct completion date August 2028 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date March 8, 2022 last update post date struct last update post date March 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Microvention-Terumo, Inc. lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory. conditions module condition list condition Wide Neck Bifurcation Intracranial Aneurysms keyword list keyword Aneurysm Intracranial Arterial Disease Cerebrovascular Disorders design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 180 enrollment type Anticipated arms interventions module arm group list arm group arm group label WEB Aneurysm Embolization Device arm group type Other arm group description WEB Aneurysm Embolization Device The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant. arm group intervention list arm group intervention name Device: WEB intervention list intervention intervention type Device intervention name WEB intervention description Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.
Other Names:
• WEB Aneurysm Embolization Device intervention arm group label list intervention arm group label WEB Aneurysm Embolization Device outcomes module primary outcome list primary outcome primary outcome measure Key Effectiveness Outcome primary outcome description Proportion of subjects with adequate aneurysm occlusion at one year after treatment. primary outcome time frame 12 Months primary outcome measure Key Safety Outcome primary outcome description Proportion of subjects with death of any nonaccidental cause or any major stroke* within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment primary outcome time frame 12 Months eligibility module eligibility criteria Key Inclusion Criteria:
Patient must be ≥ 18 at the time of screening
Patient must have a single ruptured or unruptured IA requiring treatment
Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures
Key Exclusion Criteria:
Patient has an IA with characteristics unsuitable for endovascular treatment
Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
Patient index IA was previously treated
Patient is pregnant healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Adam Arthur, MD overall official affiliation Methodist University Hospital, Memphis TN overall official role Principal Investigator overall official name David Fiorella, MD overall official affiliation Stony Brook University, Stony Brook NY overall official role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002532 condition mesh term Intracranial Aneurysm condition mesh id D000000783 condition mesh term Aneurysm condition ancestor list condition ancestor condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000020765 condition ancestor term Intracranial Arterial Diseases condition ancestor id D000002561 condition ancestor term Cerebrovascular Disorders condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M4933 condition browse leaf name Intracranial Aneurysm condition browse leaf as found Intracranial Aneurysm condition browse leaf relevance high condition browse leaf id M3265 condition browse leaf name Aneurysm condition browse leaf as found Aneurysm condition browse leaf relevance high condition browse leaf id M4962 condition browse leaf name Cerebrovascular Disorders condition browse leaf relevance low condition browse leaf id M21674 condition browse leaf name Intracranial Arterial Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M8728 intervention browse leaf name Hemostatics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Coag intervention browse branch name Coagulants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04839705 | [
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full study rank 61563 study protocol section identification module n c t id NCT04834843 org study id info org study id 2020AN0279 organization org full name Wonju Severance Christian Hospital org class OTHER brief title Temporal Trends of COronary Artery Disease and PEripheral Artery Disease (COPE) in Korea official title Temporal Trends in the Incidence, Treatment Patterns, and Outcomes of COronary Artery Disease and PEripheral Artery Disease (COPE) in Korea acronym COPE registry status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date January 1, 2009 start date type Actual primary completion date struct primary completion date December 31, 2018 primary completion date type Actual completion date struct completion date December 31, 2020 completion date type Actual study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Dong-Hyuk Cho responsible party investigator title Assistant professor responsible party investigator affiliation Wonju Severance Christian Hospital lead sponsor lead sponsor name Wonju Severance Christian Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Cardiovascular disease (CVD) is caused by atherosclerosis of the artery and is classified into coronary artery disease, cerebrovascular disease, and peripheral arterial disease, depending on the location of the artery and the target organs. However, since CVD share a similar pathophysiology and the probability of incidence of other CVD in CVD patients is very high. It is thought that CVD incidence and mortality can be reduced by predicting the degree of incidence of other CVD in CVD patients. The aim of this study is to investigate the incidence and mortality of other CVD diseases in CVD patients. conditions module condition list condition Coronary Artery Disease Peripheral Artery Disease Cardiovascular Diseases design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Retrospective enrollment info enrollment count 700000 enrollment type Actual arms interventions module intervention list intervention intervention type Other intervention name Observational study, no intervention intervention description Observational study, no intervention outcomes module primary outcome list primary outcome primary outcome measure Incidence of coronary artery disease, cerebrovascular disease, peripheral arterial disease primary outcome description Among all Koreans, percentage (%) of patients with a history of being diagnosed with CVD and underwent in-hospital treatment primary outcome time frame Up to 10 years secondary outcome list secondary outcome secondary outcome measure 1-year mortality secondary outcome description The percentage (%) of any CVD related mortality secondary outcome time frame Up to 1 year eligibility module eligibility criteria Inclusion Criteria:
Koreans who diagnosed with coronary artery disease between 2009 and 2018
Koreans who diagnosed with peripheral artery disease between 2009 and 2018
Koreans who diagnosed with cerebrovascular disease between 2009 and 2018
more than 18 years old
Exclusion Criteria:
less than 18 years old healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population People aged at least 18 years old with CAD, PAD, or cerebrovascular disease were identified from Korean national health insurance using International Classification of Diseases, tenth revision (ICD-10) codes. sampling method Probability Sample references module reference list reference reference p m i d 31883328 reference type result reference citation Sundaram V, Bloom C, Zakeri R, Halcox J, Cohen A, Bowrin K, Briere JB, Banerjee A, Simon DI, Cleland JGF, Rajagopalan S, Quint JK. Temporal trends in the incidence, treatment patterns, and outcomes of coronary artery disease and peripheral artery disease in the UK, 2006-2015. Eur Heart J. 2020 May 1;41(17):1636-1649. doi: 10.1093/eurheartj/ehz880. reference p m i d 16403930 reference type result reference citation Bhatt DL, Steg PG, Ohman EM, Hirsch AT, Ikeda Y, Mas JL, Goto S, Liau CS, Richard AJ, Rother J, Wilson PW; REACH Registry Investigators. International prevalence, recognition, and treatment of cardiovascular risk factors in outpatients with atherothrombosis. JAMA. 2006 Jan 11;295(2):180-9. doi: 10.1001/jama.295.2.180. reference p m i d 22690093 reference type result reference citation Ahn S, Park YJ, Min SI, Kim SY, Ha J, Kim SJ, Kim HS, Yoon BW, Min SK. High prevalence of peripheral arterial disease in Korean patients with coronary or cerebrovascular disease. J Korean Med Sci. 2012 Jun;27(6):625-9. doi: 10.3346/jkms.2012.27.6.625. Epub 2012 May 26. reference p m i d 33300375 reference type result reference citation Sogaard M, Nielsen PB, Skjoth F, Eldrup N, Larsen TB. Temporal Changes in Secondary Prevention and Cardiovascular Outcomes After Revascularization for Peripheral Arterial Disease in Denmark: A Nationwide Cohort Study. Circulation. 2021 Mar 2;143(9):907-920. doi: 10.1161/CIRCULATIONAHA.120.047994. Epub 2020 Dec 10. i p d sharing statement module i p d sharing No i p d sharing description The IPD from Korean national health insurance is not publicly accessible due to Korean personal information projection act derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002318 condition mesh term Cardiovascular Diseases condition mesh id D000003324 condition mesh term Coronary Artery Disease condition mesh id D000017202 condition mesh term Myocardial Ischemia condition mesh id D000003327 condition mesh term Coronary Disease condition mesh id D000058729 condition mesh term Peripheral Arterial Disease condition ancestor list condition ancestor condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000001161 condition ancestor term Arteriosclerosis condition ancestor id D000001157 condition ancestor term Arterial Occlusive Diseases condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000050197 condition ancestor term Atherosclerosis condition ancestor id D000016491 condition ancestor term Peripheral Vascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M5698 condition browse leaf name Coronary Artery Disease condition browse leaf as found Coronary Artery Disease condition browse leaf relevance high condition browse leaf id M18658 condition browse leaf name Myocardial Ischemia condition browse leaf as found Coronary Artery Disease condition browse leaf relevance high condition browse leaf id M28366 condition browse leaf name Peripheral Arterial Disease condition browse leaf as found Peripheral Artery Disease condition browse leaf relevance high condition browse leaf id M5701 condition browse leaf name Coronary Disease condition browse leaf as found Coronary Artery Disease condition browse leaf relevance high condition browse leaf id M9695 condition browse leaf name Ischemia condition browse leaf relevance low condition browse leaf id M18046 condition browse leaf name Peripheral Vascular Diseases condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id M3621 condition browse leaf name Arteriosclerosis condition browse leaf relevance low condition browse leaf id M3617 condition browse leaf name Arterial Occlusive Diseases condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M25341 condition browse leaf name Atherosclerosis condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology | NCT04834843 | [
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full study rank 61200 study protocol section identification module n c t id NCT04839562 org study id info org study id 2020P003608 organization org full name Massachusetts General Hospital org class OTHER brief title A Controlled Study of Solriamfetol for ADHD in Adults official title Solriamfetol for ADHD in Adults: A Double-Blind Placebo Controlled Pilot Study status module status verified date February 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 6, 2021 start date type Actual primary completion date struct primary completion date January 1, 2023 primary completion date type Anticipated completion date struct completion date May 1, 2023 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date February 25, 2022 last update post date struct last update post date March 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Craig B. Surman, MD responsible party investigator title Scientific Coordinator, Adult ADHD Research Program responsible party investigator affiliation Massachusetts General Hospital lead sponsor lead sponsor name Massachusetts General Hospital lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export No description module brief summary A double-blind, placebo controlled study of solriamfetol for adults age 18 to 65 with diagnosis of Attention Deficit Hyperactivity Disorder. detailed description Subjects will be between 18 and 65 years old, have at least 5 current symptoms of inattentive or impulsive-hyperactive traits, and childhood onset of ADHD symptoms, defined as two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12. Subjects will also have a score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS).
The investigators will exclude individuals who are contraindicated by current FDA label recommendations, which elaborates appropriate use of solriamfetol for individuals with sleep apnea and narcolepsy.
This will be a a six week, double blind, dose-optimization study. After giving informed consent to participate, participants will undergo a comprehensive assessment including a psychiatric assessment reviewing eligibility. conditions module condition list condition Attention Deficit Hyperactivity Disorder keyword list keyword attention deficit hyperactivity disorder clinical trial solriamfetol design module study type Interventional phase list phase Phase 2 Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label solriamfetol arm group type Experimental arm group description Participant will receive daily doses of solriamfetol, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated. arm group intervention list arm group intervention name Drug: Solriamfetol 75 MG Drug: Solriamfetol 150 MG arm group label placebo arm group type Placebo Comparator arm group description Participant will receive daily doses of placebo, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated. arm group intervention list arm group intervention name Other: Placebo intervention list intervention intervention type Drug intervention name Solriamfetol 75 MG intervention description Daily oral consumption intervention arm group label list intervention arm group label solriamfetol intervention type Drug intervention name Solriamfetol 150 MG intervention description Daily oral consumption intervention arm group label list intervention arm group label solriamfetol intervention type Other intervention name Placebo intervention description Placebo intervention arm group label list intervention arm group label placebo outcomes module primary outcome list primary outcome primary outcome measure Adult ADHD Investigator Symptom Rating Scale (AISRS) primary outcome description Difference in change in AISRS ADHD symptom rating between active vs. placebo. Range: 0-54. Higher rating indicates greater affliction of ADHD. primary outcome time frame six weeks secondary outcome list secondary outcome secondary outcome measure Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A) secondary outcome description Difference in BRIEF-A total and subscale ratings between active and placebo. Range 30-100. Higher scores indicate more executive function deficits. secondary outcome time frame rating at baseline and six weeks eligibility module eligibility criteria Inclusion Criteria:
Adults ages 18-65 years of age.
A diagnosis of childhood-onset ADHD, meeting the Diagnostic and Statistcal Manual-5 (DSM-5) criteria for ADHD in adulthood, including at least 5 current symptoms of inattentive or impulsive-hyperactive traits, and childhood onset by age 12, defined as two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12.
A score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS)
Exclusion Criteria:
Individuals with known renal insufficiency or renal impairment.
A history of intolerance to solriamfetol
Pregnant or nursing females, and individuals unwilling to use adequate contraceptive methods to avoid conception while they are receiving study agent and for 1 month after the last dose of study agent. For female subjects of childbearing potential adequate contraceptive methods will include: a medically acceptable form of birth control (such as male or female condoms with or without spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, hormonal contraceptives like birth control pills, or abstinence). For male subjects this will include use of male condom, being status post vasectomy at least 4 months prior to initation of study drug exposure, or abstinence during the study.
A known unstable major medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including hypertension ≥ 140/90 mmHg), endocrinologic (e.g. thyroid), neurologic (e.g. seizure), immunologic, hematologic, or psychiatric (including an active substance use disorder, psychosis, bipolar disorder, major depression) disorder.
Any medical condition that the Principal Investigator (PI) believes will be exacerbated by study participation.
A history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening.
A known history of narrow-angle glaucoma.
Current (within 3 months) DSM-V criteria for abuse or dependence with any psychoactive substance other than nicotine.
Multiple adverse drug reactions, defined as previous moderate to severe adverse experiences while on two or more chemically unrelated compounds, where these reactions were unpredictable from the known pharmacology of the drug.
Any other concomitant medication with primarily central nervous system activity that are catecholaminergic such as stimulants or atomoxetine, or have strong noradrenergic mechanisms of action such as duloxetine or venlafaxine or buproprion. Subjects may be included who are taking stable doses of agents with primary serotonergic (such as selective serotonin reuptake inhibitors or buspirone), gabaergic (such as gabapentin, pregabalin), or other anticonvulsants. We will also allow participation by individuals with rare (predicted to be less than twice a week) use of prn benzodiazepines or sedative-hypnotics.
Current use of MAO Inhibitor or use within the past two weeks.
Concomitant medications with high potential for dopaminergic or sympathomimetic effects.
Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
14, Reasonable suspicion of inability, in the judgement of the investigator, to appropriately monitor experiences during the study and take steps to report these experiences or respond in a manner preserving personal health and safety.
15. If clinically appropriate, any subjects taking medication exclusionary to the study (including agents used for management of ADHD) must be tapered off this medication prior to baseline visit for the length of 5 half-lives of the medication, corresponding to 95% of the agent leaving the participant's system), plus several days or otherwise sufficient period of time to allow assessment of eligibility for participation off medication.
16. Any condition, including a moderate to severe untreated sleep disorder or other mental health disorder, that renders inability, in the investigator's judgement, to determine whether ADHD symptoms are primarily due to ADHD. healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Craig Surman, MD central contact role Contact central contact phone 6177268422 central contact e mail csurman@mgh.harvard.edu overall official list overall official overall official name Craig Surman, MD overall official affiliation Mass General Brigham overall official role Principal Investigator location list location location facility Massachusetts General Hospital location status Recruiting location city Boston location state Massachusetts location zip 02114 location country United States location contact list location contact location contact name Craig B Surman, MD location contact role Contact location contact phone 617-726-2066 location contact e mail csurman@partners.org location contact name Daniel Walsh location contact role Contact location contact phone 6177261665 location contact e mail dwalsh20@mgh.harvard.edu i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006948 condition mesh term Hyperkinesis condition mesh id D000001289 condition mesh term Attention Deficit Disorder with Hyperactivity condition ancestor list condition ancestor condition ancestor id D000019958 condition ancestor term Attention Deficit and Disruptive Behavior Disorders condition ancestor id D000065886 condition ancestor term Neurodevelopmental Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition ancestor id D000020820 condition ancestor term Dyskinesias condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M3746 condition browse leaf name Attention Deficit Disorder with Hyperactivity condition browse leaf as found Attention Deficit Hyperactivity Disorder condition browse leaf relevance high condition browse leaf id M9151 condition browse leaf name Hyperkinesis condition browse leaf as found Hyperactivity condition browse leaf relevance high condition browse leaf id M20983 condition browse leaf name Attention Deficit and Disruptive Behavior Disorders condition browse leaf relevance low condition browse leaf id M29797 condition browse leaf name Neurodevelopmental Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse leaf id M21727 condition browse leaf name Dyskinesias condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology | NCT04839562 | [
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2539,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
1177,
1233,
3464,
1306,
8124,
2430,
1233,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
4539,
27989,
10224,
1204,
1209,
3531,
3828,
24429,
1104,
1177,
1233,
3464,
1306,
8124,
2430,
1233,
117,
1120,
3453,
17713,
1120,
1989,
1141,
1105,
4214,
17713,
1120,
1989,
123,
117,
1105,
1114,
6247,
1115,
18463,
1158,
3118,
6111,
1111,
1103,
1314,
1300,
2277,
1104,
2025,
6251,
117,
1216,
1115,
17718,
1209,
2367,
170,
2548,
1106,
1301,
1171,
1205,
1106,
3453,
17713,
1219,
1251,
1104,
1103,
2277,
1378,
1989,
123,
1178,
1191,
1178,
1191,
4214,
17713,
1110,
1136,
21073,
1181,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
17135,
3464,
1306,
8124,
2430,
1233,
3453,
22459,
13982,
131,
17135,
3464,
1306,
8124,
2430,
1233,
4214,
22459,
1981,
1372,
3107,
1282,
4043,
1981,
1372,
2076,
5033,
4043,
3291,
8223,
4626,
2772,
1981,
1372,
6136,
4539,
27989,
10224,
1204,
1209,
3531,
3828,
24429,
1104,
1282,
4043,
117,
1120,
3453,
17713,
1120,
1989,
1141,
1105,
4214,
17713,
1120,
1989,
123,
117,
1105,
1114,
6247,
1115,
18463,
1158,
3118,
6111,
1111,
1103,
1314,
1300,
2277,
1104,
2025,
6251,
117,
1216,
1115,
17718,
1209,
2367,
170,
2548,
1106,
1301,
1171,
1205,
1106,
3453,
17713,
1219,
1251,
1104,
1103,
2277,
1378,
1989,
123,
1178,
1191,
1178,
1191,
4214,
17713,
1110,
1136,
21073,
1181,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
5033,
4043,
9108,
2190,
9108,
9108,
2076,
13982,
9108,
1271,
17135,
3464,
1306,
8124,
2430,
1233,
3453,
22459,
9108,
6136,
5732,
9619,
8160,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
1177,
1233,
3464,
1306,
8124,
2430,
1233,
9108,
2076,
13982,
9108,
1271,
17135,
3464,
1306,
8124,
2430,
1233,
4214,
22459,
9108,
6136,
5732,
9619,
8160,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
1177,
1233,
3464,
1306,
8124,
2430,
1233,
9108,
2076,
2189,
9108,
1271,
5033,
4043,
9108,
6136,
5033,
4043,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
1282,
4043,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
11635,
5844,
23527,
1130,
5710,
3121,
25524,
1766,
156,
17162,
6451,
4165,
21632,
1158,
20334,
113,
19016,
16396,
1708,
114,
2425,
9386,
6136,
12120,
20954,
1107,
1849,
1107,
19016,
16396,
1708,
5844,
23527,
188,
17162,
6451,
4165,
5261,
1206,
2327,
5016,
119,
1282,
4043,
119,
7389,
131,
121,
118,
4335,
119,
7715,
5261,
6653,
3407,
170,
3101,
8031,
2116,
1104,
5844,
23527,
119,
2425,
9386,
1159,
4207,
1565,
2277,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
139,
24683,
21632,
1158,
1130,
14850,
4649,
1104,
4183,
16068,
5796,
118,
11635,
8812,
113,
26660,
17444,
2271,
118,
138,
114,
3718,
9386,
6136,
12120,
20954,
1107,
26660,
17444,
2271,
118,
138,
1703,
1105,
4841,
26996,
1513,
8532,
1206,
2327,
1105,
1282,
4043,
119,
7389,
1476,
118,
1620,
119,
7715,
7432,
5057,
1167,
3275,
3053,
16312,
1116,
119,
3718,
9386,
1159,
4207,
5261,
1120,
2259,
2568,
1105,
1565,
2277,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
15584,
6776,
1407,
118,
2625,
1201,
1104,
1425,
119,
138,
12645,
1104,
5153,
118,
15415,
5844,
23527,
117,
2309,
1103,
12120,
8517,
14226,
2941,
1105,
1457,
11745,
2050,
7867,
9128,
118,
126,
113,
18448,
2107,
118,
126,
114,
9173,
1111,
5844,
23527,
1107,
22777,
117,
1259,
1120,
1655,
126,
1954,
8006,
1104,
1107,
19934,
3452,
2109,
1137,
24034,
4654,
8788,
118,
177,
24312,
19667,
13474,
117,
1105,
5153,
15415,
1118,
1425,
1367,
117,
3393,
1112,
1160,
8006,
1104,
1107,
19934,
3452,
2109,
1137,
1104,
24034,
4654,
8788,
120,
177,
24312,
19667,
13474,
1118,
1103,
1425,
1104,
1367,
119,
138,
2794,
1104,
1406,
1137,
1167,
1113,
1103,
11635,
5844,
23527,
1130,
5710,
3121,
25524,
1766,
156,
17162,
6451,
4165,
7178,
20334,
113,
19016,
16396,
1708,
114,
16409,
1665,
17855,
140,
10587,
3464,
131,
26381,
1114,
1227,
1231,
7050,
22233,
9435,
23864,
1137,
1231,
7050,
24034,
8341,
1880,
119,
138,
1607,
1104,
1154,
2879,
3923,
1106,
1177,
1233,
3464,
1306,
8124,
2430,
1233,
11689,
15454,
1137,
11138,
3032,
117,
1105,
2833,
17026,
1106,
1329,
12373,
14255,
4487,
17046,
4069,
1106,
3644,
17890,
1229,
1152,
1132,
4172,
2025,
3677,
1105,
1111,
122,
2370,
1170,
1103,
1314,
13753,
1104,
2025,
3677,
119,
1370,
2130,
5174,
1104,
2027,
3962,
10832,
3209,
12373,
14255,
4487,
17046,
4069,
1209,
1511,
131,
170,
2657,
1193,
12095,
1532,
1104,
3485,
1654,
113,
1216,
1112,
2581,
1137,
2130,
23956,
1116,
1114,
1137,
1443,
20479,
27804,
3677,
117,
4267,
25890,
20484,
1306,
1137,
172,
1200,
15901,
1348,
6707,
1114,
20479,
24421,
117,
2657,
1193,
17421,
146,
2591,
2137,
117,
16358,
26654,
1348,
14255,
4487,
17046,
1116,
1176,
3485,
1654,
17029,
117,
1137,
170,
4832,
12569,
3633,
114,
119,
1370,
2581,
5174,
1142,
1209,
1511,
1329,
1104,
2581,
23956,
117,
1217,
2781,
2112,
26100,
5822,
18574,
1120,
1655,
125,
1808,
2988,
1106,
1107,
12633,
1104,
2025,
3850,
7401,
117,
1137,
170,
4832,
12569,
3633,
1219,
1103,
2025,
119,
138,
1227,
15443,
1558,
2657,
6946,
1259,
1119,
4163,
2941,
117,
1231,
7050,
117,
3245,
8005,
25195,
7542,
117,
19192,
117,
3621,
25575,
113,
1259,
177,
24312,
23826,
1988,
864,
8183,
120,
3078,
2608,
3048,
1403,
114,
117,
1322,
13335,
16987,
13791,
1596,
113,
174,
119,
176,
119,
21153,
16219,
114,
117,
24928,
11955,
13791,
1596,
113,
174,
119,
176,
119,
20752,
114,
117,
13280,
13601,
2728,
13791,
1596,
117,
23123,
10024,
13791,
1596,
117,
1137,
17123,
113,
1259,
1126,
2327,
9556,
1329,
8936,
117,
15604,
21155,
11776,
117,
16516,
23043,
1813,
8936,
117,
1558,
7560,
114,
8936,
119,
6291,
2657,
3879,
1115,
1103,
8013,
1130,
5710,
3121,
25524,
1766,
113,
153,
2240,
114,
6616,
1209,
1129,
4252,
7954,
26281,
2913,
1118,
2025,
6251,
119,
138,
1607,
1104,
4182,
113,
2589,
25813,
2241,
4182,
1443,
27154,
8419,
8830,
1137,
1107,
3465,
1358,
172,
1200,
15901,
1348,
4182,
114,
1439,
126,
1201,
2988,
1106,
11954,
119,
138,
1227,
1607,
1104,
4142,
118,
6341,
176,
15554,
8178,
1161,
119,
9493,
113,
1439,
124,
1808,
114,
18448,
2107,
118,
159,
9173,
1111,
6704,
1137,
20917,
1114,
1251,
15604,
21155,
12985,
13851,
9556,
1168,
1190,
11437,
18982,
2042,
119,
17476,
16798,
3850,
9535,
117,
3393,
1112,
2166,
8828,
1106,
5199,
16798,
5758,
1229,
1113,
1160,
1137,
1167,
5297,
1193,
16037,
10071,
117,
1187,
1292,
9535,
1127,
24213,
1121,
1103,
1227,
185,
7111,
1918,
12241,
1104,
1103,
3850,
119,
6291,
1168,
14255,
8178,
5168,
2227,
15683,
1114,
3120,
2129,
5604,
1449,
3246,
1115,
1132,
5855,
11252,
5326,
9685,
10805,
1596,
1216,
1112,
188,
3121,
13601,
23288,
1137,
18858,
10649,
26883,
1673,
117,
1137,
1138,
2012,
4040,
3556,
16717,
10805,
1596,
10748,
1104,
2168,
1216,
1112,
3840,
2858,
16056,
12569,
1137,
1396,
1179,
1742,
8057,
16594,
1162,
1137,
171,
4455,
12736,
12395,
119,
12859,
26394,
1336,
1129,
1529,
1150,
1132,
1781,
6111,
24429,
1104,
5789,
1114,
2425,
14516,
10595,
4798,
10805,
1596,
113,
1216,
1112,
14930,
14516,
10595,
11153,
1179,
1231,
4455,
13482,
27558,
1116,
1137,
3592,
8508,
18516,
114,
117,
176,
19252,
26949,
113,
1216,
1112,
176,
19252,
22083,
1394,
117,
3073,
2571,
7767,
1394,
114,
117,
1137,
1168,
2848,
7235,
25247,
3447,
7418,
119,
1284,
1209,
1145,
2621,
6251,
1118,
2833,
1114,
4054,
113,
10035,
1106,
1129,
1750,
1190,
3059,
170,
1989,
114,
1329,
1104,
185,
4558,
26181,
6112,
7168,
3171,
18351,
1116,
1137,
14516,
1810,
3946,
118,
177,
1183,
1643,
12512,
4724,
119,
9493,
1329,
1104,
9960,
2346,
1130,
23034,
1766,
1137,
1329,
1439,
1103,
1763,
1160,
2277,
119,
16752,
8178,
5168,
2227,
23897,
1114,
1344,
3209,
1111,
1202,
4163,
9685,
10805,
1596,
1137,
188,
17162,
16606,
18882,
11006,
1596,
3154,
119,
1130,
5710,
3121,
25524,
1766,
1105,
1117,
120,
1123,
5670,
1266,
132,
3393,
1112,
1103,
17805,
112,
188,
20846,
117,
6486,
117,
2027,
117,
5372,
17482,
3452,
117,
1137,
5372,
21289,
119,
1489,
117,
21642,
1895,
11340,
1104,
14267,
117,
1107,
1103,
21261,
1104,
1103,
17805,
117,
1106,
26620,
8804,
5758,
1219,
1103,
2025,
1105,
1321,
3343,
1106,
2592,
1292,
5758,
1137,
6297,
1107,
170,
4758,
16593,
2357,
2332,
1105,
3429,
119,
1405,
119,
1409,
7300,
1193,
5806,
117,
1251,
5174,
1781,
15683,
18434,
3113,
1106,
1103,
2025,
113,
1259,
5789,
1215,
1111,
2635,
1104,
5844,
23527,
114,
1538,
1129,
6649,
4359,
1228,
1142,
15683,
2988,
1106,
2259,
2568,
3143,
1111,
1103,
2251,
1104,
126,
1544,
118,
2491,
1104,
1103,
15683,
117,
7671,
1106,
4573,
110,
1104,
1103,
3677,
2128,
1103,
14031,
112,
188,
1449,
114,
117,
4882,
1317,
1552,
1137,
4303,
6664,
1669,
1104,
1159,
1106,
2621,
8670,
1104,
11768,
1111,
6251,
1228,
15683,
119,
1479,
119,
6291,
3879,
117,
1259,
170,
8828,
1106,
5199,
8362,
7877,
2913,
2946,
8936,
1137,
1168,
4910,
2332,
8936,
117,
1115,
19566,
1116,
14267,
117,
1107,
1103,
17805,
112,
188,
21261,
117,
1106,
4959,
2480,
5844,
23527,
8006,
1132,
3120,
1496,
1106,
5844,
23527,
119,
8071,
8118,
138,
19515,
15384,
1116,
3225,
1183,
19340,
5772,
1398,
5867,
1425,
1407,
5848,
4177,
1425,
2625,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2129,
3232,
2190,
2129,
3232,
2129,
3232,
1271,
6422,
17078,
1399,
117,
9292,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
5391,
1559,
1559,
25129,
1604,
23117,
1477,
2129,
3232,
174,
6346,
172,
6385,
7990,
137,
17713,
1324,
119,
5871,
13461,
2956,
119,
5048,
1358,
2905,
2078,
2190,
2905,
2078,
2905,
2078,
1271,
6422,
17078,
1399,
117,
9292,
2905,
2078,
13494,
8718,
1615,
25278,
2905,
2078,
1648,
8013,
1130,
5710,
3121,
25524,
1766,
2450,
2190,
2450,
2450,
3695,
3559,
1615,
3355,
2450,
2781,
11336,
1665,
27975,
1158,
2450,
1331,
2859,
2450,
1352,
3559,
2450,
195,
9717,
5507,
14541,
1527,
2450,
1583,
1244,
1311,
2450,
3232,
2190,
2450,
3232,
2450,
3232,
1271,
6422,
139,
17078,
1399,
117,
9292,
2450,
3232,
1648,
24367,
2450,
3232,
2179,
5391,
1559,
118,
5117,
1545,
118,
20278,
1545,
2450,
3232,
174,
6346,
172,
6385,
7990,
137,
6449,
119,
8916,
2450,
3232,
1271,
2979,
10984,
2450,
3232,
1648,
24367,
2450,
3232,
2179,
5391,
1559,
1559,
25129,
16229,
27677,
2450,
3232,
174,
6346,
173,
11487,
2737,
10973,
137,
17713,
1324,
119,
5871,
13461,
2956,
119,
5048,
1358,
178,
185,
173,
6303,
4195,
13196,
178,
185,
173,
6303,
1302,
4408,
2237,
1940,
1116,
1665,
23992,
13196,
1683,
10266,
1382,
5507,
117,
17881,
1477,
3879,
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full study rank 61378 study protocol section identification module n c t id NCT04837248 org study id info org study id PI-2021-3 organization org full name Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal org class OTHER brief title Design and Evaluation of the Effects of a Physical Therapy Program With Digital Support in Patients With Breast Cancer official title Design and Evaluation of the Effects of a Physical Therapy Program With Digital Support in Patients With Breast Cancer Surgery. A Clinical Trial. status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 2, 2021 start date type Actual primary completion date struct primary completion date December 31, 2023 primary completion date type Anticipated completion date struct completion date May 1, 2024 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 9, 2022 last update post date struct last update post date November 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ana Belén Romojaro Rodríguez responsible party investigator title Physiotherapist responsible party investigator affiliation Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal lead sponsor lead sponsor name Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Breast cancer surgery usually results in reduced range of motion of the shoulder joint, weakness of the musculature and altered scapular kinematics during movement. These factors limit activities of daily living, so rehabilitation exercises help to restore function after shoulder surgery.
Women with breast cancer often have a life conditioned by the sequelae or morbidity secondary to the treatment of the disease and, despite the high cure rate, many patients are unable to regain their initial quality of life. Cancer therapies can leave physical, psychological and psychosocial sequelae, which may manifest themselves or persist even years after the end of treatment.
For all these reasons, patients who have undergone cancer treatment need physical rehabilitation as well as psychological and social care to support them in their new stage of life, and to optimise the rehabilitation programme, it is necessary to identify each patient's individual needs,
The digital support proposed in this study enables the development of a physiotherapy programme for patients with breast cancer in a situation of health crisis, which includes providing assistance, information, accompaniment, help and treatment to these patients in a comprehensive way, based on the biopsychosocial model. detailed description DESIGN: Single-centre, assessor-blinded, parallel-group, randomised controlled clinical trial.
METHODS: The study will be carried out at the Ramon y Cajal hospital with 92 patients diagnosed and operated on for breast cancer.
Patients who come to the consultation of the rehabilitation doctors will be assessed, considering the inclusion and exclusion criteria. Those who may be candidates will be informed about the study and referred to the physiotherapy department where the treatment orders for these patients will be received and an appointment will be made. This is the start of the recruitment phase.
Those who meet the criteria and agree to participate in the study will be assigned an identification code and will be randomised into the two groups, the intervention group and the conventional treatment group.
Patients who do not meet the inclusion criteria or refuse to participate in the study will receive conventional treatment.
A 6-month pilot study will be conducted to better define patient identification, inclusion criteria, recruitment and adjustment of the intervention if required.
Once the pilot study is completed, the intervention clinical trial will begin. A first analysis of all variables will be performed after the intervention phase of the trial, 6 weeks after inclusion in the study.
An interim analysis will also be performed at 3 months in which the same variables as at 6 weeks will be assessed. This will be the main analysis of the study.
The final analysis will be carried out 6 months after inclusion in the study, and this will conclude the follow-up phase. conditions module condition list condition Breast Cancer keyword list keyword Exercise Muscle Weakness Lymphedema Fatigue Depression design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Group 1. Conventional treatment. Patients will be treated by means of a physiotherapy programme without digital support. They will be given a written document with exercises and recommendations on the first day.
Group 2. Experimental treatment. Patients will be treated with a digitally supported physiotherapy programme. design primary purpose Treatment design masking info design masking Single design masking description The assessor will assess patients at baseline, 6 weeks, 12 weeks, and 6 months and will not know which arm of the study each patient belongs to. design who masked list design who masked Outcomes Assessor enrollment info enrollment count 92 enrollment type Anticipated arms interventions module arm group list arm group arm group label Group 1. Conventional treatment arm group type Active Comparator arm group description Patients will be treated with a physiotherapy programme without digital support. arm group intervention list arm group intervention name Other: Active Comparator: Group 1. Conventional treatment arm group label Group 2. Experimental treatment. arm group type Experimental arm group description Patients will be treated using a digitally supported physiotherapy programme. arm group intervention list arm group intervention name Other: Experimental: Group 2. Experimental treatment. intervention list intervention intervention type Other intervention name Active Comparator: Group 1. Conventional treatment intervention description Patients will be treated using a physiotherapy programme without digital support. A written document with exercises and recommendations will be given to them on the first day. This booklet will detail the exercises they can do depending on their surgery and the weeks elapsed, as well as the recommendations adapted according to the needs identified in the motivational interview (MI). This is the treatment that is currently being applied in the hospital.
The patient will carry out the treatment at home and will come back after 20 sessions for the corresponding assessment. intervention arm group label list intervention arm group label Group 1. Conventional treatment intervention type Other intervention name Experimental: Group 2. Experimental treatment. intervention description A digitally supported physiotherapy programme including:
Group session: expectations, interests, experiences with regard to their health problem and the consequences on their life, joint exercise and discussion with subsequent debate will be held.
Exercise session: each week, patients will find different exercise videos on the platform according to the phase of recovery in which each one of them is, having been previously evaluated in the group session.
Relaxation session: this will be carried out by means of audio that will be posted on the platform and that the patient will be able to perform simultaneously.
Empowerment session: audio sessions that will deal with those needs that frequently arise after breast surgery in their daily lives, focusing on limiting beliefs (e.g. fear of moving), positive thoughts and information extracted from the motivational interview that should be developed. intervention arm group label list intervention arm group label Group 2. Experimental treatment. outcomes module primary outcome list primary outcome primary outcome measure Disabilities of the Arm, Shoulder and Hand Score (DASH) primary outcome description Global assessment of the functionality of the upper limb, primary outcome time frame 12 weeks primary outcome measure Disabilities of the Arm, Shoulder and Hand Score (DASH) primary outcome description Global assessment of the functionality of the upper limb, primary outcome time frame 3 months secondary outcome list secondary outcome secondary outcome measure European organization for research and treatment of cancer quality life questionnaire core 30. (QLQ-C30-B23) secondary outcome description Questionnaire to assess quality of life in cancer patients. Module B23, which is specific to breast cancer, will be used. secondary outcome time frame 12 weeks secondary outcome measure Range Of Motion (ROM) secondary outcome description Goniometry of joint range secondary outcome time frame 12 weeks secondary outcome measure Tampa Scale for Kinesiophobia (TSK-11SV) secondary outcome description The TSK is an 11-item self-report measure related to fear of movement and re-injury from movement. secondary outcome time frame 12 weeks secondary outcome measure Brief Pain Inventory (BPI) secondary outcome description The BPI is a multidimensional pain assessment tool that provides information on pain intensity and its interference with patients' daily activities. It also assesses the description, the location of pain and the level of relief provided by the treatment. secondary outcome time frame 12 weeks secondary outcome measure Hospital Anxiety and Depression Scale (HADS) secondary outcome description Questionnaire to measure levels of anxiety and depression in these people. secondary outcome time frame 12 weeks eligibility module eligibility criteria Inclusion Criteria:
Diagnosis of stage I, II or III of Breast cancer treated by surgery.
Medical authorisation for participation.
Internet access.
Basic computer skills.
Signed informed consent.
No bilateral mastectomy.
No metastases.
Post-intervention period of 10 days to 3 months.
Age 18-85 years.
No previous shoulder pathologies.
No pathology that prevents exercise.
Understanding of the Spanish language.
Exclusion Criteria:
Breast cancer treated without surgery.
Patient in severe psychiatric treatment who may present difficulties for participation in the study.
Stage IV cancer.
Any other clinical condition or previous therapy that contraindicates one or more of the techniques included in the programme, as the intervention may not be safe for the patient and therefore the person would not be eligible to participate in the study. healthy volunteers No gender All minimum age 18 Years maximum age 85 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Ana Belén Romojaro Rodriguez, PT. MSc central contact role Contact central contact phone 0034913368250 central contact e mail ana.romojaro@gmail.com central contact name Itziar Abechuco, Pharmacy central contact role Contact central contact phone 0034913368825 central contact e mail itziar.pablo@salud.madrid.org location list location location facility Fundacion Hospital Ramón y Cajal location status Recruiting location city Madrid location zip 28834 location country Spain location contact list location contact location contact name Ana Belen Romojaro Rodriguez, PT. MSc location contact role Contact location contact phone 0034 666062413 location contact e mail ana.romojaro@gmail.com references module reference list reference reference p m i d 32231493 reference type background reference citation Pellini F, Granuzzo E, Urbani S, Mirandola S, Caldana M, Lombardi D, Fiorio E, Mandarà M, Pollini GP. Male Breast Cancer: Surgical and Genetic Features and a Multidisciplinary Management Strategy. Breast Care (Basel). 2020 Feb;15(1):14-20. doi: 10.1159/000501711. Epub 2019 Sep 13. reference p m i d 24816774 reference type background reference citation Hidding JT, Beurskens CH, van der Wees PJ, van Laarhoven HW, Nijhuis-van der Sanden MW. Treatment related impairments in arm and shoulder in patients with breast cancer: a systematic review. PLoS One. 2014 May 9;9(5):e96748. doi: 10.1371/journal.pone.0096748. eCollection 2014. Review. reference p m i d 30030037 reference type background reference citation van Egmond MA, van der Schaaf M, Vredeveld T, Vollenbroek-Hutten MMR, van Berge Henegouwen MI, Klinkenbijl JHG, Engelbert RHH. Effectiveness of physiotherapy with telerehabilitation in surgical patients: a systematic review and meta-analysis. Physiotherapy. 2018 Sep;104(3):277-298. doi: 10.1016/j.physio.2018.04.004. Epub 2018 Jun 19. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001943 condition mesh term Breast Neoplasms condition ancestor list condition ancestor condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000001941 condition ancestor term Breast Diseases condition ancestor id D000012871 condition ancestor term Skin Diseases condition browse leaf list condition browse leaf condition browse leaf id M4372 condition browse leaf name Breast Neoplasms condition browse leaf as found Breast Cancer condition browse leaf relevance high condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf relevance low condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf relevance low condition browse leaf id M7516 condition browse leaf name Fatigue condition browse leaf relevance low condition browse leaf id M10358 condition browse leaf name Lymphedema condition browse leaf relevance low condition browse leaf id M12356 condition browse leaf name Paresis condition browse leaf relevance low condition browse leaf id M20097 condition browse leaf name Muscle Weakness condition browse leaf relevance low condition browse leaf id M3706 condition browse leaf name Asthenia condition browse leaf relevance low condition browse leaf id M4370 condition browse leaf name Breast Diseases condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases | NCT04837248 | [
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7091,
3673,
1154,
1103,
1160,
2114,
117,
1103,
9108,
1372,
1105,
1103,
7228,
3252,
1372,
119,
7195,
24767,
1150,
1202,
1136,
2283,
1103,
10838,
9173,
1137,
10250,
1106,
4868,
1107,
1103,
2025,
1209,
3531,
7228,
3252,
119,
138,
127,
118,
2370,
3955,
2025,
1209,
1129,
3303,
1106,
1618,
9410,
5351,
9117,
117,
10838,
9173,
117,
17964,
1105,
23427,
1104,
1103,
9108,
1191,
2320,
119,
2857,
1103,
3955,
2025,
1110,
2063,
117,
1103,
9108,
7300,
3443,
1209,
3295,
119,
138,
1148,
3622,
1104,
1155,
10986,
1209,
1129,
1982,
1170,
1103,
9108,
4065,
1104,
1103,
3443,
117,
127,
2277,
1170,
10838,
1107,
1103,
2025,
119,
1760,
10572,
3622,
1209,
1145,
1129,
1982,
1120,
124,
1808,
1107,
1134,
1103,
1269,
10986,
1112,
1120,
127,
2277,
1209,
1129,
14758,
119,
1188,
1209,
1129,
1103,
1514,
3622,
1104,
1103,
2025,
119,
1109,
1509,
3622,
1209,
1129,
2446,
1149,
127,
1808,
1170,
10838,
1107,
1103,
2025,
117,
1105,
1142,
1209,
17581,
1103,
2812,
118,
1146,
4065,
119,
2975,
13196,
3879,
2190,
3879,
139,
11811,
2050,
11558,
2501,
12565,
2190,
2501,
12565,
16409,
1200,
14636,
19569,
1116,
10536,
1284,
3715,
1757,
149,
25698,
15018,
1918,
13723,
6512,
4175,
11442,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
9108,
2235,
6136,
1990,
122,
119,
5818,
1348,
3252,
119,
7195,
24767,
1209,
1129,
5165,
1118,
2086,
1104,
170,
185,
7889,
23652,
8420,
11478,
1183,
4644,
1443,
3539,
1619,
119,
1220,
1209,
1129,
1549,
170,
1637,
5830,
1114,
11536,
1105,
11859,
1113,
1103,
1148,
1285,
119,
1990,
123,
119,
17635,
3252,
119,
7195,
24767,
1209,
1129,
5165,
1114,
170,
20328,
2726,
185,
7889,
23652,
8420,
11478,
1183,
4644,
119,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8353,
1902,
7739,
1158,
6136,
1109,
15187,
1766,
1209,
15187,
4420,
1120,
2259,
2568,
117,
127,
2277,
117,
1367,
2277,
117,
1105,
127,
1808,
1105,
1209,
1136,
1221,
1134,
1981,
1104,
1103,
2025,
1296,
5351,
7017,
1106,
119,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
3929,
19191,
1116,
1249,
8830,
21484,
10803,
23992,
10803,
5099,
5556,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
1990,
122,
119,
5818,
1348,
3252,
1981,
1372,
2076,
17244,
3291,
8223,
4626,
2772,
1981,
1372,
6136,
7195,
24767,
1209,
1129,
5165,
1114,
170,
185,
7889,
23652,
8420,
11478,
1183,
4644,
1443,
3539,
1619,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
17244,
3291,
8223,
4626,
2772,
131,
1990,
122,
119,
5818,
1348,
3252,
1981,
1372,
3107,
1990,
123,
119,
17635,
3252,
119,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
7195,
24767,
1209,
1129,
5165,
1606,
170,
20328,
2726,
185,
7889,
23652,
8420,
11478,
1183,
4644,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
17635,
131,
1990,
123,
119,
17635,
3252,
119,
9108,
2190,
9108,
9108,
2076,
2189,
9108,
1271,
17244,
3291,
8223,
4626,
2772,
131,
1990,
122,
119,
5818,
1348,
3252,
9108,
6136,
7195,
24767,
1209,
1129,
5165,
1606,
170,
185,
7889,
23652,
8420,
11478,
1183,
4644,
1443,
3539,
1619,
119,
138,
1637,
5830,
1114,
11536,
1105,
11859,
1209,
1129,
1549,
1106,
1172,
1113,
1103,
1148,
1285,
119,
1188,
21757,
1209,
6505,
1103,
11536,
1152,
1169,
1202,
5763,
1113,
1147,
6059,
1105,
1103,
2277,
8468,
11478,
5591,
117,
1112,
1218,
1112,
1103,
11859,
5546,
2452,
1106,
1103,
2993,
3626,
1107,
1103,
15710,
1348,
3669,
113,
26574,
114,
119,
1188,
1110,
1103,
3252,
1115,
1110,
1971,
1217,
3666,
1107,
1103,
2704,
119,
1109,
5351,
1209,
3564,
1149,
1103,
3252,
1120,
1313,
1105,
1209,
1435,
1171,
1170,
1406,
6887,
1111,
1103,
7671,
8670,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
1990,
122,
119,
5818,
1348,
3252,
9108,
2076,
2189,
9108,
1271,
17635,
131,
1990,
123,
119,
17635,
3252,
119,
9108,
6136,
138,
20328,
2726,
185,
7889,
23652,
8420,
11478,
1183,
4644,
1259,
131,
1990,
4912,
131,
11471,
117,
4740,
117,
5758,
1114,
7328,
1106,
1147,
2332,
2463,
1105,
1103,
8421,
1113,
1147,
1297,
117,
4091,
6730,
1105,
6145,
1114,
4194,
5655,
1209,
1129,
1316,
119,
16409,
1200,
14636,
4912,
131,
1296,
1989,
117,
4420,
1209,
1525,
1472,
6730,
6581,
1113,
1103,
3482,
2452,
1106,
1103,
4065,
1104,
7593,
1107,
1134,
1296,
1141,
1104,
1172,
1110,
117,
1515,
1151,
2331,
17428,
1107,
1103,
1372,
4912,
119,
11336,
22731,
1891,
4912,
131,
1142,
1209,
1129,
2446,
1149,
1118,
2086,
1104,
6056,
1115,
1209,
1129,
6310,
1113,
1103,
3482,
1105,
1115,
1103,
5351,
1209,
1129,
1682,
1106,
3870,
7344,
119,
18653,
25603,
4912,
131,
6056,
6887,
1115,
1209,
2239,
1114,
1343,
2993,
1115,
3933,
14368,
1170,
7209,
6059,
1107,
1147,
3828,
2491,
117,
7781,
1113,
15816,
8810,
113,
174,
119,
176,
119,
2945,
1104,
2232,
114,
117,
3112,
3578,
1105,
1869,
16939,
1121,
1103,
15710,
1348,
3669,
1115,
1431,
1129,
1872,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
1990,
123,
119,
17635,
3252,
119,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
12120,
3202,
15951,
1104,
1103,
24446,
117,
9743,
1200,
1105,
9918,
18417,
113,
141,
10719,
3048,
114,
2425,
9386,
6136,
5357,
8670,
1104,
1103,
16354,
1104,
1103,
3105,
16864,
117,
2425,
9386,
1159,
4207,
1367,
2277,
2425,
9386,
4929,
12120,
3202,
15951,
1104,
1103,
24446,
117,
9743,
1200,
1105,
9918,
18417,
113,
141,
10719,
3048,
114,
2425,
9386,
6136,
5357,
8670,
1104,
1103,
16354,
1104,
1103,
3105,
16864,
117,
2425,
9386,
1159,
4207,
124,
1808,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
1735,
2369,
1111,
1844,
1105,
3252,
1104,
4182,
3068,
1297,
2304,
24730,
4160,
1476,
119,
113,
154,
2162,
4880,
118,
140,
13144,
118,
139,
22737,
114,
3718,
9386,
6136,
22171,
24730,
1106,
15187,
3068,
1104,
1297,
1107,
4182,
4420,
119,
12556,
7641,
1513,
139,
22737,
117,
1134,
1110,
2747,
1106,
7209,
4182,
117,
1209,
1129,
1215,
119,
3718,
9386,
1159,
4207,
1367,
2277,
3718,
9386,
4929,
7389,
2096,
12153,
113,
22870,
114,
3718,
9386,
6136,
3414,
22772,
21027,
1104,
4091,
2079,
3718,
9386,
1159,
4207,
1367,
2277,
3718,
9386,
4929,
9720,
20334,
1111,
14477,
3965,
2660,
7880,
23145,
113,
157,
1708,
2428,
118,
1429,
26270,
114,
3718,
9386,
6136,
1109,
157,
1708,
2428,
1110,
1126,
1429,
118,
8926,
2191,
118,
2592,
4929,
2272,
1106,
2945,
1104,
2230,
1105,
1231,
118,
3773,
1121,
2230,
119,
3718,
9386,
1159,
4207,
1367,
2277,
3718,
9386,
4929,
139,
24683,
13304,
1130,
14850,
4649,
113,
21062,
2240,
114,
3718,
9386,
6136,
1109,
21062,
2240,
1110,
170,
4321,
3309,
2354,
24533,
2489,
8670,
6806,
1115,
2790,
1869,
1113,
2489,
7657,
1105,
1157,
11364,
1114,
4420,
112,
3828,
2619,
119,
1135,
1145,
15187,
1279,
1103,
6136,
117,
1103,
2450,
1104,
2489,
1105,
1103,
1634,
1104,
3893,
2136,
1118,
1103,
3252,
119,
3718,
9386,
1159,
4207,
1367,
2277,
3718,
9386,
4929,
3355,
1760,
8745,
20656,
1105,
11442,
20334,
113,
145,
14569,
1708,
114,
3718,
9386,
6136,
22171,
24730,
1106,
4929,
3001,
1104,
10507,
1105,
7560,
1107,
1292,
1234,
119,
3718,
9386,
1159,
4207,
1367,
2277,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
12120,
8517,
27078,
1104,
2016,
146,
117,
1563,
1137,
2684,
1104,
139,
11811,
2050,
4182,
5165,
1118,
6059,
119,
3875,
2351,
5771,
1111,
6251,
119,
4639,
2469,
119,
11568,
2775,
4196,
119,
20979,
1174,
6189,
9635,
119,
1302,
20557,
18871,
10294,
18778,
1183,
119,
1302,
27154,
8419,
8830,
119,
3799,
118,
9108,
1669,
1104,
1275,
1552,
1106,
124,
1808,
119,
4936,
1407,
118,
4859,
1201,
119,
1302,
2166,
2342,
3507,
20941,
119,
1302,
3507,
4807,
1115,
17356,
6730,
119,
21300,
1104,
1103,
2124,
1846,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
139,
11811,
2050,
4182,
5165,
1443,
6059,
119,
7195,
9080,
1107,
5199,
17123,
3252,
1150,
1336,
1675,
7866,
1111,
6251,
1107,
1103,
2025,
119,
6160,
4191,
4182,
119,
6291,
1168,
7300,
3879,
1137,
2166,
7606,
1115,
14255,
4487,
24704,
4578,
3052,
1141,
1137,
1167,
1104,
1103,
4884,
1529,
1107,
1103,
4644,
117,
1112,
1103,
9108,
1336,
1136,
1129,
2914,
1111,
1103,
5351,
1105,
3335,
1103,
1825,
1156,
1136,
1129,
7408,
1106,
4868,
1107,
1103,
2025,
119,
8071,
8118,
1302,
5772,
1398,
5867,
1425,
1407,
5848,
4177,
1425,
4859,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2129,
3232,
2190,
2129,
3232,
2129,
3232,
1271,
9954,
26744,
12640,
155,
18445,
15184,
1186,
13711,
117,
22216,
119,
10978,
1665,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
3135,
23124,
1580,
17668,
22997,
1604,
17600,
1568,
2129,
3232,
174,
6346,
1126,
1161,
119,
187,
18445,
15184,
1186,
137,
176,
14746,
119,
3254,
2129,
3232,
1271,
1135,
12432,
1197,
15849,
17143,
2528,
117,
24774,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
3135,
23124,
1580,
17668,
22997,
1604,
1604,
17600,
2129,
3232,
174,
6346,
1122,
12432,
1197,
119,
185,
6639,
2858,
137,
21718,
7535,
1181,
119,
6340,
10132,
119,
8916,
2450,
2190,
2450,
2450,
3695,
6606,
7409,
1988,
3355,
23775,
194,
140,
22558,
1233,
2450,
2781,
11336,
1665,
27975,
1158,
2450,
1331,
6331,
2450,
195,
9717,
27998,
23124,
2450,
1583,
2722,
2450,
3232,
2190,
2450,
3232,
2450,
3232,
1271,
9954,
26744,
1424,
155,
18445,
15184,
1186,
13711,
117,
22216,
119,
10978,
1665,
2450,
3232,
1648,
24367,
2450,
3232,
2179,
3135,
23124,
5046,
16480,
1545,
19598,
17668,
2450,
3232,
174,
6346,
1126,
1161,
119,
187,
18445,
15184,
1186,
137,
176,
14746,
119,
3254,
7732,
13196,
3835,
2190,
3835,
3835,
185,
182,
178,
173,
26605,
22639,
1527,
1580,
1495,
3835,
2076,
3582,
3835,
19548,
153,
12164,
2605,
143,
117,
13529,
14875,
6112,
142,
117,
6972,
1182,
156,
117,
20290,
13645,
1742,
156,
117,
11917,
6778,
1161,
150,
117,
26416,
1182,
141,
117,
17355,
20571,
142,
117,
2268,
7858,
9183,
150,
117,
24619,
4729,
15175,
119,
10882,
139,
11811,
2050,
11558,
131,
17078,
20851,
1105,
9066,
2941,
24972,
1105,
170,
18447,
26096,
3973,
18050,
119,
139,
11811,
2050,
8396,
113,
14562,
114,
119,
12795,
13650,
132,
1405,
113,
122,
114,
131,
1489,
118,
1406,
119,
9465,
131,
1275,
119,
10520,
1580,
120,
1288,
11049,
16770,
14541,
119,
142,
16091,
1830,
10351,
23181,
1492,
119,
3835,
185,
182,
178,
173,
27672,
16229,
1559,
1559,
1527,
3835,
2076,
3582,
3835,
19548,
8790,
15977,
147,
1942,
117,
4108,
7719,
6378,
1116,
24890,
117,
3498,
4167,
1284,
1279,
153,
4538,
117,
3498,
2001,
1813,
24922,
1424,
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full study rank 61541 study protocol section identification module n c t id NCT04835129 org study id info org study id PRO00041365 organization org full name Medical College of Wisconsin org class OTHER brief title Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma official title A Multisite, Phase II Study of Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma acronym IMPEDE status module status verified date February 2022 overall status Recruiting expanded access info has expanded access No start date struct start date January 10, 2022 start date type Actual primary completion date struct primary completion date January 2024 primary completion date type Anticipated completion date struct completion date January 2025 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date February 18, 2022 last update post date struct last update post date March 7, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Binod Dhakal responsible party investigator title Associate Professor responsible party investigator affiliation Medical College of Wisconsin lead sponsor lead sponsor name Medical College of Wisconsin lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary This is a multicenter, open-label phase II study in subjects with relapsed and/or refractory multiple myeloma with at least two prior lines of therapy. The main study consists of three phases: a 28-day screening phase, treatment phase that consists of 28-day cycles of isatuximab with elotuzumab, pomalidomide, and dexamethasone and a follow-up phase. detailed description The study is divided into two parts:
Part 1 (Run-in safety phase): In this safety-run in phase a total of six subjects will be enrolled at the coordinating site (Medical College of Wisconsin) to assess potential dose-limiting toxicities that may be associated with the addition of isatuximab with pomalidomide, elotuzumab and dexamethasone.
Part 2 (Expansion phase): In this part, up to 47 additional subjects will be enrolled.
The study hypothesis is that the isatuximab in combination with elotuzumab, pomalidomide, and dexamethasone (Isa-EPD) will be safe and lead to superior response rates than seen with either isatuximab with pomalidomide and dexamethasone or elotuzumab with pomalidomide and dexamethasone in subjects with relapsed and/or refractory multiple myeloma. conditions module condition list condition Multiple Myeloma keyword list keyword relapsed and/or refractory multiple myeloma salvage therapy design module study type Interventional phase list phase Phase 2 design info design allocation Non-Randomized design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 53 enrollment type Anticipated arms interventions module arm group list arm group arm group label Safety Run-in arm group type Experimental arm group description Six subjects will be enrolled. Isatuximab (10 mg/kg) intravenous (IV) on days 2, 8, 15, 22 of cycle 2 and days 1 and 15 of subsequent cycles. Pomalidomide (4 mg) by mouth (PO) days 1-21 of each cycle. Elotuzumab (10 mg/kg) on days 1, 8, 15, 22 of cycles 1 and 2; 20 mg/kg on day 1 of subsequent cycles. Dexamethasone 40 mg (20 mg if >75 years) PO or IV on days 1, 8,15 and 22 of each cycle. arm group intervention list arm group intervention name Drug: Isatuximab (for run-in portion) Drug: Pomalidomide Drug: Elotuzumab Drug: Dexamethasone arm group label Expansion arm group type Experimental arm group description Forty-seven subjects with relapsed and/or refractory multiple myeloma will be enrolled.
Isatuximab (10 mg/kg) IV on days 2, 8, 15, 22 of cycle 1 and days 1 and 15 of subsequent cycles. Pomalidomide (4 mg) PO days 1-21 of each cycle. Elotuzumab (10 mg/kg) on days 1, 8, 15, 22 of cycles 1 and 2; 20 mg/kg on day 1 of subsequent cycles. Dexamethasone 40 mg (20 mg if >75 years) PO or IV on days 1, 8,15 and 22 of each cycle. arm group intervention list arm group intervention name Drug: Isatuximab (for expansion) Drug: Pomalidomide Drug: Elotuzumab Drug: Dexamethasone intervention list intervention intervention type Drug intervention name Isatuximab (for run-in portion) intervention description 10 mg/kg IV on days 2, 8, 15, 22 of cycle 2 and days 1 and 15 of subsequent cycles. intervention arm group label list intervention arm group label Safety Run-in intervention other name list intervention other name Sarclisa SAR-650984 isatuximab-irfc intervention type Drug intervention name Isatuximab (for expansion) intervention description 10 mg/kg IV on days 2, 8, 15, 22 of cycle 1 and days 1 and 15 of subsequent cycles. intervention arm group label list intervention arm group label Expansion intervention other name list intervention other name Sarclisa SAR-650984 isatuximab-irfc intervention type Drug intervention name Pomalidomide intervention description 4 mg PO days 1-21 of each cycle. intervention arm group label list intervention arm group label Expansion Safety Run-in intervention other name list intervention other name Pomalyst Imnovid intervention type Drug intervention name Elotuzumab intervention description 10 mg/kg on days 1, 8, 15, 22 of cycles 1 and 2; 20 mg/kg on day 1 of subsequent cycles. intervention arm group label list intervention arm group label Expansion Safety Run-in intervention other name list intervention other name Empliciti HuLuc63 intervention type Drug intervention name Dexamethasone intervention description 40 mg (20 mg if >75 years) PO or IV on days 1, 8,15 and 22 of each cycle. intervention arm group label list intervention arm group label Expansion Safety Run-in intervention other name list intervention other name Baycadron Decadron DexPak TaperDex Zema-Pak ZoDex Zonacort outcomes module primary outcome list primary outcome primary outcome measure The number of subjects in each status category of the International Myeloma Working Group (stringent complete response, complete response, very good partial response, partial response, minimal response, stable disease, progressive disease). primary outcome description This will be measured using the International Myeloma Working Group criteria. For clarity, the response will be reported at the end of each treatment year. primary outcome time frame Year 1 primary outcome measure The number of subjects in each status category of the International Myeloma Working Group (stringent complete response, complete response, very good partial response, partial response, minimal response, stable disease, progressive disease). primary outcome description This will be measured using the International Myeloma Working Group criteria. For clarity, the response will be reported at the end of each treatment year. primary outcome time frame Year 2 primary outcome measure The number of subjects in each status category of the International Myeloma Working Group (stringent complete response, complete response, very good partial response, partial response, minimal response, stable disease, progressive disease). primary outcome description This will be measured using the International Myeloma Working Group criteria. For clarity, the response will be reported at the end of each treatment year. primary outcome time frame Year 3 eligibility module eligibility criteria Inclusion Criteria:
Voluntary consent must be given before performance of any study related procedure.
Male or female subjects ≥18 years.
Multiple myeloma subjects with at least 2 prior therapies that included lenalidomide and proteasome inhibitor combined or in different regimens, and refractory to most recent line of therapy.
Measurable disease as defined by any of the following:
Serum M-protein level ≥0.5 g/dL OR
Urine M-protein level ≥200 mg/24 hours; OR
Light chain multiple myeloma without measurable disease in the urine: serum Ig free light chains (FLC) ≥10 mg/dL and abnormal serum Ig kappa/lambda FLC ratio.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Female subjects who:
Are postmenopausal (see Appendix 4 for definition) for at least one year before the screening visit, OR
Are surgically sterile, OR
Females of childbearing potential or male subjects with female partners of childbearing potential shall be required to use effective contraceptive methods (double barrier method, intrauterine device, oral contraception or abstinence) starting two weeks before first study drug(s) administration, while on therapy and for 16 weeks following the last dose of study drug(s). A woman is considered of childbearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Any of the following highly effective methods of contraception are accepted:
Established use of oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation.
Established use of oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation.
Placement of an intrauterine device or intrauterine hormone-releasing system.
Barrier methods of contraception: male condom with either cap, diaphragm or sponge with spermicide (double-barrier methods). The use of double-barrier methods should always be supplemented with the use of a spermicide. Female condom and male condom should not be used together.
Male sterilization (provided that the partner is the sole sexual partner of the subject and that the sterilized partner has received medical assessment of the surgical success).
Sexual abstinence.
Female subjects must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction starting two weeks before first study drug(s) administration, while on therapy and for 16 weeks following the last dose of study drug(s).
Females of childbearing potential must have a negative serum or urine pregnancy test prior to enrollment.
Male subjects, even if surgically sterilized (i.e., status post vasectomy), who:
Agree to practice effective barrier contraception during the entire study treatment period from the time of signing the informed consent through and through four months after the last dose of study drug(s) (female and male condoms should not be used together), or
Agree to practice true abstinence during the entire study treatment period from the time of signing the informed consent through four months after the last dose of study drug(s), when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post ovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)
Due to the teratogenicity of pomalidomide and the lack of adequate reproductive toxicity data for isatuximab and/or elotuzumab, in addition to the user independent highly effective method of contraception, a male or female condom with or without spermicide, diaphragm, or cervical cap is required. Male condom and female condom should not be used together (due to risk of failure with friction).
Exclusion Criteria:
Diagnosed or treated for malignancy other than multiple myeloma, except:
Malignancy treated with curative intent and with no known active disease present for ≥3 years before enrollment.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated carcinoma in situ (e.g., cervical, breast) with no evidence of disease.
Exhibiting clinical signs of or has a known history of meningeal or central nervous system involvement by multiple myeloma.
Subjects refractory to prior signaling lymphocytic activation molecule F7 (SLAMF7) monoclonal antibody
Prior cluster of differentiation 38 (CD38) monoclonal antibody is allowed as long it has been >6 months and patients had achieved at least a partial response or better.
Subject refractory or intolerant to prior pomalidomide therapy.
Known chronic obstructive pulmonary disease
Known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification. Note: Subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study.
Known to be seropositive for human immunodeficiency virus, known to have hepatitis B surface antigen positivity, or known to have untreated or active hepatitis C.
Concurrent medical condition or disease (e.g., active systemic infection) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study.
Clinically significant cardiac disease, including:
Myocardial infarction within six months before enrollment or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV).
Uncontrolled cardiac arrhythmia (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] Version 5 Grade 2 or higher) or clinically significant electrocardiogram (ECG) abnormalities.
Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) >470 msec.
Uncontrolled hypertension (BP >160/100 in the presence of blood pressure medications)
Subjects who have inadequate evidence of bone marrow/hepatic/renal function as defined by the following:
Absolute neutrophil count <1.0 × 109/L; no growth factors in the previous seven days is allowed.
Hemoglobin level ≤7.5 g/dL (≤5 mmol/L); blood transfusions to maintain hemoglobin >7.5 g/dL are acceptable.
Platelet count <75 × 109/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells; otherwise, platelet count <50 × 109/L; no platelet transfusions in the past seven days are allowed.
Alanine aminotransferase (ALT) level ≥2.5 × ULN
Aspartate aminotransferase (AST) level ≥2.5 × ULN
Total bilirubin level ≥1.5 × ULN, (except for Gilbert Syndrome: direct bilirubin ≥2 × ULN)
Corrected serum calcium >14.0 mg/dL (>3.5 mmol/L) or free ionized calcium >6.5 mg/dL (>1.6 mmol/L)
Known allergies, hypersensitivity (if not amenable to premedication with steroids, or H2 blockers), or intolerance to monoclonal antibodies or human proteins, isatuximab or its excipients or known sensitivity to mammalian-derived products.
Plasma cell leukemia (>2.0 × 10^9/L circulating plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and/or skin changes), or light-chain amyloidosis.
Known or suspected of not being able to comply with the study protocol (e.g., because of alcoholism, drug dependency, or psychological disorder) or the subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments.
Pregnant or breastfeeding or planning to become pregnant starting two weeks before first study drug(s) administration, while on therapy and for 16 weeks following the last dose of study drug(s).
Plans to father a child starting two weeks before first study drug(s) administration, while on therapy and for 16 weeks following the last dose of study drug(s).
Had major surgery within two weeks before Cycle 1, Day 1, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study or within two weeks after the last dose of study drug administration. Note: Subjects with planned surgical procedures to be conducted under local anesthesia are not excluded. Kyphoplasty is not considered a major surgery. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Medical College of Wisconsin Cancer Center Clinical Trials Office central contact role Contact central contact phone 414-805-8900 central contact e mail cccto@mcw.edu overall official list overall official overall official name Binod Dhakal, MD overall official affiliation Medical College of Wisconsin overall official role Principal Investigator location list location location facility Froedtert Hospital & the Medical College of Wisconsin location status Recruiting location city Milwaukee location state Wisconsin location zip 53226 location country United States location contact list location contact location contact name Binod Dhakal, MD location contact role Contact location contact phone 414-805-4600 location contact e mail bdhakal@mcw.edu i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009101 condition mesh term Multiple Myeloma condition mesh id D000054219 condition mesh term Neoplasms, Plasma Cell condition ancestor list condition ancestor condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000020141 condition ancestor term Hemostatic Disorders condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000010265 condition ancestor term Paraproteinemias condition ancestor id D000001796 condition ancestor term Blood Protein Disorders condition ancestor id D000006402 condition ancestor term Hematologic Diseases condition ancestor id D000006474 condition ancestor term Hemorrhagic Disorders condition ancestor id D000008232 condition ancestor term Lymphoproliferative Disorders condition ancestor id D000007160 condition ancestor term Immunoproliferative Disorders condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11210 condition browse leaf name Multiple Myeloma condition browse leaf as found Multiple Myeloma condition browse leaf relevance high condition browse leaf id M26741 condition browse leaf name Neoplasms, Plasma Cell condition browse leaf as found Multiple Myeloma condition browse leaf relevance high condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M21130 condition browse leaf name Hemostatic Disorders condition browse leaf relevance low condition browse leaf id M4211 condition browse leaf name Blood Coagulation Disorders condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M12330 condition browse leaf name Paraproteinemias condition browse leaf relevance low condition browse leaf id M4229 condition browse leaf name Blood Protein Disorders condition browse leaf relevance low condition browse leaf id M8642 condition browse leaf name Hematologic Diseases condition browse leaf relevance low condition browse leaf id M8712 condition browse leaf name Hemorrhagic Disorders condition browse leaf relevance low condition browse leaf id M10377 condition browse leaf name Lymphoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9358 condition browse leaf name Immunoproliferative Disorders condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T3947 condition browse leaf name Multiple Myeloma condition browse leaf as found Multiple Myeloma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000003907 intervention mesh term Dexamethasone intervention mesh id C000467566 intervention mesh term Pomalidomide intervention mesh id C000546027 intervention mesh term Elotuzumab intervention mesh id D000000911 intervention mesh term Antibodies, Monoclonal intervention ancestor list intervention ancestor intervention ancestor id D000000893 intervention ancestor term Anti-Inflammatory Agents intervention ancestor id D000000932 intervention ancestor term Antiemetics intervention ancestor id D000001337 intervention ancestor term Autonomic Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000005765 intervention ancestor term Gastrointestinal Agents intervention ancestor id D000005938 intervention ancestor term Glucocorticoids intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000018931 intervention ancestor term Antineoplastic Agents, Hormonal intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000020533 intervention ancestor term Angiogenesis Inhibitors intervention ancestor id D000043924 intervention ancestor term Angiogenesis Modulating Agents intervention ancestor id D000006133 intervention ancestor term Growth Substances intervention ancestor id D000006131 intervention ancestor term Growth Inhibitors intervention browse leaf list intervention browse leaf intervention browse leaf id M6254 intervention browse leaf name Dexamethasone intervention browse leaf as found Blood intervention browse leaf relevance high intervention browse leaf id M235540 intervention browse leaf name Dexamethasone acetate intervention browse leaf relevance low intervention browse leaf id M199079 intervention browse leaf name BB 1101 intervention browse leaf relevance low intervention browse leaf id M233278 intervention browse leaf name Pomalidomide intervention browse leaf as found Standard treatment intervention browse leaf relevance high intervention browse leaf id M272243 intervention browse leaf name Elotuzumab intervention browse leaf as found Greater than or equal to intervention browse leaf relevance high intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf relevance low intervention browse leaf id M3382 intervention browse leaf name Antibodies, Monoclonal intervention browse leaf as found Concurrent Chemoradiotherapy intervention browse leaf relevance high intervention browse leaf id M3369 intervention browse leaf name Anti-Inflammatory Agents intervention browse leaf relevance low intervention browse leaf id M3403 intervention browse leaf name Antiemetics intervention browse leaf relevance low intervention browse leaf id M8033 intervention browse leaf name Gastrointestinal Agents intervention browse leaf relevance low intervention browse leaf id M8199 intervention browse leaf name Glucocorticoids intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse leaf id M20119 intervention browse leaf name Antineoplastic Agents, Hormonal intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse leaf id M21471 intervention browse leaf name Angiogenesis Inhibitors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev AnEm intervention browse branch name Antiemetics intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04835129 | [
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114,
153,
2346,
1137,
4191,
1113,
1552,
122,
117,
129,
117,
1405,
1105,
1659,
1104,
1296,
5120,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
27334,
7926,
8745,
1918,
1830,
113,
1111,
4298,
114,
13982,
131,
18959,
7435,
12894,
3080,
2007,
13982,
131,
2896,
3329,
14875,
10161,
1830,
13982,
131,
23058,
16470,
7702,
2142,
1162,
9108,
2190,
9108,
9108,
2076,
13982,
9108,
1271,
27334,
7926,
8745,
1918,
1830,
113,
1111,
1576,
118,
1107,
3849,
114,
9108,
6136,
1275,
17713,
120,
4023,
4191,
1113,
1552,
123,
117,
129,
117,
1405,
117,
1659,
1104,
5120,
123,
1105,
1552,
122,
1105,
1405,
1104,
4194,
13874,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
9218,
6728,
118,
1107,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
17784,
19878,
6137,
1161,
13411,
2069,
118,
14166,
1580,
1604,
1527,
1110,
2980,
5025,
8628,
1830,
118,
178,
11931,
1665,
9108,
2076,
13982,
9108,
1271,
27334,
7926,
8745,
1918,
1830,
113,
1111,
4298,
114,
9108,
6136,
1275,
17713,
120,
4023,
4191,
1113,
1552,
123,
117,
129,
117,
1405,
117,
1659,
1104,
5120,
122,
1105,
1552,
122,
1105,
1405,
1104,
4194,
13874,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
16409,
10224,
8427,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
17784,
19878,
6137,
1161,
13411,
2069,
118,
14166,
1580,
1604,
1527,
1110,
2980,
5025,
8628,
1830,
118,
178,
11931,
1665,
9108,
2076,
13982,
9108,
1271,
18959,
7435,
12894,
3080,
2007,
9108,
6136,
125,
17713,
153,
2346,
1552,
122,
118,
1626,
1104,
1296,
5120,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
16409,
10224,
8427,
9218,
6728,
118,
1107,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
18959,
7435,
6834,
1204,
146,
1306,
15847,
2386,
9108,
2076,
13982,
9108,
1271,
2896,
3329,
14875,
10161,
1830,
9108,
6136,
1275,
17713,
120,
4023,
1113,
1552,
122,
117,
129,
117,
1405,
117,
1659,
1104,
13874,
122,
1105,
123,
132,
1406,
17713,
120,
4023,
1113,
1285,
122,
1104,
4194,
13874,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
16409,
10224,
8427,
9218,
6728,
118,
1107,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
18653,
1643,
18726,
1182,
20164,
2162,
21977,
1545,
1495,
9108,
2076,
13982,
9108,
1271,
23058,
16470,
7702,
2142,
1162,
9108,
6136,
1969,
17713,
113,
1406,
17713,
1191,
135,
3453,
1201,
114,
153,
2346,
1137,
4191,
1113,
1552,
122,
117,
129,
117,
1405,
1105,
1659,
1104,
1296,
5120,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
16409,
10224,
8427,
9218,
6728,
118,
1107,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
2410,
2599,
21844,
13063,
3556,
3484,
23058,
2101,
3715,
22515,
3365,
2137,
11708,
163,
14494,
118,
26850,
163,
1186,
2137,
11708,
163,
7637,
19248,
1204,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
1109,
1295,
1104,
5174,
1107,
1296,
2781,
4370,
1104,
1103,
1570,
1422,
19773,
1918,
9612,
1990,
113,
5101,
3452,
2335,
2593,
117,
2335,
2593,
117,
1304,
1363,
7597,
2593,
117,
7597,
2593,
117,
10298,
2593,
117,
6111,
3653,
117,
8706,
3653,
114,
119,
2425,
9386,
6136,
1188,
1209,
1129,
7140,
1606,
1103,
1570,
1422,
19773,
1918,
9612,
1990,
9173,
119,
1370,
19041,
117,
1103,
2593,
1209,
1129,
2103,
1120,
1103,
1322,
1104,
1296,
3252,
1214,
119,
2425,
9386,
1159,
4207,
2381,
122,
2425,
9386,
4929,
1109,
1295,
1104,
5174,
1107,
1296,
2781,
4370,
1104,
1103,
1570,
1422,
19773,
1918,
9612,
1990,
113,
5101,
3452,
2335,
2593,
117,
2335,
2593,
117,
1304,
1363,
7597,
2593,
117,
7597,
2593,
117,
10298,
2593,
117,
6111,
3653,
117,
8706,
3653,
114,
119,
2425,
9386,
6136,
1188,
1209,
1129,
7140,
1606,
1103,
1570,
1422,
19773,
1918,
9612,
1990,
9173,
119,
1370,
19041,
117,
1103,
2593,
1209,
1129,
2103,
1120,
1103,
1322,
1104,
1296,
3252,
1214,
119,
2425,
9386,
1159,
4207,
2381,
123,
2425,
9386,
4929,
1109,
1295,
1104,
5174,
1107,
1296,
2781,
4370,
1104,
1103,
1570,
1422,
19773,
1918,
9612,
1990,
113,
5101,
3452,
2335,
2593,
117,
2335,
2593,
117,
1304,
1363,
7597,
2593,
117,
7597,
2593,
117,
10298,
2593,
117,
6111,
3653,
117,
8706,
3653,
114,
119,
2425,
9386,
6136,
1188,
1209,
1129,
7140,
1606,
1103,
1570,
1422,
19773,
1918,
9612,
1990,
9173,
119,
1370,
19041,
117,
1103,
2593,
1209,
1129,
2103,
1120,
1103,
1322,
1104,
1296,
3252,
1214,
119,
2425,
9386,
1159,
4207,
2381,
124,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
5713,
19529,
1616,
9635,
1538,
1129,
1549,
1196,
2099,
1104,
1251,
2025,
2272,
7791,
119,
10882,
1137,
2130,
5174,
864,
15292,
1201,
119,
17476,
1139,
19773,
1918,
5174,
1114,
1120,
1655,
123,
2988,
1103,
14543,
1905,
1115,
1529,
5837,
7050,
12894,
3080,
2007,
1105,
5250,
1566,
2225,
6758,
27558,
3490,
1137,
1107,
1472,
6716,
2316,
117,
1105,
1231,
27476,
9363,
1183,
1106,
1211,
2793,
1413,
1104,
7606,
119,
2508,
2225,
27984,
3653,
1112,
3393,
1118,
1251,
1104,
1103,
1378,
131,
19536,
1818,
150,
118,
4592,
1634,
864,
1568,
119,
126,
176,
120,
173,
2162,
23066,
158,
8643,
150,
118,
4592,
1634,
864,
10973,
1568,
17713,
120,
1572,
2005,
132,
23066,
3935,
4129,
2967,
1139,
19773,
1918,
1443,
1143,
2225,
27984,
3653,
1107,
1103,
19968,
131,
23651,
146,
1403,
1714,
1609,
9236,
113,
23485,
1658,
114,
864,
10424,
17713,
120,
173,
2162,
1105,
22832,
23651,
146,
1403,
24181,
13059,
120,
2495,
12913,
1810,
23485,
1658,
6022,
119,
2882,
22892,
1212,
12241,
1990,
113,
16028,
2346,
2349,
114,
2099,
2781,
1104,
121,
118,
123,
119,
9714,
5174,
1150,
131,
2372,
2112,
2354,
4184,
25134,
1348,
113,
1267,
138,
20564,
12090,
1775,
125,
1111,
5754,
114,
1111,
1120,
1655,
1141,
1214,
1196,
1103,
11954,
3143,
117,
23066,
2372,
13467,
1193,
188,
2083,
4759,
117,
23066,
27464,
1104,
2027,
3962,
10832,
3209,
1137,
2581,
5174,
1114,
2130,
6449,
1104,
2027,
3962,
10832,
3209,
4103,
1129,
2320,
1106,
1329,
3903,
14255,
4487,
17046,
4069,
113,
2702,
9391,
3442,
117,
1107,
4487,
18614,
2042,
4442,
117,
9619,
14255,
4487,
19792,
1137,
170,
4832,
12569,
3633,
114,
2547,
1160,
2277,
1196,
1148,
2025,
3850,
113,
188,
114,
3469,
117,
1229,
1113,
7606,
1105,
1111,
1479,
2277,
1378,
1103,
1314,
13753,
1104,
2025,
3850,
113,
188,
114,
119,
138,
1590,
1110,
1737,
1104,
2027,
3962,
10832,
3209,
117,
178,
119,
174,
119,
117,
16332,
117,
1378,
1441,
1813,
4386,
1105,
1235,
2479,
2112,
2354,
4184,
25134,
1348,
4895,
8321,
188,
2083,
4759,
119,
6291,
1104,
1103,
1378,
3023,
3903,
4069,
1104,
14255,
4487,
19792,
1132,
3134,
131,
14633,
1329,
1104,
9619,
117,
1107,
4487,
2497,
10533,
1348,
117,
1137,
14715,
2692,
7435,
3490,
113,
12890,
26767,
1105,
5250,
7562,
2430,
4915,
4051,
114,
16358,
26654,
1348,
14255,
4487,
19792,
2628,
1114,
1107,
16485,
1104,
184,
25247,
6840,
119,
14633,
1329,
1104,
9619,
117,
1107,
16811,
1895,
117,
1137,
24034,
9180,
1895,
5250,
7562,
2430,
4915,
118,
1178,
16358,
26654,
1348,
14255,
4487,
19792,
2628,
1114,
1107,
16485,
1104,
184,
25247,
6840,
119,
5033,
1880,
1104,
1126,
1107,
4487,
18614,
2042,
4442,
1137,
1107,
4487,
18614,
2042,
21055,
118,
8210,
1449,
119,
21715,
2852,
4069,
1104,
14255,
4487,
19792,
131,
2581,
23956,
1114,
1719,
6707,
117,
4267,
25890,
20484,
1306,
1137,
188,
5674,
12377,
1114,
20479,
24421,
113,
2702,
118,
9391,
4069,
114,
119,
1109,
1329,
1104,
2702,
118,
9391,
4069,
1431,
1579,
1129,
22625,
1114,
1103,
1329,
1104,
170,
20479,
24421,
119,
9714,
23956,
1105,
2581,
23956,
1431,
1136,
1129,
1215,
1487,
119,
10882,
188,
2083,
15100,
113,
2136,
1115,
1103,
3547,
1110,
1103,
6753,
3785,
3547,
1104,
1103,
2548,
1105,
1115,
1103,
188,
2083,
15892,
3547,
1144,
1460,
2657,
8670,
1104,
1103,
13467,
2244,
114,
119,
21843,
170,
4832,
12569,
3633,
119,
9714,
5174,
1538,
5340,
1136,
1106,
23969,
6471,
113,
184,
2497,
117,
184,
26431,
114,
1111,
1103,
4998,
1104,
6842,
16600,
2547,
1160,
2277,
1196,
1148,
2025,
3850,
113,
188,
114,
3469,
117,
1229,
1113,
7606,
1105,
1111,
1479,
2277,
1378,
1103,
1314,
13753,
1104,
2025,
3850,
113,
188,
114,
119,
27464,
1104,
2027,
3962,
10832,
3209,
1538,
1138,
170,
4366,
23651,
1137,
19968,
10203,
2774,
2988,
1106,
10803,
119,
10882,
5174,
117,
1256,
1191,
13467,
1193,
188,
2083,
15892,
113,
178,
119,
174,
119,
117,
2781,
2112,
26100,
5822,
18574,
114,
117,
1150,
131,
138,
1403,
8871,
1106,
2415,
3903,
9391,
14255,
4487,
19792,
1219,
1103,
2072,
2025,
3252,
1669,
1121,
1103,
1159,
1104,
6086,
1103,
6189,
9635,
1194,
1105,
1194,
1300,
1808,
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1103,
1314,
13753,
1104,
2025,
3850,
113,
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114,
113,
2130,
1105,
2581,
23956,
1116,
1431,
1136,
1129,
1215,
1487,
114,
117,
1137,
138,
1403,
8871,
1106,
2415,
2276,
170,
4832,
12569,
3633,
1219,
1103,
2072,
2025,
3252,
1669,
1121,
1103,
1159,
1104,
6086,
1103,
6189,
9635,
1194,
1300,
1808,
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1103,
1314,
13753,
1104,
2025,
3850,
113,
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114,
117,
1165,
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1103,
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4400,
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1103,
2548,
119,
113,
16477,
1596,
170,
4832,
12569,
3633,
164,
174,
119,
176,
119,
117,
8729,
117,
184,
25247,
6840,
117,
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17162,
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7435,
117,
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184,
25247,
6840,
4069,
1111,
1103,
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3547,
166,
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117,
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25606,
1178,
117,
1105,
2495,
5822,
21404,
1821,
26601,
11096,
13836,
1132,
1136,
12095,
4069,
1104,
14255,
4487,
19792,
119,
114,
4187,
1106,
1103,
21359,
24306,
19438,
1785,
1104,
185,
7903,
17299,
18882,
2007,
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1103,
2960,
1104,
12373,
17505,
25954,
2233,
1111,
1110,
2980,
5025,
8628,
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120,
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8468,
3329,
14875,
10161,
1830,
117,
1107,
1901,
1106,
1103,
4795,
2457,
3023,
3903,
3442,
1104,
14255,
4487,
19792,
117,
170,
2581,
1137,
2130,
23956,
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1443,
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24421,
117,
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25890,
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117,
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172,
1200,
15901,
1348,
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119,
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16630,
114,
119,
16409,
1665,
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140,
10587,
3464,
131,
12120,
8517,
22583,
1181,
1137,
5165,
1111,
12477,
2646,
12149,
7232,
1168,
1190,
2967,
1139,
19773,
1918,
117,
2589,
131,
17168,
12149,
7232,
5165,
1114,
16408,
15306,
7676,
1105,
1114,
1185,
1227,
2327,
3653,
1675,
1111,
864,
1495,
1201,
1196,
10803,
119,
24930,
1162,
13284,
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118,
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4371,
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2241,
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2554,
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3653,
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24930,
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16430,
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1107,
3465,
1358,
113,
174,
119,
176,
119,
117,
172,
1200,
15901,
1348,
117,
7209,
114,
1114,
1185,
2554,
1104,
3653,
119,
16409,
23034,
1158,
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full study rank 61224 study protocol section identification module n c t id NCT04839250 org study id info org study id 3D system-CPJ organization org full name Wenzhou Medical University org class OTHER brief title Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery official title Study on The Difference Between Three-Dimensional Heads-Up Surgery System and Traditional Surgery Methods in Cataract Surgery status module status verified date May 2022 overall status Completed expanded access info has expanded access No start date struct start date February 1, 2021 start date type Actual primary completion date struct primary completion date October 31, 2021 primary completion date type Actual completion date struct completion date October 31, 2021 completion date type Actual study first submit date April 4, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date May 7, 2022 last update post date struct last update post date May 12, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Yune Zhao responsible party investigator title Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University responsible party investigator affiliation Wenzhou Medical University lead sponsor lead sponsor name Wenzhou Medical University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery detailed description To evaluate the differences between three-Dimensional heads-Up surgery system and traditional surgery methods of cataract surgery.Prospective research.One eligible eye from patients having cataract surgery performed using the 3-D head-up technique were included in the study as an experimental group,in the meanwhile eyes performed cataract surgery by traditional microsurgery included as a control group.All eyes in the study are operated by the same doctor. Corneal incision form,corneal endothelial cell density and best corrected visual acuity are included to evaluate the results of cataract surgery. conditions module condition list condition Cataract keyword list keyword three-dimensional surgery microsurgery phacoemulsification design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 60 enrollment type Actual arms interventions module arm group list arm group arm group label cataract surgery performed by heads-up method arm group type Experimental arm group description 3D heads-up surgery was performed under the NGENUITY® 3D visualization system arm group intervention list arm group intervention name Procedure: heads-up method arm group label Traditional surgery arm group type No Intervention arm group description Traditional surgery was performed under a surgical microscope. intervention list intervention intervention type Procedure intervention name heads-up method intervention description 3D surgical video system, which includes Alcon NGENUITY 3D visualization system (Alcon, Fort Worth, TX) and Leica M822 and M844 microscopes (Leica Microsystems, Wetzlar, Germany),can be used to perform head-up phacoemulsification combined with intraocular lens implantation surgery. intervention arm group label list intervention arm group label cataract surgery performed by heads-up method outcomes module primary outcome list primary outcome primary outcome measure change of corneal incision from 1day after surgery to 1 months primary outcome description the shape and length of the corneal incision ，if descemet's layer detachment happens primary outcome time frame up to 1day,1week,1 month primary outcome measure corneal endothelial cell density primary outcome description the number of corneal endothelial cells per unit area primary outcome time frame up to 1 month secondary outcome list secondary outcome secondary outcome measure best corrected visual acuity secondary outcome description best corrected visual acuity secondary outcome time frame up to 1 month secondary outcome measure change from baseline central corneal thickness at 1 months secondary outcome description thickness in micrometer secondary outcome time frame up to 1 day,1 week,1 month secondary outcome measure change from baseline corneal incision thickness at 1 months secondary outcome description Thickness of corneal incision secondary outcome time frame up to 1 day,1 week,1 month eligibility module eligibility criteria Inclusion Criteria:
Diagnose age-related cataract;
Plan to perform phacoemulsification of cataract with intraocular lens implantation;
Willing to cooperate with the re-examination of 1 day, 1 week, and 1 month after surgery;
Able to understand and independently fill in the informed consent form and postoperative follow-up plan.
Exclusion Criteria:
Cataract caused by other reasons;
Fundus diseases such as severe diabetic retinopathy, high myopic retinopathy or macular degeneration;
Corneal diseases, corneal endothelial cells <1800/mm2;
Small palpebral fissure;
Those with a history of glaucoma, uveitis, eye trauma or eye surgery;
Those who cannot cooperate with the inspection and have not completed the one-month follow-up healthy volunteers No gender All minimum age 50 Years maximum age 90 Years std age list std age Adult Older Adult contacts locations module location list location location facility Eye Hospital of Wenzhou Medical College location city Wenzhou location state Zhejiang location country China references module reference list reference reference p m i d 35749016 reference type derived reference citation Zhu Z, Chang P, Huang F, Shen S, Zhao X, Ji X, Zhao YE. Comparison of Three-Dimensional Surgical System Versus Binocular Microscope for Clear Corneal Incision in Cataract Surgery. Ophthalmol Ther. 2022 Aug;11(4):1589-1600. doi: 10.1007/s40123-022-00537-4. Epub 2022 Jun 24. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002386 condition mesh term Cataract condition ancestor list condition ancestor condition ancestor id D000007905 condition ancestor term Lens Diseases condition ancestor id D000005128 condition ancestor term Eye Diseases condition browse leaf list condition browse leaf condition browse leaf id M4790 condition browse leaf name Cataract condition browse leaf as found Cataract condition browse leaf relevance high condition browse leaf id M10069 condition browse leaf name Lens Diseases condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M252669 intervention browse leaf name Dipivefrin intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04839250 | [
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25524,
1766,
2784,
1710,
17805,
1554,
1271,
27413,
1162,
16749,
2784,
1710,
17805,
1641,
4070,
2084,
1104,
9329,
3355,
1104,
23158,
10753,
3875,
1239,
117,
23158,
10753,
3875,
1239,
2784,
1710,
17805,
13494,
23158,
10753,
3875,
1239,
1730,
10767,
1730,
10767,
1271,
23158,
10753,
3875,
1239,
1730,
10767,
1705,
152,
24162,
9637,
20051,
13196,
20051,
1144,
173,
182,
172,
1302,
1110,
175,
173,
170,
12521,
3850,
1302,
1110,
175,
173,
170,
12521,
4442,
1302,
6136,
13196,
4094,
14940,
1706,
17459,
1103,
5408,
1206,
1210,
118,
12120,
2354,
24533,
4075,
118,
3725,
6059,
1449,
1105,
2361,
6059,
4069,
1104,
5855,
4626,
5822,
6059,
6448,
6136,
1706,
17459,
1103,
5408,
1206,
1210,
118,
12120,
2354,
24533,
4075,
118,
3725,
6059,
1449,
1105,
2361,
6059,
4069,
1104,
5855,
4626,
5822,
6059,
119,
24667,
2109,
1844,
119,
1448,
7408,
2552,
1121,
4420,
1515,
5855,
4626,
5822,
6059,
1982,
1606,
1103,
124,
118,
141,
1246,
118,
1146,
5531,
1127,
1529,
1107,
1103,
2025,
1112,
1126,
6700,
1372,
117,
1107,
1103,
17527,
1257,
1982,
5855,
4626,
5822,
6059,
1118,
2361,
17599,
6385,
26206,
1183,
1529,
1112,
170,
1654,
1372,
119,
1398,
1257,
1107,
1103,
2025,
1132,
2622,
1118,
1103,
1269,
3995,
119,
3291,
12275,
1348,
1107,
16073,
1532,
117,
11184,
13003,
1322,
12858,
21091,
1348,
2765,
3476,
1105,
1436,
13808,
5173,
170,
10182,
1785,
1132,
1529,
1106,
17459,
1103,
2686,
1104,
5855,
4626,
5822,
6059,
119,
2975,
13196,
3879,
2190,
3879,
8572,
4626,
5822,
2501,
12565,
2190,
2501,
12565,
1210,
118,
8611,
6059,
17599,
6385,
26206,
1183,
185,
2328,
16123,
13601,
3447,
5783,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8353,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
4539,
27989,
10224,
1204,
10803,
23992,
10803,
5099,
2539,
10803,
2076,
2173,
4746,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
5855,
4626,
5822,
6059,
1982,
1118,
4075,
118,
1146,
3442,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
7860,
4075,
118,
1146,
6059,
1108,
1982,
1223,
1103,
151,
16523,
21760,
12150,
3663,
28167,
7860,
5173,
2734,
1449,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
5096,
9650,
3313,
131,
4075,
118,
1146,
3442,
1981,
1372,
3107,
12144,
6059,
1981,
1372,
2076,
1302,
11300,
21987,
1981,
1372,
6136,
12144,
6059,
1108,
1982,
1223,
170,
13467,
17599,
15300,
119,
9108,
2190,
9108,
9108,
2076,
5096,
9650,
3313,
9108,
1271,
4075,
118,
1146,
3442,
9108,
6136,
7860,
13467,
1888,
1449,
117,
1134,
2075,
2586,
7235,
151,
16523,
21760,
12150,
3663,
7860,
5173,
2734,
1449,
113,
2586,
7235,
117,
3144,
12554,
117,
21514,
114,
1105,
3180,
4578,
150,
1604,
20581,
1105,
150,
1604,
25041,
17599,
15300,
1116,
113,
3180,
4578,
27730,
5821,
13894,
4206,
117,
27855,
1584,
5815,
117,
1860,
114,
117,
1169,
1129,
1215,
1106,
3870,
1246,
118,
1146,
185,
2328,
16123,
13601,
3447,
5783,
3490,
1114,
1107,
4487,
13335,
5552,
11039,
24034,
9180,
1891,
6059,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
5855,
4626,
5822,
6059,
1982,
1118,
4075,
118,
1146,
3442,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
1849,
1104,
11184,
13003,
1107,
16073,
1121,
122,
6194,
1170,
6059,
1106,
122,
1808,
2425,
9386,
6136,
1103,
3571,
1105,
2251,
1104,
1103,
11184,
13003,
1107,
16073,
1099,
1191,
3532,
2093,
11006,
112,
188,
6440,
15146,
5940,
2425,
9386,
1159,
4207,
1146,
1106,
122,
6194,
117,
122,
21394,
117,
122,
2370,
2425,
9386,
4929,
11184,
13003,
1322,
12858,
21091,
1348,
2765,
3476,
2425,
9386,
6136,
1103,
1295,
1104,
11184,
13003,
1322,
12858,
21091,
1348,
3652,
1679,
2587,
1298,
2425,
9386,
1159,
4207,
1146,
1106,
122,
2370,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
1436,
13808,
5173,
170,
10182,
1785,
3718,
9386,
6136,
1436,
13808,
5173,
170,
10182,
1785,
3718,
9386,
1159,
4207,
1146,
1106,
122,
2370,
3718,
9386,
4929,
1849,
1121,
2259,
2568,
2129,
11184,
13003,
15830,
1120,
122,
1808,
3718,
9386,
6136,
15830,
1107,
17599,
19401,
3718,
9386,
1159,
4207,
1146,
1106,
122,
1285,
117,
122,
1989,
117,
122,
2370,
3718,
9386,
4929,
1849,
1121,
2259,
2568,
11184,
13003,
1107,
16073,
15830,
1120,
122,
1808,
3718,
9386,
6136,
157,
11239,
1377,
1757,
1104,
11184,
13003,
1107,
16073,
3718,
9386,
1159,
4207,
1146,
1106,
122,
1285,
117,
122,
1989,
117,
122,
2370,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
12120,
8517,
22583,
1425,
118,
2272,
5855,
4626,
5822,
132,
7382,
1106,
3870,
185,
2328,
16123,
13601,
3447,
5783,
1104,
5855,
4626,
5822,
1114,
1107,
4487,
13335,
5552,
11039,
24034,
9180,
1891,
132,
3100,
1158,
1106,
19204,
1114,
1103,
1231,
118,
8179,
1104,
122,
1285,
117,
122,
1989,
117,
1105,
122,
2370,
1170,
6059,
132,
138,
2165,
1106,
2437,
1105,
8942,
5475,
1107,
1103,
6189,
9635,
1532,
1105,
2112,
19807,
5838,
2812,
118,
1146,
2197,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
8572,
4626,
5822,
2416,
1118,
1168,
3672,
132,
6606,
1361,
8131,
1216,
1112,
5199,
4267,
22377,
2941,
1231,
20064,
12233,
117,
1344,
1139,
4184,
1596,
1231,
20064,
12233,
1137,
23639,
5552,
1260,
27054,
6108,
132,
3291,
12275,
1348,
8131,
117,
11184,
13003,
1322,
12858,
21091,
1348,
3652,
133,
9558,
120,
2608,
1477,
132,
6844,
185,
1348,
3186,
6766,
1233,
20497,
3954,
3313,
132,
4435,
1114,
170,
1607,
1104,
176,
15554,
8178,
1161,
117,
190,
2707,
10721,
117,
2552,
14780,
1137,
2552,
6059,
132,
4435,
1150,
2834,
19204,
1114,
1103,
11820,
1105,
1138,
1136,
2063,
1103,
1141,
118,
2370,
2812,
118,
1146,
8071,
8118,
1302,
5772,
1398,
5867,
1425,
1851,
5848,
4177,
1425,
3078,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2450,
2190,
2450,
2450,
3695,
9329,
3355,
1104,
23158,
10753,
3875,
1531,
2450,
1331,
23158,
10753,
2450,
1352,
163,
4638,
16172,
2450,
1583,
1975,
7732,
13196,
3835,
2190,
3835,
3835,
185,
182,
178,
173,
2588,
1559,
1527,
21500,
16229,
3835,
2076,
4408,
3835,
19548,
16920,
163,
117,
11497,
153,
117,
16831,
143,
117,
26197,
156,
117,
16749,
161,
117,
13997,
161,
117,
16749,
162,
2036,
119,
3291,
8223,
26464,
1320,
1104,
2677,
118,
12120,
2354,
24533,
17078,
20851,
3910,
159,
1468,
1361,
21700,
13335,
5552,
27730,
15300,
1111,
15458,
3291,
12275,
1348,
3561,
15575,
1107,
8572,
4626,
5822,
17910,
119,
9126,
17439,
7654,
3702,
1233,
1109,
1197,
119,
17881,
1477,
16892,
132,
1429,
113,
125,
114,
131,
18960,
1580,
118,
15567,
119,
9465,
131,
1275,
119,
1620,
1559,
120,
188,
12882,
11964,
1495,
118,
5507,
1477,
118,
3135,
24239,
1559,
118,
125,
119,
142,
16091,
1830,
17881,
1477,
12865,
1572,
119,
178,
185,
173,
6303,
4195,
13196,
178,
185,
173,
6303,
1302,
4408,
2237,
1940,
1116,
1665,
23992,
13196,
1683,
10266,
1382,
5507,
117,
17881,
1477,
3879,
11424,
1162,
13196,
3879,
24000,
2190,
3879,
24000,
3879,
24000,
25021,
141,
7629,
7629,
1568,
22737,
22392,
3879,
24000,
1858,
8572,
4626,
5822,
3879,
13596,
2190,
3879,
13596,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1559,
21500,
1571,
3879,
13596,
1858,
22824,
1116,
20012,
1116,
3879,
13596,
25021,
141,
7629,
7629,
1568,
24050,
24606,
3879,
13596,
1858,
9329,
20012,
1116,
3879,
11424,
1162,
7404,
2190,
3879,
11424,
1162,
7404,
3879,
11424,
1162,
7404,
25021,
150,
24766,
21500,
3879,
11424,
1162,
7404,
1271,
8572,
4626,
5822,
3879,
11424,
1162,
7404,
1112,
1276,
8572,
4626,
5822,
3879,
11424,
1162,
7404,
25319,
1344,
3879,
11424,
1162,
7404,
25021,
26528,
7629,
1545,
1580,
3879,
11424,
1162,
7404,
1271,
22824,
1116,
20012,
1116,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
7404,
25021,
150,
1559,
23117,
1495,
3879,
11424,
1162,
7404,
1271,
9329,
20012,
1116,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
3392,
2190,
3879,
11424,
1162,
3392,
3879,
11424,
1162,
3392,
170,
13834,
1874,
1964,
3823,
14541,
3879,
11424,
1162,
3392,
1271,
9329,
20012,
1116,
3879,
11424,
1162,
3392,
170,
13834,
1874,
1964,
1398,
3879,
11424,
1162,
3392,
1271,
1398,
16752,
16718,
9108,
11424,
1162,
13196,
9108,
11424,
1162,
7404,
2190,
9108,
11424,
1162,
7404,
9108,
11424,
1162,
7404,
25021,
150,
17600,
25129,
1545,
1580,
9108,
11424,
1162,
7404,
1271,
12120,
8508,
2707,
2087,
4854,
9108,
11424,
1162,
7404,
25319,
1822,
9108,
11424,
1162,
3392,
2190,
9108,
11424,
1162,
3392,
9108,
11424,
1162,
3392,
170,
13834,
1874,
1964,
1398,
9108,
11424,
1162,
3392,
1271,
1398,
26500,
1105,
10957,
1116,
102
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full study rank 61285 study protocol section identification module n c t id NCT04838457 org study id info org study id CDX 21-005 organization org full name VA Office of Research and Development org class FED brief title Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease official title Telehealth Treatment of Veterans With Alcohol Misuse at Risk for Cardiovascular Disease (CDA 19-035) acronym ACME-TM status module status verified date December 2021 overall status Recruiting expanded access info has expanded access No start date struct start date December 1, 2021 start date type Actual primary completion date struct primary completion date September 30, 2024 primary completion date type Anticipated completion date struct completion date May 9, 2026 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date December 8, 2021 last update post date struct last update post date December 10, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name VA Office of Research and Development lead sponsor class FED oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary The primary objective of this project is to refine a cognitive-behavioral intervention for comorbid alcohol misuse and modifiable CVD risk with diverse stakeholder input, so that the intervention can be deployed within existing VA systems. The intervention will deliver telehealth CBT for alcohol misuse, tailored and timely text messages facilitating clinical traction with CVD risk reduction, and a telehealth coaching call to transition focus of treatment targets. The primary hypotheses of this study are that the developed intervention will be feasible to deliver, acceptable to Veterans and clinicians, and show signs of reducing alcohol misuse and increasing behaviors associated with cardiovascular health. detailed description Specific Aims: Aim 1 -Characterize a national cohort of Veterans with alcohol misuse and modifiable CVD risk, their alcohol services utilization, and clinical outcomes. Aim 2 - Qualitatively assess barriers to treatment for Veterans with alcohol misuse and CVD risk across multiple stakeholders. Aim 3 - Use a successive cohort design to iteratively develop an intervention based on patient feedback. Aim 4 - Test the acceptability and feasibility of an intervention to reduce alcohol misuse and CVD risk in Veterans.
Innovation: This application is highly innovative in its attempt to address for the first time: 1) perceptions of barriers to treatment in this population, 2) the utility of a combined intervention for alcohol misuse and CVD risk, 3) multimorbid patient preferences for timing of treatments for multiple different targets, and 4) the sustainability of health behavior habits in VA formed by an intervention using "implementation intentions." Methodology: Aim 1 will use electronic health records to examine the status of key health criteria and services utilization among Veterans with alcohol misuse, both with and without comorbid CVD risk. Aim 2 will use qualitative interviews of both Veterans with comorbid alcohol misuse and elevated modifiable CVD risk, their providers across different settings, and systems-level stakeholders to assess current treatment barriers. Aim 3 will employ a successive cohort design to iteratively test the proposed intervention with rapid and early feedback from multiple Veteran cohorts. Aim 4 will test a refined intervention based on feedback from Aims 2 and 3 to determine the acceptability to Veteran patients, as well as the feasibility of recruitment, randomization, and intervention. conditions module condition list condition Alcohol Misuse Hypertension Elevated Cardiovascular Risk keyword list keyword Alcohol Cardiovascular Disease Telehealth Cognitive Behavioral Therapy SMS Text design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design intervention model description The interventional model takes place in two parts. Part 1 is a successive cohort design in which a small cohort of participants complete the treatment, and provide qualitative and quantitative feedback on the treatment. The treatment process is then revised accordingly. A second and third cohort of participants complete treatment, followed by the same revision process. Part 2 involves a single-arm pilot trial of acceptability and feasibility of recruiting methods, treatment, and measurement of outcomes for participants. design primary purpose Health Services Research design masking info design masking None (Open Label) enrollment info enrollment count 40 enrollment type Anticipated arms interventions module arm group list arm group arm group label ACME-TM arm group type Experimental arm group description Participants will obtain 4 sessions of telehealth cognitive behavioral therapy (CBT) focused on reducing alcohol misuse. Participants will receive a 5th telehealth coaching call to develop a plan for ensuing treatment regarding their elevated cardiovascular risk factors. Participants will then receive daily texts for one month aimed at helping them decrease these cardiovascular risk factors. arm group intervention list arm group intervention name Behavioral: Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM) intervention list intervention intervention type Behavioral intervention name Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM) intervention description Participants will obtain 4 sessions of telehealth cognitive behavioral therapy (CBT) focused on reducing alcohol misuse. Participants will receive a 5th telehealth coaching call to develop a plan for ensuing treatment regarding their elevated cardiovascular risk factors. Participants will then receive daily texts for one month aimed at helping them decrease these cardiovascular risk factors. intervention arm group label list intervention arm group label ACME-TM outcomes module primary outcome list primary outcome primary outcome measure Enrollment Feasibility primary outcome description Intervention and trial feasibility will be evaluated by tracking patient recruitment (feasibility of enrollment; proportion contacted/proportion enrolled and consented). primary outcome time frame Baseline Only primary outcome measure Treatment Feasibility primary outcome description Intervention and trial feasibility will be evaluated by tracking patient adherence/retention during treatment (feasibility of treatment; adherence cutoff of 75% of sessions). primary outcome time frame 10 Weeks Post-Baseline primary outcome measure Treatment Acceptability primary outcome description Acceptability will be measured by the Treatment Acceptability and Preferences (TAP). Post-treatment, patients will complete the TAP measure and open-ended questions to assess their knowledge about their conditions, experiences with treatment, and satisfaction. primary outcome time frame 10 Weeks Post-Baseline primary outcome measure Therapist Fidelity primary outcome description Therapist fidelity will be measured by structured independent ratings of a random sample of 20% of recordings using the Yale Adherence and Competence Scale (YACS). primary outcome time frame 6 Weeks Post-Baseline primary outcome measure SMS Text Acceptability primary outcome description SMS text utilization metrics (read reports on 75% of texts, or affirmative responses to receipt of 75% of texts) and open-ended post-treatment responses will be used to measure SMS text acceptability. primary outcome time frame 10 Weeks Post-Baseline secondary outcome list secondary outcome secondary outcome measure Systolic Blood Pressure secondary outcome description Three measures at 1-minute intervals will be obtained using electronic BP cuffs after patients rest for 5 minutes. BP values for each time point will be the average of the 3 measures. Reductions of 5 mmHg will be considered clinically significant. secondary outcome time frame 6 months Post-Baseline secondary outcome measure Past-Month Self-Reported Heavy Drinking Days secondary outcome description Past month self-reported days (via Timeline Follow-back, with heavy drinking defined as 5 drinks (men), 3 drinks (women)) over the previous month will be measured. secondary outcome time frame 6 months Post-Baseline secondary outcome measure ReComp Pharmacy Refill Compliance Estimate for CVD medications secondary outcome description Aggregated 3-month (90 day), and 6-month (180 day) adherence will be calculated on pharmacy refill data across all CVD medications, including antihypertensives, statins, and oral hypoglycemics. Refill rates will be calculated using the modified ReComp definition. secondary outcome time frame 6 months Post-Baseline eligibility module eligibility criteria Inclusion Criteria:
Enrolled in 1 of 3 primary care clinics associated with the Durham VAHCS, as evidenced by at least one outpatient PCP visit recorded in Managerial Cost Accounting (MCA) system.
Diagnosis of hypertension, hyperlipidemia, and/or diabetes mellitus in EHR (ICD-10 codes I10, E78.xx, and E11.xxxx) for at least one year.
Uncontrolled BP (indicated by average outpatient past year systolic BP of >140/100mmHg). > 1 measurement required.
Currently prescribed at least one oral medication for hypertension, hyperlipidemia, and/or diabetes mellitus as evidenced by at least one pharmacy refill within the previous year.
Most recent EHR AUDIT-C 5 (suggestive of alcohol misuse).
Self-reported access to any SMS text-capable phone.
Appropriate medication regimen for CVD prevention, screened by research coordinator and reviewed by Matt Crowley, MD (Mentor).
Exclusion Criteria:
Current enrollment in another trial for CVD risk reduction or medication adherence specifically.
Current participation in other alcohol misuse treatment programming.
EHR AUDIT-C suggestive of severe alcohol dependence requiring medical treatment, defined as 10-12 for both men and women.
Any recent or impending procedures that would warrant inpatient hospital stays or considerable changes to current medications (e.g., any changes other than altered doses).
Current palliative care or care through a nursing/hospice home.
History of clinically significant alcohol withdrawal symptoms, as evidenced by a score 10 on the CIWA.
Contraindicated medication regimen for CVD prevention, screened by research coordinator and reviewed by Matt Crowley, MD (Mentor). healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Daniel Blalock, PhD central contact role Contact central contact phone (919) 286-0411 central contact phone ext 174026 central contact e mail daniel.blalock@va.gov central contact name Heidi D Bassani central contact role Contact central contact phone (919) 286-0411 central contact e mail Heidi.Bassani@va.gov overall official list overall official overall official name Daniel Blalock, PhD overall official affiliation Durham VA Medical Center, Durham, NC overall official role Principal Investigator location list location location facility Durham VA Medical Center, Durham, NC location status Recruiting location city Durham location state North Carolina location zip 27705 location country United States location contact list location contact location contact name Heidi D Bassani location contact role Contact location contact phone 919-286-0411 location contact e mail Heidi.Bassani@va.gov location contact name Kimberly C Porter, AB location contact role Contact location contact phone (919) 286-0411 location contact phone ext 177098 location contact e mail kimberly.porter3@va.gov location contact name Daniel Blalock, PhD location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002318 condition mesh term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M9176 condition browse leaf name Hypertension condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M2929 intervention browse leaf name Ethanol intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04838457 | [
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19294,
1306,
122,
118,
23543,
3708,
170,
1569,
1884,
13252,
1204,
1104,
14027,
1114,
6272,
1940,
24784,
1105,
182,
5412,
20643,
140,
23935,
3187,
117,
1147,
6272,
1826,
190,
19621,
2734,
117,
1105,
7300,
13950,
119,
19294,
1306,
123,
118,
154,
4746,
24936,
1193,
15187,
14317,
1106,
3252,
1111,
14027,
1114,
6272,
1940,
24784,
1105,
140,
23935,
3187,
1506,
2967,
26027,
119,
19294,
1306,
124,
118,
11696,
170,
11598,
1884,
13252,
1204,
1902,
1106,
1122,
21126,
1193,
3689,
1126,
9108,
1359,
1113,
5351,
13032,
119,
19294,
1306,
125,
118,
5960,
1103,
4392,
6328,
1105,
175,
14517,
7706,
1104,
1126,
9108,
1106,
4851,
6272,
1940,
24784,
1105,
140,
23935,
3187,
1107,
14027,
119,
13886,
131,
1188,
4048,
1110,
3023,
10034,
1107,
1157,
2661,
1106,
4134,
1111,
1103,
1148,
1159,
131,
122,
114,
11170,
1116,
1104,
14317,
1106,
3252,
1107,
1142,
1416,
117,
123,
114,
1103,
10345,
1104,
170,
3490,
9108,
1111,
6272,
1940,
24784,
1105,
140,
23935,
3187,
117,
124,
114,
4321,
26271,
14598,
5351,
20935,
1111,
11491,
1104,
14115,
1111,
2967,
1472,
7539,
117,
1105,
125,
114,
1103,
20598,
1104,
2332,
4658,
15640,
1107,
19497,
1824,
1118,
1126,
9108,
1606,
107,
7249,
11489,
119,
107,
20569,
4807,
131,
19294,
1306,
122,
1209,
1329,
4828,
2332,
3002,
1106,
11755,
1103,
2781,
1104,
2501,
2332,
9173,
1105,
1826,
190,
19621,
2734,
1621,
14027,
1114,
6272,
1940,
24784,
117,
1241,
1114,
1105,
1443,
3254,
1766,
14598,
140,
23935,
3187,
119,
19294,
1306,
123,
1209,
1329,
186,
4746,
24936,
7397,
1104,
1241,
14027,
1114,
3254,
1766,
14598,
6272,
1940,
24784,
1105,
8208,
182,
5412,
20643,
140,
23935,
3187,
117,
1147,
12263,
1506,
1472,
11106,
117,
1105,
2344,
118,
1634,
26027,
1106,
15187,
1954,
3252,
14317,
119,
19294,
1306,
124,
1209,
12912,
170,
11598,
1884,
13252,
1204,
1902,
1106,
1122,
21126,
1193,
2774,
1103,
3000,
9108,
1114,
6099,
1105,
1346,
13032,
1121,
2967,
159,
24951,
1389,
1884,
13252,
2145,
119,
19294,
1306,
125,
1209,
2774,
170,
16686,
9108,
1359,
1113,
13032,
1121,
19294,
4206,
123,
1105,
124,
1106,
4959,
1103,
4392,
6328,
1106,
159,
24951,
1389,
4420,
117,
1112,
1218,
1112,
1103,
175,
14517,
7706,
1104,
17964,
117,
7091,
2734,
117,
1105,
9108,
119,
2975,
13196,
3879,
2190,
3879,
2586,
2528,
14084,
12107,
24784,
145,
24312,
23826,
1988,
2896,
12853,
1906,
10103,
25575,
19547,
2501,
12565,
2190,
2501,
12565,
2586,
2528,
14084,
10103,
25575,
20012,
11341,
10486,
13003,
1582,
3291,
22152,
3946,
4108,
2328,
17564,
1348,
23789,
25345,
18430,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
151,
120,
138,
1902,
9108,
2235,
8353,
1990,
1249,
19638,
1880,
1902,
9108,
2235,
6136,
1109,
9108,
1348,
2235,
2274,
1282,
1107,
1160,
2192,
119,
4539,
122,
1110,
170,
11598,
1884,
13252,
1204,
1902,
1107,
1134,
170,
1353,
1884,
13252,
1204,
1104,
6635,
2335,
1103,
3252,
117,
1105,
2194,
186,
4746,
24936,
1105,
25220,
13032,
1113,
1103,
3252,
119,
1109,
3252,
1965,
1110,
1173,
8182,
17472,
119,
138,
1248,
1105,
1503,
1884,
13252,
1204,
1104,
6635,
2335,
3252,
117,
1723,
1118,
1103,
1269,
16547,
1965,
119,
4539,
123,
6808,
170,
1423,
118,
1981,
3955,
3443,
1104,
4392,
6328,
1105,
175,
14517,
7706,
1104,
16226,
4069,
117,
3252,
117,
1105,
11842,
1104,
13950,
1111,
6635,
119,
1902,
2425,
3007,
3225,
4326,
2713,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
7330,
113,
3353,
20943,
114,
10803,
23992,
10803,
5099,
1969,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
9690,
14424,
118,
157,
2107,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
4539,
27989,
21868,
1209,
6268,
125,
6887,
1104,
21359,
1513,
13836,
6066,
1324,
12176,
18560,
7606,
113,
18893,
1942,
114,
3378,
1113,
7914,
6272,
1940,
24784,
119,
4539,
27989,
21868,
1209,
3531,
170,
4025,
21359,
1513,
13836,
6066,
1324,
7600,
1840,
1106,
3689,
170,
2197,
1111,
14332,
3252,
4423,
1147,
8208,
3621,
25575,
3187,
5320,
119,
4539,
27989,
21868,
1209,
1173,
3531,
3828,
6685,
1111,
1141,
2370,
5850,
1120,
4395,
1172,
9711,
1292,
3621,
25575,
3187,
5320,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
2586,
2528,
14084,
1105,
140,
23935,
3973,
1105,
13832,
2571,
20512,
1194,
11341,
10486,
13003,
1582,
1105,
182,
3048,
13003,
1582,
113,
9690,
14424,
118,
157,
2107,
114,
9108,
2190,
9108,
9108,
2076,
4108,
2328,
17564,
1348,
9108,
1271,
2586,
2528,
14084,
1105,
140,
23935,
3973,
1105,
13832,
2571,
20512,
1194,
11341,
10486,
13003,
1582,
1105,
182,
3048,
13003,
1582,
113,
9690,
14424,
118,
157,
2107,
114,
9108,
6136,
4539,
27989,
21868,
1209,
6268,
125,
6887,
1104,
21359,
1513,
13836,
6066,
1324,
12176,
18560,
7606,
113,
18893,
1942,
114,
3378,
1113,
7914,
6272,
1940,
24784,
119,
4539,
27989,
21868,
1209,
3531,
170,
4025,
21359,
1513,
13836,
6066,
1324,
7600,
1840,
1106,
3689,
170,
2197,
1111,
14332,
3252,
4423,
1147,
8208,
3621,
25575,
3187,
5320,
119,
4539,
27989,
21868,
1209,
1173,
3531,
3828,
6685,
1111,
1141,
2370,
5850,
1120,
4395,
1172,
9711,
1292,
3621,
25575,
3187,
5320,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
9690,
14424,
118,
157,
2107,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
13832,
10747,
1880,
11907,
17506,
5474,
2425,
9386,
6136,
11300,
21987,
1105,
3443,
175,
14517,
7706,
1209,
1129,
17428,
1118,
10066,
5351,
17964,
113,
175,
14517,
7706,
1104,
10803,
132,
10807,
12017,
120,
10807,
7945,
1105,
9635,
1174,
114,
119,
2425,
9386,
1159,
4207,
14562,
2042,
2809,
2425,
9386,
4929,
19165,
11907,
17506,
5474,
2425,
9386,
6136,
11300,
21987,
1105,
3443,
175,
14517,
7706,
1209,
1129,
17428,
1118,
10066,
5351,
8050,
21634,
120,
23406,
1219,
3252,
113,
175,
14517,
7706,
1104,
3252,
132,
8050,
21634,
2195,
5792,
1104,
3453,
110,
1104,
6887,
114,
119,
2425,
9386,
1159,
4207,
1275,
23519,
3799,
118,
14562,
2042,
2425,
9386,
4929,
19165,
138,
19515,
15384,
6328,
2425,
9386,
6136,
138,
19515,
15384,
6328,
1209,
1129,
7140,
1118,
1103,
19165,
138,
19515,
15384,
6328,
1105,
11689,
16792,
1116,
113,
157,
12240,
114,
119,
3799,
118,
3252,
117,
4420,
1209,
2335,
1103,
157,
12240,
4929,
1105,
1501,
118,
2207,
3243,
1106,
15187,
1147,
3044,
1164,
1147,
2975,
117,
5758,
1114,
3252,
117,
1105,
10241,
119,
2425,
9386,
1159,
4207,
1275,
23519,
3799,
118,
14562,
2042,
2425,
9386,
4929,
1109,
14543,
1776,
17355,
18860,
2425,
9386,
6136,
1109,
14543,
1776,
20497,
18860,
1209,
1129,
7140,
1118,
15695,
2457,
8532,
1104,
170,
7091,
6876,
1104,
1406,
110,
1104,
5982,
1606,
1103,
7534,
24930,
21634,
1105,
3291,
8223,
16618,
3633,
20334,
113,
162,
8101,
1708,
114,
119,
2425,
9386,
1159,
4207,
127,
23519,
3799,
118,
14562,
2042,
2425,
9386,
4929,
25345,
18430,
138,
19515,
15384,
6328,
2425,
9386,
6136,
25345,
3087,
190,
19621,
2734,
12676,
1116,
113,
2373,
3756,
1113,
3453,
110,
1104,
6685,
117,
1137,
170,
3101,
3161,
21943,
2109,
11317,
1106,
1231,
27333,
1104,
3453,
110,
1104,
6685,
114,
1105,
1501,
118,
2207,
2112,
118,
3252,
11317,
1209,
1129,
1215,
1106,
4929,
25345,
3087,
4392,
6328,
119,
2425,
9386,
1159,
4207,
1275,
23519,
3799,
118,
14562,
2042,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
156,
6834,
2430,
8031,
5657,
2544,
3313,
3718,
9386,
6136,
2677,
5252,
1120,
122,
118,
2517,
14662,
1209,
1129,
3836,
1606,
4828,
21062,
27917,
1170,
4420,
1832,
1111,
126,
1904,
119,
21062,
4718,
1111,
1296,
1159,
1553,
1209,
1129,
1103,
1903,
1104,
1103,
124,
5252,
119,
2156,
18305,
1116,
1104,
126,
2608,
3048,
1403,
1209,
1129,
1737,
7300,
1193,
2418,
119,
3718,
9386,
1159,
4207,
127,
1808,
3799,
118,
14562,
2042,
3718,
9386,
4929,
11415,
118,
17545,
9434,
118,
7178,
1174,
10580,
1987,
10223,
1158,
6637,
3718,
9386,
6136,
11415,
2370,
2191,
118,
2103,
1552,
113,
2258,
2614,
2568,
19253,
118,
1171,
117,
1114,
2302,
5464,
3393,
1112,
126,
8898,
113,
1441,
114,
117,
124,
8898,
113,
1535,
114,
114,
1166,
1103,
2166,
2370,
1209,
1129,
7140,
119,
3718,
9386,
1159,
4207,
127,
1808,
3799,
118,
14562,
2042,
3718,
9386,
4929,
11336,
1658,
4165,
1643,
24774,
11336,
18591,
3291,
8223,
20541,
142,
2050,
15774,
1111,
140,
23935,
23897,
3718,
9386,
6136,
138,
9705,
1874,
10901,
124,
118,
2370,
113,
3078,
1285,
114,
117,
1105,
127,
118,
2370,
113,
7967,
1285,
114,
8050,
21634,
1209,
1129,
10056,
1113,
22759,
1231,
18591,
2233,
1506,
1155,
140,
23935,
23897,
117,
1259,
2848,
7889,
17786,
5026,
11355,
117,
188,
19756,
4935,
117,
1105,
9619,
177,
1183,
5674,
18901,
2093,
7257,
1116,
119,
11336,
18591,
5600,
1209,
1129,
10056,
1606,
1103,
5847,
11336,
1658,
4165,
1643,
5754,
119,
3718,
9386,
1159,
4207,
127,
1808,
3799,
118,
14562,
2042,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
13832,
10747,
1174,
1107,
122,
1104,
124,
2425,
1920,
20562,
2628,
1114,
1103,
8975,
19497,
15779,
1708,
117,
1112,
23526,
1118,
1120,
1655,
1141,
1149,
27420,
7054,
2101,
3143,
1802,
1107,
7165,
2916,
3291,
2050,
23693,
113,
24955,
114,
1449,
119,
12120,
8517,
27078,
1104,
177,
24312,
23826,
1988,
117,
177,
24312,
10913,
3269,
8191,
117,
1105,
120,
1137,
17972,
1143,
6473,
4814,
1107,
142,
3048,
2069,
113,
146,
14107,
118,
1275,
9812,
146,
10424,
117,
142,
1559,
1604,
119,
193,
1775,
117,
1105,
142,
14541,
119,
193,
1775,
1775,
1775,
114,
1111,
1120,
1655,
1141,
1214,
119,
12118,
7235,
8005,
11572,
21062,
113,
4668,
1118,
1903,
1149,
27420,
1763,
1214,
188,
6834,
2430,
8031,
21062,
1104,
135,
8183,
120,
1620,
6262,
3048,
1403,
114,
119,
135,
122,
11842,
2320,
119,
7199,
17421,
1120,
1655,
1141,
9619,
15683,
1111,
177,
24312,
23826,
1988,
117,
177,
24312,
10913,
3269,
8191,
117,
1105,
120,
1137,
17972,
1143,
6473,
4814,
1112,
23526,
1118,
1120,
1655,
1141,
22759,
1231,
18591,
1439,
1103,
2166,
1214,
119,
2082,
2793,
142,
3048,
2069,
21646,
17243,
1942,
118,
140,
126,
113,
5996,
2109,
1104,
6272,
1940,
24784,
114,
119,
9434,
118,
2103,
2469,
1106,
1251,
25345,
3087,
118,
4451,
2179,
119,
138,
8661,
12736,
3464,
1566,
15683,
6716,
1179,
1111,
140,
23935,
13347,
117,
12468,
1118,
1844,
13443,
1105,
7815,
1118,
3895,
22804,
117,
9292,
113,
3401,
2772,
114,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
9493,
10803,
1107,
1330,
3443,
1111,
140,
23935,
3187,
7234,
1137,
15683,
8050,
21634,
4418,
119,
9493,
6251,
1107,
1168,
6272,
1940,
24784,
3252,
4159,
119,
142,
3048,
2069,
21646,
17243,
1942,
118,
140,
5996,
2109,
1104,
5199,
6272,
20917,
8753,
2657,
3252,
117,
3393,
1112,
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full study rank 61631 study protocol section identification module n c t id NCT04833959 org study id info org study id IRB-57641 secondary id info list secondary id info secondary id PANC0037 secondary id type Other Identifier secondary id domain OnCore secondary id NCI-2021-03447 secondary id type Other Identifier secondary id domain CTRP organization org full name Stanford University org class OTHER brief title Pilot Study of 89-Zr Panitumumab in Pancreas Cancer official title Pilot Study of 89Zr Panitumumab in Pancreas Cancer status module status verified date June 2022 overall status Suspended why stopped Business Decision expanded access info has expanded access No start date struct start date March 26, 2021 start date type Actual primary completion date struct primary completion date March 2024 primary completion date type Anticipated completion date struct completion date March 2024 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date June 15, 2022 last update post date struct last update post date June 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Stanford University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary The main purpose of the study is to assess the safety of 89Zr-panitumumab as a molecular imaging agent in patients with (metastatic) pancreas cancer. conditions module condition list condition Pancreas Cancer design module study type Interventional phase list phase Phase 1 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 14 enrollment type Anticipated arms interventions module arm group list arm group arm group label 89Zr-Panitumumab arm group type Experimental arm group description Subjects will be injected with 1 mCi (+/- 20%) of 89Zr-panitumumab followed by PET/CT imaging 4-7 days after study drug injection. arm group intervention list arm group intervention name Drug: 89Zr-panitumumab intervention list intervention intervention type Drug intervention name 89Zr-panitumumab intervention description Imaging Agent intervention arm group label list intervention arm group label 89Zr-Panitumumab outcomes module primary outcome list primary outcome primary outcome measure Incidence of treatment emergent adverse events assessed by CTCAE v5 primary outcome description Safety is defined by the number of CTCAE v5 grade 2 or higher adverse events by Day 7 determined that are significant, definitely, probably or possibly related to 89Zr-panitumumab. Safety data will be summarized by grade, severity, and type. primary outcome time frame 7 days eligibility module eligibility criteria Inclusion Criteria:
Confirmed diagnosis of pancreatic cancer.
Exclusion Criteria:
Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
History of infusion reactions to monoclonal antibody therapies.
Pregnant or breastfeeding.
Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
Severe renal disease or anuria.
Known hypersensitivity to deferoxamine or any of its components. healthy volunteers No gender All minimum age 19 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Andrei Iagaru overall official affiliation Stanford Universiy overall official role Principal Investigator location list location location facility Stanford University location city Stanford location state California location zip 94305 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010190 condition mesh term Pancreatic Neoplasms condition ancestor list condition ancestor condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004701 condition ancestor term Endocrine Gland Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000010182 condition ancestor term Pancreatic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M12262 condition browse leaf name Pancreatic Neoplasms condition browse leaf as found Pancreas Cancer condition browse leaf relevance high condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M7015 condition browse leaf name Endocrine Gland Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M12254 condition browse leaf name Pancreatic Diseases condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id T4387 condition browse leaf name Pancreatic Cancer condition browse leaf as found Pancreas Cancer condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000077544 intervention mesh term Panitumumab intervention ancestor list intervention ancestor intervention ancestor id D000074322 intervention ancestor term Antineoplastic Agents, Immunological intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M1822 intervention browse leaf name Panitumumab intervention browse leaf as found Analogue intervention browse leaf relevance high intervention browse leaf id M21707 intervention browse leaf name Pancrelipase intervention browse leaf relevance low intervention browse leaf id M12266 intervention browse leaf name Pancreatin intervention browse leaf relevance low intervention browse leaf id M1346 intervention browse leaf name Antineoplastic Agents, Immunological intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents | NCT04833959 | [
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full study rank 61677 study protocol section identification module n c t id NCT04833361 org study id info org study id 10000366 secondary id info list secondary id info secondary id 000366-EI organization org full name National Institutes of Health Clinical Center (CC) org class NIH brief title Potential Environmental Causes of Uveal Coloboma official title Pilot Evaluation of Potential Environmental Causes of Uveal Coloboma status module status verified date September 20, 2022 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date December 7, 2022 start date type Anticipated primary completion date struct primary completion date December 31, 2023 primary completion date type Anticipated completion date struct completion date December 31, 2023 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date December 1, 2022 last update post date struct last update post date December 2, 2022 last update post date type Estimate sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name National Eye Institute (NEI) lead sponsor class NIH oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Background:
Uveal coloboma is a congenital eye malformation. It is thought to be a genetic condition. But it might have environmental causes as well. Researchers want to study the mothers of children with coloboma. They will use parts of the National Birth Defects Prevention Study (NBDPS) Mother Questionnaire. NBDPS was a large study of birth defects. It collected data from 1997 to 2011. Researchers will use NBDPS and NIH data as well as the new survey to produce data that can serve as a basis for further study.
Objective:
To explore maternal factors and exposures during the first trimester of pregnancy as potential causes of uveal coloboma and to correlate exposure data to clinical data from affected children.
Eligibility:
Mothers of probands with coloboma who have taken part in NIH study 06-EI-0230, 04-EI-0039, or 13-EI-0049.
Design:
This is a hybrid study. It will use existing data from NBDPS and NIH studies. It will also use NBDPS for a new survey of mothers of children with coloboma.
Participants will take the survey by phone. Their pregnancy records may be reviewed. They will be asked about:
Important dates
Health and medicines
Tobacco, alcohol, and substance use
Parents occupations
Family demographics.
The survey will take 1 hour or less to complete.
Some data were obtained in past NIH studies. These data are largely from children. Some family data may be used as well. For example, eye exam data, gene test results, and family history of coloboma may be used. If a participant did not consent to the future use of their data, then their data will not be used.
Data will be stored in a secure NIH database.
... detailed description Uveal coloboma is a rare, potentially-blinding congenital eye malformation due to failure of the optic fissure to close during the 5th week of human gestation. Although coloboma is thought to have a significant genetic component, the yield of systematic screening of known causative genes remains low. Environmental causes for coloboma have been suggested, yet few to none have been proven and most studies have not been undertaken in the United States6-8. Potential environmental causes include maternal nutritional deficiencies, drug exposure (including alcohol), and endocrine abnormalities. Some reports are conflicting (e.g., maternal diabetes) and some associations have been suggested by animal models, but not explored in humans . Most human studies are level III and IV evidence by the Agency for Healthcare Research and Quality grading scale.
Uveal coloboma is often grouped together with anophthalmia ( no eyes ) and microphthalmia ( small eyes ), designated by the acronym MAC . Detailed, population-based studies of the epidemiology of microphthalmia and anophthalmia have been conducted as part of birth defect surveillance programs.
The proposed pilot evaluation of potential environmental causes of coloboma is being undertaken to explore the experiences in a large cohort of probands and their families. It will utilize portions of the validated National Birth Defects Prevention Study (NBDPS) Mother Questionnaire. The NBDPS was a large population-based multicenter case-control study of many major birth defects that collected data from October 1997 through December 2011. Interview pregnancy information was obtained in 32,187 cases and 11,814 controls. The findings are intended to produce descriptive statistics and serve as a basis for further epidemiologic (and possibly laboratory) study. conditions module condition list condition Coloboma keyword list keyword Questionnaire Microphthalmia Birth Defects Natural History design module study type Observational design info design observational model list design observational model Family-Based design time perspective list design time perspective Other enrollment info enrollment count 180 enrollment type Anticipated arms interventions module arm group list arm group arm group label Mothers arm group description Mothers of children with coloboma. outcomes module primary outcome list primary outcome primary outcome measure % of participants with x exposure compared to historical data primary outcome description % of participants with x exposure compared to historical data from NBDPS study. primary outcome time frame ongoing eligibility module eligibility criteria INCLUSION CRITERIA:
mothers of probands with coloboma that have previously been consented to an NIH protocol studying coloboma. healthy volunteers Accepts Healthy Volunteers gender Female minimum age 18 Years std age list std age Adult Older Adult study population Up to 180 mothers of probands with coloboma that have previously been consented to an NIH protocol studying coloboma. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Brian P Brooks, M.D. overall official affiliation National Eye Institute (NEI) overall official role Principal Investigator location list location location facility National Eye Institute (NEI) location city Bethesda location state Maryland location zip 20892 location country United States i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003103 condition mesh term Coloboma condition ancestor list condition ancestor condition ancestor id D000005124 condition ancestor term Eye Abnormalities condition ancestor id D000005128 condition ancestor term Eye Diseases condition ancestor id D000015785 condition ancestor term Eye Diseases, Hereditary condition ancestor id D000000013 condition ancestor term Congenital Abnormalities condition browse leaf list condition browse leaf condition browse leaf id M12 condition browse leaf name Congenital Abnormalities condition browse leaf relevance low condition browse leaf id M5483 condition browse leaf name Coloboma condition browse leaf as found Coloboma condition browse leaf relevance high condition browse leaf id M10973 condition browse leaf name Microphthalmos condition browse leaf relevance low condition browse leaf id M7419 condition browse leaf name Eye Abnormalities condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse leaf id M17491 condition browse leaf name Eye Diseases, Hereditary condition browse leaf relevance low condition browse leaf id T3796 condition browse leaf name Microphthalmia condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases | NCT04833361 | [
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full study rank 61816 study protocol section identification module n c t id NCT04831554 org study id info org study id mashaohua1976-4 organization org full name Peking University Third Hospital org class OTHER brief title Which is Better Between Single Chest Tube and Multiple Tubes Drainage in Primary Spontaneous Pneumothorax official title Comparison of the Efficacy of Single Tube Versus Multiple Tubes Drainage After Bullectomy and Pleurodesis for Primary Spontaneous Pneumothorax status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date October 31, 2021 start date type Anticipated primary completion date struct primary completion date May 1, 2023 primary completion date type Anticipated completion date struct completion date October 31, 2023 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date October 9, 2021 last update post date struct last update post date October 18, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Peking University Third Hospital lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary There was no evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis.This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis. After routine procedure the participants will randomized to either placed single chest tube or multiple chest tubes detailed description Primary spontaneous pneumothorax (PSP) occurs after the rupture of small bullae or a subpleural bleb in otherwise normal lungs. The indications for surgical treatment include persistent air leak after intercostal tube drainage, recurrent PSP, and contralateral PSP. The video-assisted thoracoscopic surgery (VATS) approach probably represents the treatment of choice for PSP.
The presence of a residual pleural space after surgery may be a factor associated with increased risk of recurrence. One possible hypothesis to explain the association between residual pleural space and recurrence of pneumothorax may be the failed pleurodesis due to lack of pleura-pleura apposition. Multiple chest tubes are effective in clinical practice, but there was no convinctive evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis. This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis.After routine procedure the participants will randomized to either placed multiple chest tubes or single chest tube.
The recurrence of the two group and other postoperative clinical parameters will be observed. conditions module condition list condition Primary Spontaneous Pneumothorax keyword list keyword number of chest tube Bullectomy Pleurodesis Primary Spontaneous Pneumothorax design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 200 enrollment type Anticipated arms interventions module arm group list arm group arm group label single chest tube group arm group type Experimental arm group intervention list arm group intervention name Procedure: single chest tube drainage arm group label multiple chest tubes group arm group type No Intervention intervention list intervention intervention type Procedure intervention name single chest tube drainage intervention description place single chest tube after surgery of PSP intervention arm group label list intervention arm group label single chest tube group outcomes module primary outcome list primary outcome primary outcome measure recurrence primary outcome description Recurrence of pneumothorax during 2 years follow-up primary outcome time frame 2 years after operation secondary outcome list secondary outcome secondary outcome measure complications secondary outcome description post-operation complications，such as air leakage secondary outcome time frame 30days after operation eligibility module eligibility criteria Inclusion Criteria:
Diagnosed by chest radiograph or CT as primary spontaneous pneumothorax
Underwent bullectomy and pleurodesis
Postoperative indwelling chest tubes
Exclusion Criteria:
Secondary pneumothorax, traumatic pneumothorax and iatrogenic pneumothorax
Previous surgery history
People with severe comorbidities healthy volunteers No gender All minimum age 16 Years maximum age 40 Years std age list std age Child Adult references module reference list reference reference p m i d 24370202 reference type background reference citation Jiang L, Jiang G, Zhu Y, Hao W, Zhang L. Risk factors predisposing to prolonged air leak after video-assisted thoracoscopic surgery for spontaneous pneumothorax. Ann Thorac Surg. 2014 Mar;97(3):1008-13. doi: 10.1016/j.athoracsur.2013.10.031. Epub 2013 Dec 25. reference p m i d 28457339 reference type background reference citation Sudduth CL, Shinnick JK, Geng Z, McCracken CE, Clifton MS, Raval MV. Optimal surgical technique in spontaneous pneumothorax: a systematic review and meta-analysis. J Surg Res. 2017 Apr;210:32-46. doi: 10.1016/j.jss.2016.10.024. Epub 2016 Nov 3. Review. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011030 condition mesh term Pneumothorax condition ancestor list condition ancestor condition ancestor id D000010995 condition ancestor term Pleural Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M13072 condition browse leaf name Pneumothorax condition browse leaf as found Spontaneous Pneumothorax condition browse leaf relevance high condition browse leaf id M13037 condition browse leaf name Pleural Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id T4713 condition browse leaf name Primary Spontaneous Pneumothorax condition browse leaf as found Primary Spontaneous Pneumothorax condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases | NCT04831554 | [
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full study rank 61656 study protocol section identification module n c t id NCT04833634 org study id info org study id AAG-O-H-2008 organization org full name Aesculap AG org class INDUSTRY brief title Follow-Up of the Prevision® Hip Stem official title Retrospective Follow-Up of the Prevision® Hip Stem in a Consecutive Case Series acronym PRESPECT status module status verified date November 2022 overall status Completed expanded access info has expanded access No start date struct start date May 14, 2021 start date type Actual primary completion date struct primary completion date June 13, 2022 primary completion date type Actual completion date struct completion date June 13, 2022 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date November 17, 2022 last update post date struct last update post date November 18, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Aesculap AG lead sponsor class INDUSTRY oversight module oversight has d m c No description module brief summary The main objective of this study is to represent the treatment reality at the study site and to draw conclusions from cases of failure or suboptimal outcome. Potential risk factors for revision surgery, suboptimal outcome or radiologic sign of loosening, bone non-union or stem subsidence will be evaluated. Next to the functional outcome, stem subsidence will be used as an important indicator for a stable fixation of the revision stem. conditions module condition list condition Periprosthetic Fracture Around Prosthetic Joint Implant Aseptic Loosening of Prosthetic Joint keyword list keyword arthroplasty, replacement, hip implant failure failed primary hip arthroplasty severe bone defects complex bone fractures septic loosening poor bone remodeling design module study type Observational design info design observational model list design observational model Case-Only design time perspective list design time perspective Retrospective enrollment info enrollment count 46 enrollment type Actual outcomes module primary outcome list primary outcome primary outcome measure Hip stem survival measured by Kaplan-Meier primary outcome description The primary endpoint of the study is hip stem survival, which is a common indicator for implant performance, which can also be used for comparison with implant registry data. primary outcome time frame One scheduled Follow-Up visit per patient, 2-7 years after initial implantation secondary outcome list secondary outcome secondary outcome measure Functional Outcome: Oxford Hip Score secondary outcome description The Oxford Hip Score is a 12-item questionnaire that assesses hip function and pain. The score ranges between 12 and 60, with a lower score indicating less disability secondary outcome time frame One scheduled Follow-Up visit per patient, 2-7 years after initial implantation secondary outcome measure Patient satisfaction with their endoprosthetic revision treatment secondary outcome description The Patients are asked to grade their level of satisfaction with the outcome of the surgery at time of follow-up, with the grades: "very dissatisfied", "dissatisfied", "satisfied", "very satisfied".
The grades may be summarized as "satisfied" vs. "dissatisfied". secondary outcome time frame One scheduled Follow-Up visit per patient, 2-7 years after initial implantation secondary outcome measure Radiological evaluation (standard x-rays): Bone healing secondary outcome description Union of the osteotomy
o Healing of the fracture and of the greater trochanter, if applicable secondary outcome time frame One scheduled Follow-Up visit per patient, 2-7 years after initial implantation secondary outcome measure Radiological evaluation (standard x-rays): osseointegration secondary outcome description Distal and proximal radiographic bone ingrowth and Qualitative proximal remodeling secondary outcome time frame One scheduled Follow-Up visit per patient, 2-7 years after initial implantation secondary outcome measure Radiological evaluation (standard x-rays): radiographic loosening secondary outcome description Signs of radiographic loosening in the distal fixation zone secondary outcome time frame One scheduled Follow-Up visit per patient, 2-7 years after initial implantation secondary outcome measure Radiological evaluation (standard x-rays): stem subsidence secondary outcome description Stem subsidence from ap x-rays using landmarks of the femur (typically lesser trochanter) and of the prosthesis secondary outcome time frame One scheduled Follow-Up visit per patient, 2-7 years after initial implantation secondary outcome measure Leg length difference secondary outcome description Discrepancy of leg length is often considered to be a problem after total hip replacement and can adversely affect an otherwise excellent outcome and may be associated with patient dissatisfaction. secondary outcome time frame One scheduled Follow-Up visit per patient, 2-7 years after initial implantation secondary outcome measure Descriptive Analysis of (Serious) adverse events secondary outcome description (Serious) adverse events that are potentially related to the Total hip arthroplasty (THA) procedure or the THA implants will be recorded. These are events as reported by the patient, observed in the follow-up examinations or taken from the patient record secondary outcome time frame One scheduled Follow-Up visit per patient, 2-7 years after initial implantation other outcome list other outcome other outcome measure Descriptive Analysis of Patient characteristics other outcome description Age, weight, gender, date of surgery, indication for revision, comorbidities, intraoperative details other outcome time frame One scheduled Follow-Up visit per patient, 2-7 years after initial implantation eligibility module eligibility criteria Inclusion Criteria:
All patients implanted with a Prevision® hip stem at the study site between 2014 and 2019
Written informed patient consent
Exclusion Criteria:
- Patients < 18 years at surgery healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population All patients were implanted 2-7 year before the start of the retrospective study activities. sampling method Non-Probability Sample contacts locations module location list location location facility Caritas-Krankenhaus Bad Mergentheim, Klinik für Orthopädie und Unfallchirurgie location city Bad Mergentheim location zip 97980 location country Germany derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000057068 condition mesh term Periprosthetic Fractures condition ancestor list condition ancestor condition ancestor id D000050723 condition ancestor term Fractures, Bone condition ancestor id D000014947 condition ancestor term Wounds and Injuries condition browse leaf list condition browse leaf condition browse leaf id M25523 condition browse leaf name Fractures, Bone condition browse leaf relevance low condition browse leaf id M27846 condition browse leaf name Periprosthetic Fractures condition browse leaf as found Periprosthetic Fractures condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions | NCT04833634 | [
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] |
full study rank 61436 study protocol section identification module n c t id NCT04836494 org study id info org study id CoA-101 organization org full name CoA Therapeutics, Inc., a BridgeBio company org class INDUSTRY brief title A First in Human, Dose Escalation Study to Evaluate the Safety and Tolerability of BBP-671 in Healthy Volunteers and Patients With Propionic Acidemia or Methylmalonic Acidemia official title A First-in-human, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Escalation to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBP-671 in Healthy Subjects and In Patients With Propionic Acidemia or Methylmalonic Acidemia status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 25, 2021 start date type Actual primary completion date struct primary completion date May 31, 2023 primary completion date type Anticipated completion date struct completion date May 31, 2023 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 7, 2022 last update post date struct last update post date October 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name CoA Therapeutics, Inc., a BridgeBio company lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No description module brief summary The purpose of this study is to assess the safety, tolerability, PK and PD of BBP-671 in healthy volunteers and patients with Propionic Acidemia or Methylmalonic Acidemia. detailed description This is the first-in-human study with BBP-671 and is designed to provide healthy subjects single- and multiple-dose and patient multidose safety, tolerability, PK, and PD data regarding BBP-671 for future clinical studies. conditions module condition list condition Healthy Volunteers Propionic Acidemia Methylmalonic Acidemia Organic Acidemia design module study type Interventional phase list phase Phase 1 design info design allocation Randomized design intervention model Sequential Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Care Provider Investigator enrollment info enrollment count 128 enrollment type Anticipated arms interventions module arm group list arm group arm group label BBP-671 for SAD arm group type Experimental arm group description The SAD portion of the study will consist of up to 8 cohorts. Six (6) healthy male or female adult subjects will be randomized to receive BBP-671 per cohort (6:2 ratio, BBP-671:placebo). arm group intervention list arm group intervention name Drug: BBP-671 arm group label Placebo for SAD arm group type Placebo Comparator arm group description The SAD portion of the study will consist of up to 8 cohorts. Two (2) healthy male or female adult subjects will be randomized to receive matching placebo per cohort (6:2 ratio, BBP-671:placebo). arm group intervention list arm group intervention name Drug: Placebo arm group label BBP-671 for MAD arm group type Experimental arm group description The MAD portion of the study will consist of up to 6 cohorts. Six (6) healthy male or female adult subjects will be randomized to receive BBP-671 per cohort (6:2 ratio, BBP-671:placebo). arm group intervention list arm group intervention name Drug: BBP-671 arm group label Placebo for MAD arm group type Placebo Comparator arm group description The MAD portion of the study will consist of up to 6 cohorts. Two (2) healthy male or female adult subjects will be randomized to receive matching placebo per cohort (6:2 ratio, BBP-671:placebo). arm group intervention list arm group intervention name Drug: Placebo arm group label BBP-671 for SAD Food Effect arm group type Experimental arm group description Eight (8) healthy male or female adult subjects will be randomized to receive BBP-671. arm group intervention list arm group intervention name Drug: BBP-671 arm group label BBP-671 for PA and MMA Patients arm group type Experimental arm group description Up to eight (8) PA patients and eight (8) MMA patients will receive BBP-671. arm group intervention list arm group intervention name Drug: BBP-671 intervention list intervention intervention type Drug intervention name BBP-671 intervention description BBP-671, oral suspension intervention arm group label list intervention arm group label BBP-671 for MAD BBP-671 for SAD BBP-671 for SAD Food Effect intervention type Drug intervention name Placebo intervention description Placebo matching BBP-671 intervention arm group label list intervention arm group label Placebo for MAD Placebo for SAD intervention type Drug intervention name BBP-671 intervention description BBP-671, tablet intervention arm group label list intervention arm group label BBP-671 for PA and MMA Patients outcomes module primary outcome list primary outcome primary outcome measure Incidence of adverse events following administration of BBP-671 primary outcome time frame 49 days primary outcome measure BBP-671 concentration dependent change in change from baseline in QTcF primary outcome time frame 49 days primary outcome measure Pharmacokinetic Assessments: Cmax primary outcome description Time to maximum concentration (Cmax) primary outcome time frame 49 days primary outcome measure Pharmacokinetic Assessments: Tmax primary outcome description Time to reach maximum observed plasma concentration (Tmax) primary outcome time frame 49 days primary outcome measure Pharmacokinetic Assessments: t1/2 primary outcome description Plasma decay half-life (t1/2) primary outcome time frame 49 days primary outcome measure Pharmacokinetic Assessments: AUC0-tau primary outcome description Area under the plasma concentration-time curve (AUC0-tau) primary outcome time frame 49 days primary outcome measure Pharmacokinetic Assessments: CL/F primary outcome description Apparent clearance (CL/F) primary outcome time frame 15 days primary outcome measure Pharmacokinetic Assessments: Vz/F primary outcome description Apparent volume of distribution (Vz/F) primary outcome time frame 15 days primary outcome measure Pharmacokinetic Assessments: CLr primary outcome description Renal clearance (CLr) primary outcome time frame 15 days secondary outcome list secondary outcome secondary outcome measure Food Effect: Cmax secondary outcome description Time to maximum concentration secondary outcome time frame 10 days secondary outcome measure Food Effect: Tmax secondary outcome description Time to reach maximum observed plasma concentration secondary outcome time frame 10 days secondary outcome measure Food Effect: AUC secondary outcome description Area under the plasma concentration-time curve secondary outcome time frame 10 days secondary outcome measure Pharmacodynamic Assessment: Whole blood, plasma, and urine biomarker concentrations will be quantified and summarized using appropriate descriptive parameters secondary outcome description Measurement will be done using liquid chromatography-tandem mass spectrometry secondary outcome time frame 49 days eligibility module eligibility criteria Inclusion Criteria (Healthy Volunteers):
Subject is male or female 18 to 55 yrs old
Subject has a BMI 18 to 32 kg/m^2
Female and male subjects must use effective method of birth control
Female subjects must have negative pregnancy test prior to first dose of study drug
Subject must not have any clinically significant eye abnormality
Subject must not have any clinically significant history or presence of ECG findings
Subject must be in good general health
Inclusion Criteria (PA or MMA Patients):
Patient is male or female 18 to 55 yrs old
Patient has a BMI 18 to 32 kg/m^2
Female and male patients must use effective method of birth control
Female patients must have negative pregnancy test prior to first dose of study drug
Patient must not have any clinically significant eye abnormality
Patient must not have any clinically significant history or presence of ECG findings
Patient must have confirmed PA or MMA diagnosis
Patient with MMA must have elevated plasma MMA levels
Patient is willing to provide access to medical records for the last 6-12 months of care prior to study initiation
Patient is on consistent disease management and treatment regimen is stable for at least 30 days prior to study initiation.
Exclusion Criteria (Healthy Volunteers):
Subject has used prescription drugs within 4 weeks before first dose of study drug or over-the-counter medication within 7 days of the first dose of study drug
Subject who has taken the COVID-19 vaccine, the last vaccine dose must be at least 14 days prior to first dose of study drug.
Subject has abnormal laboratory test results
Subject has a baseline eGFR <90 mL/minute
Subject has positive result for Hepatitis B, Hepatitis C, or HIV
Female subject is non-pregnant and non-lactating
Subject is a smoker or has used nicotine or nicotine-containing products
Subject has a history of alcohol or drug abuse within 12 months prior to first dose of study drug and/or has a positive result prior to dosing or throughout the study
Subject has donated blood or blood products >450mL within 30 days prior to study drug dosing
Subject has a history of relevant drug or food allergies
Subject has received study drug in another investigational study within 30 days of dosing
Exclusion Criteria (PA or MMA Patients):
Patient has used prescription drugs within 4 weeks before first dose of study drug or over-the-counter medication within 7 days of the first dose of study drug that is not part of their PA or MMA disease management and treatment
Patient who has taken the COVID-19 vaccine, the last vaccine dose (or booster) must be at least 14 days prior to first dose of study drug.
Patient has clinically significant abnormal laboratory test results unrelated to PA or MMA
Patient has a baseline eGFR <60 mL/minute
Patient has positive result for Hepatitis B, Hepatitis C, or HIV
Female patient is non-pregnant and non-lactating
Patient has a history of alcohol or drug abuse within 12 months prior to first dose of study drug and/or has a positive result prior to dosing or throughout the study
Patient has donated blood or blood products >450mL within 30 days prior to study drug dosing
Patient has a history of relevant drug or food allergies
Patient has received study drug in another investigational study within 30 days of dosing
Patient has had a recent infection requiring system antibiotics within 4 weeks of Baseline or any active infection that precludes the patient from participation
Patient with PA has undergone prior liver and/or kidney transplant healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 55 Years std age list std age Adult contacts locations module central contact list central contact central contact name Medical Information central contact role Contact central contact phone (650) 391-9740 central contact e mail medinfo@coatherapeutics.com overall official list overall official overall official name Medical Monitor overall official affiliation VP Clinical Development, CoA Therapeutics, Inc., a Bridgebio company overall official role Study Chair location list location location facility Community Health Clinic location status Recruiting location city Topeka location state Indiana location zip 46571 location country United States location facility UPMC Children's Hospital of Pittsburg location status Recruiting location city Pittsburgh location state Pennsylvania location zip 15224 location country United States location facility PPD Development, LP location status Completed location city Austin location state Texas location zip 78744 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000592 condition mesh term Amino Acid Metabolism, Inborn Errors condition mesh id D000056693 condition mesh term Propionic Acidemia condition mesh id D000000138 condition mesh term Acidosis condition ancestor list condition ancestor condition ancestor id D000000137 condition ancestor term Acid-Base Imbalance condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000008661 condition ancestor term Metabolism, Inborn Errors condition ancestor id D000030342 condition ancestor term Genetic Diseases, Inborn condition browse leaf list condition browse leaf condition browse leaf id M27706 condition browse leaf name Propionic Acidemia condition browse leaf as found Propionic Acidemia condition browse leaf relevance high condition browse leaf id M3084 condition browse leaf name Amino Acid Metabolism, Inborn Errors condition browse leaf as found Methylmalonic Acidemia condition browse leaf relevance high condition browse leaf id M10793 condition browse leaf name Metabolism, Inborn Errors condition browse leaf relevance low condition browse leaf id M2651 condition browse leaf name Acidosis condition browse leaf as found Acidemia condition browse leaf relevance high condition browse leaf id M2650 condition browse leaf name Acid-Base Imbalance condition browse leaf relevance low condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M22839 condition browse leaf name Genetic Diseases, Inborn condition browse leaf relevance low condition browse leaf id T3748 condition browse leaf name Methylmalonic Acidemia condition browse leaf as found Methylmalonic Acidemia condition browse leaf relevance high condition browse leaf id T4751 condition browse leaf name Propionic Acidemia condition browse leaf as found Propionic Acidemia condition browse leaf relevance high condition browse leaf id T4272 condition browse leaf name Organic Acidemias condition browse leaf as found Organic Acidemia condition browse leaf relevance high condition browse leaf id T3036 condition browse leaf name Inborn Amino Acid Metabolism Disorder condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases | NCT04836494 | [
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full study rank 61670 study protocol section identification module n c t id NCT04833452 org study id info org study id Endoscopic DCR organization org full name Menoufia University org class OTHER brief title Comparative Study Between Wide and Narrow Fenstrum Endoscopic DCR official title Comparative Study Between Wide and Narrow Fenstrum Endoscopic DCR status module status verified date April 2021 overall status Active, not recruiting expanded access info has expanded access No start date struct start date September 18, 2018 start date type Actual primary completion date struct primary completion date August 18, 2021 primary completion date type Anticipated completion date struct completion date October 18, 2021 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Essam Ahmed EL-mezien responsible party investigator title Investigator responsible party investigator affiliation Menoufia University lead sponsor lead sponsor name Menoufia University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The aim of the study is to compare the efficacy and effectiveness of Endoscopic Endonasal DCR with narrow fenstrum approach and Endoscopic Endonasal DCR with wide fenstrum approach . detailed description The lacrimal sac and the nasolacrimal duct are contiguous structures . The part of the sac superior to the medial canthal tendon (MCT) is called the fundus, with its vertical length being 3-5 mm . The body of the sac, inferior to the MCT, is about 10 mm in length. The lacrimal sac fossa comprises of the anterior frontal process of the maxillary bone and the posterior lacrimal bone .
Lacrimal clearance relies on several factors, such as gravity, capillary attraction forces, evaporation, absorption by the conjunctival surface and the lacrimal "pump" which relies on the action of the orbicularis oculi muscle, particularly its deeper part (Horner's muscle). During the eye closing, the Horner's muscle contracts and the temporal four-fifths part of the canaliculus is pressed and closed, the nasal one-fifth part is pulled posteriorly and opens with shortening of the canalicular length. Therefore, the lacrimal fluid is effectively transported from temporal to nasal sides, finally reaching the lacrimal sac cavity. During the eye opening, as the Horner's muscle relaxes, the temporal four-fifths part of the canaliculus is expanded and the nasal one-fifth part is pressed and closed. The upper part of the lacrimal sac is directly affected by the Horner's muscle movement. During eye closing the sac expands temporally, during the eye opening the sac shrinks with an additional help of its elasticity.
The clinical evaluation of the lacrimal drainage system was originally outlined by Lester Jones. Evaluation was in the form of a dye disappearance test followed by a Jones I and Jones II test. The dye disappearance test (DDT) is useful for assessing the presence or absence of adequate lacrimal outflow, especially in unilateral cases. Using a drop of sterile 2% fluorescein solution or a moistened fluorescein strip, the examiner instills fluorescein into the conjunctival fornices of each eye and then observes the tear film.
Endoscopic DCR is a widely accepted treatment option for epiphora and dacryocystitis. endoscopic DCR has been widely performed as it has several advantages over external DCR including the absence of face scarring and better visualization via endoscopy. The purpose of DCR is to create a bypass, a rhinostoma, between the lacrimal sac and the nasal cavity.
Obstruction site in the lacrimal system is one of the characteristics contributing to a poor prognosis. False localization of the lacrimal sac and inadequate removal of the medial wall of the sac are the most common causes of failure . A systematic review showed that there was a trend towards improved outcomes and reduced granulation without increased complication rates in groups where nasal mucosal and lacrimal flaps were preserved. A study reviewing 100 failed DCR patients showed that inadequate osteotomy, incomplete sac marsupialization, and cicatricial closure of the ostium were the most common causes of failure.
To avoid or prevent obstruction of the neo-ostium, many modified techniques have been attempted. These include complete separation of the sac from the nasolacrimal duct to divert lacrimal flow to the neo-ostium, use of steroids or mitomycin-C , silicon tubing and use of mucosal flaps after wide resection of bone surrounding the sac .
Initially, endoscopic DCR relied on the creation of a relatively small fenstrum into the lacrimal sac, with the surgeon opening only the lower half of the sac. Many authors claim that the axilla of the middle turbinate is a landmark for the roof of the lacrimal sac. However, Wormald and co-authors, in a study with 47 CT-DCG patients, showed that the major part of the lacrimal sac (10 mm) is situated above the axilla of the middle turbinate, extending 1-2 mm below this landmark.
Obtaining a large marsupialized lacrimal sac with wide removal of the covering bone, medial wall of the sac and use of mucosal flaps yields a good surgical result that is comparable to the results of conventional endoscopic DCR techniques with two advantages first, primary surgical failures are amenable to technically simple and highly successful surgical revisions, second, there is a possibility for obtaining wide fenstrum without silicone tube stenting.
Success after lacrimal surgery is ill defined, and this has led to confusion in the interpretation of results for various surgical methods. The most practical measure of success is the control of symptoms, although this can be at odds with anatomic outcome.
Subjective success in turn can be assessed from the patients' symptoms. Complete relief or significant improvement of complaints can be considered a subjective success.
Anatomical patency can readily be judged in objective tests: functional endoscopic dye test or inspection of the ostium, irrigation or fluorescein retention test. Functional NLDO was first described by Demorest and Miller in 1955 to encompass lacrimal drainage dysfunction in the presence of anatomical patency. In those cases, there is a need to exclude other conditions causing epiphora, such as hyper-secretion, lacrimal pump failure, discontinuous drainage apparatus and partial lacrimal duct obstruction. The anatomical success rate i.e. the patency is reported to be higher than the functional success, which highlights the importance of measuring the physiological success and there relief of the patient's symptoms. conditions module condition list condition Epiphora Dacryocystitis Dacryocystocele keyword list keyword Endoscopic DCR design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 30 enrollment type Actual arms interventions module arm group list arm group arm group label Wide fenstrum Endoscopic DCR arm group type Active Comparator arm group intervention list arm group intervention name Procedure: Endoscopic dacryocystorhinostomy arm group label Narrow Fenstrum Endoscopic DCR arm group type Active Comparator arm group intervention list arm group intervention name Procedure: Endoscopic dacryocystorhinostomy intervention list intervention intervention type Procedure intervention name Endoscopic dacryocystorhinostomy intervention description Endoscopic DCR intervention arm group label list intervention arm group label Narrow Fenstrum Endoscopic DCR Wide fenstrum Endoscopic DCR outcomes module primary outcome list primary outcome primary outcome measure Endoscopic assessment primary outcome description Measurement dimensions of the DCR ostium by measuring length and width in mile meters by using nasal endoscope primary outcome time frame 1 year postoperative primary outcome measure Objective assessment primary outcome description Objective assessment by flourscine disappearance test primary outcome time frame 1 year postoperative eligibility module eligibility criteria Inclusion Criteria:
All patients presented with epiphora due to nasolacrimal duct obstruction with patent canaliculi.
failed conservative treatment in the form of systemic antibiotics, steroid/antibiotic eye drops, decongestant nasal drops and local nasal steroid spray.
fit for surgery under general anesthesia.
Exclusion Criteria:
1- Epiphora due to pre-saccal obstruction of lacrimal drainage system.
2. Eye disease causing increased lacrimation and eyelid malposition
3. Lacrimal fistula.
4. Tumors of the lacrimal passage, nose or paranasal sinus.
5. Patients with abnormal bleeding or coagulation time. healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module location list location location facility Ahmed ragab location city Cairo location zip 002 location country Egypt references module reference list reference reference p m i d 33388192 reference type background reference citation Bertaux PJ, Gan G, Hirtz G, Mouret P, El-Hachem F, Lhuillier L, Perone JM. Evaluation of ostium size following endoscopic dacryocystorhinostomy as a predictive factor of outcome: A prospective study. J Fr Ophtalmol. 2021 Mar;44(3):397-403. doi: 10.1016/j.jfo.2020.05.024. Epub 2020 Dec 30. reference p m i d 25525327 reference type background reference citation Ali MJ, Psaltis AJ, Wormald PJ. Dacryocystorhinostomy ostium: parameters to evaluate and DCR ostium scoring. Clin Ophthalmol. 2014 Dec 9;8:2491-9. doi: 10.2147/OPTH.S73998. eCollection 2014. reference p m i d 16826055 reference type background reference citation Mann BS, Wormald PJ. Endoscopic assessment of the dacryocystorhinostomy ostium after endoscopic surgery. Laryngoscope. 2006 Jul;116(7):1172-4. doi: 10.1097/01.mlg.0000218099.33523.19. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007766 condition mesh term Lacrimal Apparatus Diseases condition mesh id D000003607 condition mesh term Dacryocystitis condition ancestor list condition ancestor condition ancestor id D000005128 condition ancestor term Eye Diseases condition browse leaf list condition browse leaf condition browse leaf id M5962 condition browse leaf name Dacryocystitis condition browse leaf as found Dacryocystitis condition browse leaf relevance high condition browse leaf id M9938 condition browse leaf name Lacrimal Apparatus Diseases condition browse leaf as found Epiphora condition browse leaf relevance high condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev All condition browse branch name All Conditions | NCT04833452 | [
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10540,
1104,
1103,
2495,
1665,
22657,
12779,
1449,
1108,
2034,
15530,
1118,
14682,
2690,
119,
27845,
1108,
1107,
1103,
1532,
1104,
170,
23966,
14158,
2774,
1723,
1118,
170,
2690,
146,
1105,
2690,
1563,
2774,
119,
1109,
23966,
14158,
2774,
113,
23232,
1942,
114,
1110,
5616,
1111,
23529,
1103,
2915,
1137,
5884,
1104,
12373,
2495,
1665,
22657,
1149,
12712,
117,
2108,
1107,
8362,
8009,
16719,
2740,
119,
7993,
170,
3968,
1104,
188,
2083,
4759,
123,
110,
23896,
12238,
2093,
1394,
5072,
1137,
170,
11758,
4772,
23896,
12238,
2093,
1394,
6322,
117,
1103,
11755,
1197,
22233,
19621,
3447,
23896,
12238,
2093,
1394,
1154,
1103,
14255,
20327,
15895,
1111,
7770,
1279,
1104,
1296,
2552,
1105,
1173,
27641,
1103,
7591,
1273,
119,
5135,
2155,
22258,
5227,
2069,
1110,
170,
3409,
3134,
3252,
5146,
1111,
174,
8508,
7880,
6533,
1105,
5358,
1665,
26503,
3457,
2050,
10721,
119,
1322,
2155,
22258,
5227,
2069,
1144,
1151,
3409,
1982,
1112,
1122,
1144,
1317,
13300,
1166,
6298,
5227,
2069,
1259,
1103,
5884,
1104,
1339,
14161,
3384,
1105,
1618,
5173,
2734,
2258,
1322,
2155,
20739,
119,
1109,
3007,
1104,
5227,
2069,
1110,
1106,
2561,
170,
13981,
117,
170,
187,
21918,
12223,
1918,
117,
1206,
1103,
2495,
1665,
22657,
21718,
1665,
1105,
1103,
21447,
19421,
119,
152,
4832,
17993,
1751,
1107,
1103,
2495,
1665,
22657,
1449,
1110,
1141,
1104,
1103,
5924,
7773,
1106,
170,
2869,
5250,
25566,
4863,
119,
143,
7264,
1162,
1469,
2734,
1104,
1103,
2495,
1665,
22657,
21718,
1665,
1105,
15694,
8116,
1104,
1103,
27598,
2095,
1104,
1103,
21718,
1665,
1132,
1103,
1211,
1887,
4680,
1104,
4290,
119,
138,
12818,
3189,
2799,
1115,
1175,
1108,
170,
10209,
2019,
4725,
13950,
1105,
3549,
176,
4047,
6856,
1443,
2569,
3254,
15534,
5600,
1107,
2114,
1187,
21447,
182,
21977,
9275,
1233,
1105,
2495,
1665,
22657,
23841,
1116,
1127,
6018,
119,
138,
2025,
19730,
1620,
2604,
5227,
2069,
4420,
2799,
1115,
15694,
184,
13894,
12355,
4527,
117,
13975,
21718,
1665,
12477,
1733,
4455,
2916,
2734,
117,
1105,
172,
4578,
11048,
2916,
8354,
1104,
1103,
184,
2050,
3656,
1127,
1103,
1211,
1887,
4680,
1104,
4290,
119,
1706,
3644,
1137,
3843,
184,
4832,
17993,
1104,
1103,
15242,
118,
184,
2050,
3656,
117,
1242,
5847,
4884,
1138,
1151,
3867,
119,
1636,
1511,
2335,
8865,
1104,
1103,
21718,
1665,
1121,
1103,
9468,
24313,
7409,
22657,
26862,
1106,
23448,
1204,
2495,
1665,
22657,
4235,
1106,
1103,
15242,
118,
184,
2050,
3656,
117,
1329,
1104,
188,
25710,
7540,
1137,
26410,
18574,
16430,
118,
140,
117,
22818,
15511,
1158,
1105,
1329,
1104,
182,
21977,
9275,
1233,
23841,
1116,
1170,
2043,
1231,
25461,
1104,
6028,
3376,
1103,
21718,
1665,
119,
7245,
117,
1322,
2155,
22258,
5227,
2069,
13892,
1113,
1103,
3707,
1104,
170,
3860,
1353,
175,
5026,
18062,
1818,
1154,
1103,
2495,
1665,
22657,
21718,
1665,
117,
1114,
1103,
10690,
2280,
1178,
1103,
2211,
1544,
1104,
1103,
21718,
1665,
119,
2408,
5752,
3548,
1115,
1103,
170,
8745,
3848,
1104,
1103,
2243,
189,
2149,
23051,
1566,
1110,
170,
10755,
1111,
1103,
3664,
1104,
1103,
2495,
1665,
22657,
21718,
1665,
119,
1438,
117,
160,
24211,
18728,
1105,
1884,
118,
5752,
117,
1107,
170,
2025,
1114,
3862,
16899,
118,
5227,
2349,
4420,
117,
2799,
1115,
1103,
1558,
1226,
1104,
1103,
2495,
1665,
22657,
21718,
1665,
113,
1275,
2608,
114,
1110,
3629,
1807,
1103,
170,
8745,
3848,
1104,
1103,
2243,
189,
2149,
23051,
1566,
117,
8177,
122,
118,
123,
2608,
2071,
1142,
10755,
119,
152,
21238,
8104,
1158,
170,
1415,
12477,
1733,
4455,
2916,
2200,
2495,
1665,
22657,
21718,
1665,
1114,
2043,
8116,
1104,
1103,
4576,
6028,
117,
27598,
2095,
1104,
1103,
21718,
1665,
1105,
1329,
1104,
182,
21977,
9275,
1233,
23841,
1116,
17376,
170,
1363,
13467,
1871,
1115,
1110,
12763,
1106,
1103,
2686,
1104,
7228,
1322,
2155,
22258,
5227,
2069,
4884,
1114,
1160,
13300,
1148,
117,
2425,
13467,
16676,
1132,
1821,
7076,
2165,
1106,
12444,
3014,
1105,
3023,
2265,
13467,
16547,
1116,
117,
1248,
117,
1175,
1110,
170,
5417,
1111,
11621,
2043,
175,
5026,
18062,
1818,
1443,
22818,
1162,
7159,
188,
5208,
1916,
119,
25911,
1170,
2495,
1665,
22657,
6059,
1110,
5178,
3393,
117,
1105,
1142,
1144,
1521,
1106,
6406,
1107,
1103,
7628,
1104,
2686,
1111,
1672,
13467,
4069,
119,
1109,
1211,
6691,
4929,
1104,
2244,
1110,
1103,
1654,
1104,
8006,
117,
1780,
1142,
1169,
1129,
1120,
10653,
1114,
1126,
10024,
7257,
9386,
119,
12859,
20913,
2244,
1107,
1885,
1169,
1129,
14758,
1121,
1103,
4420,
112,
8006,
119,
12735,
3893,
1137,
2418,
8331,
1104,
11344,
1169,
1129,
1737,
170,
23481,
2244,
119,
9954,
18778,
4571,
26227,
9517,
1169,
12337,
1129,
13680,
1107,
7649,
5715,
131,
8458,
1322,
2155,
22258,
23966,
2774,
1137,
11820,
1104,
1103,
184,
2050,
3656,
117,
14448,
1137,
23896,
12238,
2093,
1394,
23406,
2774,
119,
16068,
17264,
21239,
2137,
2346,
1108,
1148,
1758,
1118,
3177,
4982,
2050,
1105,
3902,
1107,
3115,
1106,
4035,
8178,
11229,
2495,
1665,
22657,
12779,
173,
6834,
26420,
1107,
1103,
2915,
1104,
1126,
10024,
7257,
1348,
26227,
9517,
119,
1130,
1343,
2740,
117,
1175,
1110,
170,
1444,
1106,
26132,
1168,
2975,
3989,
174,
8508,
7880,
6533,
117,
1216,
1112,
177,
24312,
118,
3318,
1988,
117,
2495,
1665,
22657,
11188,
4290,
117,
19959,
26728,
8163,
12779,
16486,
1105,
7597,
2495,
1665,
22657,
26862,
184,
4832,
17993,
119,
1109,
1126,
10024,
7257,
1348,
2244,
2603,
178,
119,
174,
119,
1103,
26227,
9517,
1110,
2103,
1106,
1129,
2299,
1190,
1103,
8458,
2244,
117,
1134,
12976,
1103,
4495,
1104,
10099,
1103,
23292,
2244,
1105,
1175,
3893,
1104,
1103,
5351,
112,
188,
8006,
119,
2975,
13196,
3879,
2190,
3879,
142,
8508,
7880,
6533,
10136,
1665,
26503,
3457,
2050,
10721,
10136,
1665,
26503,
3457,
12223,
18389,
1162,
2501,
12565,
2190,
2501,
12565,
5135,
2155,
22258,
5227,
2069,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8353,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
4539,
27989,
10224,
1204,
10803,
23992,
10803,
5099,
1476,
10803,
2076,
2173,
4746,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
15268,
175,
5026,
18062,
1818,
5135,
2155,
22258,
5227,
2069,
1981,
1372,
2076,
17244,
3291,
8223,
4626,
2772,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
5096,
9650,
3313,
131,
5135,
2155,
22258,
5358,
1665,
26503,
3457,
12223,
1197,
21918,
12223,
4527,
1981,
1372,
3107,
11896,
8674,
27868,
2050,
5697,
5135,
2155,
22258,
5227,
2069,
1981,
1372,
2076,
17244,
3291,
8223,
4626,
2772,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
5096,
9650,
3313,
131,
5135,
2155,
22258,
5358,
1665,
26503,
3457,
12223,
1197,
21918,
12223,
4527,
9108,
2190,
9108,
9108,
2076,
5096,
9650,
3313,
9108,
1271,
5135,
2155,
22258,
5358,
1665,
26503,
3457,
12223,
1197,
21918,
12223,
4527,
9108,
6136,
5135,
2155,
22258,
5227,
2069,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
11896,
8674,
27868,
2050,
5697,
5135,
2155,
22258,
5227,
2069,
15268,
175,
5026,
18062,
1818,
5135,
2155,
22258,
5227,
2069,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
5135,
2155,
22258,
8670,
2425,
9386,
6136,
2508,
2225,
3313,
1880,
10082,
1104,
1103,
5227,
2069,
184,
2050,
3656,
1118,
10099,
2251,
1105,
9346,
1107,
2837,
4865,
1118,
1606,
21447,
1322,
2155,
16260,
2425,
9386,
1159,
4207,
122,
1214,
2112,
19807,
5838,
2425,
9386,
4929,
152,
24380,
2109,
8670,
2425,
9386,
6136,
152,
24380,
2109,
8670,
1118,
15068,
1116,
15459,
14158,
2774,
2425,
9386,
1159,
4207,
122,
1214,
2112,
19807,
5838,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
1398,
4420,
2756,
1114,
174,
8508,
7880,
6533,
1496,
1106,
9468,
24313,
7409,
22657,
26862,
184,
4832,
17993,
1114,
8581,
7684,
1596,
15818,
119,
2604,
6588,
3252,
1107,
1103,
1532,
1104,
27410,
2848,
25523,
117,
188,
25710,
2386,
120,
2848,
22400,
2552,
8949,
117,
1260,
7235,
7562,
17071,
21447,
8949,
1105,
1469,
21447,
188,
25710,
2386,
13477,
119,
4218,
1111,
6059,
1223,
1704,
1126,
2556,
27300,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
122,
118,
142,
8508,
7880,
6533,
1496,
1106,
3073,
118,
21718,
19495,
1233,
184,
4832,
17993,
1104,
2495,
1665,
22657,
12779,
1449,
119,
123,
119,
9329,
3653,
3989,
2569,
2495,
1665,
19123,
2116,
1105,
2552,
17299,
12477,
1233,
14572,
124,
119,
23929,
22657,
7374,
5886,
119,
125,
119,
17037,
26271,
1116,
1104,
1103,
2495,
1665,
22657,
5885,
117,
3678,
1137,
18311,
13146,
1348,
11850,
1361,
119,
126,
119,
7195,
24767,
1114,
22832,
9793,
1137,
1884,
28026,
6840,
1159,
119,
8071,
8118,
1302,
5772,
1398,
5867,
1425,
1407,
5848,
4177,
1425,
2625,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2450,
2190,
2450,
2450,
3695,
10045,
26133,
6639,
2450,
1331,
11086,
2450,
195,
9717,
3135,
1477,
2450,
1583,
4498,
7732,
13196,
3835,
2190,
3835,
3835,
185,
182,
178,
173,
23335,
1604,
1604,
16382,
1477,
3835,
2076,
3582,
3835,
19548,
15035,
10172,
153,
4538,
117,
144,
1389,
144,
117,
8790,
3740,
1584,
144,
117,
12556,
3313,
1204,
153,
117,
2896,
118,
11679,
4386,
1306,
143,
117,
149,
23618,
14367,
1197,
149,
117,
14286,
4798,
147,
2107,
119,
27845,
1104,
184,
2050,
3656,
2060,
1378,
1322,
2155,
22258,
5358,
1665,
26503,
3457,
12223,
1197,
21918,
12223,
4527,
1112,
170,
17163,
2109,
5318,
1104,
9386,
131,
138,
19916,
2025,
119,
147,
13359,
9126,
26489,
13505,
4063,
119,
17881,
1475,
9751,
132,
3140,
113,
124,
114,
131,
3614,
1559,
118,
1969,
1495,
119,
9465,
131,
1275,
119,
7393,
1545,
120,
179,
119,
179,
14467,
119,
12795,
119,
4991,
119,
5507,
1527,
119,
142,
16091,
1830,
12795,
13063,
1476,
119,
3835,
185,
182,
178,
173,
22589,
17600,
17101,
1559,
3835,
2076,
3582,
3835,
19548,
4149,
150,
4538,
117,
153,
11794,
6620,
22078,
117,
160,
24211,
18728,
153,
4538,
119,
10136,
1665,
26503,
3457,
12223,
1197,
21918,
12223,
4527,
184,
2050,
3656,
131,
11934,
1106,
17459,
1105,
5227,
2069,
184,
2050,
3656,
3859,
119,
140,
2836,
9126,
17439,
7654,
3702,
1233,
119,
1387,
13063,
130,
132,
129,
131,
26409,
1475,
118,
130,
119,
9465,
131,
1275,
119,
21692,
1559,
120,
152,
2101,
24162,
119,
156,
1559,
24786,
1580,
1604,
119,
174,
1658,
12666,
10294,
2116,
1387,
119,
3835,
185,
182,
178,
173,
18030,
25129,
1568,
25491,
3835,
2076,
3582,
3835,
19548,
10852,
21948,
117,
160,
24211,
18728,
153,
4538,
119,
5135,
2155,
22258,
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full study rank 61268 study protocol section identification module n c t id NCT04838678 org study id info org study id STU2020-0749 organization org full name University of Texas Southwestern Medical Center org class OTHER brief title Sympathetic Transduction in Obesity-associated Hypertension (OB-HTN) official title Sympathetic Neural Patterns and Transduction in Obesity-associated Hypertension acronym OB-HTN status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 18, 2021 start date type Actual primary completion date struct primary completion date September 2025 primary completion date type Anticipated completion date struct completion date September 2025 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date August 8, 2022 last update post date struct last update post date August 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Christopher Hearon responsible party investigator title Assistant Instructor responsible party investigator affiliation University of Texas Southwestern Medical Center lead sponsor lead sponsor name University of Texas Southwestern Medical Center lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No description module brief summary The purpose of this study is to understand how the nervous system communicates to blood vessels to increase blood pressure during stress. The study will also investigate how hypertension and obesity influence the nervous system and vascular function. The study will involve measuring sympathetic nervous system activity and blood flow during common laboratory physiological stress protocols (e.g. hypoxia, exercise), and in response to infusion of drugs that cause vasodilation or vasoconstriction. conditions module condition list condition Hypertension Obesity keyword list keyword NPY design module study type Interventional phase list phase Early Phase 1 design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Basic Science design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Healthy Control arm group type Experimental arm group description Healthy age matched controls with no history of cardiovascular disease and normal bodyweight arm group intervention list arm group intervention name Drug: Neuropeptide Y arm group label Hypertensive arm group type Experimental arm group description Hypertensive adults who are not obese arm group intervention list arm group intervention name Drug: Neuropeptide Y arm group label Obese arm group type Experimental arm group description Obese adults who are not hypertensive arm group intervention list arm group intervention name Drug: Neuropeptide Y arm group label Obese-hypertensive arm group type Experimental arm group description Obese adults who are being treated for hypertension arm group intervention list arm group intervention name Drug: Neuropeptide Y intervention list intervention intervention type Drug intervention name Neuropeptide Y intervention description intra-arterial infusion of neuropeptide Y intervention arm group label list intervention arm group label Healthy Control Hypertensive Obese Obese-hypertensive outcomes module primary outcome list primary outcome primary outcome measure Blood flow measured by doppler ultrasound primary outcome description brachial and femoral artery blood flow primary outcome time frame Acutely on the day of study primary outcome measure Muscle sympathetic nervous system activity primary outcome description recording of sympathetic nervous system activity from the peroneal or radial nerve primary outcome time frame Acutely on the day of study eligibility module eligibility criteria Inclusion Criteria:
Control - BMI<30, age 18-55
Hypertensive - BMI<30, age 18-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring Obese- BMI>30, age 18-55 Obese-hypertensive- BMI>30, age 18-55, diagnosis of hypertension by 24-hour ambulatory blood pressure monitoring
Exclusion Criteria:
All groups - presence of other significant cardiovascular disease, renal disease, history of smoking, diabetes, healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 55 Years std age list std age Adult contacts locations module central contact list central contact central contact name Christopher M Hearon, Ph.D. central contact role Contact central contact phone 214-345-4624 central contact e mail christopher.hearon@utsouthwestern.edu central contact name Mary Childers central contact role Contact central contact phone 214-345-6459 central contact e mail marychilders@texashealth.org location list location location facility University of Texas Southwestern Medical Center location status Recruiting location city Dallas location state Texas location zip 75231 location country United States location contact list location contact location contact name CHristopher Hearon location contact role Contact location contact phone 815-540-5612 location contact e mail christopherhearon@texashealth.org derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006973 condition mesh term Hypertension condition mesh id D000009765 condition mesh term Obesity condition ancestor list condition ancestor condition ancestor id D000044343 condition ancestor term Overnutrition condition ancestor id D000009748 condition ancestor term Nutrition Disorders condition ancestor id D000050177 condition ancestor term Overweight condition ancestor id D000001835 condition ancestor term Body Weight condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M11853 condition browse leaf name Obesity condition browse leaf as found Obesity condition browse leaf relevance high condition browse leaf id M9176 condition browse leaf name Hypertension condition browse leaf as found Hypertension condition browse leaf relevance high condition browse leaf id M24460 condition browse leaf name Overnutrition condition browse leaf relevance low condition browse leaf id M11836 condition browse leaf name Nutrition Disorders condition browse leaf relevance low condition browse leaf id M25339 condition browse leaf name Overweight condition browse leaf relevance low condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases | NCT04838678 | [
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23249,
1545,
1559,
1604,
8916,
2025,
25021,
23992,
8916,
2025,
25021,
23676,
2591,
10973,
10973,
118,
5004,
1527,
1580,
2369,
8916,
1554,
1271,
1239,
1104,
2245,
22557,
3875,
1945,
8916,
1705,
152,
24162,
9637,
4094,
1641,
156,
17162,
16606,
9265,
13809,
11243,
1107,
152,
27655,
118,
2628,
145,
24312,
23826,
1988,
113,
152,
2064,
118,
145,
1942,
2249,
114,
2078,
1641,
156,
17162,
16606,
9265,
151,
8816,
1348,
7195,
16748,
1116,
1105,
13809,
11243,
1107,
152,
27655,
118,
2628,
145,
24312,
23826,
1988,
22478,
152,
2064,
118,
145,
1942,
2249,
2781,
13196,
2781,
22480,
2236,
1360,
17881,
1477,
2905,
2781,
11336,
1665,
27975,
1158,
3631,
2469,
23992,
1144,
3631,
2469,
1302,
1838,
2236,
188,
23055,
1838,
2236,
1351,
1407,
117,
17881,
1475,
1838,
2236,
2076,
2173,
4746,
2425,
6026,
2236,
188,
23055,
2425,
6026,
2236,
1347,
17881,
1571,
2425,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
6026,
2236,
188,
23055,
6026,
2236,
1347,
17881,
1571,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
2025,
1148,
12295,
2236,
1364,
127,
117,
17881,
1475,
2025,
1148,
12295,
186,
172,
2236,
1364,
129,
117,
17881,
1475,
2025,
1148,
2112,
2236,
188,
23055,
2025,
1148,
2112,
2236,
1364,
130,
117,
17881,
1475,
2025,
1148,
2112,
2236,
2076,
2173,
4746,
1314,
11984,
12295,
2236,
1360,
129,
117,
17881,
1477,
1314,
11984,
2112,
2236,
188,
23055,
1314,
11984,
2112,
2236,
1360,
1275,
117,
17881,
1477,
1314,
11984,
2112,
2236,
2076,
2173,
4746,
10767,
24146,
13196,
2784,
1710,
2784,
1710,
2076,
8013,
1130,
5710,
3121,
25524,
1766,
2784,
1710,
17805,
1554,
1271,
4978,
22038,
1320,
2784,
1710,
17805,
1641,
5414,
1130,
2050,
5082,
9363,
2784,
1710,
17805,
13494,
1239,
1104,
2245,
22557,
3875,
1945,
1730,
10767,
1730,
10767,
1271,
1239,
1104,
2245,
22557,
3875,
1945,
1730,
10767,
1705,
152,
24162,
9637,
20051,
13196,
20051,
1144,
173,
182,
172,
2160,
1110,
175,
173,
170,
12521,
3850,
2160,
1110,
175,
173,
170,
12521,
4442,
1302,
6136,
13196,
4094,
14940,
1109,
3007,
1104,
1142,
2025,
1110,
1106,
2437,
1293,
1103,
5604,
1449,
10621,
1116,
1106,
1892,
5956,
1106,
2773,
1892,
2997,
1219,
6600,
119,
1109,
2025,
1209,
1145,
8242,
1293,
177,
24312,
23826,
1988,
1105,
184,
27655,
2933,
1103,
5604,
1449,
1105,
26557,
3053,
119,
1109,
2025,
1209,
8803,
10099,
13493,
5604,
1449,
3246,
1105,
1892,
4235,
1219,
1887,
8087,
23292,
6600,
19755,
113,
174,
119,
176,
119,
177,
1183,
26466,
1465,
117,
6730,
114,
117,
1105,
1107,
2593,
1106,
1107,
17149,
1104,
5557,
1115,
2612,
191,
2225,
5412,
16230,
1137,
191,
2225,
13335,
4199,
11048,
2116,
119,
2975,
13196,
3879,
2190,
3879,
145,
24312,
23826,
1988,
152,
27655,
2501,
12565,
2190,
2501,
12565,
151,
2101,
3663,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
4503,
12278,
122,
1902,
23992,
1902,
18205,
7922,
118,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
11568,
2444,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
7330,
113,
3353,
20943,
114,
10803,
23992,
10803,
5099,
1620,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
3225,
1183,
6342,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
3225,
1183,
1425,
10260,
7451,
1114,
1185,
1607,
1104,
3621,
25575,
3653,
1105,
2999,
1404,
7150,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
151,
8816,
15622,
6451,
3269,
162,
1981,
1372,
3107,
145,
24312,
27291,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
145,
24312,
27291,
6323,
1150,
1132,
1136,
184,
12866,
1162,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
151,
8816,
15622,
6451,
3269,
162,
1981,
1372,
3107,
152,
12866,
1162,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
152,
12866,
1162,
6323,
1150,
1132,
1136,
177,
24312,
27291,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
151,
8816,
15622,
6451,
3269,
162,
1981,
1372,
3107,
152,
12866,
1162,
118,
177,
24312,
27291,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
152,
12866,
1162,
6323,
1150,
1132,
1217,
5165,
1111,
177,
24312,
23826,
1988,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
151,
8816,
15622,
6451,
3269,
162,
9108,
2190,
9108,
9108,
2076,
13982,
9108,
1271,
151,
8816,
15622,
6451,
3269,
162,
9108,
6136,
1107,
4487,
118,
1893,
19860,
1107,
17149,
1104,
24928,
11955,
3186,
6451,
3269,
162,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
3225,
1183,
6342,
145,
24312,
27291,
152,
12866,
1162,
152,
12866,
1162,
118,
177,
24312,
27291,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
5657,
4235,
7140,
1118,
1202,
8661,
2879,
18737,
22909,
2425,
9386,
6136,
12418,
27018,
1233,
1105,
175,
5521,
17536,
18593,
1892,
4235,
2425,
9386,
1159,
4207,
138,
23987,
1193,
1113,
1103,
1285,
1104,
2025,
2425,
9386,
4929,
19569,
1116,
10536,
13493,
5604,
1449,
3246,
2425,
9386,
6136,
2730,
1104,
13493,
5604,
1449,
3246,
1121,
1103,
1679,
4798,
1348,
1137,
17172,
9071,
2425,
9386,
1159,
4207,
138,
23987,
1193,
1113,
1103,
1285,
1104,
2025,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
6342,
118,
139,
14038,
133,
1476,
117,
1425,
1407,
118,
3731,
145,
24312,
27291,
118,
139,
14038,
133,
1476,
117,
1425,
1407,
118,
3731,
117,
12645,
1104,
177,
24312,
23826,
1988,
1118,
1572,
118,
2396,
1821,
23601,
6207,
1892,
2997,
9437,
152,
12866,
1162,
118,
139,
14038,
135,
1476,
117,
1425,
1407,
118,
3731,
152,
12866,
1162,
118,
177,
24312,
27291,
118,
139,
14038,
135,
1476,
117,
1425,
1407,
118,
3731,
117,
12645,
1104,
177,
24312,
23826,
1988,
1118,
1572,
118,
2396,
1821,
23601,
6207,
1892,
2997,
9437,
16409,
1665,
17855,
140,
10587,
3464,
131,
1398,
2114,
118,
2915,
1104,
1168,
2418,
3621,
25575,
3653,
117,
1231,
7050,
3653,
117,
1607,
1104,
9987,
117,
17972,
117,
8071,
8118,
138,
19515,
15384,
1116,
3225,
1183,
19340,
5772,
1398,
5867,
1425,
1407,
5848,
4177,
1425,
3731,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
10492,
4541,
13196,
2129,
3232,
2190,
2129,
3232,
2129,
3232,
1271,
4978,
150,
22038,
1320,
117,
7642,
119,
141,
119,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
21692,
118,
26625,
118,
3993,
19598,
2129,
3232,
174,
6346,
22572,
26691,
15940,
119,
2100,
1320,
137,
190,
2145,
16397,
14291,
16748,
119,
5048,
1358,
2129,
3232,
1271,
2090,
6405,
1468,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
21692,
118,
26625,
118,
3324,
1571,
1580,
2129,
3232,
174,
6346,
12477,
1616,
21289,
1468,
137,
21359,
20192,
21581,
1348,
1582,
119,
8916,
2450,
2190,
2450,
2450,
3695,
1239,
1104,
2245,
22557,
3875,
1945,
2450,
2781,
11336,
1665,
27975,
1158,
2450,
1331,
5043,
2450,
1352,
2245,
2450,
195,
9717,
3453,
22737,
1475,
2450,
1583,
1244,
1311,
2450,
3232,
2190,
2450,
3232,
2450,
3232,
1271,
24890,
26691,
15940,
22038,
1320,
2450,
3232,
1648,
24367,
2450,
3232,
2179,
5615,
1571,
118,
22120,
118,
4376,
11964,
2450,
3232,
174,
6346,
22572,
26691,
15940,
13836,
3484,
137,
21359,
20192,
21581,
1348,
1582,
119,
8916,
4408,
2237,
1940,
1116,
1665,
23992,
13196,
1683,
10266,
1382,
5507,
117,
17881,
1477,
3879,
11424,
1162,
13196,
3879,
24000,
2190,
3879,
24000,
3879,
24000,
25021,
141,
7629,
7629,
1568,
1545,
1580,
1559,
1495,
3879,
24000,
1858,
145,
24312,
23826,
1988,
3879,
24000,
25021,
141,
7629,
7629,
1568,
1580,
1559,
27677,
3879,
24000,
1858,
152,
27655,
3879,
13596,
2190,
3879,
13596,
3879,
13596,
25021,
141,
7629,
7629,
25041,
23124,
1495,
3879,
13596,
1858,
3278,
12251,
7729,
1988,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1580,
1559,
19203,
3879,
13596,
1858,
151,
23016,
12120,
21484,
10097,
3879,
13596,
25021,
141,
7629,
7629,
11049,
16770,
1559,
3879,
13596,
1858,
3278,
7150,
3879,
13596,
25021,
141,
7629,
7629,
24400,
1604,
19297,
3879,
13596,
1858,
10341,
25589,
3879,
13596,
25021,
141,
7629,
7629,
17175,
27677,
1477,
3879,
13596,
1858,
159,
2225,
11702,
20012,
1116,
3879,
13596,
25021,
141,
7629,
7629,
1568,
22737,
15292,
3879,
13596,
1858,
10103,
25575,
20012,
1116,
3879,
11424,
1162,
7404,
2190,
3879,
11424,
1162,
7404,
3879,
11424,
1162,
7404,
25021,
26528,
15292,
24239,
3879,
11424,
1162,
7404,
1271,
152,
27655,
3879,
11424,
1162,
7404,
1112,
1276,
152,
27655,
3879,
11424,
1162,
7404,
25319,
1344,
3879,
11424,
1162,
7404,
25021,
150,
1580,
16770,
1545,
3879,
11424,
1162,
7404,
1271,
145,
24312,
23826,
1988,
3879,
11424,
1162,
7404,
1112,
1276,
145,
24312,
23826,
1988,
3879,
11424,
1162,
7404,
25319,
1344,
3879,
11424,
1162,
7404,
25021,
150,
19598,
23435,
1568,
3879,
11424,
1162,
7404,
1271,
3278,
12251,
7729,
1988,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
7404,
25021,
26528,
15292,
22997,
3879,
11424,
1162,
7404,
1271,
151,
23016,
12120,
21484,
10097,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
7404,
25021,
150,
17600,
23493,
1580,
3879,
11424,
1162,
7404,
1271,
3278,
7150,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
7404,
25021,
150,
23117,
1545,
1545,
3879,
11424,
1162,
7404,
1271,
10341,
25589,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
7404,
25021,
26528,
27677,
1571,
1477,
3879,
11424,
1162,
7404,
1271,
159,
2225,
11702,
20012,
1116,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
3392,
2190,
3879,
11424,
1162,
3392,
3879,
11424,
1162,
3392,
170,
13834,
1874,
1964,
3823,
15292,
3879,
11424,
1162,
3392,
1271,
151,
23016,
1348,
1105,
19415,
6639,
14987,
20012,
1116,
3879,
11424,
1162,
3392,
170,
13834,
1874,
1964,
3823,
22737,
3879,
11424,
1162,
3392,
1271,
156,
17162,
6451,
17112,
1105,
1615,
17392,
4807,
3879,
11424,
1162,
3392,
170,
13834,
1874,
1964,
1398,
3879,
11424,
1162,
3392,
1271,
1398,
16752,
16718,
3879,
11424,
1162,
3392,
170,
13834,
1874,
1964,
3823,
17175,
3879,
11424,
1162,
3392,
1271,
4641,
1105,
5657,
20012,
1116,
102
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full study rank 61405 study protocol section identification module n c t id NCT04836897 org study id info org study id A-valve-2020-07 organization org full name Shanghai NewMed Medical Co., Ltd. org class INDUSTRY brief title PrizValve® Transcatheter Aortic Valve Replacement Study official title Evaluation of the Efficacy and Safety of the Transcatheter Aortic Valve Replacement System in Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk status module status verified date June 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date January 19, 2021 start date type Actual primary completion date struct primary completion date June 2023 primary completion date type Anticipated completion date struct completion date June 2028 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date June 27, 2022 last update post date struct last update post date June 28, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Shanghai NewMed Medical Co., Ltd. lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery. detailed description This study is an multicenter, single-arm, prospective, safety and performance clinical study. conditions module condition list condition Aortic Valve Stenosis design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 120 enrollment type Anticipated arms interventions module arm group list arm group arm group label Treatment arm group type Experimental arm group description Transcatheter aortic valve replacement arm group intervention list arm group intervention name Device: PrizValve® valve and transapical delivery system intervention list intervention intervention type Device intervention name PrizValve® valve and transapical delivery system intervention description Transcatheter aortic valve replacement system intervention arm group label list intervention arm group label Treatment outcomes module primary outcome list primary outcome primary outcome measure Freedom from all-cause mortality primary outcome description All-cause mortality within 12 months of TAVI procedure primary outcome time frame 12 months secondary outcome list secondary outcome secondary outcome measure Freedom from all-cause mortality secondary outcome description All-cause mortality within 2-5 years of TAVI procedure secondary outcome time frame 2-5 years secondary outcome measure Device success secondary outcome description Device success after TAVI secondary outcome time frame immediate post-surgical secondary outcome measure Procedural success secondary outcome description Procedural success after TAVI secondary outcome time frame immediate post-surgical secondary outcome measure Rate of Myocardial infarction secondary outcome description Rate of Myocardial infarction after TAVI secondary outcome time frame 30 days、6 months、1-5 years secondary outcome measure Rate of All disabling stroke secondary outcome description Rate of All disabling stroke after TAVI secondary outcome time frame 30 days、6 months、1-5 years secondary outcome measure Rate of Severe bleeding secondary outcome description Rate of Severe bleeding after TAVI secondary outcome time frame 30 days、6 months、1-5 years eligibility module eligibility criteria Inclusion Criteria:
Age ≥ 65 years ;
Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area<1.0cm2, or AVA <0.5cm2 /m2);
NYHA ≥ II;
Life expectancy> 12 months;
Patients who are anatomically suitable for transcatheter aortic valve implantation;
After evaluation by two or more cardiovascular surgeons, patients who are unsuitable for surgery; or patients who refuse surgery after sufficient communication by the surgeons and are at high risk of routine surgery;
Patients who can understand the purpose of the trial, voluntarily participate in and signed informed consent form, and are willing to accept relevant examinations and clinical follow-ups.
Exclusion Criteria:
Acute myocardial infarction occurred within 1 month before this treatment;
Congenital single leaf aortic valve;
Any therapeutic cardiac operation (including placement of coronary drug-eluting stents) within 30 days;
The patient's heart has been implanted with other artificial heart valves, artificial rings, or severe mitral regurgitation (>3+);
Blood system diseases or abnormalities, including leukopenia (WBC<3×109/L), acute anemia (HB <90g/L), thrombocytopenia (PLT<50×109/L), bleeding constitution and coagulopathy ；
Untreated severe coronary artery stenosis that requires revascularization;
Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
Patients who need emergency surgery for any reason;
Hypertrophic cardiomyopathy with obstruction;
Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
The echocardiogram indicates the presence of a heart mass, thrombus or vegetation;
A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
Are allergic to cobalt-chromium alloys or contrast agents, and cannot tolerate anticoagulation and antiplatelet therapy;
The diameter of the aortic valve annulus <16mm or >28mm;
In any case, patients who refuse surgical treatment in emergency situations;
Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;
Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, obvious curvature of the aortic arch, atherosclerosis of the aortic arch, narrowing of the abdominal or thoracic aorta, and obvious curvature or extension of the thoracic aorta;
The iliac-femoral artery is severely obstructed with calcification, severely tortuous or unable to place the 1418F catheter sheath kit;
Active infective endocarditis or other active infections;
Aortic valve leaflets calcified plaque close to the coronary ostium;
Severe disability Alzheimer's disease and unable to take care of oneself in life;
Those who have participated in clinical trials of other drugs or medical devices before entering the group and have not yet reached the time limit of the primary research endpoint;
The researcher judged that the patient had poor compliance and could not complete the study as required. healthy volunteers No gender All minimum age 65 Years std age list std age Older Adult contacts locations module overall official list overall official overall official name Chen mao, Chief overall official affiliation Study Principal Investigator overall official role Study Chair location list location location facility Department of Cardiology, West China Hospital, Sichuan University location city Sichuan location country China i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001024 condition mesh term Aortic Valve Stenosis condition mesh id D000003251 condition mesh term Constriction, Pathologic condition ancestor list condition ancestor condition ancestor id D000020763 condition ancestor term Pathological Conditions, Anatomical condition ancestor id D000082862 condition ancestor term Aortic Valve Disease condition ancestor id D000006349 condition ancestor term Heart Valve Diseases condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000014694 condition ancestor term Ventricular Outflow Obstruction condition browse leaf list condition browse leaf condition browse leaf id M3492 condition browse leaf name Aortic Valve Stenosis condition browse leaf as found Aortic Valve Stenosis condition browse leaf relevance high condition browse leaf id M5627 condition browse leaf name Constriction, Pathologic condition browse leaf as found Stenosis condition browse leaf relevance high condition browse leaf id M21672 condition browse leaf name Pathological Conditions, Anatomical condition browse leaf relevance low condition browse leaf id M2380 condition browse leaf name Aortic Valve Disease condition browse leaf relevance low condition browse leaf id M8589 condition browse leaf name Heart Valve Diseases condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id M16592 condition browse leaf name Ventricular Outflow Obstruction condition browse leaf relevance low condition browse leaf id T449 condition browse leaf name Aortic Valve Stenosis condition browse leaf as found Aortic Valve Stenosis condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases | NCT04836897 | [
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full study rank 61785 study protocol section identification module n c t id NCT04831957 org study id info org study id UZCompte3 organization org full name Universitair Ziekenhuis Brussel org class OTHER brief title Hypothyroidism After the TAVI Procedure in Elderly Patients official title Hypothyroidism After the TAVI Procedure in Elderly Patients status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date July 26, 2021 start date type Actual primary completion date struct primary completion date December 31, 2023 primary completion date type Anticipated completion date struct completion date December 31, 2023 completion date type Anticipated study first submit date March 19, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date November 6, 2022 last update post date struct last update post date November 8, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Nathalie compté responsible party investigator title Clinic head of geriatric unit responsible party investigator affiliation Universitair Ziekenhuis Brussel lead sponsor lead sponsor name Universitair Ziekenhuis Brussel lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Aortic stenosis is highly prevalent in advancing age. The prognosis of this disease has dramatically changed with the surgical replacement of the aortic valve and the trans catheter aortic valve re-placement (TAVI). The TAVI procedure is also successful in octogenarians and frail patients. However, the evaluation before the TAVI procedure requires a high dosage of iodinated contrast agent with, consequently, an increased risk for thyroid dysfunction. The primary endpoint of this study is to assess, prospectively, the incidence and the predictive factors (underlying thyroid disease, medication, food preservative, topical antiseptics) of hypothyroidism after a TAVI procedure. The secondary endpoint is the influence of the occurrence of hypothyroidism after the TAVI procedure on the geriatric assessment. detailed description Aortic stenosis is highly prevalent in advancing age. The prevalence is 2.5% at an age of 75 years and 8.1% at an age of 85 years. The estimated mortality after onset of symptoms (dizziness, syncope, thoracic pain and dyspnea) with conventional medical treatment is 75% after 3 years follow up. The prognosis of this disease has dramatically changed with the surgical replacement of the aortic valve. However, an open surgical procedure is not always possible in high risk patients for anatomical reasons (sternotomy, radiation and chest deformation) or comorbidities defined by the Euroscore and the Society of Thoracic Surgeons' risk score (STS score).
Trans-catheter aortic valve replacement (TAVI) is becoming the standard care of patients suffering of non-operable, high risk severe and symptomatic aortic stenosis. The TAVI procedure is associated with immediate hemodynamic improvement characterized by a decreased aortic valve mean pressure gradient, an improved left ventricular end systolic volume and mass, a decreased end ventricular diastolic volume and a better ejection fraction. This hemodynamic improvement translates into better clinical outcomes. Mortality rates (2.2% and 6.7% at one month and at one year) and long term stroke rate are similar after TAVI or surgical replacement.
The TAVI procedure is also successful in octogenarian and in frail patients. Consequently, patient's frailty is a growing argument to refer the patient for a percutaneous treatment of valve disease instead of a conventional surgical approach.
The standard evaluation before the TAVI procedure comprises some radiologic studies with iodinated contrast agent (coronarography, thoracic CT scanner and the TAVI procedure itself). Furthermore, some patients require a treatment with Amiodarone® because of the occurrence of atrial fibrillation during the procedure.
A typical iodinated contrast study confers 13500 µg of free iodine and 15-60g of bound iodine (several hundred thousand times above the recommended daily intake). An excess of iodium expo-sure can lead to thyroid dysfunction:
Hyperthyroidism particularly in patients with underlying nodular thyroid disease (Jod-Basedow effect).
Hypothyroidism in patients with underlying thyroid disease or in patients who are taking medication (lithium, amiodarone) which can lead to thyroid dysfunction. The mechanism of iodinated contrast agent hypothyroidism is the failure to escape of the acute Wolf-Chaikoff effect.
Amiodarone confers 3-21 mg iodine daily and can also lead to thyroid dysfunction particularly in patients with underlying thyroid disease because of the failure to escape of the acute Wolf-Chaikoff effect. An autoimmune mechanism is also described.
Epidemiology In our recent clinical practice (geriatric day hospital UZ Brussel), an increased incidence of hypothyroidism in elderly patients after a TAVI procedure has been observed. In our knowledge, there are no data about the incidence of hypothyroidism and what could be the impact for elderly patients after a TAVI procedure. conditions module condition list condition Hypothyroidism TAVI keyword list keyword Hypothyroidism TAVI design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design intervention model description Academic trial, prospective study design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 20 enrollment type Anticipated arms interventions module arm group list arm group arm group label Patient underwent TAVI procedure arm group type Other arm group description - Elderly patients who will undergo a TAVI procedure coming to the geriatric day hospital arm group intervention list arm group intervention name Diagnostic Test: Assesment of thyroïd function intervention list intervention intervention type Diagnostic Test intervention name Assesment of thyroïd function intervention description Blood sample for TSH, fT4, fT3, anti TPO, anti TG thyroid ultra sound Iodine urine sample intervention arm group label list intervention arm group label Patient underwent TAVI procedure outcomes module primary outcome list primary outcome primary outcome measure to assess prospectively the incidence of hypothyroidism after a TAVI procedure. primary outcome description Change is value of TSH and fT4, primary outcome time frame Baseline, at 4-8-12 weeks primary outcome measure To assess the underlying thyroid disease primary outcome description Presence of thyroid nodule door ultra sound primary outcome time frame At baseline primary outcome measure To assess the influence of iodinated constrast on hypothyroidism primary outcome description Value of presence of Iodine in urine sample primary outcome time frame At 4 weeks primary outcome measure To assess the influence of autoimmune disease on hypothyroidism after TAVI primary outcome description Anti TPO primary outcome time frame Baseline primary outcome measure To assess the influence of presence of antibodies on hypothyroidism after TAVI primary outcome description Anti TG primary outcome time frame Baseline secondary outcome list secondary outcome secondary outcome measure to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on dependence level secondary outcome description Value of dependance through :
- Katz scale (ADL: assessment of activities of daily living): It rates 6 tasks of daily liv-ing (bathing, dressing, toilet, transfer, continence and eating) on a scale from 1 to 4. A low score means absence of dependence, and a high score the maximum of de-pendence for the task secondary outcome time frame Baseline and at 1 month secondary outcome measure to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on the cognitive function secondary outcome description Value of MMSE (Mini Mental Status Examination): a 0-30 score of cognitive func-tions,<25/30 meaning cognitive function impairment secondary outcome time frame Baseline and at 1 month secondary outcome measure to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on depression secondary outcome description Value of GDS (geriatric depression scale) a 0-15 score. A score > 15 means risk for depression secondary outcome time frame Baseline and at 1 month secondary outcome measure to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on mobility secondary outcome description Value of mobility through
Tinetti : a 0-28 score : a score < 26 means mobility problems
Timed up and go : Impaired mobility if > 12.5s
4 meter walking speed : risico for sarcopenia if speed > 0.7m/s secondary outcome time frame Baseline and at 1 month secondary outcome measure to assess the influence of the occurrence of hypothyroidism after the TAVI procedure on instrumental daily living secondary outcome description - lawton scale (assessment of instrumentary assessment of activities of daily living) a 0-27 score; a high score means independence; a low score means dependence secondary outcome time frame Baseline and at 1 month eligibility module eligibility criteria Inclusion Criteria:
Provision of signed and dated, written Informed Consent prior to any study specific proce-dures
Patient: males and females must be ≥ 70 years old
Patients who will undergo a TAVI procedure
Exclusion Criteria:
- No obtained signed, dated and written Informed Consent.
Known thyroid dysfunction (for example: Basedow, Hashimoto,...)
Patients receiving any of the following: Lithium, Strumazol or a recent treatment of radio-Iode healthy volunteers No gender All minimum age 70 Years std age list std age Older Adult contacts locations module central contact list central contact central contact name nathalie Compté, Dr, PhD central contact role Contact central contact phone 024749159 central contact phone ext 9159 central contact e mail nathalie.compte@uzbrussel.be central contact name Bert Bravenboer, Dr, PhD central contact role Contact central contact phone 024749512 central contact phone ext 9512 central contact e mail bert.Bravenboer@uzbrussel.be location list location location facility UZ brussel location status Recruiting location city Brussel location zip 1090 location country Belgium location contact list location contact location contact name Nathalie Compté, PhD location contact role Contact location contact phone 024749159 location contact phone ext 9159 location contact e mail nathalie.compte@uzbrussel.be location contact name Bert Bravenboer, PhD location contact role Contact location contact phone 024749512 location contact phone ext 9512 location contact e mail bert.bravenboer@uzbrussel.be references module reference list reference reference p m i d 23176901 reference type background reference citation Stone ML, Kern JA, Sade RM. Transcatheter aortic valve replacement: clinical aspects and ethical considerations. Ann Thorac Surg. 2012 Dec;94(6):1791-5. doi: 10.1016/j.athoracsur.2012.09.047. Review. reference p m i d 19379882 reference type background reference citation Leontyev S, Walther T, Borger MA, Lehmann S, Funkat AK, Rastan A, Kempfert J, Falk V, Mohr FW. Aortic valve replacement in octogenarians: utility of risk stratification with EuroSCORE. Ann Thorac Surg. 2009 May;87(5):1440-5. doi: 10.1016/j.athoracsur.2009.01.057. reference p m i d 22443479 reference type background reference citation Kodali SK, Williams MR, Smith CR, Svensson LG, Webb JG, Makkar RR, Fontana GP, Dewey TM, Thourani VH, Pichard AD, Fischbein M, Szeto WY, Lim S, Greason KL, Teirstein PS, Malaisrie SC, Douglas PS, Hahn RT, Whisenant B, Zajarias A, Wang D, Akin JJ, Anderson WN, Leon MB; PARTNER Trial Investigators. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012 May 3;366(18):1686-95. doi: 10.1056/NEJMoa1200384. Epub 2012 Mar 26. reference p m i d 22820214 reference type background reference citation Leung AM, Braverman LE. Iodine-induced thyroid dysfunction. Curr Opin Endocrinol Diabetes Obes. 2012 Oct;19(5):414-9. doi: 10.1097/MED.0b013e3283565bb2. Review. reference p m i d 30309693 reference type background reference citation Trohman RG, Sharma PS, McAninch EA, Bianco AC. Amiodarone and thyroid physiology, pathophysiology, diagnosis and management. Trends Cardiovasc Med. 2019 Jul;29(5):285-295. doi: 10.1016/j.tcm.2018.09.005. Epub 2018 Sep 20. i p d sharing statement module i p d sharing No i p d sharing description no sharing plan derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000007037 condition mesh term Hypothyroidism condition ancestor list condition ancestor condition ancestor id D000013959 condition ancestor term Thyroid Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M9239 condition browse leaf name Hypothyroidism condition browse leaf as found Hypothyroidism condition browse leaf relevance high condition browse leaf id M15870 condition browse leaf name Thyroid Diseases condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M9640 intervention browse leaf name Iodine intervention browse leaf relevance low intervention browse leaf id M229687 intervention browse leaf name Cadexomer iodine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Micro intervention browse branch name Micronutrients intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04831957 | [
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full study rank 61392 study protocol section identification module n c t id NCT04837066 org study id info org study id IRB-FY20-339 organization org full name California State University, Northridge org class OTHER brief title Dynamic Vision Testing and Concussion Management official title Dynamic Vision Testing and Concussion Management status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 31, 2021 start date type Actual primary completion date struct primary completion date August 15, 2024 primary completion date type Anticipated completion date struct completion date August 15, 2024 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 12, 2022 last update post date struct last update post date April 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Aimie Kachingwe responsible party investigator title Primary Investigator responsible party investigator affiliation California State University, Northridge lead sponsor lead sponsor name California State University, Northridge lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play. detailed description The subjects of interest are CSUN student-athletes who give consent to participate in the study. Dynamic vision will be assessed through the administration of the Dynamic Visual Acuity (DVA) test and the Gaze Stabilization Test (GST). Additionally, the 6-condition Balance Error Scoring System (BESS), which is currently a component of CSUN's established concussion protocol, will be administered to assess balance impairments. This cluster of tests will be administered three times per athlete: (1) during preseason to establish baseline measures, (2) acutely post-concussion once the athlete subject has been cleared by the team physician for return to exercise, and (3) when cleared to return to sport. The results will be used to evaluate whether or not dynamic vision results have returned to baseline by the time that CSUN Athletics clears the athlete to "Return to Play." conditions module condition list condition Head Injury Sport Injury Concussion, Brain design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 100 enrollment type Anticipated arms interventions module intervention list intervention intervention type Diagnostic Test intervention name Dynamic Vision Testing (Bertec Vision Advantage System) and Balance Error Scoring System intervention description Assessment tool and computerized tests designed to evaluate postural stability and vestibulo-ocular reflex (VOR) function while assisting with return to play decision after a sports-related concussion. outcomes module primary outcome list primary outcome primary outcome measure 6-Condition BESS primary outcome description Number of errors and time subject was able to hold position primary outcome time frame August 15, 2021 - August 15, 2024 primary outcome measure Gaze Stabilization Test (GST) primary outcome description Maximum head velocity in degrees/second primary outcome time frame August 15, 2021 - August 15, 2024 primary outcome measure Dynamic Visual Acuity (DVA) primary outcome description Log of minimal angle resolvable units (LogMAR). The number of lines on an eye chart that are lost with head moving (DVA) compared to the head steady condition, known as static visual acuity (SVA) primary outcome time frame August 15, 2021 - August 15, 2024 eligibility module eligibility criteria Inclusion Criteria:
California State University Northridge athletes
Participants are able to give consent to participate in the study
Completion of preseason testing for the 6-condition, BESS, DVA, GST with the research team
Sustained a concussion as diagnosed by the medical staff during the 2020-2021 season of play.
Sampling of convenience on a volunteer basis
Exclusion Criteria:
Athletes with preseason baseline tests on BESS or DVA that are not within the normative value range for an unimpaired individual.
The initial 6- condition BESS score is >20 errors
The subject is unable to attain a minimum of 85 degrees per second of horizontal head rotation when performing the DVA test. healthy volunteers Accepts Healthy Volunteers gender All std age list std age Child Adult Older Adult study population Due to COVID-19 and the uncertainty of which teams will be competing during the academic year, our subject pool will potentially come from any athlete who provides consent from an equal number of men's and women's teams who are competing that semester. sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Aimie Kachingwe, Dr. central contact role Contact central contact phone 818-677-4684 central contact e mail aimie.kachingwe@csun.edu central contact name Margaret Roller, Dr. central contact role Contact central contact phone 818-677-4684 central contact e mail peggy.roller@csun.edu overall official list overall official overall official name Aimie Kachingwe, Dr. overall official affiliation CSUN overall official role Principal Investigator overall official name Margaret Roller, Dr. overall official affiliation CSUN overall official role Principal Investigator location list location location facility California State University, Northridge, Jacaranda Hall 1578, 1576, 1574 location status Recruiting location city Northridge location state California location zip 91330-8411 location country United States location contact list location contact location contact name Aimie Kachingwe, Dr. location contact role Contact location contact phone 818-677-4684 location contact e mail aimie.kachingwe@csun.edu i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006259 condition mesh term Craniocerebral Trauma condition mesh id D000001924 condition mesh term Brain Concussion condition mesh id D000014947 condition mesh term Wounds and Injuries condition mesh id D000001265 condition mesh term Athletic Injuries condition ancestor list condition ancestor condition ancestor id D000020196 condition ancestor term Trauma, Nervous System condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000070642 condition ancestor term Brain Injuries, Traumatic condition ancestor id D000001930 condition ancestor term Brain Injuries condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000016489 condition ancestor term Head Injuries, Closed condition ancestor id D000014949 condition ancestor term Wounds, Nonpenetrating condition browse leaf list condition browse leaf condition browse leaf id M3722 condition browse leaf name Athletic Injuries condition browse leaf as found Sport Injury condition browse leaf relevance high condition browse leaf id M8501 condition browse leaf name Craniocerebral Trauma condition browse leaf as found Head Injury condition browse leaf relevance high condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf as found Injury condition browse leaf relevance high condition browse leaf id M4353 condition browse leaf name Brain Concussion condition browse leaf as found Concussion, Brain condition browse leaf relevance high condition browse leaf id M21176 condition browse leaf name Trauma, Nervous System condition browse leaf relevance low condition browse leaf id M4359 condition browse leaf name Brain Injuries condition browse leaf relevance low condition browse leaf id M628 condition browse leaf name Brain Injuries, Traumatic condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M18044 condition browse leaf name Head Injuries, Closed condition browse leaf relevance low condition browse leaf id M16839 condition browse leaf name Wounds, Nonpenetrating condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id C000082359 intervention mesh term Imidacloprid intervention ancestor list intervention ancestor intervention ancestor id D000018678 intervention ancestor term Cholinergic Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M251696 intervention browse leaf name Imidacloprid intervention browse leaf as found Wipes intervention browse leaf relevance high intervention browse leaf id M19911 intervention browse leaf name Cholinergic Agents intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04837066 | [
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full study rank 61339 study protocol section identification module n c t id NCT04837755 org study id info org study id CORSAAR1 organization org full name Universität des Saarlandes org class OTHER brief title CORONA in the Saarland official title CORONA in the Saarland acronym CORSAAR status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date March 1, 2020 start date type Actual primary completion date struct primary completion date December 31, 2025 primary completion date type Anticipated completion date struct completion date December 31, 2025 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 24, 2022 last update post date struct last update post date October 25, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Robert Bals responsible party investigator title Professor responsible party investigator affiliation Universität des Saarlandes lead sponsor lead sponsor name Universität des Saarlandes lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The CORSAAR study is an observational, prospective study to investigate the natural biology of COVID-19 detailed description Patients with all forms of COVID-19 are included and followed up. Medical history, measurements and biomarkers are registered and collected at baseline, dung hospitalization and after discharge. In addition, patients with LONG-COVID-19 are recruited. conditions module condition list condition Covid19 design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective bio spec bio spec retention Samples With DNA bio spec description Serum, Plasma, EDTA, PaxGene enrollment info enrollment count 300 enrollment type Anticipated arms interventions module intervention list intervention intervention type Diagnostic Test intervention name Cytokine measurements intervention description The serum concentrations of multiple cytokines are measured. outcomes module primary outcome list primary outcome primary outcome measure Correlation of biomarkers with mortality and disease subgroups primary outcome time frame 2 years after initial disease eligibility module eligibility criteria Inclusion Criteria:
all form of COVID-19 including long-COVID-19
Exclusion Criteria:
- healthy volunteers No gender All minimum age 0 Years maximum age 110 Years std age list std age Child Adult Older Adult study population All COVID-19 patients in the State of Saarland sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Robert Bals, MD PhD central contact role Contact central contact phone +4968411615051 central contact e mail robert.bals@uks.eu location list location location facility Saarland University location status Recruiting location city Homburg location state Saarland location zip 66421 location country Germany location contact list location contact location contact name Robert Bals location contact role Contact location contact phone +4968411615051 location contact e mail robert.bals@uks.eu i p d sharing statement module i p d sharing Yes i p d sharing info type list i p d sharing info type Study Protocol derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions | NCT04837755 | [
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full study rank 61610 study protocol section identification module n c t id NCT04834232 org study id info org study id stenting & compression therapy organization org full name Assiut University org class OTHER brief title Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration official title Comparative Study Between Iliac Vein Stenting and Compression Therapy in Recurrent Venous Ulceration status module status verified date April 2021 overall status Enrolling by invitation expanded access info has expanded access No start date struct start date May 1, 2021 start date type Anticipated primary completion date struct primary completion date December 1, 2021 primary completion date type Anticipated completion date struct completion date December 1, 2021 completion date type Anticipated study first submit date September 26, 2020 study first submit q c date April 3, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Mohamed hesham abdelrahem husiein responsible party investigator title principal investigator responsible party investigator affiliation Assiut University lead sponsor lead sponsor name Assiut University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Comparing the result of of iliac vein stenting and compression therapy in management of recurrent venous ulceration. detailed description Venous ulceration is the most common etiology of lower extremity ulceration, approximately affecting almost 1% of the world's population. although its overall prevalence is relatively low, the refractory nature of venous ulceration increases morbidity, mortality , the patient's quality of life, and have a significant financial burden on the global budget. the primary risk factors are: old age, obesity deep venous thrombosis, phlebitis and previous leg injuries.
Iliac vein compression is a prevalent finding in patients with venous system pathology. It has a variety of causes, including May-Turner syndrome, endometriosis, bladder distension, common iliac artery aneurysm or internal iliac artery aneurysm.
venous compression becomes clinically significant when there's an increase in venous pressure, which in turn causes venous insufficiency. This contributes to the development of a state of chronic venous stasis, which sequentially causes pooling of blood, triggers further capillary damage and activates inflammatory mediators with the end result of venous ulcer development and impaired wound healing.
Located on bony prominences, venous ulcers are typically shallow, irregular with granulation tissue and fibrin present in their bases. A careful physical examination is required for a proper diagnosis, but he clinical challenge remains in its management, which includes prevention or the treatment of the clinical implications.
Treatment modalities should always be directed to the cause of the ulcer; they can be divided into:
non invasive management, such as medical therapy, bandaging and dressings.
invasive, such as endovascular and surgical techniques. conditions module condition list condition Venous Ulcer Recurrent design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 100 enrollment type Anticipated arms interventions module intervention list intervention intervention type Device intervention name compression therapy intervention description compression bandaging or graduated compression hosiery consists of applying a type of elastic device, mainly on the limbs, to exert a controlled pressure on the lower limbs. The controlled pressure exerted by medical compression stockings reduces the diameter of major veins, thereby increasing the velocity and volume of blood flow, along with conditions beneficial for the healing of chronic inflammatory disorders (e.g. cellulitis, erysipelas, venous leg ulcers, etc.), through reduced pro-inflammatory cytokine levels and higher levels of the anti-inflammatory cytokines. intervention type Procedure intervention name iliac vein stenting intervention description using x-ray guidance (fluoroscopy) to place a an expandable metal mesh tube against the vein walls, acting as a scaffold to keep the veins open and improve blood flow outcomes module primary outcome list primary outcome primary outcome measure ulcer healing within 6 months primary outcome description comparing the results of both modalities in recurrent venous ulcer healing primary outcome time frame baseline secondary outcome list secondary outcome secondary outcome measure patency on stents secondary outcome description primary assisted patency included those requiring reintervention to maintain patency; and secondary patency was defined as stents that were blocked and successfully reopened. secondary outcome time frame baseline secondary outcome measure compliance secondary outcome description to anticoagulation in case of stenting, or to elastic stocking in case of compression therapy, using methods that include patient self-reporting and clinical estimates secondary outcome time frame baseline secondary outcome measure assessment of venous disability score (VDS) secondary outcome description the VDS evaluates the effect of venous disease by quantifying the level of work based disability.
It is scored on a scale of 0 to 3 (with 0 being the least severe and 3 the most severe), based on the ability to work an 8-hour day with or without provisions for external support. secondary outcome time frame baseline secondary outcome measure assessment of venous clinical severity score secondary outcome description the score is obtained by imaging vein segments with duplex Doppler or phlebography.
It includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3. secondary outcome time frame baseline eligibility module eligibility criteria Inclusion Criteria:
iliac vein compression.
competent superficial venous system.
isolated iliac vein lesion.
patent femoropopliteal segment.
ulcers located in the gaiter area.
age > 12 years
patients with ulcers located in the gaiter area, along with the following associated symptoms: leg heaviness, pain, varicose veins, edema, hemosedrin staining, pruritus, venous dermatitis, lipodermatoscelrosis, telangiectasias, corona phlebectatica, atrophie blanche and deformity of the leg.
Exclusion Criteria:
patients with arterial disease in the same limb.
patients with history of phlebitis.
patients with congenital venous malformation
patients with malignancy.
patients with raised renal chemistry.
patients with skin allergy.
diabetic neuropathic ulcer.
atypical site of venous ulcer.
acute onset DVT.
age < 12 years. healthy volunteers Accepts Healthy Volunteers gender All minimum age 12 Years maximum age 75 Years std age list std age Child Adult Older Adult study population all patients fulfilling both the inclusion and the exclusion criteria will be included in the study. sampling method Non-Probability Sample contacts locations module location list location location facility Faculty of Medicine location city Asyut location zip 71515 location country Egypt references module reference list reference reference p m i d 23433816 reference type background reference citation Raju S. Best management options for chronic iliac vein stenosis and occlusion. J Vasc Surg. 2013 Apr;57(4):1163-9. doi: 10.1016/j.jvs.2012.11.084. Epub 2013 Feb 20. reference p m i d 29942813 reference type background reference citation Xie T, Ye J, Rerkasem K, Mani R. The venous ulcer continues to be a clinical challenge: an update. Burns Trauma. 2018 Jun 15;6:18. doi: 10.1186/s41038-018-0119-y. eCollection 2018. Review. reference p m i d 24953000 reference type background reference citation George R, Verma H, Ram B, Tripathi R. The effect of deep venous stenting on healing of lower limb venous ulcers. Eur J Vasc Endovasc Surg. 2014 Sep;48(3):330-6. doi: 10.1016/j.ejvs.2014.04.031. Epub 2014 Jun 18. reference p m i d 25165679 reference type background reference citation Nair B. Compression therapy for venous leg ulcers. Indian Dermatol Online J. 2014 Jul;5(3):378-82. doi: 10.4103/2229-5178.137822. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000014647 condition mesh term Varicose Ulcer condition mesh id D000012008 condition mesh term Recurrence condition ancestor list condition ancestor condition ancestor id D000020969 condition ancestor term Disease Attributes condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000014648 condition ancestor term Varicose Veins condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000007871 condition ancestor term Leg Ulcer condition ancestor id D000012883 condition ancestor term Skin Ulcer condition ancestor id D000012871 condition ancestor term Skin Diseases condition browse leaf list condition browse leaf condition browse leaf id M14002 condition browse leaf name Recurrence condition browse leaf as found Recurrent condition browse leaf relevance high condition browse leaf id M16547 condition browse leaf name Varicose Ulcer condition browse leaf as found Venous Ulcers condition browse leaf relevance high condition browse leaf id M16358 condition browse leaf name Ulcer condition browse leaf relevance low condition browse leaf id M21853 condition browse leaf name Disease Attributes condition browse leaf relevance low condition browse leaf id M16548 condition browse leaf name Varicose Veins condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M10035 condition browse leaf name Leg Ulcer condition browse leaf relevance low condition browse leaf id M14838 condition browse leaf name Skin Ulcer condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3369 intervention browse leaf name Anti-Inflammatory Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04834232 | [
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full study rank 61722 study protocol section identification module n c t id NCT04832776 org study id info org study id Cetu-Bev-FOLFOXIRI organization org full name Fudan University org class OTHER brief title FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases official title FOLFOXIRI Plus Cetuximab Versus FOLFOXIRI Plus Bevacizumab in Conversion Therapy of Right-sided Colon Cancer Liver Metastases status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 17, 2021 start date type Anticipated primary completion date struct primary completion date December 31, 2023 primary completion date type Anticipated completion date struct completion date December 31, 2025 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Sanjun Cai responsible party investigator title Department of Colorectal Surgery responsible party investigator affiliation Fudan University lead sponsor lead sponsor name Fudan University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary To compare the efficacy of FOLFOXIRI plus Cetuximab and FOLFOXIRI plus Bevacuzumab in the conversion therapy of right-sided colon cancer liver metastases conditions module condition list condition Liver Metastasis Colon Cancer keyword list keyword FOLFOXIRI cetuximab bevacizumab design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 160 enrollment type Anticipated arms interventions module arm group list arm group arm group label FOLFOXIRI+C225 arm group type Experimental arm group intervention list arm group intervention name Drug: Cetuximab Drug: FOLFOXIRI arm group label FOLFOXIRI+BEV arm group type Active Comparator arm group intervention list arm group intervention name Drug: Bevacizumab Drug: FOLFOXIRI intervention list intervention intervention type Drug intervention name Cetuximab intervention description one group plus cetuximab intervention arm group label list intervention arm group label FOLFOXIRI+C225 intervention type Drug intervention name Bevacizumab intervention description one group plus bevacizumab intervention arm group label list intervention arm group label FOLFOXIRI+BEV intervention type Drug intervention name FOLFOXIRI intervention description FOLFOXIRI intervention arm group label list intervention arm group label FOLFOXIRI+BEV FOLFOXIRI+C225 outcomes module primary outcome list primary outcome primary outcome measure ORR primary outcome description objective response rate primary outcome time frame up to 8 weeks secondary outcome list secondary outcome secondary outcome measure R0 resection rate of liver metastases secondary outcome description R0 resection rate of liver metastases secondary outcome time frame up to 8 weeks secondary outcome measure NED rate secondary outcome description percentage of patients who reach NED secondary outcome time frame up to 8 weeks secondary outcome measure OS secondary outcome description overal survival secondary outcome time frame up to 6 months secondary outcome measure PFS secondary outcome description progression free survival secondary outcome time frame up to 8 weeks eligibility module eligibility criteria Inclusion Criteria:
ECOG perfomance 0-1
pathologically confirmed colorectal carcinoma, with RAS wild type
inital unresectable liver metastases discussed by MDT
prior no systemical therapy or exceed 6 months after the adjuvant chemotherapy of primary tumor surgery.
without extraheptic metastatic lesions, except for locally controlled lung metastases (RFA or SBRT)
adequate blood, liver and renal function
expected survival longer than 6 months
Exclusion Criteria:
with bleeding risk
interestinal obstruction or disease
uncontrolled hypertension and severe heart disease
previous severe thrombotic events
central nervous system metastases
accompanied with other malignant tumor healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Wenhua Li central contact role Contact central contact phone 13817922257 central contact phone ext 13817922257 central contact e mail whliiris@hotmail.com overall official list overall official overall official name Wen Zhang overall official affiliation Fudan University overall official role Principal Investigator location list location location facility Department of Colorectal Surgery Fudan University Shanghai Cancer Center location status Recruiting location city Shanghai location state Shanghai location zip 200032 location country China location contact list location contact location contact name Sanjun Cai, M.D location contact role Contact location contact phone +86-21-64175590 location contact phone ext 81108 location contact e mail caisanjuncsj@163.com derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000009362 condition mesh term Neoplasm Metastasis condition mesh id D000003110 condition mesh term Colonic Neoplasms condition mesh id D000008113 condition mesh term Liver Neoplasms condition ancestor list condition ancestor condition ancestor id D000009385 condition ancestor term Neoplastic Processes condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000015179 condition ancestor term Colorectal Neoplasms condition ancestor id D000007414 condition ancestor term Intestinal Neoplasms condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000003108 condition ancestor term Colonic Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000008107 condition ancestor term Liver Diseases condition browse leaf list condition browse leaf condition browse leaf id M11459 condition browse leaf name Neoplasm Metastasis condition browse leaf as found Metastases condition browse leaf relevance high condition browse leaf id M5490 condition browse leaf name Colonic Neoplasms condition browse leaf as found Colon Cancer condition browse leaf relevance high condition browse leaf id M10265 condition browse leaf name Liver Neoplasms condition browse leaf as found Liver Metastases condition browse leaf relevance high condition browse leaf id M11482 condition browse leaf name Neoplastic Processes condition browse leaf relevance low condition browse leaf id M17042 condition browse leaf name Colorectal Neoplasms condition browse leaf relevance low condition browse leaf id M9600 condition browse leaf name Intestinal Neoplasms condition browse leaf relevance low condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M5488 condition browse leaf name Colonic Diseases condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M10259 condition browse leaf name Liver Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000068258 intervention mesh term Bevacizumab intervention mesh id D000068818 intervention mesh term Cetuximab intervention ancestor list intervention ancestor intervention ancestor id D000074322 intervention ancestor term Antineoplastic Agents, Immunological intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000020533 intervention ancestor term Angiogenesis Inhibitors intervention ancestor id D000043924 intervention ancestor term Angiogenesis Modulating Agents intervention ancestor id D000006133 intervention ancestor term Growth Substances intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000006131 intervention ancestor term Growth Inhibitors intervention browse leaf list intervention browse leaf intervention browse leaf id M246 intervention browse leaf name Bevacizumab intervention browse leaf as found Sessions intervention browse leaf relevance high intervention browse leaf id M315 intervention browse leaf name Cetuximab intervention browse leaf as found Dexamethasone intervention browse leaf relevance high intervention browse leaf id M10262 intervention browse leaf name Liver Extracts intervention browse leaf relevance low intervention browse leaf id M1346 intervention browse leaf name Antineoplastic Agents, Immunological intervention browse leaf relevance low intervention browse leaf id M21471 intervention browse leaf name Angiogenesis Inhibitors intervention browse leaf relevance low intervention browse leaf id T120 intervention browse leaf name Cola intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Hemat intervention browse branch name Hematinics intervention browse branch abbrev HB intervention browse branch name Herbal and Botanical | NCT04832776 | [
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9518,
1320,
11558,
3374,
1197,
19415,
12788,
23105,
2078,
1641,
143,
13901,
2271,
24569,
18172,
2240,
8696,
24664,
7926,
8745,
1918,
1830,
159,
1468,
1361,
143,
13901,
2271,
24569,
18172,
2240,
8696,
4108,
2497,
6617,
10337,
1918,
1830,
1107,
16752,
12475,
23789,
1104,
4114,
118,
11641,
9518,
1320,
11558,
3374,
1197,
19415,
12788,
23105,
2781,
13196,
2781,
22480,
2236,
1364,
17881,
1475,
2905,
2781,
11336,
1665,
27975,
1158,
3631,
2469,
23992,
1144,
3631,
2469,
1302,
1838,
2236,
188,
23055,
1838,
2236,
1364,
1542,
117,
17881,
1475,
1838,
2236,
2076,
8329,
6617,
16963,
1181,
2425,
6026,
2236,
188,
23055,
2425,
6026,
2236,
1382,
1955,
117,
17881,
1495,
2425,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
6026,
2236,
188,
23055,
6026,
2236,
1382,
1955,
117,
17881,
1571,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
2025,
1148,
12295,
2236,
1364,
123,
117,
17881,
1475,
2025,
1148,
12295,
186,
172,
2236,
1364,
126,
117,
17881,
1475,
2025,
1148,
2112,
2236,
188,
23055,
2025,
1148,
2112,
2236,
1364,
127,
117,
17881,
1475,
2025,
1148,
2112,
2236,
2076,
2173,
4746,
1314,
11984,
12295,
2236,
1364,
126,
117,
17881,
1475,
1314,
11984,
2112,
2236,
188,
23055,
1314,
11984,
2112,
2236,
1364,
127,
117,
17881,
1475,
1314,
11984,
2112,
2236,
2076,
2173,
4746,
10767,
24146,
13196,
2784,
1710,
2784,
1710,
2076,
8013,
1130,
5710,
3121,
25524,
1766,
2784,
1710,
17805,
1554,
1271,
1727,
17936,
140,
3814,
2784,
1710,
17805,
1641,
1951,
1104,
13066,
10294,
6163,
17910,
2784,
1710,
17805,
13494,
14763,
6778,
1239,
1730,
10767,
1730,
10767,
1271,
14763,
6778,
1239,
1730,
10767,
1705,
152,
24162,
9637,
20051,
13196,
20051,
1144,
173,
182,
172,
1302,
1110,
175,
173,
170,
12521,
3850,
1302,
1110,
175,
173,
170,
12521,
4442,
1302,
1110,
190,
188,
10107,
1302,
6136,
13196,
4094,
14940,
1706,
14133,
1103,
23891,
1104,
143,
13901,
2271,
24569,
18172,
2240,
4882,
24664,
7926,
8745,
1918,
1830,
1105,
143,
13901,
2271,
24569,
18172,
2240,
4882,
4108,
2497,
10182,
10337,
1918,
1830,
1107,
1103,
7497,
7606,
1104,
1268,
118,
11641,
1884,
4934,
4182,
11911,
27154,
8419,
8830,
2975,
13196,
3879,
2190,
3879,
3374,
1197,
19415,
12788,
14229,
9518,
1320,
11558,
2501,
12565,
2190,
2501,
12565,
143,
13901,
2271,
24569,
18172,
2240,
172,
2105,
5025,
8628,
1830,
1129,
2497,
6617,
10337,
1918,
1830,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
12278,
123,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
7330,
113,
3353,
20943,
114,
10803,
23992,
10803,
5099,
7690,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
143,
13901,
2271,
24569,
18172,
2240,
116,
140,
20581,
1571,
1981,
1372,
2076,
17635,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
24664,
7926,
8745,
1918,
1830,
13982,
131,
143,
13901,
2271,
24569,
18172,
2240,
1981,
1372,
3107,
143,
13901,
2271,
24569,
18172,
2240,
116,
139,
2036,
2559,
1981,
1372,
2076,
17244,
3291,
8223,
4626,
2772,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
4108,
2497,
6617,
10337,
1918,
1830,
13982,
131,
143,
13901,
2271,
24569,
18172,
2240,
9108,
2190,
9108,
9108,
2076,
13982,
9108,
1271,
24664,
7926,
8745,
1918,
1830,
9108,
6136,
1141,
1372,
4882,
172,
2105,
5025,
8628,
1830,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
143,
13901,
2271,
24569,
18172,
2240,
116,
140,
20581,
1571,
9108,
2076,
13982,
9108,
1271,
4108,
2497,
6617,
10337,
1918,
1830,
9108,
6136,
1141,
1372,
4882,
1129,
2497,
6617,
10337,
1918,
1830,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
143,
13901,
2271,
24569,
18172,
2240,
116,
139,
2036,
2559,
9108,
2076,
13982,
9108,
1271,
143,
13901,
2271,
24569,
18172,
2240,
9108,
6136,
143,
13901,
2271,
24569,
18172,
2240,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
143,
13901,
2271,
24569,
18172,
2240,
116,
139,
2036,
2559,
143,
13901,
2271,
24569,
18172,
2240,
116,
140,
20581,
1571,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
23066,
2069,
2425,
9386,
6136,
7649,
2593,
2603,
2425,
9386,
1159,
4207,
1146,
1106,
129,
2277,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
155,
1568,
1231,
25461,
2603,
1104,
11911,
27154,
8419,
8830,
3718,
9386,
6136,
155,
1568,
1231,
25461,
2603,
1104,
11911,
27154,
8419,
8830,
3718,
9386,
1159,
4207,
1146,
1106,
129,
2277,
3718,
9386,
4929,
26546,
2137,
2603,
3718,
9386,
6136,
6556,
1104,
4420,
1150,
2519,
26546,
2137,
3718,
9386,
1159,
4207,
1146,
1106,
129,
2277,
3718,
9386,
4929,
11570,
3718,
9386,
6136,
1166,
1348,
8115,
3718,
9386,
1159,
4207,
1146,
1106,
127,
1808,
3718,
9386,
4929,
153,
17691,
3718,
9386,
6136,
16147,
1714,
8115,
3718,
9386,
1159,
4207,
1146,
1106,
129,
2277,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
16028,
2346,
2349,
1679,
14467,
1399,
2093,
121,
118,
122,
3507,
7542,
1193,
3659,
2942,
10294,
6163,
1610,
16430,
7903,
117,
1114,
26547,
1708,
4098,
2076,
1107,
19058,
8362,
4894,
10294,
8637,
11911,
27154,
8419,
8830,
6352,
1118,
9292,
1942,
2988,
1185,
27410,
1348,
7606,
1137,
13908,
127,
1808,
1170,
1103,
8050,
9380,
14194,
22572,
5521,
20939,
1104,
2425,
14601,
6059,
119,
1443,
3908,
4638,
8956,
27154,
27372,
26052,
117,
2589,
1111,
6889,
4013,
13093,
27154,
8419,
8830,
113,
24695,
1592,
1137,
156,
26166,
1942,
114,
12373,
1892,
117,
11911,
1105,
1231,
7050,
3053,
2637,
8115,
2039,
1190,
127,
1808,
16409,
1665,
17855,
140,
10587,
3464,
131,
1114,
9793,
3187,
2199,
14196,
184,
4832,
17993,
1137,
3653,
8362,
7235,
8005,
11572,
177,
24312,
23826,
1988,
1105,
5199,
1762,
3653,
2166,
5199,
24438,
16071,
19937,
1596,
1958,
2129,
5604,
1449,
27154,
8419,
8830,
4977,
1114,
1168,
12477,
2646,
15454,
14601,
8071,
8118,
1302,
5772,
1398,
5867,
1425,
1407,
5848,
4177,
1425,
3453,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2129,
3232,
2190,
2129,
3232,
2129,
3232,
1271,
23158,
12491,
5255,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
15731,
16770,
1580,
20581,
17600,
1559,
2129,
3232,
2179,
4252,
1204,
15731,
16770,
1580,
20581,
17600,
1559,
2129,
3232,
174,
6346,
192,
8495,
6904,
4889,
137,
2633,
14746,
119,
3254,
2905,
2078,
2190,
2905,
2078,
2905,
2078,
1271,
23158,
9132,
2905,
2078,
13494,
14763,
6778,
1239,
2905,
2078,
1648,
8013,
1130,
5710,
3121,
25524,
1766,
2450,
2190,
2450,
2450,
3695,
1951,
1104,
13066,
10294,
6163,
17910,
14763,
6778,
1239,
7962,
11558,
1945,
2450,
2781,
11336,
1665,
27975,
1158,
2450,
1331,
7962,
2450,
1352,
7962,
2450,
195,
9717,
1539,
17101,
2450,
1583,
1975,
2450,
3232,
2190,
2450,
3232,
2450,
3232,
1271,
1727,
17936,
140,
3814,
117,
150,
119,
141,
2450,
3232,
1648,
24367,
2450,
3232,
2179,
116,
5942,
118,
1626,
118,
3324,
16770,
25491,
21500,
2450,
3232,
2179,
4252,
1204,
5615,
10424,
1604,
2450,
3232,
174,
6346,
11019,
21599,
17936,
6063,
3361,
137,
19207,
119,
3254,
4408,
2237,
1940,
1116,
1665,
23992,
13196,
1683,
10266,
1382,
5507,
117,
17881,
1477,
3879,
11424,
1162,
13196,
3879,
24000,
2190,
3879,
24000,
3879,
24000,
25021,
141,
7629,
7629,
1568,
1580,
22997,
1477,
3879,
24000,
1858,
14521,
1643,
7580,
1306,
19415,
12788,
14229,
3879,
24000,
25021,
141,
7629,
7629,
1568,
22639,
10424,
3879,
24000,
1858,
9518,
13207,
14521,
1643,
7580,
4206,
3879,
24000,
25021,
141,
7629,
7629,
1568,
1604,
14541,
1495,
3879,
24000,
1858,
3374,
1197,
14521,
1643,
7580,
4206,
3879,
13596,
2190,
3879,
13596,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1580,
23249,
1571,
3879,
13596,
1858,
14521,
1643,
20519,
18821,
1279,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1580,
22997,
1580,
3879,
13596,
1858,
14521,
1643,
7580,
4206,
3879,
13596,
25021,
141,
7629,
7629,
10424,
23493,
1571,
3879,
13596,
1858,
17392,
12805,
11007,
18821,
1279,
3879,
13596,
25021,
141,
7629,
7629,
16337,
16770,
1580,
3879,
13596,
1858,
13066,
10294,
6163,
14521,
1643,
7580,
4206,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1559,
25892,
1527,
3879,
13596,
1858,
1130,
13053,
14196,
14521,
1643,
7580,
4206,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1571,
1559,
20829,
3879,
13596,
1858,
12384,
8005,
10879,
2556,
14196,
14521,
1643,
7580,
4206,
3879,
13596,
25021,
141,
7629,
7629,
1568,
12882,
1545,
1559,
3879,
13596,
1858,
27348,
2109,
3910,
14521,
1643,
7580,
4206,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1580,
26303,
1475,
3879,
13596,
1858,
14521,
1643,
7580,
4206,
1118,
9338,
3879,
13596,
25021,
141,
7629,
7629,
1568,
12882,
1545,
1545,
3879,
13596,
1858,
27348,
2109,
3910,
20012,
1116,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1571,
1559,
1545,
1559,
3879,
13596,
1858,
12384,
8005,
10879,
2556,
14196,
20012,
1116,
3879,
13596,
25021,
141,
7629,
7629,
1568,
22639,
1568,
1604,
3879,
13596,
1858,
9518,
13207,
20012,
1116,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1559,
25892,
1568,
3879,
13596,
1858,
1130,
13053,
14196,
20012,
1116,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1604,
10424,
1559,
3879,
13596,
1858,
3374,
1197,
20012,
1116,
3879,
11424,
1162,
7404,
2190,
3879,
11424,
1162,
7404,
3879,
11424,
1162,
7404,
25021,
26528,
17175,
1571,
1580,
3879,
11424,
1162,
7404,
1271,
14521,
1643,
7580,
1306,
19415,
12788,
14229,
3879,
11424,
1162,
7404,
1112,
1276,
19415,
12788,
23105,
3879,
11424,
1162,
7404,
25319,
1344,
3879,
11424,
1162,
7404,
25021,
150,
1571,
1527,
21500,
3879,
11424,
1162,
7404,
1271,
9518,
13207,
14521,
1643,
7580,
4206,
3879,
11424,
1162,
7404,
1112,
1276,
9518,
1320,
11558,
3879,
11424,
1162,
7404,
25319,
1344,
3879,
11424,
1162,
7404,
25021,
26528,
1568,
25129,
1571,
3879,
11424,
1162,
7404,
1271,
3374,
1197,
14521,
1643,
7580,
4206,
3879,
11424,
1162,
7404,
1112,
1276,
3374,
1197,
19415,
12788,
23105,
3879,
11424,
1162,
7404,
25319,
1344,
3879,
11424,
1162,
7404,
25021,
26528,
17175,
1604,
1477,
3879,
11424,
1162,
7404,
1271,
14521,
1643,
20519,
18821,
1279,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
7404,
25021,
26528,
20829,
23117,
3879,
11424,
1162,
7404,
1271,
13066,
10294,
6163,
14521,
1643,
7580,
4206,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
7404,
25021,
150,
1580,
16480,
1568,
3879,
11424,
1162,
7404,
1271,
1130,
13053,
14196,
14521,
1643,
7580,
4206,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
7404,
25021,
150,
18910,
23249,
3879,
11424,
1162,
7404,
1271,
12384,
8005,
10879,
2556,
14196,
14521,
1643,
7580,
4206,
3879,
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] |
full study rank 61277 study protocol section identification module n c t id NCT04838561 org study id info org study id 21/26X organization org full name Children's Hospital of Eastern Ontario org class OTHER brief title Assessing the Impact of Control-IQ Technology official title Assessing the Impact of Control-IQ Technology on Quality of Life and Glycemic Control in Children and Youth With Type 1 Diabetes in a Canadian Context status module status verified date January 2022 overall status Completed expanded access info has expanded access No start date struct start date March 15, 2021 start date type Actual primary completion date struct primary completion date October 26, 2021 primary completion date type Actual completion date struct completion date October 26, 2021 completion date type Actual study first submit date March 29, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date January 19, 2022 last update post date struct last update post date January 21, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Caroline Zuijdwijk responsible party investigator title Pediatric Endrocinologist, MD FRCPC responsible party investigator affiliation Children's Hospital of Eastern Ontario lead sponsor lead sponsor name Children's Hospital of Eastern Ontario lead sponsor class OTHER collaborator list collaborator collaborator name Tandem Diabetes Care, Inc. collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a single-centre, mixed-methods, prospective study in pediatric patients with T1D initiating Control-IQ technology on the Tandem t-slim X2 insulin pump.
Primary Objective:
To determine pediatric T1D patients' and their parents' perceptions of the impact of Control-IQ on their psychosocial functioning and quality of life. detailed description Background Information & Rationale
The management of type 1 diabetes (T1D) is rapidly evolving to offer technology that aims to improve metabolic control and decrease the burden of diabetes management. Hybrid-closed loop systems are at the forefront of this technology. They are comprised of an insulin pump and continuous glucose monitoring (CGM) system that interface in order to automatically adjust the delivery of basal insulin through the pump, based on CGM data. Insulin boluses for meals and snacks must still be entered manually by the user.
Studies of hybrid closed loop systems have primarily focused on clinical trials that show improved glycemic outcomes.1-3 Few studies have assessed real-world glycemic outcomes or patient-reported outcomes, and none have focused on a pediatric population.
A recent study published by Pinsker et al.4 showed improvement in psychosocial outcomes and persistent achievement of glycemic targets in a real-world setting in adults with T1D using the Tandem t:slim X2 pump with Control-IQ technology.
The Tandem t:slim X2 pump with Control-IQ is a hybrid closed loop system (using Dexcom G6 CGM) that has recently been approved for use by Health Canada, but has been used in the U.S. for the last year. This new technology will launch in Canada in March 2021, at which time existing Tandem t:slim X2 insulin pump users (with concurrent CGM use) will be able to upgrade their insulin pump software to access this technology (following review of an online module).
The Children's Hospital of Eastern Ontario (CHEO), is located in Ottawa, ON Canada. CHEO follows approximately 800 children with diabetes, approximately 85 of whom are managed on the Tandem t:slim X2 pump with concurrent Dexcom G6 CGM use.
The upcoming launch of Control-IQ presents a unique opportunity to gain a better understanding of the real-world impact of this technology on our Canadian pediatric population. The benefits of conducting this study in our population are two-fold:
The Canadian context offers the study a diverse patient population given our universal healthcare system and provincially-funded insulin pump program. Because pumps and supplies are funded by the government, they are available to all of our patients, regardless of socio-economic status and whether or not they have private health insurance.
Studying a pediatric population offers the unique perspective of children and youth (and their parents) whose management practices and goals differ from those of adults. While adult patients and parents of children with T1D are motivated by attaining glycemic targets for long term health outcomes, children and youth live in moment with emphasis on how they feel now. As such, patient reported outcomes, while important to all ages, are often the most important motivator for children and youth when choosing a treatment regimen.
Study Design This is a single-centre, mixed-methods, prospective study in pediatric patients with T1D initiating Control-IQ technology on the Tandem t-slim X2 insulin pump.
Participants will enroll in the study prior to initiating use of Control-IQ on their Tandem insulin pump.
Recruitment will occur over an eight-week period starting mid-March 2021. Participation in this study will last 16 weeks.
Study Objectives
Primary Objective: To determine pediatric T1D patients' and their parents' perceptions of the impact of Control-IQ on their psychosocial functioning and quality of life (as measured by the INSPIRE Questionnaire, post assessment).
Secondary Objectives:
To assess the effect of Control-IQ technology on other patient and parent reported outcomes (PROs) including:
Diabetes Impact and Device Satisfaction (DIDS) scale,
Hypoglycemia Fear Survey (child and parent version),
WHO-5 (emotional well-being)
To determine the impact of Control-IQ technology on glycemic control in pediatric T1D patients who are experienced sensor-augmented pump users.
Exploratory Objectives:
To explore the effect of Control-IQ technology on patient and parents' sleep, school, activities/ sports, mood and family dynamics.
To explore whether or not youth and parents' expectations of Control-IQ align with their experience of using this this automated insulin delivery system.
Participant Characteristics:
The following data will be collected from each chart at baseline:
Date of birth
Gender
Date of T1D diagnosis
Date of initiation of insulin pump therapy
Date of first insulin pump start
Date of Tandem t:slim X2 pump start
Current use of CGM (yes/ no)
Last measured HbA1c ( if available within the last 3 months
Number of hospitalizations due to diabetes complications within the past year
Sociodemographic measures will be collected by questionnaire at baseline, including:
Family structure
Parental education - highest level achieved
Household income
Private health insurance
Ethnicity (self-reported)
Statistical Plan The patient population will be described using descriptive statistics. The study team will compare patient reported outcomes, measures of glycemic control, and measures of insulin pump management pre and 16 weeks post-initiation of Control-IQ technology, using paired t-test and Wilcoxon signed-rank test, depending on the distributional characteristics of the outcomes. Analysis of open-ended questions will be done by a qualitative research specialist.
Sample Size Determination CHEO currently has 85 patients on the Tandem t:slim X2 pump with CGM, with an estimated 10-15 patients more estimated to start before March 2021. Historically, the patient population at CHEO has been highly engaged with research with an anticipated participation rate of 90-95%. The Investigator expects that recruitment rates would be similar for this study, allowing for a sample size of 70 participants.
This sample size is sufficient to provide > 80% power for detecting a "medium size" effect (Cohen's d = 0.5), which corresponds to a mean score of 70 from the post assessment INSPIRE Questionnaire, 10 units larger than a mean score of 60 (the null hypothesis). Cohen's d is expressed by the ratio of the mean difference over the standard deviation. Here, we use sd = 20 as an estimate of the standard deviation of the score, which is conservative considering previously presented estimates (e.g. sd = 16.44 described in Weissberg-Benchell et al [5]). conditions module condition list condition Type 1 Diabetes design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective enrollment info enrollment count 65 enrollment type Actual outcomes module primary outcome list primary outcome primary outcome measure INsulin delivery Systems: Perceptions, Ideas, Reflections and Expectations Questionnaire Post Intervention (Youth and Parent Versions) primary outcome description Measures perceptions of the impact of automated insulin delivery systems on users' psychosocial functioning and quality of life.
Score 0-100- mean score is significantly larger than 60 (out of 100). A score of greater than 60 indicates a perceived benefit of Control-IQ on psychosocial functioning and quality of life. primary outcome time frame 16 weeks secondary outcome list secondary outcome secondary outcome measure Change in Diabetes Impact and Device Satisfaction scale secondary outcome description Evaluates users' experience interacting with their insulin delivery device, and the impact of diabetes on their life on a 10-point Likert Scale. Scoring: Device Satisfaction average of items 1-7 (#5, #7 are reverse scored), Diabetes Impact: Average of items 8-11. Higher Score Indicates increased device satisfaction. secondary outcome time frame Baseline and 16 weeks secondary outcome measure Hypoglycemia Fear Survey (child and parent version) secondary outcome description Assess change in fear of hypoglycemia among children with type 1 diabetes and parents of children with type 1 diabetes.
Mean score will be compared pre and post study Behaviour (score 0-40) - lower score better (less behaviours associated with fear of hypo) Worry (score 0-60) - lower score better (less worry re: hypoglycemia) secondary outcome time frame Baseline and 16 weeks secondary outcome measure The World Health Organisation- Five Well-Being Index secondary outcome description Assessing change in subjective psychological well-being in research and clinical settings.
The WHO-5 consists of five statements, which respondents rate according to the scale below (in relation to the past two weeks).
All of the time = 5
Most of the time = 4
More than half of the time = 3
Less than half of the time = 2
Some of the time = 1
At no time = 0.
The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. secondary outcome time frame Baseline and 16 weeks secondary outcome measure % time in target range 3.9-10.0 mmol/L (overall, day,and night) secondary outcome description Measure of glycemic control will be collected from the Dexcom Clarity Platform will be compared at each time frame. secondary outcome time frame 0, 4, 8, 12, and 16 weeks secondary outcome measure % time below target range <3.0mmol/L (overall, day, and night) secondary outcome description Measure of glycemic control will be collected from the Dexcom Clarity Platform will be compared at each time frame. secondary outcome time frame 0, 4, 8, 12, and 16 weeks secondary outcome measure % time below target range <3.9mmol/L (overall, day, and night) secondary outcome description Measure of glycemic control will be collected from the Dexcom Clarity Platform will be compared at each time frame. secondary outcome time frame 0, 4, 8, 12, and 16 weeks secondary outcome measure % time above target range >10mmol/L (overall, day, and night) secondary outcome description Measure of glycemic control will be collected from the Dexcom Clarity Platform will be compared at each time frame.. secondary outcome time frame 0, 4, 8, 12, and 16 weeks secondary outcome measure % time above target range >13.9mmol/L (overall, day, and night) secondary outcome description Measure of glycemic control will be collected from the Dexcom Clarity Platform will be compared at each time frame. secondary outcome time frame 0, 4, 8, 12, and 16 weeks secondary outcome measure Average glucose and standard deviation (mmol/L) secondary outcome description Measure of glycemic control will be collected from the Dexcom Clarity Platform will be compared at each time frame. secondary outcome time frame 0, 4, 8, 12, and 16 weeks secondary outcome measure Coefficient of variation (%) secondary outcome description Measure of glycemic control will be collected from the Dexcom Clarity Platform. secondary outcome time frame 0, 4, 8, 12, and 16 weeks secondary outcome measure Estimated HbA1c (%) secondary outcome description Will be collected from the Dexcom Clarity Platform. secondary outcome time frame 0, 4, 8, 12, and 16 weeks other outcome list other outcome other outcome measure Open-Ended Questionnaire other outcome description Explores the effect of Control-IQ technology on patient and parents' sleep, school, activities/ sports, mood and family dynamics other outcome time frame 16 weeks other outcome measure INsulin delivery Systems: Perceptions, Ideas, Reflections and Expectations Questionnaire (Baseline and Post Intervention) other outcome description To explore whether or not youth and parents' expectations of Control-IQ align with their experience of using this this automated insulin delivery system (by comparing the INSPIRE Questionnaire baseline and post-assessment scores)
Score 0-100- mean score is significantly larger than 60 (out of 100). A score of greater than 60 indicates a perceived benefit of Control-IQ on psychosocial functioning and quality of life.
Mean baseline INPSIRE score will be compared to the mean post-assessment INSPIRE score to assess if expectations of Control-IQ align with the experience of using this automated insulin delivery system. other outcome time frame Baseline and 16 weeks eligibility module eligibility criteria Inclusion Criteria:
Diagnosis of T1D
Age 6-18 years
Currently using the Tandem t:slim X2 insulin pump with Dexcom G6 CGM, who are initiating Control-IQ
Exclusion Criteria:
Patients under the age of 6 years of age
Patients who are not English or French speaking
Patients unwilling to provide consent (assent where applicable). healthy volunteers No gender All minimum age 6 Years maximum age 18 Years std age list std age Child Adult study population Children and youth with T1D followed at CHEO will be invited to participate in the study. sampling method Probability Sample contacts locations module overall official list overall official overall official name Caroline Zuijdwijk, MD, FRCPC overall official affiliation Children's Hopsital of Eastern Ontario overall official role Principal Investigator location list location location facility Children's Hospital of Eastern Ontario location city Ottawa location state Ontario location zip K1H8L1 location country Canada references module reference list reference reference p m i d 33155824 reference type background reference citation O'Malley G, Messer LH, Levy CJ, Pinsker JE, Forlenza GP, Isganaitis E, Kudva YC, Ekhlaspour L, Raghinaru D, Lum J, Brown SA; iDCL Trial Research Group. Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial. Diabetes Technol Ther. 2021 Apr;23(4):245-252. doi: 10.1089/dia.2020.0472. reference p m i d 31618560 reference type background reference citation Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16. reference p m i d 30159816 reference type background reference citation Dadlani V, Pinsker JE, Dassau E, Kudva YC. Advances in Closed-Loop Insulin Delivery Systems in Patients with Type 1 Diabetes. Curr Diab Rep. 2018 Aug 29;18(10):88. doi: 10.1007/s11892-018-1051-z. Review. reference p m i d 32846114 reference type background reference citation Pinsker JE, Müller L, Constantin A, Leas S, Manning M, McElwee Malloy M, Singh H, Habif S. Real-World Patient-Reported Outcomes and Glycemic Results with Initiation of Control-IQ Technology. Diabetes Technol Ther. 2021 Feb;23(2):120-127. doi: 10.1089/dia.2020.0388. Epub 2020 Sep 10. reference p m i d 30761592 reference type background reference citation Weissberg-Benchell J, Shapiro JB, Hood K, Laffel LM, Naranjo D, Miller K, Barnard K. Assessing patient-reported outcomes for automated insulin delivery systems: the psychometric properties of the INSPIRE measures. Diabet Med. 2019 May;36(5):644-652. doi: 10.1111/dme.13930. Epub 2019 Mar 20. reference p m i d 3677982 reference type background reference citation Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G, Butterfield J. Fear of hypoglycemia: quantification, validation, and utilization. Diabetes Care. 1987 Sep-Oct;10(5):617-21. doi: 10.2337/diacare.10.5.617. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003922 condition mesh term Diabetes Mellitus, Type 1 condition ancestor list condition ancestor condition ancestor id D000003920 condition ancestor term Diabetes Mellitus condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000001327 condition ancestor term Autoimmune Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M6269 condition browse leaf name Diabetes Mellitus, Type 1 condition browse leaf as found Type 1 Diabetes condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders | NCT04838561 | [
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full study rank 61883 study protocol section identification module n c t id NCT04830670 org study id info org study id WIDE&NARROW organization org full name International Piezosurgery Academy org class OTHER brief title Bone Formation Maxillary Sinus Width official title Comparison of Bone Formation According to Different Maxillary Sinus Width: a Multicenter Prospective Study. status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date March 15, 2017 start date type Actual primary completion date struct primary completion date March 15, 2020 primary completion date type Actual completion date struct completion date March 15, 2021 completion date type Actual study first submit date March 25, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name International Piezosurgery Academy lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary According to previous scientific evidence lining on biological concept of bone regeneration into the maxillary sinus, an observational study was set up to record possible (hypothesized) difference in bone formation between different width of the maxillary sinus itself. Therefore, a multicenter study was set up that foresaw a surgical intervention of sinus lift with lateral approach, the 6 months healing phase, the implant insertion in two sites with the implant site preparation made by a trephine bur to retrieve a bone specimen for histomorphometric examination without any additive invasively for the patient. detailed description Material and Methods Study protocol This study was designed as a multicenter prospective study following STROBE (STrengthening the Reporting of Observational studies in Epidemiology) guidelines. All procedures were performed in strict accordance with the recommendations of the Declaration of Helsinki as revised in Fortaleza for investigations with human subjects. The study protocol had been approved by the relevant ethical committee (Comitato Etico Calabria-Sezione Area Nord n. 55/2016). Patients, after being thoroughly informed about the study protocol, the treatment, its alternatives and any potential risk, signed a written informed consent for the participation in the study and authorized the use of their data for research purposes.
Any patient with Kennedy class II partial edentulism requiring unilateral sinus floor elevation for the placement of two not adjacent dental implants supporting a fixed partial prosthesis was eligible for entering this study.
Pre-surgical phase Patients recruited in the present study underwent a careful clinical examination, including assessment of periodontal conditions (probing and periapical radiographs), evaluation of available bone volume in the edentulous areas on cone beam computed tomography and analysis of occlusal relationships (diagnostic wax-up). A surgical resin guide was manufactured by duplicating the diagnostic wax-up.
All patients received professional mechanical tooth cleaning and periodontal debridement one week prior to surgery and were prescribed with chlorhexidine digluconate 0.2% mouthwash twice a day.
Surgical procedure All patients underwent antibiotic prophylaxis (2 g single-dose amoxicillin one hour before surgery). After performing local anaesthesia (articaine 4% with epinephrine 1:100.000) and elevating a full-thickness flap, the surgical guide was placed in position and an antrostomy was created by consuming the lateral wall of the maxillary sinus with ultrasonic instrumentation in the area between the two planned implant sites. The sinus membrane was then carefully elevated and, after checking its integrity with visual inspection and Valsalva maneuver, the subantral space was filled with a composite graft in granules [50% cortico-cancellous porcine graft (Gen-Os, Tecnoss, Pianezza, Italy) - 50% synthetic nano-hydroxyapatite (Fisiograft Bone, Ghimas, Casalecchio di Reno, Italy)]. A resorbable bovine collagen membrane (Bio-Gide, Geistlich, Wolhusen, Switzerland) fixed with two pins was placed to cover the lateral antrostomy and flaps were sutured with Sentineri sutures and single stitches using synthetic monofilament. Patients were prescribed with antibiotics for 4 days (amoxicillin 1 g three times a day) and NSAID (ibuprofen 600 mg), when needed. Sutures were removed after 10 days.
After 6 months of healing, a cone beam tc scan was performed to evaluate the radiographic outcome of the regenerative procedure and to plan implant insertion. With the assistance of the surgical template, two bone-core biopsy biopsies were harvested in the planned implant sites by using 3-mm diameter trephine drills (2982.Y0.30, DenTag, Maniago, Italy) (Fig. 3-4). Dental implants were then inserted in the biopsy sites: after 5 months of submerged healing, they were restored with screwed ceramic crowns.
Radiographic measurements Radiographic measurements were taken from the three cone beam CT cross-sectional slices (step 1 mm; width 1 mm) corresponding to the position where the biopsy was retrieved. Two independent calibrated examiners (A.R. and Fe.Be.) measured residual bone height (RBH) between the alveolar ridge and the sinus floor; sinus width (SW) (distance between buccal and palatal walls at 10-mm level, comprising the residual alveolar crest. Distances were measured by using the specific tool of an imaging software (OsiriX MD, Pixmeo SARL, Bernex, Switzerland) and were expressed in millimeters. Intra-examiner reliability was assessed with Cohen's K test.
Sample processing for histological analysis Histologic and histomorphometric analyses of all specimens were performed by one of the authors (VN), blinded to the study design and to biopsy origin. Immediately after harvesting, biopsies were carefully rinsed with cold 5% glucose solution to remove blood remnants maintaining the correct osmolarity (278 milliosmole/L).
Specimens were subsequently fixed for three days in 10% buffered formalin solution at pH 7.2, and then dehydrated in an ascending series of alcohol rinses and embedded in a methacrylate resin (Technovit 7200 VLC, Kulzer, Wehrheim, Germany). After 12 days of polymerization, biopsies were cut along their longitudinal axis with a high-precision carborundum disk at 50 µm and then ground down under running water with a series of polishing discs to about 30 ± 10 µm. The slides were then mounted and stained with acid fuchsine-toluidine blue and von Kossa staining.
Histomorphometry The following variables were measured for each biopsy: total area of the biopsy (in mm2), percentage of newly-formed bone (NFB),percentage of connective tissue/marrow spaces (MS), and percentage of residual graft particles (RG). The analysis was performed using transmitted brightfield light microscope (Biostar B3; Exacta Optech, San Prospero, Italy), connected to high resolution digital camera (Moticam 5.0; Motic Microscopy, Kowloon, China). A software with image capturing capabilities (Image-Pro Plus 6.0; Media Cybernetics Inc., Bethesda, MD, U.S.A.) was used to analyze images. Software calibration was performed for each image analysis by using the "Calibration Wizard" tool, which reports the number of pixels between two selected points. Linear remapping of the pixel numbers was used to calibrate the distance in µm or in mm according to the magnification degree.
Predictor and outcome variables This prospective study tested the null hypothesis of no differences in new bone formation among areas of different width in the same sinus against the alternative hypothesis of a difference.
The primary predictor variables were sinus width (SW) and residual bone height (RBH).
Primary outcome measure:
• new bone formation (NFB) after six months of healing
Secondary outcome measures:
residual graft (RG): after six months of healing
any complications or adverse events
Sample size calculation and statistical power A statistical software (Statistica per Discipline Biomediche, Version 6.0, Mc Graw-Hill, New York, NY, U.S.A.) was used to determine the sample size of this prospective study, basing on data of a previous publication. Expected difference in NFB (as mean percentage) between narrow and wide part of the sinus was 13.8±18.25% (using sinus width=13 mm as a cut-off). A sample of 16 histological specimens for each group was required to detect significant differences between the two groups (confidence level 5% with statistical power of 80%).
Statistical analysis An independent investigator (A.R.) analyzed all datasets with statistical software (IBM SPSS Statistics for Windows, Version 25.0, IBM Corp., Armonk, NY, USA). Data normality was assessed with Shapiro-Wilk test: all datasets met the required assumptions for using parametric methods. Descriptive statistics included mean and standard deviation. The value of α was set to 0.05.
Differences in NFB between mesial and distal sites were evaluated by means of paired samples t-test. The potential influence of sinus width and RBH on NFB and RG percentage was evaluated by using Pearson correlation coefficient. conditions module condition list condition Alveolar Bone Resorption keyword list keyword Sinus lift; sinus elevation; sinus width; bone graft histomorphometry alveolar bone atrophy design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Prospective bio spec bio spec retention Samples With DNA bio spec description alveolar bone specimen containing native bone, regenerated bone (with residual graft particles); the specimens were retrieved with a trephine bur that prepared the same time the implant site. enrollment info enrollment count 16 enrollment type Actual arms interventions module arm group list arm group arm group label Large sinus arm group description same patient, sinus width > 12mm measured at 10mm from the alveolar crest at the planned implant site arm group intervention list arm group intervention name Procedure: sinus floor elevation with lateral approach arm group label narrow sinus arm group description same patient, sinus width < 12mm measured at 10mm from the alveolar crest at the planned implant site arm group intervention list arm group intervention name Procedure: sinus floor elevation with lateral approach intervention list intervention intervention type Procedure intervention name sinus floor elevation with lateral approach intervention description sinus floor elevation with lateral approach. 6 months healing phase. implant site preparation with trephine bur and bone specimen retrieval. intervention arm group label list intervention arm group label Large sinus narrow sinus outcomes module primary outcome list primary outcome primary outcome measure quantity (%) of newly formed bone primary outcome description quantity (%) of newly formed bone (NFB) in histomorphometric analysis primary outcome time frame 6 months secondary outcome list secondary outcome secondary outcome measure quantity (%) of graft secondary outcome description quantity (%) of residual graft (RG) in histomorphometric analysis secondary outcome time frame 6 months secondary outcome measure quantity of complications secondary outcome description quantity of any complications or adverse events secondary outcome time frame through study completion, an average of 1 year eligibility module eligibility criteria Inclusion Criteria:
height of the residual bone crest <5 mm in both sites where implant placement was planned;
age >18 years;
written informed consent given.
Exclusion Criteria:
general contraindications to implant surgery
smokers
uncontrolled diabetes (HBA1c > 7.5%)
treated or under treatment with intravenous antiresorptive drugs
allergy to bovine collagen
immunosuppressed
irradiated in the head and neck area
pregnant or breastfeeding
substance abusers
psychiatric problems or unrealistic expectations
patient not fully able to comply with the study protocol.
maxillary sinus conditions contraindicating sinus floor elevation
poor oral hygiene and motivation (FMPS >25 and or FMBS>20)
Schneiderian membrane perforation during surgery healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Any patient with Kennedy class II partial edentulism (Kennedy 1928) requiring unilateral sinus floor elevation for the placement of two not adjacent dental implants supporting a fixed partial prosthesis was eligible for entering this study sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Claudio Stacchi, Dr. overall official affiliation Piezoelectricsurgery Academy overall official role Principal Investigator location list location location facility Hesire location city Cassano allo Ionio location state CS location zip 87011 location country Italy location facility Studio location city Gorizia location state GO location zip 34170 location country Italy location facility Studio B location city Verona location state VR location zip 37045 location country Italy references module reference list reference reference p m i d 32233183 reference type result reference citation Stacchi C, Spinato S, Lombardi T, Bernardello F, Bertoldi C, Zaffe D, Nevins M. Minimally Invasive Management of Implant-Supported Rehabilitation in the Posterior Maxilla, Part I. Sinus Floor Elevation: Biologic Principles and Materials. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e85-e93. doi: 10.11607/prd.4497. reference p m i d 32233185 reference type result reference citation Stacchi C, Spinato S, Lombardi T, Bernardello F, Bertoldi C, Zaffe D, Nevins M. Minimally Invasive Management of Implant-Supported Rehabilitation in the Posterior Maxilla, Part II. Surgical Techniques and Decision Tree. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e95-e102. doi: 10.11607/prd.4498. reference p m i d 23968289 reference type result reference citation Stacchi C, Vercellotti T, Toschetti A, Speroni S, Salgarello S, Di Lenarda R. Intraoperative complications during sinus floor elevation using two different ultrasonic approaches: a two-center, randomized, controlled clinical trial. Clin Implant Dent Relat Res. 2015 Jan;17 Suppl 1:e117-25. doi: 10.1111/cid.12136. Epub 2013 Aug 22. reference p m i d 20450402 reference type result reference citation Avila G, Wang HL, Galindo-Moreno P, Misch CE, Bagramian RA, Rudek I, Benavides E, Moreno-Riestra I, Braun T, Neiva R. The influence of the bucco-palatal distance on sinus augmentation outcomes. J Periodontol. 2010 Jul;81(7):1041-50. doi: 10.1902/jop.2010.090686. i p d sharing statement module i p d sharing No i p d sharing description data will be shared after data managing and statistics derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000001862 condition mesh term Bone Resorption condition ancestor list condition ancestor condition ancestor id D000001847 condition ancestor term Bone Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition browse leaf list condition browse leaf condition browse leaf id M3741 condition browse leaf name Atrophy condition browse leaf relevance low condition browse leaf id M17899 condition browse leaf name Alveolar Bone Loss condition browse leaf relevance low condition browse leaf id M4293 condition browse leaf name Bone Resorption condition browse leaf as found Bone Resorption condition browse leaf relevance high condition browse leaf id M4278 condition browse leaf name Bone Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev BC07 condition browse branch name Mouth and Tooth Diseases | NCT04830670 | [
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2734,
117,
25128,
3491,
1905,
1127,
2195,
1373,
1147,
23191,
9840,
1114,
170,
1344,
118,
13218,
1610,
12207,
6775,
1818,
10437,
1120,
1851,
216,
1306,
1105,
1173,
1747,
1205,
1223,
1919,
1447,
1114,
170,
1326,
1104,
185,
25694,
8840,
17973,
1106,
1164,
1476,
212,
1275,
216,
1306,
119,
1109,
15766,
1127,
1173,
5378,
1105,
9729,
1114,
5190,
175,
9827,
10606,
1162,
118,
1106,
7535,
2386,
2042,
2221,
1105,
3262,
19892,
11655,
24754,
1158,
119,
1230,
18778,
1766,
7880,
6758,
6013,
1109,
1378,
10986,
1127,
7140,
1111,
1296,
25128,
12685,
131,
1703,
1298,
1104,
1103,
25128,
12685,
113,
1107,
2608,
1477,
114,
117,
6556,
1104,
3599,
118,
1824,
6028,
113,
151,
24366,
114,
117,
6556,
1104,
7543,
2109,
7918,
120,
12477,
8674,
6966,
113,
10978,
114,
117,
1105,
6556,
1104,
25399,
176,
15371,
9150,
113,
155,
2349,
114,
119,
1109,
3622,
1108,
1982,
1606,
12086,
3999,
2427,
1609,
17599,
15300,
113,
139,
10714,
6817,
139,
1495,
132,
16409,
11179,
1161,
9126,
22218,
117,
1727,
5096,
20623,
1186,
117,
2413,
114,
117,
3387,
1106,
1344,
6021,
3539,
4504,
113,
12556,
11761,
1306,
126,
119,
121,
132,
12556,
2941,
27730,
11428,
5005,
117,
19892,
10481,
6931,
117,
1975,
114,
119,
138,
3594,
1114,
3077,
12203,
9816,
113,
15065,
118,
5096,
8696,
127,
119,
121,
132,
3957,
27688,
3169,
6097,
4724,
3561,
119,
117,
6452,
1279,
1810,
117,
9292,
117,
158,
119,
156,
119,
138,
119,
114,
1108,
1215,
1106,
19774,
4351,
119,
10331,
11019,
2646,
6766,
2116,
1108,
1982,
1111,
1296,
3077,
3622,
1118,
1606,
1103,
107,
11917,
13292,
6108,
16369,
107,
6806,
117,
1134,
3756,
1103,
1295,
1104,
185,
28076,
1116,
1206,
1160,
2700,
1827,
119,
2800,
1813,
1231,
1918,
13044,
1104,
1103,
185,
28076,
2849,
1108,
1215,
1106,
11019,
2646,
6766,
1566,
1103,
2462,
1107,
216,
1306,
1137,
1107,
2608,
2452,
1106,
1103,
12477,
22152,
11531,
2178,
119,
11689,
28113,
1766,
1105,
9386,
10986,
1188,
19916,
2025,
7289,
1103,
26280,
11066,
1104,
1185,
5408,
1107,
1207,
6028,
3855,
1621,
1877,
1104,
1472,
9346,
1107,
1103,
1269,
11850,
1361,
1222,
1103,
4174,
11066,
1104,
170,
3719,
119,
1109,
2425,
17163,
1766,
10986,
1127,
11850,
1361,
9346,
113,
156,
2924,
114,
1105,
25399,
6028,
3976,
113,
24718,
3048,
114,
119,
6933,
9386,
4929,
131,
794,
1207,
6028,
3855,
113,
151,
24366,
114,
1170,
1565,
1808,
1104,
9523,
7934,
9386,
5252,
131,
25399,
176,
15371,
113,
155,
2349,
114,
131,
1170,
1565,
1808,
1104,
9523,
1251,
13522,
1137,
16798,
1958,
2687,
7136,
2060,
19218,
1105,
11435,
1540,
138,
11435,
3594,
113,
1457,
11745,
5668,
1161,
1679,
14856,
9717,
2568,
139,
2660,
4611,
26312,
117,
8812,
127,
119,
121,
117,
150,
1665,
144,
28115,
118,
2404,
117,
1203,
1365,
117,
5883,
117,
158,
119,
156,
119,
138,
119,
114,
1108,
1215,
1106,
4959,
1103,
6876,
2060,
1104,
1142,
19916,
2025,
117,
8434,
1403,
1113,
2233,
1104,
170,
2166,
4128,
119,
16409,
26426,
1174,
3719,
1107,
151,
24366,
113,
1112,
1928,
6556,
114,
1206,
4142,
1105,
2043,
1226,
1104,
1103,
11850,
1361,
1108,
1492,
119,
129,
28168,
15292,
119,
1512,
110,
113,
1606,
11850,
1361,
9346,
134,
1492,
2608,
1112,
170,
2195,
118,
1228,
114,
119,
138,
6876,
1104,
1479,
1117,
2430,
7810,
9985,
1111,
1296,
1372,
1108,
2320,
1106,
11552,
2418,
5408,
1206,
1103,
1160,
2114,
113,
6595,
1634,
126,
110,
1114,
11435,
1540,
1104,
2908,
110,
114,
119,
12121,
3622,
1760,
2457,
17805,
113,
138,
119,
155,
119,
114,
17689,
1155,
2233,
27948,
1114,
11435,
3594,
113,
9768,
16625,
12480,
10910,
1111,
5647,
117,
8812,
1512,
119,
121,
117,
9768,
13619,
119,
117,
24446,
1320,
1377,
117,
5883,
117,
3066,
114,
119,
7154,
2999,
1785,
1108,
14758,
1114,
27747,
118,
160,
2723,
1377,
2774,
131,
1155,
2233,
27948,
1899,
1103,
2320,
19129,
1111,
1606,
18311,
13689,
4069,
119,
14177,
13590,
2109,
9161,
1529,
1928,
1105,
2530,
1260,
27444,
119,
1109,
2860,
1104,
418,
1108,
1383,
1106,
121,
119,
4991,
119,
12120,
20954,
1116,
1107,
151,
24366,
1206,
1143,
6370,
1233,
1105,
4267,
19760,
3911,
1127,
17428,
1118,
2086,
1104,
13185,
8025,
189,
118,
2774,
119,
1109,
3209,
2933,
1104,
11850,
1361,
9346,
1105,
24718,
3048,
1113,
151,
24366,
1105,
155,
2349,
6556,
1108,
17428,
1118,
1606,
13079,
18741,
21130,
119,
2975,
13196,
3879,
2190,
3879,
2586,
2707,
21459,
17722,
11336,
21484,
18225,
2501,
12565,
2190,
2501,
12565,
14009,
1361,
6012,
132,
11850,
1361,
6252,
132,
11850,
1361,
9346,
132,
6028,
176,
15371,
1117,
18778,
1766,
7880,
6758,
6013,
2393,
2707,
21459,
6028,
1120,
12736,
7889,
1902,
13196,
2025,
2076,
152,
4832,
1200,
11583,
1348,
5351,
25097,
1302,
1902,
23992,
1902,
8310,
1348,
2235,
2190,
1902,
8310,
1348,
2235,
9060,
118,
6342,
1902,
1159,
7281,
2190,
1902,
1159,
7281,
24667,
2109,
25128,
188,
25392,
25128,
188,
25392,
23406,
2687,
15377,
1556,
5394,
25128,
188,
25392,
6136,
2393,
2707,
21459,
6028,
11678,
4051,
2900,
6028,
117,
1231,
26038,
1181,
6028,
113,
1114,
25399,
176,
15371,
9150,
114,
132,
1103,
9985,
1127,
14408,
1114,
170,
189,
1874,
21587,
171,
2149,
1115,
4029,
1103,
1269,
1159,
1103,
24034,
9180,
1751,
119,
10803,
23992,
10803,
5099,
1479,
10803,
2076,
2173,
4746,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
10236,
11850,
1361,
1981,
1372,
6136,
1269,
5351,
117,
11850,
1361,
9346,
135,
1367,
6262,
7140,
1120,
1275,
6262,
1121,
1103,
2393,
2707,
21459,
13468,
1120,
1103,
2919,
24034,
9180,
1751,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
5096,
9650,
3313,
131,
11850,
1361,
1837,
6252,
1114,
11937,
3136,
1981,
1372,
3107,
4142,
11850,
1361,
1981,
1372,
6136,
1269,
5351,
117,
11850,
1361,
9346,
133,
1367,
6262,
7140,
1120,
1275,
6262,
1121,
1103,
2393,
2707,
21459,
13468,
1120,
1103,
2919,
24034,
9180,
1751,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
5096,
9650,
3313,
131,
11850,
1361,
1837,
6252,
1114,
11937,
3136,
9108,
2190,
9108,
9108,
2076,
5096,
9650,
3313,
9108,
1271,
11850,
1361,
1837,
6252,
1114,
11937,
3136,
9108,
6136,
11850,
1361,
1837,
6252,
1114,
11937,
3136,
119,
127,
1808,
9523,
4065,
119,
24034,
9180,
1751,
7288,
1114,
189,
1874,
21587,
171,
2149,
1105,
6028,
11678,
1231,
19091,
17885,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
10236,
11850,
1361,
4142,
11850,
1361,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
11978,
113,
110,
114,
1104,
3599,
1824,
6028,
2425,
9386,
6136,
11978,
113,
110,
114,
1104,
3599,
1824,
6028,
113,
151,
24366,
114,
1107,
1117,
18778,
1766,
7880,
23930,
3622,
2425,
9386,
1159,
4207,
127,
1808,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
11978,
113,
110,
114,
1104,
176,
15371,
3718,
9386,
6136,
11978,
113,
110,
114,
1104,
25399,
176,
15371,
113,
155,
2349,
114,
1107,
1117,
18778,
1766,
7880,
23930,
3622,
3718,
9386,
1159,
4207,
127,
1808,
3718,
9386,
4929,
11978,
1104,
13522,
3718,
9386,
6136,
11978,
1104,
1251,
13522,
1137,
16798,
1958,
3718,
9386,
1159,
4207,
1194,
2025,
6026,
117,
1126,
1903,
1104,
122,
1214,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
3976,
1104,
1103,
25399,
6028,
13468,
133,
126,
2608,
1107,
1241,
3911,
1187,
24034,
9180,
12693,
1108,
2919,
132,
1425,
135,
1407,
1201,
132,
1637,
6189,
9635,
1549,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
1704,
14255,
4487,
24704,
4578,
6126,
1106,
24034,
9180,
6059,
5427,
1733,
8362,
7235,
8005,
11572,
17972,
113,
145,
8215,
1475,
1665,
135,
128,
119,
126,
110,
114,
5165,
1137,
1223,
3252,
1114,
1107,
4487,
7912,
2285,
2848,
4894,
1766,
6451,
2109,
5557,
1155,
1200,
4873,
1106,
171,
3292,
2042,
1884,
3848,
4915,
13280,
13601,
14226,
4455,
15716,
178,
10582,
7168,
1906,
1107,
1103,
1246,
1105,
2455,
1298,
6391,
1137,
7209,
8124,
17141,
9556,
6704,
1733,
17123,
2645,
1137,
8362,
16330,
5562,
11471,
5351,
1136,
3106,
1682,
1106,
14616,
1114,
1103,
2025,
11309,
119,
12477,
8745,
12576,
1183,
11850,
1361,
2975,
14255,
4487,
24704,
4578,
1916,
11850,
1361,
1837,
6252,
2869,
9619,
177,
21431,
1105,
15710,
113,
3941,
10197,
135,
1512,
1105,
1137,
3941,
9782,
135,
1406,
114,
15934,
1811,
10936,
1679,
14467,
6108,
1219,
6059,
8071,
8118,
138,
19515,
15384,
1116,
3225,
1183,
19340,
5772,
1398,
5867,
1425,
1407,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
2025,
1416,
6291,
5351,
1114,
5107,
1705,
1563,
7597,
5048,
3452,
15818,
6602,
113,
5107,
3825,
114,
8753,
8362,
8009,
16719,
11850,
1361,
1837,
6252,
1111,
1103,
12693,
1104,
1160,
1136,
4903,
15360,
24034,
23288,
4374,
170,
4275,
7597,
5250,
2050,
22063,
1108,
7408,
1111,
5273,
1142,
2025,
18200,
3442,
7922,
118,
5096,
2822,
5474,
2687,
7136,
10492,
4541,
13196,
2905,
2078,
2190,
2905,
2078,
2905,
2078,
1271,
22363,
1457,
7409,
4313,
117,
1987,
119,
2905,
2078,
13494,
26424,
6112,
11194,
5822,
4907,
6385,
26206,
1183,
2127,
2905,
2078,
1648,
8013,
1130,
5710,
3121,
25524,
1766,
2450,
2190,
2450,
2450,
3695,
1124,
19496,
1162,
2450,
1331,
17500,
7428,
1155,
1186,
19447,
2660,
2450,
1352,
24821,
2450,
195,
9717,
5966,
24400,
1475,
2450,
1583,
2413,
2450,
3695,
6125,
2450,
1331,
3414,
28021,
1465,
2450,
1352,
27157,
2450,
195,
9717,
3236,
16770,
1568,
2450,
1583,
2413,
2450,
3695,
6125,
139,
2450,
1331,
22051,
2450,
1352,
159,
2069,
2450,
195,
9717,
17455,
21336,
2450,
1583,
2413,
7732,
13196,
3835,
2190,
3835,
3835,
185,
182,
178,
173,
26605,
23493,
15292,
1495,
3835,
2076,
1871,
3835,
19548,
1457,
7409,
4313,
140,
117,
22878,
10024,
156,
117,
26416,
1182,
157,
117,
6190,
13323,
143,
117,
15035,
11015,
1182,
140,
117,
163,
9823,
8124,
141,
117,
151,
6348,
4935,
150,
119,
14393,
7435,
1193,
1130,
25007,
3973,
1104,
146,
8223,
9180,
118,
8704,
1174,
11336,
27778,
1107,
1103,
3799,
9866,
1766,
3405,
5878,
117,
4539,
146,
119,
14009,
1361,
22774,
2896,
12853,
2116,
131,
139,
19840,
8032,
1596,
22265,
1105,
19591,
119,
1130,
1204,
147,
16477,
9921,
4724,
20515,
6533,
3946,
14760,
1204,
119,
12795,
1318,
120,
12865,
132,
1969,
113,
124,
114,
131,
174,
1604,
1571,
118,
174,
1580,
1495,
119,
9465,
131,
1275,
119,
13096,
1568,
1559,
120,
185,
2956,
119,
3140,
1580,
1559,
119,
3835,
185,
182,
178,
173,
26605,
23493,
15292,
1571,
3835,
2076,
1871,
3835,
19548,
1457,
7409,
4313,
140,
117,
22878,
10024,
156,
117,
26416,
1182,
157,
117,
6190,
13323,
143,
117,
15035,
11015,
1182,
140,
117,
163,
9823,
8124,
141,
117,
151,
6348,
4935,
150,
119,
14393,
7435,
1193,
1130,
25007,
3973,
1104,
146,
8223,
9180,
118,
8704,
1174,
11336,
27778,
1107,
1103,
3799,
9866,
1766,
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full study rank 61388 study protocol section identification module n c t id NCT04837118 org study id info org study id 2020-0147 secondary id info list secondary id info secondary id NCI-2021-02028 secondary id type Registry Identifier secondary id domain CTRP (Clinical Trial Reporting Program) secondary id 2020-0147 secondary id type Other Identifier secondary id domain M D Anderson Cancer Center organization org full name M.D. Anderson Cancer Center org class OTHER brief title Resistance Training Intervention to Improve Physical Function in Patients With Pancreatic Cancer Receiving Combination Chemotherapy or Have Undergone Surgery, PancStrength Study official title PancStrength: Safety, Feasibility, and Acceptability of a Tele-Exercise Resistance Training Intervention During Pancreatic Cancer Treatment status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date February 15, 2021 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name M.D. Anderson Cancer Center lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This clinical trial studies the safety of a real-time tele-exercise resistance training (training done using a tablet) in maintaining skeletal muscle, strength, physical function, and health-related quality of life in patients with pancreatic cancer who are receiving combination chemotherapy or have undergone surgery for the treatment of pancreatic cancer. Tele-exercise resistance training may improve physical function and quality of life in patients with pancreatic cancer. detailed description PRIMARY OBJECTIVE:
I. Evaluate the safety of a progressive, home-based, tele-exercise resistance training (tele-RT) intervention in patients undergoing first line FOLFIRINOX chemotherapy for advanced pancreatic ductal adenocarcinoma (PDAC) (Study 1) and in survivors who have undergone pancreatic cancer resection (Study 2).
SECONDARY OBJECTIVES:
I. Evaluate the feasibility and acceptability of the tele-RT intervention.
II. Evaluate changes in the following exploratory outcome measures over the course of first-line FOLFIRINOX for advanced PDAC and associations between resistance training (RT) volumes and their changes:
IIa. Muscular strength IIb. Muscular endurance IIc. Body composition (skeletal muscle mass) IId. Aerobic fitness IIe. Self-reported physical activity IIf. Self-reported physical functioning IIg. Fatigue IIh. Peripheral neuropathy IIi. Health-related quality of life (QOL) IIj. Completion of intended chemotherapy dose (Among patients who are undergoing chemotherapy; all participants in Study 1 and some in Study 2) IIk. Exercise motivation IIl. Exercise self-efficacy IIm. Social support for exercise IIn. Reduction or change in FOLFIRINOX treatment plan III. Evaluate cancer care providers' (treating physicians and other clinical personnel) perspectives regarding the feasibility and acceptability of the tele-RT intervention for their patients.
OUTLINE:
STUDY 1: During the first 2-3 months of first line FOLFIRINOX chemotherapy, patients complete at least 4 tele-RT sessions over 30-45 minutes each, every 2 weeks. Patients receive handouts created by MD Anderson Cancer Center (MDACC) clinical dietitians including individualized recommendations for daily protein intake and information about healthy protein supplementation during chemotherapy. Patient may also attend a visit with a registered dietician (or delegate dietician) per standard of care, if they have renal insufficiency, special dietary needs, or difficulty adhering to protein recommendations.
STUDY 2: After standard of care surgical resection, patients complete at least 4 tele-RT sessions over 30-45 minutes each, every 2 weeks for 2-3 months. Patients receive handouts created by MDACC clinical dietitians including individualized recommendations for daily protein intake and information about healthy protein supplementation during chemotherapy. Patient may also attend a visit with a registered dietician (or delegate dietician) per standard of care, if they have renal insufficiency, special dietary needs, or difficulty adhering to protein recommendations. conditions module condition list condition Advanced Pancreatic Adenocarcinoma Pancreatic Adenocarcinoma Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Supportive Care design masking info design masking None (Open Label) enrollment info enrollment count 75 enrollment type Anticipated arms interventions module arm group list arm group arm group label Supportive care (resistance training) arm group type Experimental arm group description SEE DETAILED DESCRIPTION. arm group intervention list arm group intervention name Other: Educational Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Resistance Training intervention list intervention intervention type Other intervention name Educational Intervention intervention description Receive handouts containing dietary recommendations intervention arm group label list intervention arm group label Supportive care (resistance training) intervention other name list intervention other name Education for Intervention Intervention by Education Intervention through Education Intervention, Educational intervention type Other intervention name Quality-of-Life Assessment intervention description Ancillary studies intervention arm group label list intervention arm group label Supportive care (resistance training) intervention other name list intervention other name Quality of Life Assessment intervention type Other intervention name Questionnaire Administration intervention description Ancillary studies intervention arm group label list intervention arm group label Supportive care (resistance training) intervention type Other intervention name Resistance Training intervention description Participate in a resistance training program intervention arm group label list intervention arm group label Supportive care (resistance training) intervention other name list intervention other name Strength Training outcomes module primary outcome list primary outcome primary outcome measure Safety of the tele-resistance training (RT) program primary outcome description Safety will be assessed based on the rate of musculoskeletal injuries and other adverse health events that participants incur while participating in tele-RT sessions. Participants will be monitored throughout the exercise intervention for musculoskeletal injuries and other adverse health events and referred to a Physical Medicine and Rehabilitation physician or their gastrointestinal (GI) Medical Oncology teams as necessary. The association of the injury with strength training will be assessed by asking participants to rate the injury on a scale of 1-4 (1=not related, 2=unlikely related, 3=likely related, 4=definitely related). The severity of the injury will be rated on a scale of 1-4 (1=mild/no change in daily activity, 2=some limitation of daily activity, 3=major limitation of daily activity, 4=life threatening). The duration for which daily activities were impacted will be rated on a scale from 1-5 (1=no change, 2=1-3 days, 3=4-7 days, 4=1-2 weeks, 5=more than 2 weeks). primary outcome time frame 3-4 months primary outcome measure Post-exercise muscle soreness primary outcome description Soreness will be assessed at the beginning of each tele-RT session, with participants asked to describe how soreness has changed since the previous RT session and how soreness has changed over the course of RT sessions. If soreness is not becoming more manageable with ongoing RT, participants will be referred to Dr. Ngo-Huang (study co-principal investigator [PI] and physiatrist) for follow-up to rule out any underlying injuries. primary outcome time frame 3-4 months primary outcome measure Body composition primary outcome description Cross-sectional areas (CSA) of skeletal muscle, intramuscular fat, visceral fat, and subcutaneous fat will be measured using SliceOMatic software (TomoVision, 2012) using computed tomography images routinely obtained for cancer assessment and staging purposes. Imaging dates will align with cancer staging and restaging appointments at T0 and T1. Cross-sectional areas at the L3 vertebral level will be standardized to the square of participants' heights in meters. Average radiodensity (in Hounsfield Units) of skeletal muscle will also be collected using SliceOMatic software. primary outcome time frame 3-4 months primary outcome measure Aerobic fitness primary outcome description Will be measured using 6-minute walk test (6MWT) distance, measured in meters. For participants who undergo remote exercise testing, the 2-minute step test will be used to assess aerobic fitness. Participants will be guided to step in place as quickly as possible, raising each knee to the proper height (midway between the opposite knee and hip), with trainers recording the number of complete steps they can complete in 2 minutes. primary outcome time frame 3-4 months secondary outcome list secondary outcome secondary outcome measure Acceptability for Feasibility secondary outcome description Will be assessed with the following variables: 1)Uptake rate: Study enrollment will be considered feasible if 70% of eligible patients who are approached to consider study enrollment actually consent and enroll. 2) Study completion rate: If 70% of participants who complete T0 measures (fitness and survey measures) also complete measures at T1. 3) Tele-RT session attendance rate: If the rate of session completion is >= 70%. 4) Adherence to prescribed exercise volume (sets x repetitions x resistance): If the volume of exercise completed is >= 70% of the volume prescribed. secondary outcome time frame 3-4 months secondary outcome measure Acceptability for participants secondary outcome description Assessed with the Participant Evaluation of Feasibility and Acceptability questionnaire, adapted from Ingram, et al (2010). This questionnaire includes both Likert Scale and open-ended questions. Likert Scale items will be rated on 5-point scales (1=strongly disagree, 2=disagree, 3=neutral, 4=agree, 5=strongly agree). Acceptability will be assessed on an item-by-item basis and as an average item score, with scores >= 4 ("agree" to "strongly agree") indicating acceptability. Responses to open-ended questions will be analyzed qualitatively to inform development of further iterations of the exercise intervention. Qualitative analysis will follow a content analysis strategy to systematically define units of text, quantify them, and group them into meaningful categories. secondary outcome time frame 3-4 months secondary outcome measure Acceptability for providers secondary outcome description Assessed with a brief program evaluation questionnaire distributed to all GI medical oncologists, GI surgeons, advanced practice providers, and clinical dietitians who are involved in participants' care and have some interaction with intervention personnel during recruitment, referral, scheduling, or follow up. Provider acceptability questionnaires will be distributed via REDCap immediately following collection of T1 data from the final study participant and will include Likert Scale items and open-ended items adapted from the Participant Evaluation of Feasibility and Acceptability. secondary outcome time frame 3-4 months secondary outcome measure Dynamic upper- and lower-body muscular strength secondary outcome description Strength in upper- and lower-body muscle groups will be measured using the following 1-repetition maximum (1RM) lifts: chest press, seated row, leg press, and leg extension. 1RM tests are considered the gold standard for assessing muscular strength in non-laboratory situations. 1RM tests are defined as the maximal weight that can be lifted once with correct lifting technique and are used by athletic trainers, health and fitness professionals and rehabilitation specialists to assess strength and to evaluate training programs. They will be performed in the following sequence, ordered from largest to smallest muscle groups and alternating between upper and lower body movements to allow for sufficient rest: leg press, chest press, leg extension, seated row. secondary outcome time frame 3-4 months secondary outcome measure Dynamic upper- and lower-body muscular endurance secondary outcome description Endurance of upper and lower body muscle groups as measured by the maximum number of repetitions performed at 70% of the T0 1RM for each of the following lifts: leg press, chest press, leg extension, seated row. Participants will rest sufficiently between movements and will perform tests in the same order that they performed 1RM testing. Participants who undergo remote enrollment and exercise testing will undergo the following exercise "field tests" to assess muscular strength and endurance: 1) 30-second chair stand test (to assess lower body strength and muscular endurance) and 30-second arm curl test (to assess upper body strength and muscular endurance). secondary outcome time frame 3-4 months secondary outcome measure Fatigue secondary outcome description Self-reported fatigue will be measured using the Functional Assessment of Cancer Therapy-Fatigue (FACT-F). The FACT-F consists of 13 fatigue-related items and has demonstrated validity and reliability as a brief, standalone measure of fatigue among cancer survivors. The FACT-F will provide a single score, with higher scores indicating better quality of life (QOL) (less fatigue). The FACT-F will be distributed and completed via REDCap at T0 and T1. secondary outcome time frame 3-4 months secondary outcome measure Chemotherapy-induced peripheral neuropathy (CIPN) secondary outcome description CIPN will be self-reported using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - CIPN-20 item scale. This is a 20-item questionnaire regarding sensory, motor, and autonomic neuropathy symptoms with each item scored from 1 (not at all) to 4 (very much), and all items are summed to result in a score range of 20 to 80. A higher score on the questionnaire indicates more symptom burden from CIPN. Will only administer and score items 1-19 with scores ranging from 16 to 76. This questionnaire will be distributed and completed via REDCap at T0 and T1. secondary outcome time frame 3-4 months secondary outcome measure Health-related QOL secondary outcome description Will be self-reported using the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire (FACT-Hep). The FACT-Hep is composed of two parts: the 27-question FACT General (FACT-G) and the 18-question Hepatobiliary Subscale (HS). The FACT-G measures cancer-related QOL in four domains: physical, social/family, emotional, and functional well-being. The HS evaluates the severity of hepatobiliary cancer-specific symptoms. All questions are scored on a Likert scale from 0 to 4 (some are reversed) and added to create FACT-G and HS scores, and these are added to create a FACT-Hep score. A higher FACT-G subscore denotes better QOL. A higher HS subscore denotes a lower degree of disease-related symptoms. The FACT-Hep will be distributed and completed via REDCap at T0 and T1. secondary outcome time frame 3-4 months secondary outcome measure Chemotherapy tolerance and delivery secondary outcome description Chemotherapy tolerance will be assessed based on relative dose intensities (RDI; defined as the ratio of administered cumulative dose over planned cumulative dose) of the 4 drugs comprising the FOLFIRINOX regimen (39). These data will be collected from participants' electronic health records. Will record if there are any changes in the prescribed regimen (reduction in dose or change in medications) during the study period. secondary outcome time frame 3-4 months secondary outcome measure Exercise motivation secondary outcome description Will be measured using Behavioral Regulation in Exercise Questionnaire-Version 3 (BREQ-3). The BREQ-3 has subscales measuring external (i.e., performed because of an outside demand or potential reward), introjected (i.e., performed to demonstrate an ability), identified (i.e., consciously valuing exercise), and intrinsic forms of exercise behavior regulation. Participant responses will be evaluated as separate subscale scores and as an overall score, with higher overall scores indicating higher relative autonomy in exercise regulation (i.e., higher personal valuation of exercise and higher intrinsic motivation to exercise). The BREQ-3 will be distributed and completed via REDCap at T0 and T1. secondary outcome time frame 3-4 months secondary outcome measure Exercise barriers self-efficacy secondary outcome description Participants will complete the Barriers Self-efficacy survey developed by Marcus et al. and adapted by Tirado-Gomez et al. This survey includes 14 questions that assess how confident an individual is in his or her ability to exercise when facing various barriers, such as sickness, fatigue, and lack of time. Participants will indicate their level of confidence using a scale ranging from 1 (not at all confident) to 5 (extremely confident). Responses to the 14 individual items will be summed to obtain an overall score, with a range of 14 to 70. secondary outcome time frame 3-4 months secondary outcome measure Social support for exercise secondary outcome description Social support for exercise from family and friends will be measured using the Social Support for Exercise Survey (SSES). The SSES lists 13 items that family members or friends may do or say to someone who is trying to exercise regularly, from providing emotional support. The SSES also captures social influences that may hinder exercise. Patients responded to each item separately for friends and family, scoring each item on a Likert-like scale from 1=none to 5=very often. Scores for family and friend participation and family rewards and punishment will be computed following published protocols. Participants will also complete the 13 item scale regarding perceived social support from study interventionists/staff, with instructions to record "does not apply" for items such as "planned for exercise on recreational outings" and "helped plan activities around my exercise." The SSES will be distributed and completed via REDCap at T0 and T1. secondary outcome time frame 3-4 months secondary outcome measure Self-reported physical activity secondary outcome description Measured using a modified version of the Godin-Shephard Leisure Time Physical Activity Questionnaire (GLTPAQ). The GLTPAQ will be modified as in Vallerand, et al. (2017) to include both aerobic exercise and strengthening exercise related questions and to ascertain performance of guideline-concordant physical activity. To reflect current exercise recommendations, patients will be instructed to include any exercise that lasted at least 5 minutes. Additionally, we will include a single item that asks how many times per week participants perform strengthening exercise (i.e., exercise that improves muscular strength such as weight lifting, resistance bands, sit ups, or push-ups). This question will be extracted from the Health Information National Trends Survey (HINTS) conducted by the National Cancer Institute. secondary outcome time frame 3-4 months secondary outcome measure Self-reported physical functioning secondary outcome description Self-reported physical functioning will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Physical Function 12a. The instrument consists of 12 questions assessing respondents' abilities to perform physical tasks and activities of daily living. Items are scored on 5-point Likert scales, with higher scores indicating higher physical functioning. The PROMIS will be distributed and completed via REDCap at T0 and T1. secondary outcome time frame 3-4 months secondary outcome measure Feasibility of Automated Self Assisted 24-hour recall (ASA24) (24-hour dietary recall) secondary outcome description Will be assessed by determining the proportion of participants who complete the survey at each target assessment. We will measure the adoption of nutrition recommendations by comparing the recall responses from within the study period to their baseline responses at the time of enrollment. Will also compare adherence to our nutrition recommendations (i.e., protein intake) through the ASA-24 survey at each targeted assessment. secondary outcome time frame At time of enrollment up to 7-10 days before date of surgery eligibility module eligibility criteria Inclusion Criteria:
Biopsy-proven pancreatic adenocarcinoma, advanced stage (III-IV) (study 1) OR biopsy-proven pancreatic adenocarcinoma, at least 10 weeks post-surgical tumor resection and currently with no radiographic evidence of disease on recent computerized tomography (CT) scan (study 2)
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Treatment plan of first-line FOLFIRINOX chemotherapy with planned return visit to MD Anderson Main Campus for restaging (study 1) OR plans to return to MDACC for restaging appointments in 3-4 months, including follow up CT scan (study 2)
Able to schedule baseline (T0) appointment for fitness testing and program teaching at the Behavioral Research and Treatment Center (BRTC) or able to schedule remote fitness testing and program teaching
Able to understand the description of the study, exercise program, and willing to participate
Home access to wireless internet (Wi-Fi) and agreement to engage with study personnel for real-time tele-RT sessions
Age >= 18
Meet all screening requirements
PROVIDERS (FOR ACCEPTABILITY INTERVENTION): All GI medical oncologists, GI surgeons, advanced practice providers, and clinical dietitians who are involved in participants' care and have some interaction with intervention personnel during recruitment, referral, scheduling, or follow up will be asked to complete questionnaires assessing intervention acceptability. The exact number of providers who will be asked to complete questionnaires will depend on whether patients enroll from the different GI Medical Oncology and GI Surgery clinics, but we expect 10-20 providers to be eligible
Exclusion Criteria:
Non-English speaking
Has participated in regular RT (RT for all major muscle groups at least twice per week) throughout the month prior to recruitment
Unable to complete the baseline assessment questionnaires or functional assessments
Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and/or Patient Reported Outcomes Measurement Information System (PROMIS) questions
Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
Recent fracture or acute musculoskeletal injury that precludes the ability to weight bear fully on all 4 limbs in order to participate in an exercise intervention
Numeric pain rating scale of >= 7 out of 10
Myopathic or rheumatologic disease that impacts physical function
FEMALES ONLY: Known pregnancy, as communicated to study personnel by clinicians in gastrointestinal (GI) Medical Oncology; females of childbearing potential receive advice to use methods of contraception per usual care healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Nathan H Parker overall official affiliation M.D. Anderson Cancer Center overall official role Principal Investigator location list location location facility M D Anderson Cancer Center location status Recruiting location city Houston location state Texas location zip 77030 location country United States location contact list location contact location contact name Nathan H. Parker location contact role Contact location contact phone 713-745-1769 location contact e mail nhparker@mdanderson.org location contact name Nathan H. Parker location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000230 condition mesh term Adenocarcinoma condition mesh id D000010190 condition mesh term Pancreatic Neoplasms condition ancestor list condition ancestor condition ancestor id D000002277 condition ancestor term Carcinoma condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000004701 condition ancestor term Endocrine Gland Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000010182 condition ancestor term Pancreatic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition browse leaf list condition browse leaf condition browse leaf id M2737 condition browse leaf name Adenocarcinoma condition browse leaf as found Adenocarcinoma condition browse leaf relevance high condition browse leaf id M12262 condition browse leaf name Pancreatic Neoplasms condition browse leaf as found Pancreatic Cancer condition browse leaf relevance high condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf relevance low condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M7015 condition browse leaf name Endocrine Gland Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M12254 condition browse leaf name Pancreatic Diseases condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id T4387 condition browse leaf name Pancreatic Cancer condition browse leaf as found Pancreatic Cancer condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases | NCT04837118 | [
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2013,
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2013,
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2013,
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2013,
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2013,
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114,
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113,
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1920,
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151,
120,
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1990,
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1981,
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1981,
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1981,
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1920,
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2013,
114,
1981,
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1981,
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119,
1981,
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1981,
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131,
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21987,
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21987,
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1981,
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1981,
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1920,
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2013,
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1981,
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1920,
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1981,
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1920,
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2013,
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1920,
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2013,
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118,
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2013,
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1942,
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1958,
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118,
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1942,
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119,
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1111,
182,
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1958,
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1106,
170,
10618,
5734,
1105,
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7454,
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3245,
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113,
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114,
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1929,
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119,
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2013,
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1103,
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1942,
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2014,
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1942,
117,
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1987,
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164,
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124,
118,
125,
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2425,
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113,
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118,
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119,
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117,
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117,
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131,
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117,
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117,
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117,
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119,
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124,
118,
125,
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141,
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118,
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118,
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1404,
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1982,
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110,
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1103,
157,
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122,
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1111,
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117,
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1982,
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119,
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118,
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114,
1105,
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118,
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1981,
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113,
1106,
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3105,
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14310,
20655,
114,
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125,
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119,
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118,
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113,
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119,
174,
119,
117,
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1104,
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1796,
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3209,
10703,
114,
117,
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113,
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119,
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119,
117,
1982,
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10541,
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114,
117,
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113,
178,
119,
174,
119,
117,
27835,
191,
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27989,
10224,
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11317,
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117,
1114,
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13987,
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113,
178,
119,
174,
119,
117,
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191,
1348,
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1104,
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27799,
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114,
119,
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2036,
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118,
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full study rank 61215 study protocol section identification module n c t id NCT04839367 org study id info org study id CLP03 organization org full name Clarity Pharmaceuticals Ltd org class INDUSTRY brief title Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER) official title Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study acronym PROPELLER status module status verified date July 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date July 13, 2021 start date type Actual primary completion date struct primary completion date August 2022 primary completion date type Anticipated completion date struct completion date August 2022 completion date type Anticipated study first submit date April 7, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 27, 2022 last update post date struct last update post date July 28, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Clarity Pharmaceuticals Ltd lead sponsor class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The aim of this study is to determine the safety and tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer. detailed description This is a multi-centre, blinded review, dose ranging, non-randomized study of 64Cu-SAR-bisPSMA administered to participants with confirmed Prostate Cancer. 30 eligible participants will be allocated (1:1:3) to 1 of 3 dosing cohorts to be administered with 64Cu-SAR-bisPSMA 100 MBq, 150 MBq or 200 MBq. PET/CT scan images will be sent to blinded central readers to assess the capacity of 64Cu-SAR-bisPSMA to detect primary Prostate Cancer, to assess image quality of the various dose cohorts, and to assess the PET/CT scan features of 64Cu-SAR-bisPSMA in comparison standard of care. conditions module condition list condition Prostatic Neoplasms design module study type Interventional phase list phase Phase 1 design info design allocation Non-Randomized design intervention model Sequential Assignment design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Actual arms interventions module arm group list arm group arm group label Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA arm group type Experimental arm group description Participants will receive a single administration, a bolus injection of 100 MBq 64Cu-SAR-bisPSMA. arm group intervention list arm group intervention name Drug: 64Cu-SAR-bisPSMA arm group label Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA arm group type Experimental arm group description Participants will receive a single administration, a bolus injection of 150 MBq 64Cu-SAR-bisPSMA. arm group intervention list arm group intervention name Drug: 64Cu-SAR-bisPSMA arm group label Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA arm group type Experimental arm group description Participants will receive a single administration, a bolus injection of 200 MBq 64Cu-SAR-bisPSMA. arm group intervention list arm group intervention name Drug: 64Cu-SAR-bisPSMA intervention list intervention intervention type Drug intervention name 64Cu-SAR-bisPSMA intervention description 64Cu-SAR-bisPSMA intervention arm group label list intervention arm group label Cohort 1 - 100 MBq 64Cu-SAR-bisPSMA Cohort 2 - 150 MBq 64Cu-SAR-bisPSMA Cohort 3 - 200 MBq 64Cu-SAR-bisPSMA outcomes module primary outcome list primary outcome primary outcome measure Safety and tolerability of 64Cu-SAR-bisPSMA using Common Terminology Criteria for Adverse Events version 5 primary outcome description Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting. primary outcome time frame 11 weeks primary outcome measure Efficacy of 64Cu-SAR-bisPSMA in the Detection of Primary Prostate Caner Compared to Histopathology primary outcome description Efficacy will be measured by the proportion of 64Cu-SAR-bisPSMA PET/CT scans assessed as True Positive or False Negative for primary Prostate Cancer, as confirmed by histopathology. primary outcome time frame 11 weeks secondary outcome list secondary outcome secondary outcome measure Comparison of image quality at varying dose levels of 64CuSAR-bisPSMA for each dose cohort (100 MBq, 150 MBq and 200 MBq). secondary outcome description Image quality will be assessed by 2 blinded central readers. secondary outcome time frame 11 weeks eligibility module eligibility criteria Inclusion Criteria:
Signed informed consent;
≥18 years of age;
Life expectancy >3 months;
Confirmation of Prostate Cancer by histopathology and planned radical prostatectomy;
Have ≥1 of the following intermediate- to high-risk features:
PSA level greater than or equal to 10.0 ng/ml within 12 weeks prior to enrolment;
International Society of Urological Pathology (ISUP) Grade Group 3 (i.e. Gleason score of 7 (4+3) or above;
Clinical stage greater than or equal to T2b;
Participants must have adequate renal function;
Sexually active participants who have female partners of childbearing potential: Partner and/or participant must agree to use an acceptable form of contraception. Further participants must refrain from donating sperm;
A 68Ga-PSMA-11 PET/CT scan performed within 5 weeks, but not closer than 6 hours prior to the administration of 64Cu-SAR-bisPSMA.
Exclusion Criteria:
Prior prostatectomy or any other treatment for Prostate Cancer, including Androgen Deprivation Therapy and radiation therapy;
Previous treatment with PSMA-targeted therapy within 3 months prior to enrolment, and administration of other investigational agents within 4 weeks prior to entering the study (except 68Ga-PSMA-11);
Known hypersensitivity to the components of 64Cu-SAR-bisPSMA;
Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible, as are participants with adequately treated non-melanoma skin cancer, superficial bladder cancer;
Any serious medical condition which the Investigator feels may interfere with the procedures or evaluations of the study;
Patients unwilling or unable to comply with protocol or with a history of noncompliance or inability to grant informed consent. healthy volunteers No gender Male minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Nepean Hospital location city Kingswood location state New South Wales location zip 2751 location country Australia location facility St. Vincent's Hospital location city Sydney location state New South Wales location zip 2010 location country Australia location facility GenesisCare CTA, SJOG Medical Clinic location city Murdoch location state Western Australia location zip 6150 location country Australia i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011471 condition mesh term Prostatic Neoplasms condition ancestor list condition ancestor condition ancestor id D000005834 condition ancestor term Genital Neoplasms, Male condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000011469 condition ancestor term Prostatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M13487 condition browse leaf name Prostatic Neoplasms condition browse leaf as found Prostatic Neoplasms condition browse leaf relevance high condition browse leaf id M8098 condition browse leaf name Genital Neoplasms, Male condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M13485 condition browse leaf name Prostatic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions | NCT04839367 | [
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full study rank 61478 study protocol section identification module n c t id NCT04835948 org study id info org study id 38361620.0.0000.5327 organization org full name Hospital de Clinicas de Porto Alegre org class OTHER brief title Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplantation official title Study of the Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplant Outcomes status module status verified date March 2021 overall status Completed expanded access info has expanded access No start date struct start date October 20, 2018 start date type Actual primary completion date struct primary completion date March 31, 2020 primary completion date type Actual completion date struct completion date April 13, 2021 completion date type Actual study first submit date March 30, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 16, 2021 last update post date struct last update post date April 19, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Fabiani Palagi Machado responsible party investigator title Principal Investigator responsible party investigator affiliation Hospital de Clinicas de Porto Alegre lead sponsor lead sponsor name Hospital de Clinicas de Porto Alegre lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary The use of polyclonal anti-T cell antibodies (ATG) has benefits in kidney transplantation, however, its use is associated mainly with hematological, infectious, and neoplastic complications. Monitoring T cells in patients receiving ATG was first proposed in 1975 to improve efficacy in preventing acute rejection and avoiding excessive immunosuppression. The dose regimen is guided by a daily count of TCD3+ lymphocytes. Monitoring the dose of thymoglobulin through its biological effects on T cells is a rational and safe method of titrating the dose of that antibody. This way, it is possible to reduce the total amount of drug administered to the patient and, consequently, reduce undesirable complications, as well as the cost of treatment, without losing effect on the benefit of immunosuppression.
Currently, the usual cumulative dose of ATG for induction in kidney transplant patients is 6mg/kg, in divided doses. However, the ideal dose and duration of therapy are still the subject of studies, with protocols between centers varying from total doses of 3 to 6 mg/kg, either fractionated or single, to achieve the lowest dose with fewer undesirable effects, and with reduced length of inpatient stay.
The use of ATG in a single dose of 3 mg/kg was successfully assessed for risks of infection and rejection in patients with low immunological risk.
This study proposes evaluating the efficacy and safety of a single 3mg/kg dose of ATG for patients with low and standard immune risk, with TCD3+ lymphocyte monitoring, to assess the duration of the TCD3+ cells in the peripheral blood. detailed description Kidney transplantation is one of the major advances in medicine in the past 60 years. Currently, is considered the best treatment for terminal chronic kidney disease in the medium and long term, and the least costly. To obtain these successful outcomes, the immune response to the graft must be properly controlled and monitored since its implantation. T and B lymphocytes are crucial in the alloimmune response by mediating cellular and antibody-mediated rejections, respectively, and along with anti-HLA antibodies are the main effectors of acute and chronic rejections.
Anti-thymocyte globulin (ATG) has a key role in the immunosuppressive induction regimens used in kidney transplants as well as in the treatment of acute rejections. It is a purified solution that contains a variety of T cell-specific immunoglobulins, including CD2, CD3, CD4, CD8, CD11a, CD18, CD25, HLA-DR, and class I HLA (human leukocyte antigen). This solution is produced by immunizing rabbits with human thymocytes. The use of these agents is particularly important in inducing patients who are more predisposed to the nephrotoxic effects of calcineurin inhibitors (CI), allowing the delayed introduction of the CI. Induction with antibodies is also of great value in patients with higher immunological risk, such as pediatric, Afro-descendants, re-transplanted, and previously sensitized to HLA antigens recipients.
Polyclonal antibodies have definite benefits in kidney transplantation, but their use is associated with hematological, infectious, and neoplastic complications. The use of reduced doses of ATG has been the subject of recent studies, but still with inconclusive results.
The concept of monitoring T cells in patients receiving ATG was first proposed in 1975 to improve efficacy in preventing acute rejection and avoiding excessive immunosuppression. The dose regimen is guided by a daily count of peripheral blood TCD3+ lymphocytes. Monitoring the dose of thymoglobulin through its biological effects on T cells is a rational and safe method of titrating the dose of that antibody. This way, it is possible to reduce the total amount of drug administered to the patient and, consequently, reduce undesirable complications, as well as the cost of treatment, hopefully without losing effect on the benefit of immunosuppression.
A 60% reduction in the total dose of ATG and 58% reduction in therapy cost was observed in patients who were monitored using TCD3+ cell counts. Currently, the usual total dose of ATG for induction in kidney transplant patients is 6mg/kg, divided into 4 doses, which can be administered from day zero until day 14 (maximum) of transplantation. However, the ideal dose and duration of therapy are still the subject of investigation, with protocols between centers varying from total doses of 3 to 6 mg/kg, fractionated or single, to attempt to achieve the lowest dose with fewer undesirable effects, and with reduced length of inpatient stay. The use of ATG in a single dose of 3 mg/kg was successfully assessed for risks of infection and rejection in patients with low immunological risk.
Considering that the adverse effects associated with the use of ATG are relevant in the clinical context of kidney transplantation, the use of a lower dose, keeping its immunomodulatory effect, with a safer profile, is desirable.
The study evaluates the efficacy and safety of a single dose of 3mg/kg ATG for patients with low and standard immune risk, with TCD3+ lymphocyte monitoring, to assess the clinical efficacy and the modulation of the T cell response. conditions module condition list condition Kidney Transplant; Complications Immunosuppression keyword list keyword Immunosuppression kidney transplantation CD3+ T lymphocytes Anti-thymocyte globulin Rejection design module study type Observational patient registry No design info design observational model list design observational model Case-Control design time perspective list design time perspective Retrospective enrollment info enrollment count 200 enrollment type Actual arms interventions module arm group list arm group arm group label Multiple doses of anti-thymocyte globulin (ATG) arm group description Control group that received fractionated doses of 1.5 mg/kg adding up to a total of 6 mg/kg arm group intervention list arm group intervention name Drug: single dose of Anti-thymocyte globulin intervention list intervention intervention type Drug intervention name single dose of Anti-thymocyte globulin intervention description Used anti-thymocyte globulin (ATG) in a single dose of 3 mg/kg for immunosuppression induction in the immediate postoperative period intervention arm group label list intervention arm group label Multiple doses of anti-thymocyte globulin (ATG) outcomes module primary outcome list primary outcome primary outcome measure Immunomodulatory effect primary outcome description Immunomodulatory effect of a single dose of 3mg/kg ATG on TCD3+ lymphocytes in kidney transplant patients by comparing it with the effect of the regular fractionated dose of 6 mg/kg by counting daily the number of TCD3+ lymphocytes in peripheral blood. primary outcome time frame one year secondary outcome list secondary outcome secondary outcome measure Incidence of acute rejection secondary outcome description Number of patients with acute rejection diagnosed by renal biopsy with the single-dose ATG strategy. secondary outcome time frame one year secondary outcome measure Occurence of cytomegalovirus infection secondary outcome description Number of patients with cytomegalovirus infection (positive detection through polymerase chain reaction or active disease). secondary outcome time frame One year secondary outcome measure Incidence of delayed graft function secondary outcome description Number of patients with delayed graft function (DGF) through the number of dialysis needed in the first week after kidney transplantation. secondary outcome time frame one year secondary outcome measure One year survival of kidney grafts secondary outcome description Survival of kidney grafts at 1 year after receiving a single dose of ATG. secondary outcome time frame One year secondary outcome measure One year survival graft grafts secondary outcome description Patient survival at the end of 1 year of a single dose of ATG. secondary outcome time frame one year other outcome list other outcome other outcome measure Occurence of infections and neoplasms other outcome description Number of patients with development of other infections and neoplasms of any etiology within one year proven by clinical features and laboratory or anatomopathological tests in the study patients. other outcome time frame One year other outcome measure Hematological effects of the drug. other outcome description Number of patients with hematological effects (laboratory analysis of anemia, leukopenia and thrombocytopenia) of ATG. other outcome time frame One year other outcome measure Time of inpatient stay (days). other outcome description Length of stay in days between groups with a single and fractionated dose of atg. other outcome time frame One year eligibility module eligibility criteria Inclusion Criteria:
Kidney transplant patients from Hospital de Clínicas de Porto Alegre (HCPA) between October 2018 to March 2020 who received a single 3 mg/kg ATG dose at the immediate postoperative period. Recipients of standard and low immunological risk (PRA - panel reactive antibodies <50% and without donor-specific antibodies), regardless of the time of cold ischemia and the presence of kidney failure in the donor.
Control group consisting of patients from the same and previous period, who received fractionated ATG dosing up to 6 mg/kg total dose.
Exclusion Criteria:
Patients who used other induction strategies that did not include ATG in a single dose of 3 mg/kg or the fractionated dose of 6 mg/kg.
Patients who died within 24 hours after transplantation.
Patients who had a transplant nephrectomy within 24 hours after transplantation.
Pediatric recipients (< 14 years old).
Recipients with incomplete data. healthy volunteers No gender All std age list std age Child Adult Older Adult study population The study population will consist of patients who received a kidney transplant at a single institution between October 2018 and March 2020 and received ATG at a single dose of 3 mg/kg for induction of immunosuppression in the immediate postoperative period and a control group that received fractionated doses of 1.5 mg/kg adding up to a total of 6 mg/kg. sampling method Probability Sample contacts locations module location list location location facility Hospital de Clínicas de Porto Alegre location city Porto Alegre location state RS location country Brazil references module reference list reference reference p m i d 20925547 reference type background reference citation Nankivell BJ, Alexander SI. Rejection of the kidney allograft. N Engl J Med. 2010 Oct 7;363(15):1451-62. doi: 10.1056/NEJMra0902927. 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Transplant Proc. 2010 Jun;42(5):1395-400. doi: 10.1016/j.transproceed.2010.04.019. Review. reference p m i d 10755529 reference type background reference citation Djamali A, Turc-Baron C, Portales P, Leverson G, Chong G, Clot J, Mourad G. Low dose antithymocyte globulins in renal transplantation: daily versus intermittent administration based on T-cell monitoring. Transplantation. 2000 Mar 15;69(5):799-805. reference p m i d 23774740 reference type background reference citation Thiyagarajan UM, Ponnuswamy A, Bagul A. Thymoglobulin and its use in renal transplantation: a review. Am J Nephrol. 2013;37(6):586-601. doi: 10.1159/000351643. Epub 2013 Jun 12. Review. reference p m i d 16842513 reference type background reference citation Alangaden GJ, Thyagarajan R, Gruber SA, Morawski K, Garnick J, El-Amm JM, West MS, Sillix DH, Chandrasekar PH, Haririan A. Infectious complications after kidney transplantation: current epidemiology and associated risk factors. 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Clin Transplant. 2012 Nov-Dec;26(6):900-9. doi: 10.1111/j.1399-0012.2012.01656.x. Epub 2012 Jun 4. reference p m i d 12023634 reference type background reference citation Peddi VR, Bryant M, Roy-Chaudhury P, Woodle ES, First MR. Safety, efficacy, and cost analysis of thymoglobulin induction therapy with intermittent dosing based on CD3+ lymphocyte counts in kidney and kidney-pancreas transplant recipients. Transplantation. 2002 May 15;73(9):1514-8. reference p m i d 7778170 reference type background reference citation Abouna GM, al-Abdullah IH, Kelly-Sullivan D, Kumar MS, Loose J, Phillips K, Yost S, Seirka D. Randomized clinical trial of antithymocyte globulin induction in renal transplantation comparing a fixed daily dose with dose adjustment according to T cell monitoring. Transplantation. 1995 Jun 15;59(11):1564-8. reference p m i d 15686739 reference type background reference citation Uber WE, Uber LA, VanBakel AB, Crumbley AJ 3rd, Pereira NL, Ikonomidis JS, Feldman DS. CD3 monitoring and thymoglobulin therapy in cardiac transplantation: clinical outcomes and pharmacoeconomic implications. Transplant Proc. 2004 Dec;36(10):3245-9. reference p m i d 11981432 reference type background reference citation Krasinskas AM, Kreisel D, Acker MA, Bavaria JE, Pochettino A, Kotloff RM, Arcasoy S, Blumenthal N, Kamoun M, Moore JS, Rosengard BR. CD3 monitoring of antithymocyte globulin therapy in thoracic organ transplantation. Transplantation. 2002 Apr 27;73(8):1339-41. reference p m i d 9365628 reference type background reference citation Grandtnerovà B, Mocikovà H, Kohutovà M. CD2+, CD3+, and CD19+ depletion after a course of antithymocyte globulin for a steroid-resistant rejection. Transplant Proc. 1997 Nov;29(7):2958-9. reference p m i d 22410573 reference type background reference citation Kho MM, Bouvy AP, Cadogan M, Kraaijeveld R, Baan CC, Weimar W. The effect of low and ultra-low dosages Thymoglobulin on peripheral T, B and NK cells in kidney transplant recipients. Transpl Immunol. 2012 Jun;26(4):186-90. doi: 10.1016/j.trim.2012.02.003. Epub 2012 Mar 5. reference p m i d 28376289 reference type background reference citation Nafar M, Dalili N, Poor-Reza-Gholi F, Ahmadpoor P, Samadian F, Samavat S. The appropriate dose of thymoglobulin induction therapy in kidney transplantation. Clin Transplant. 2017 Jun;31(6). doi: 10.1111/ctr.12977. Epub 2017 Apr 18. reference p m i d 25988935 reference type background reference citation Tedesco-Silva H, Felipe C, Ferreira A, Cristelli M, Oliveira N, Sandes-Freitas T, Aguiar W, Campos E, Gerbase-DeLima M, Franco M, Medina-Pestana J. Reduced Incidence of Cytomegalovirus Infection in Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses. Am J Transplant. 2015 Oct;15(10):2655-64. doi: 10.1111/ajt.13327. Epub 2015 May 18. reference p m i d 25164240 reference type background reference citation Mohty M, Bacigalupo A, Saliba F, Zuckermann A, Morelon E, Lebranchu Y. New directions for rabbit antithymocyte globulin (Thymoglobulin(®)) in solid organ transplants, stem cell transplants and autoimmunity. Drugs. 2014 Sep;74(14):1605-34. doi: 10.1007/s40265-014-0277-6. Review. Erratum in: Drugs. 2014 Dec;74(18):2217. reference p m i d 32436821 reference type background reference citation Bauer AC, Franco RF, Manfro RC. Immunosuppression in Kidney Transplantation: State of the Art and Current Protocols. Curr Pharm Des. 2020;26(28):3440-3450. doi: 10.2174/1381612826666200521142448. Review. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 intervention browse module intervention mesh list intervention mesh intervention mesh id D000000961 intervention mesh term Antilymphocyte Serum intervention ancestor list intervention ancestor intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M3431 intervention browse leaf name Antilymphocyte Serum intervention browse leaf as found Phase II Trial intervention browse leaf relevance high intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04835948 | [
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118,
2747,
13280,
13601,
2728,
1403,
2858,
27515,
4935,
117,
1259,
2891,
1477,
117,
2891,
1495,
117,
2891,
1527,
117,
2891,
1604,
117,
2891,
14541,
1161,
117,
2891,
15292,
117,
2891,
17600,
117,
145,
10783,
118,
22219,
117,
1105,
1705,
146,
145,
10783,
113,
1769,
5837,
7563,
13335,
14300,
2848,
4915,
114,
119,
1188,
5072,
1110,
1666,
1118,
13280,
13601,
2605,
6185,
25164,
1114,
1769,
21153,
3702,
3457,
3052,
119,
1109,
1329,
1104,
1292,
5789,
1110,
2521,
1696,
1107,
1107,
17484,
4420,
1150,
1132,
1167,
3073,
10396,
13541,
1106,
1103,
24928,
7880,
10595,
10649,
1596,
3154,
1104,
11019,
1233,
15459,
8212,
1179,
27558,
1116,
113,
140,
2240,
114,
117,
3525,
1103,
8088,
4784,
1104,
1103,
140,
2240,
119,
1130,
11243,
1114,
26491,
1110,
1145,
1104,
1632,
2860,
1107,
4420,
1114,
2299,
13280,
13601,
22176,
3187,
117,
1216,
1112,
185,
24795,
117,
20075,
118,
8395,
117,
1231,
118,
26965,
1174,
117,
1105,
2331,
14516,
2316,
17030,
5305,
1106,
145,
10783,
2848,
21144,
18509,
119,
17129,
1183,
1665,
4934,
1348,
26491,
1138,
16428,
6245,
1107,
16042,
26965,
1891,
117,
1133,
1147,
1329,
1110,
2628,
1114,
23123,
10024,
7810,
117,
20342,
117,
1105,
15242,
1643,
20519,
13522,
119,
1109,
1329,
1104,
3549,
24429,
1104,
13020,
2349,
1144,
1151,
1103,
2548,
1104,
2793,
2527,
117,
1133,
1253,
1114,
1107,
7235,
16891,
2686,
119,
1109,
3400,
1104,
9437,
157,
3652,
1107,
4420,
4172,
13020,
2349,
1108,
1148,
3000,
1107,
2429,
1106,
4607,
23891,
1107,
10878,
12104,
14732,
1105,
10101,
12177,
13280,
13601,
14226,
4455,
11135,
1988,
119,
1109,
13753,
6716,
1179,
1110,
8610,
1118,
170,
3828,
5099,
1104,
17963,
1892,
157,
14107,
1495,
116,
181,
25698,
26431,
119,
24803,
1158,
1103,
13753,
1104,
21153,
3702,
1403,
2858,
27515,
1394,
1194,
1157,
7269,
3154,
1113,
157,
3652,
1110,
170,
12478,
1105,
2914,
3442,
1104,
189,
2875,
7969,
1103,
13753,
1104,
1115,
2848,
14637,
119,
1188,
1236,
117,
1122,
1110,
1936,
1106,
4851,
1103,
1703,
2971,
1104,
3850,
8318,
1106,
1103,
5351,
1105,
117,
14007,
117,
4851,
5576,
18766,
9739,
13522,
117,
1112,
1218,
1112,
1103,
2616,
1104,
3252,
117,
16121,
1443,
3196,
2629,
1113,
1103,
5257,
1104,
13280,
13601,
14226,
4455,
11135,
1988,
119,
138,
2539,
110,
7234,
1107,
1103,
1703,
13753,
1104,
13020,
2349,
1105,
4650,
110,
7234,
1107,
7606,
2616,
1108,
4379,
1107,
4420,
1150,
1127,
19232,
1606,
157,
14107,
1495,
116,
2765,
10664,
119,
7199,
117,
1103,
4400,
1703,
13753,
1104,
13020,
2349,
1111,
18293,
1107,
16042,
26965,
4420,
1110,
127,
1306,
1403,
120,
4023,
117,
3233,
1154,
125,
24429,
117,
1134,
1169,
1129,
8318,
1121,
1285,
6756,
1235,
1285,
1489,
113,
4177,
114,
1104,
26965,
1891,
119,
1438,
117,
1103,
7891,
13753,
1105,
9355,
1104,
7606,
1132,
1253,
1103,
2548,
1104,
4449,
117,
1114,
19755,
1206,
6425,
9507,
1121,
1703,
24429,
1104,
124,
1106,
127,
17713,
120,
4023,
117,
13394,
2913,
1137,
1423,
117,
1106,
2661,
1106,
5515,
1103,
6905,
13753,
1114,
8307,
5576,
18766,
9739,
3154,
117,
1105,
1114,
3549,
2251,
1104,
1107,
27420,
2215,
119,
1109,
1329,
1104,
13020,
2349,
1107,
170,
1423,
13753,
1104,
124,
17713,
120,
4023,
1108,
4358,
14758,
1111,
11040,
1104,
8974,
1105,
14732,
1107,
4420,
1114,
1822,
13280,
13601,
22176,
3187,
119,
23243,
1115,
1103,
16798,
3154,
2628,
1114,
1103,
1329,
1104,
13020,
2349,
1132,
7503,
1107,
1103,
7300,
5618,
1104,
16042,
26965,
1891,
117,
1103,
1329,
1104,
170,
2211,
13753,
117,
3709,
1157,
13280,
13601,
2728,
3702,
7641,
13389,
1183,
2629,
117,
1114,
170,
15033,
6168,
117,
1110,
17483,
119,
1109,
2025,
17459,
1116,
1103,
23891,
1105,
3429,
1104,
170,
1423,
13753,
1104,
124,
1306,
1403,
120,
4023,
13020,
2349,
1111,
4420,
1114,
1822,
1105,
2530,
11650,
3187,
117,
1114,
157,
14107,
1495,
116,
181,
25698,
13335,
14300,
9437,
117,
1106,
15187,
1103,
7300,
23891,
1105,
1103,
182,
5412,
6856,
1104,
1103,
157,
2765,
2593,
119,
2975,
13196,
3879,
2190,
3879,
9847,
4695,
13809,
1643,
9180,
132,
3291,
8223,
20721,
1116,
146,
6262,
26761,
6385,
8661,
26779,
2501,
12565,
2190,
2501,
12565,
146,
6262,
26761,
6385,
8661,
26779,
16042,
26965,
1891,
2891,
1495,
116,
157,
181,
25698,
26431,
8329,
118,
21153,
3702,
3457,
1566,
176,
2858,
27515,
1394,
11336,
26857,
1902,
13196,
2025,
2076,
152,
4832,
1200,
11583,
1348,
5351,
25097,
1302,
1902,
23992,
1902,
8310,
1348,
2235,
2190,
1902,
8310,
1348,
2235,
9060,
118,
6342,
1902,
1159,
7281,
2190,
1902,
1159,
7281,
11336,
8005,
16776,
10803,
23992,
10803,
5099,
2363,
10803,
2076,
2173,
4746,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
17476,
24429,
1104,
2848,
118,
21153,
3702,
3457,
1566,
176,
2858,
27515,
1394,
113,
13020,
2349,
114,
1981,
1372,
6136,
6342,
1372,
1115,
1460,
13394,
2913,
24429,
1104,
122,
119,
126,
17713,
120,
4023,
5321,
1146,
1106,
170,
1703,
1104,
127,
17713,
120,
4023,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
1423,
13753,
1104,
8329,
118,
21153,
3702,
3457,
1566,
176,
2858,
27515,
1394,
9108,
2190,
9108,
9108,
2076,
13982,
9108,
1271,
1423,
13753,
1104,
8329,
118,
21153,
3702,
3457,
1566,
176,
2858,
27515,
1394,
9108,
6136,
17627,
2848,
118,
21153,
3702,
3457,
1566,
176,
2858,
27515,
1394,
113,
13020,
2349,
114,
1107,
170,
1423,
13753,
1104,
124,
17713,
120,
4023,
1111,
13280,
13601,
14226,
4455,
11135,
1988,
18293,
1107,
1103,
5670,
2112,
19807,
5838,
1669,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
17476,
24429,
1104,
2848,
118,
21153,
3702,
3457,
1566,
176,
2858,
27515,
1394,
113,
13020,
2349,
114,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
146,
6262,
26761,
3702,
7641,
13389,
1183,
2629,
2425,
9386,
6136,
146,
6262,
26761,
3702,
7641,
13389,
1183,
2629,
1104,
170,
1423,
13753,
1104,
124,
1306,
1403,
120,
4023,
13020,
2349,
1113,
157,
14107,
1495,
116,
181,
25698,
26431,
1107,
16042,
26965,
4420,
1118,
15089,
1122,
1114,
1103,
2629,
1104,
1103,
2366,
13394,
2913,
13753,
1104,
127,
17713,
120,
4023,
1118,
11128,
3828,
1103,
1295,
1104,
157,
14107,
1495,
116,
181,
25698,
26431,
1107,
17963,
1892,
119,
2425,
9386,
1159,
4207,
1141,
1214,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
3561,
26859,
2093,
1104,
12104,
14732,
3718,
9386,
6136,
7421,
1104,
4420,
1114,
12104,
14732,
11534,
1118,
1231,
7050,
25128,
12685,
1114,
1103,
1423,
118,
13753,
13020,
2349,
5564,
119,
3718,
9386,
1159,
4207,
1141,
1214,
3718,
9386,
4929,
152,
19515,
22920,
2093,
1104,
172,
25669,
6758,
6997,
3292,
3161,
1361,
8974,
3718,
9386,
6136,
7421,
1104,
4420,
1114,
172,
25669,
6758,
6997,
3292,
3161,
1361,
8974,
113,
3112,
11432,
1194,
21176,
6530,
4129,
3943,
1137,
2327,
3653,
114,
119,
3718,
9386,
1159,
4207,
1448,
1214,
3718,
9386,
4929,
3561,
26859,
2093,
1104,
8088,
176,
15371,
3053,
3718,
9386,
6136,
7421,
1104,
4420,
1114,
8088,
176,
15371,
3053,
113,
141,
2349,
2271,
114,
1194,
1103,
1295,
1104,
17693,
6834,
1548,
1834,
1107,
1103,
1148,
1989,
1170,
16042,
26965,
1891,
119,
3718,
9386,
1159,
4207,
1141,
1214,
3718,
9386,
4929,
1448,
1214,
8115,
1104,
16042,
176,
15371,
1116,
3718,
9386,
6136,
26849,
1104,
16042,
176,
15371,
1116,
1120,
122,
1214,
1170,
4172,
170,
1423,
13753,
1104,
13020,
2349,
119,
3718,
9386,
1159,
4207,
1448,
1214,
3718,
9386,
4929,
1448,
1214,
8115,
176,
15371,
176,
15371,
1116,
3718,
9386,
6136,
7195,
9080,
8115,
1120,
1103,
1322,
1104,
122,
1214,
1104,
170,
1423,
13753,
1104,
13020,
2349,
119,
3718,
9386,
1159,
4207,
1141,
1214,
1168,
9386,
2190,
1168,
9386,
1168,
9386,
4929,
152,
19515,
22920,
2093,
1104,
16565,
1105,
15242,
1643,
7580,
4206,
1168,
9386,
6136,
7421,
1104,
4420,
1114,
1718,
1104,
1168,
16565,
1105,
15242,
1643,
7580,
4206,
1104,
1251,
3084,
17288,
1439,
1141,
1214,
9893,
1118,
7300,
1956,
1105,
8087,
1137,
1126,
10024,
3702,
16606,
7542,
5715,
1107,
1103,
2025,
4420,
119,
1168,
9386,
1159,
4207,
1448,
1214,
1168,
9386,
4929,
1124,
21943,
7542,
3154,
1104,
1103,
3850,
119,
1168,
9386,
6136,
7421,
1104,
4420,
1114,
23123,
10024,
7810,
3154,
113,
8087,
3622,
1104,
1126,
20504,
117,
5837,
7563,
15622,
5813,
1105,
24438,
16071,
4043,
3457,
9870,
23179,
114,
1104,
13020,
2349,
119,
1168,
9386,
1159,
4207,
1448,
1214,
1168,
9386,
4929,
2614,
1104,
1107,
27420,
2215,
113,
1552,
114,
119,
1168,
9386,
6136,
16758,
1104,
2215,
1107,
1552,
1206,
2114,
1114,
170,
1423,
1105,
13394,
2913,
13753,
1104,
1120,
1403,
119,
1168,
9386,
1159,
4207,
1448,
1214,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
9847,
4695,
26965,
4420,
1121,
3355,
1260,
140,
1233,
7326,
4578,
1116,
1260,
14333,
2586,
12606,
1874,
113,
18315,
10147,
114,
1206,
1357,
1857,
1106,
1345,
12795,
1150,
1460,
170,
1423,
124,
17713,
120,
4023,
13020,
2349,
13753,
1120,
1103,
5670,
2112,
19807,
5838,
1669,
119,
11336,
6617,
15418,
5240,
1104,
2530,
1105,
1822,
13280,
13601,
22176,
3187,
113,
11629,
1592,
118,
5962,
26844,
26491,
133,
1851,
110,
1105,
1443,
16667,
118,
2747,
26491,
114,
117,
8334,
1104,
1103,
1159,
1104,
2504,
1110,
4386,
8191,
1105,
1103,
2915,
1104,
16042,
4290,
1107,
1103,
16667,
119,
6342,
1372,
4721,
1104,
4420,
1121,
1103,
1269,
1105,
2166,
1669,
117,
1150,
1460,
13394,
2913,
13020,
2349,
18463,
1158,
1146,
1106,
127,
17713,
120,
4023,
1703,
13753,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
7195,
24767,
1150,
1215,
1168,
18293,
10700,
1115,
1225,
1136,
1511,
13020,
2349,
1107,
170,
1423,
13753,
1104,
124,
17713,
120,
4023,
1137,
1103,
13394,
2913,
13753,
1104,
127,
17713,
120,
4023,
119,
7195,
24767,
1150,
1452,
1439,
1572,
2005,
1170,
26965,
1891,
119,
7195,
24767,
1150,
1125,
170,
26965,
24928,
7880,
1874,
5822,
18574,
1439,
1572,
2005,
1170,
26965,
1891,
119,
153,
24795,
18509,
113,
133,
1489,
1201,
1385,
114,
119,
11336,
6617,
15418,
5240,
1114,
13975,
2233,
119,
8071,
8118,
1302,
5772,
1398,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
6405,
11635,
26694,
11635,
2025,
1416,
1109,
2025,
1416,
1209,
8296,
1104,
4420,
1150,
1460,
170,
16042,
26965,
1120,
170,
1423,
5375,
1206,
1357,
1857,
1105,
1345,
12795,
1105,
1460,
13020,
2349,
1120,
170,
1423,
13753,
1104,
124,
17713,
120,
4023,
1111,
18293,
1104,
13280,
13601,
14226,
4455,
11135,
1988,
1107,
1103,
5670,
2112,
19807,
5838,
1669,
1105,
170,
1654,
1372,
1115,
1460,
13394,
2913,
24429,
1104,
122,
119,
126,
17713,
120,
4023,
5321,
1146,
1106,
170,
1703,
1104,
127,
17713,
120,
4023,
119,
18200,
3442,
5096,
2822,
5474,
2687,
7136,
10492,
4541,
13196,
2450,
2190,
2450,
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full study rank 61542 study protocol section identification module n c t id NCT04835116 org study id info org study id AFIU Rawalpindi organization org full name Armed Forces Institute of Urology, Rawalpindi org class OTHER brief title Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy. official title Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy. status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date April 11, 2019 start date type Actual primary completion date struct primary completion date October 11, 2019 primary completion date type Actual completion date struct completion date October 11, 2019 completion date type Actual study first submit date March 28, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 10, 2021 last update post date struct last update post date April 14, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Musab Umair Khalid responsible party investigator title Doctor responsible party investigator affiliation Armed Forces Institute of Urology, Rawalpindi lead sponsor lead sponsor name Armed Forces Institute of Urology, Rawalpindi lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous post-operative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain. detailed description The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous postoperative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain. conditions module condition list condition Pain Postoperative Pain keyword list keyword Local anesthesia, Percutaneous nephrolithotomy. design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 68 enrollment type Actual arms interventions module arm group list arm group arm group label Local Anesthesia arm group type Other arm group description Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine. arm group intervention list arm group intervention name Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg. Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg. arm group label Intravenous Analgesics arm group type Other arm group description Group B patients received postoperative intravenous analgesia. arm group intervention list arm group intervention name Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg. Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg. intervention list intervention intervention type Drug intervention name Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg. intervention description Group A patients were administered per-operative peri tract local anesthesia infiltration with 0.25% bupivacaine augmented by post-operative oral analgesia with a combination of Paracetamol 650 mg and Orphenadrine 50mg 6 hourly. intervention arm group label list intervention arm group label Intravenous Analgesics Local Anesthesia intervention other name list intervention other name Local Anesthesia intervention type Drug intervention name paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg. intervention description Group B patients were only given post-operative intra-venous analgesia by Paracetamol 1gm intravenous 8 hourly augmented with a combination of Tramadol 50mg and Dimenhydrinate 50mg as and when required intervention arm group label list intervention arm group label Intravenous Analgesics Local Anesthesia intervention other name list intervention other name Intravenous analgesic outcomes module primary outcome list primary outcome primary outcome measure Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy. primary outcome description Efficacy of peri-tract infiltration of bupivacaine over standard oral analgesia in patients undergoing PCNL.
Measurement: Postoperative pain Measurement tool: Visual analog scale primary outcome time frame 6 months eligibility module eligibility criteria Inclusion Criteria:
all patients undergoing PCNL
age from 12-65 years
normal renal functions
no history of chronic pain
ASA I, II & III
Both genders
Exclusion Criteria:
history of local anaesthesia allergy
Redo PCNL
Multiple punctures during PCNL
Excessive intra-operative bleeding
Diabetes mellitus
Coagulopathy
Mental disorder
ASA IV & V
Active urinary tract infection. healthy volunteers Accepts Healthy Volunteers gender All minimum age 12 Years maximum age 65 Years std age list std age Child Adult Older Adult contacts locations module overall official list overall official overall official name Musab Umair, MBBS overall official affiliation Armed Forces Institute of Urology. overall official role Principal Investigator location list location location facility Armed Forces Institute of Urology. location city Rawalpindi location state Punjab location zip 47040 location country Pakistan i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000010149 condition mesh term Pain, Postoperative condition ancestor list condition ancestor condition ancestor id D000011183 condition ancestor term Postoperative Complications condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M12221 condition browse leaf name Pain, Postoperative condition browse leaf as found Postoperative Pain condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M13217 condition browse leaf name Postoperative Complications condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000000082 intervention mesh term Acetaminophen intervention mesh id D000014147 intervention mesh term Tramadol intervention mesh id D000000700 intervention mesh term Analgesics intervention mesh id D000009966 intervention mesh term Orphenadrine intervention mesh id D000004111 intervention mesh term Dimenhydrinate intervention mesh id D000002045 intervention mesh term Bupivacaine intervention ancestor list intervention ancestor intervention ancestor id D000000779 intervention ancestor term Anesthetics, Local intervention ancestor id D000000777 intervention ancestor term Anesthetics intervention ancestor id D000002492 intervention ancestor term Central Nervous System Depressants intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000018689 intervention ancestor term Sensory System Agents intervention ancestor id D000018373 intervention ancestor term Peripheral Nervous System Agents intervention ancestor id D000018712 intervention ancestor term Analgesics, Non-Narcotic intervention ancestor id D000058633 intervention ancestor term Antipyretics intervention ancestor id D000000701 intervention ancestor term Analgesics, Opioid intervention ancestor id D000009294 intervention ancestor term Narcotics intervention ancestor id D000000978 intervention ancestor term Antiparkinson Agents intervention ancestor id D000018726 intervention ancestor term Anti-Dyskinesia Agents intervention ancestor id D000009125 intervention ancestor term Muscle Relaxants, Central intervention ancestor id D000009465 intervention ancestor term Neuromuscular Agents intervention ancestor id D000010276 intervention ancestor term Parasympatholytics intervention ancestor id D000001337 intervention ancestor term Autonomic Agents intervention ancestor id D000018727 intervention ancestor term Muscarinic Antagonists intervention ancestor id D000018680 intervention ancestor term Cholinergic Antagonists intervention ancestor id D000018678 intervention ancestor term Cholinergic Agents intervention ancestor id D000018377 intervention ancestor term Neurotransmitter Agents intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000065686 intervention ancestor term Cytochrome P-450 CYP2B6 Inhibitors intervention ancestor id D000065607 intervention ancestor term Cytochrome P-450 Enzyme Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000000932 intervention ancestor term Antiemetics intervention ancestor id D000005765 intervention ancestor term Gastrointestinal Agents intervention ancestor id D000006634 intervention ancestor term Histamine H1 Antagonists intervention ancestor id D000006633 intervention ancestor term Histamine Antagonists intervention ancestor id D000018494 intervention ancestor term Histamine Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M4467 intervention browse leaf name Bupivacaine intervention browse leaf as found Grade 1 intervention browse leaf relevance high intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse leaf id M16053 intervention browse leaf name Tramadol intervention browse leaf as found Personalized intervention browse leaf relevance high intervention browse leaf id M3184 intervention browse leaf name Analgesics intervention browse leaf as found Resuscitation intervention browse leaf relevance high intervention browse leaf id M6447 intervention browse leaf name Dimenhydrinate intervention browse leaf as found Antimetabolite intervention browse leaf relevance high intervention browse leaf id M12044 intervention browse leaf name Orphenadrine intervention browse leaf as found Food Frequency Questionnaire intervention browse leaf relevance high intervention browse leaf id M2341 intervention browse leaf name Acetaminophen intervention browse leaf as found Anterior intervention browse leaf relevance high intervention browse leaf id M3261 intervention browse leaf name Anesthetics, Local intervention browse leaf relevance low intervention browse leaf id M19939 intervention browse leaf name Analgesics, Non-Narcotic intervention browse leaf relevance low intervention browse leaf id M28329 intervention browse leaf name Antipyretics intervention browse leaf relevance low intervention browse leaf id M3185 intervention browse leaf name Analgesics, Opioid intervention browse leaf relevance low intervention browse leaf id M11397 intervention browse leaf name Narcotics intervention browse leaf relevance low intervention browse leaf id M3447 intervention browse leaf name Antiparkinson Agents intervention browse leaf relevance low intervention browse leaf id M12341 intervention browse leaf name Parasympatholytics intervention browse leaf relevance low intervention browse leaf id M19954 intervention browse leaf name Muscarinic Antagonists intervention browse leaf relevance low intervention browse leaf id M19913 intervention browse leaf name Cholinergic Antagonists intervention browse leaf relevance low intervention browse leaf id M19911 intervention browse leaf name Cholinergic Agents intervention browse leaf relevance low intervention browse leaf id M19657 intervention browse leaf name Neurotransmitter Agents intervention browse leaf relevance low intervention browse leaf id M29690 intervention browse leaf name Cytochrome P-450 Enzyme Inhibitors intervention browse leaf relevance low intervention browse leaf id M3403 intervention browse leaf name Antiemetics intervention browse leaf relevance low intervention browse leaf id M8033 intervention browse leaf name Gastrointestinal Agents intervention browse leaf relevance low intervention browse leaf id M8862 intervention browse leaf name Histamine H1 Antagonists intervention browse leaf relevance low intervention browse leaf id M8860 intervention browse leaf name Histamine intervention browse leaf relevance low intervention browse leaf id M212140 intervention browse leaf name Histamine phosphate intervention browse leaf relevance low intervention browse leaf id M8861 intervention browse leaf name Histamine Antagonists intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev AnEm intervention browse branch name Antiemetics intervention browse branch abbrev Gast intervention browse branch name Gastrointestinal Agents intervention browse branch abbrev AnDyAg intervention browse branch name Anti-Dyskinesia Agents intervention browse branch abbrev MuRelCen intervention browse branch name Muscle Relaxants, Central intervention browse branch abbrev Antipy intervention browse branch name Antipyretics | NCT04835116 | [
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10803,
5099,
5599,
10803,
2076,
2173,
4746,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
5328,
1760,
2556,
27300,
1981,
1372,
2076,
2189,
1981,
1372,
6136,
1990,
138,
4420,
1460,
1679,
1182,
14441,
1469,
1126,
5024,
2050,
27300,
1107,
8702,
21875,
1114,
121,
119,
1512,
110,
139,
4455,
12416,
2599,
2042,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
139,
4455,
12416,
2599,
2042,
145,
19694,
1732,
10885,
3269,
121,
119,
1512,
110,
1130,
26857,
119,
23994,
2093,
20284,
4063,
14166,
1306,
1403,
119,
2926,
27801,
1605,
23632,
2042,
1851,
1306,
1403,
119,
13982,
131,
18311,
2093,
20284,
4063,
6087,
1306,
1403,
119,
157,
21571,
2572,
1233,
1851,
1306,
1403,
119,
12120,
2354,
7889,
23632,
14248,
1851,
1306,
1403,
119,
1981,
1372,
3107,
1130,
4487,
7912,
2285,
9954,
21463,
5053,
6063,
1981,
1372,
2076,
2189,
1981,
1372,
6136,
1990,
139,
4420,
1460,
2112,
19807,
5838,
1107,
4487,
7912,
2285,
24443,
7562,
1465,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
139,
4455,
12416,
2599,
2042,
145,
19694,
1732,
10885,
3269,
121,
119,
1512,
110,
1130,
26857,
119,
23994,
2093,
20284,
4063,
14166,
1306,
1403,
119,
2926,
27801,
1605,
23632,
2042,
1851,
1306,
1403,
119,
13982,
131,
18311,
2093,
20284,
4063,
6087,
1306,
1403,
119,
157,
21571,
2572,
1233,
1851,
1306,
1403,
119,
12120,
2354,
7889,
23632,
14248,
1851,
1306,
1403,
119,
9108,
2190,
9108,
9108,
2076,
13982,
9108,
1271,
139,
4455,
12416,
2599,
2042,
145,
19694,
1732,
10885,
3269,
121,
119,
1512,
110,
1130,
26857,
119,
23994,
2093,
20284,
4063,
14166,
1306,
1403,
119,
2926,
27801,
1605,
23632,
2042,
1851,
1306,
1403,
119,
9108,
6136,
1990,
138,
4420,
1127,
8318,
1679,
118,
13035,
1679,
1182,
14441,
1469,
1126,
2556,
27300,
1107,
8702,
21875,
1114,
121,
119,
1512,
110,
171,
4455,
12416,
2599,
2042,
22337,
1118,
2112,
118,
13035,
9619,
24443,
7562,
1465,
1114,
170,
4612,
1104,
23994,
2093,
20284,
4063,
14166,
17713,
1105,
2926,
27801,
1605,
23632,
2042,
1851,
1306,
1403,
127,
24308,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
1130,
4487,
7912,
2285,
9954,
21463,
5053,
6063,
5328,
1760,
2556,
27300,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
5328,
1760,
2556,
27300,
9108,
2076,
13982,
9108,
1271,
18311,
2093,
20284,
4063,
6087,
1306,
1403,
119,
157,
21571,
2572,
1233,
1851,
1306,
1403,
119,
12120,
2354,
7889,
23632,
14248,
1851,
1306,
1403,
119,
9108,
6136,
1990,
139,
4420,
1127,
1178,
1549,
2112,
118,
13035,
1107,
4487,
118,
1396,
23901,
24443,
7562,
1465,
1118,
23994,
2093,
20284,
4063,
122,
1403,
1306,
1107,
4487,
7912,
2285,
129,
24308,
22337,
1114,
170,
4612,
1104,
157,
21571,
2572,
1233,
1851,
1306,
1403,
1105,
12120,
2354,
7889,
23632,
14248,
1851,
1306,
1403,
1112,
1105,
1165,
2320,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
1130,
4487,
7912,
2285,
9954,
21463,
5053,
6063,
5328,
1760,
2556,
27300,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
1130,
4487,
7912,
2285,
24443,
7562,
1596,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
3291,
8223,
26464,
1320,
1104,
3799,
118,
5434,
3946,
9954,
21463,
6370,
1556,
14286,
1182,
157,
19366,
1204,
5328,
1760,
2556,
27300,
1130,
8702,
21875,
1105,
26925,
9954,
21463,
6370,
159,
1468,
1361,
3799,
118,
5434,
3946,
1130,
4487,
7912,
2285,
9954,
21463,
6370,
1258,
14286,
12734,
13064,
151,
8043,
8167,
11014,
1582,
12355,
4527,
119,
2425,
9386,
6136,
142,
3101,
4578,
3457,
1104,
1679,
1182,
118,
14441,
1107,
8702,
21875,
1104,
171,
4455,
12416,
2599,
2042,
1166,
2530,
9619,
24443,
7562,
1465,
1107,
4420,
15819,
7054,
20734,
119,
2508,
2225,
3313,
1880,
131,
3799,
19807,
5838,
2489,
2508,
2225,
3313,
1880,
6806,
131,
12071,
13022,
3418,
2425,
9386,
1159,
4207,
127,
1808,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
1155,
4420,
15819,
7054,
20734,
1425,
1121,
1367,
118,
2625,
1201,
2999,
1231,
7050,
4226,
1185,
1607,
1104,
13306,
2489,
15278,
1592,
146,
117,
1563,
111,
2684,
2695,
5772,
1116,
16409,
1665,
17855,
140,
10587,
3464,
131,
1607,
1104,
1469,
1126,
5024,
2050,
27300,
1155,
1200,
4873,
2156,
1186,
7054,
20734,
17476,
23609,
26405,
12463,
1219,
7054,
20734,
16409,
22371,
2109,
1107,
4487,
118,
13035,
9793,
12120,
22377,
3052,
1143,
6473,
4814,
3291,
28026,
13200,
23610,
16725,
8936,
15278,
1592,
4191,
111,
159,
17244,
190,
9324,
1616,
14441,
8974,
119,
8071,
8118,
138,
19515,
15384,
1116,
3225,
1183,
19340,
5772,
1398,
5867,
1425,
1367,
5848,
4177,
1425,
2625,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
6405,
11635,
26694,
11635,
10492,
4541,
13196,
2905,
2078,
2190,
2905,
2078,
2905,
2078,
1271,
27389,
1830,
12189,
8341,
117,
19443,
9782,
2905,
2078,
13494,
8776,
4791,
2024,
1104,
158,
13166,
15741,
119,
2905,
2078,
1648,
8013,
1130,
5710,
3121,
25524,
1766,
2450,
2190,
2450,
2450,
3695,
8776,
4791,
2024,
1104,
158,
13166,
15741,
119,
2450,
1331,
14108,
1348,
6709,
3309,
2450,
1352,
8907,
2450,
195,
9717,
23146,
12882,
2450,
1583,
3658,
178,
185,
173,
6303,
4195,
13196,
178,
185,
173,
6303,
1302,
4408,
2237,
1940,
1116,
1665,
23992,
13196,
1683,
10266,
1382,
5507,
117,
17881,
1477,
3879,
11424,
1162,
13196,
3879,
24000,
2190,
3879,
24000,
3879,
24000,
25021,
141,
7629,
7629,
10424,
17175,
1580,
3879,
24000,
1858,
13304,
117,
3799,
19807,
5838,
3879,
13596,
2190,
3879,
13596,
3879,
13596,
25021,
141,
7629,
7629,
14541,
15292,
1495,
3879,
13596,
1858,
3799,
19807,
5838,
3291,
8223,
20721,
1116,
3879,
13596,
25021,
141,
7629,
7629,
10424,
23493,
1571,
3879,
13596,
1858,
17392,
12805,
11007,
18821,
1279,
3879,
13596,
25021,
141,
7629,
7629,
10424,
17175,
1545,
3879,
13596,
1858,
13304,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1580,
23435,
1475,
3879,
13596,
1858,
151,
8816,
12805,
11007,
2268,
24603,
8419,
6126,
3879,
11424,
1162,
7404,
2190,
3879,
11424,
1162,
7404,
3879,
11424,
1162,
7404,
25021,
26528,
20581,
18202,
3879,
11424,
1162,
7404,
1271,
13304,
117,
3799,
19807,
5838,
3879,
11424,
1162,
7404,
1112,
1276,
3799,
19807,
5838,
13304,
3879,
11424,
1162,
7404,
25319,
1344,
3879,
11424,
1162,
7404,
25021,
26528,
20581,
15292,
3879,
11424,
1162,
7404,
1271,
13304,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
7404,
25021,
26528,
17101,
16770,
3879,
11424,
1162,
7404,
1271,
3799,
19807,
5838,
3291,
8223,
20721,
1116,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
7404,
25021,
26528,
16337,
1571,
1545,
3879,
11424,
1162,
7404,
1271,
151,
8816,
12805,
11007,
2268,
24603,
8419,
6126,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
3392,
2190,
3879,
11424,
1162,
3392,
3879,
11424,
1162,
3392,
170,
13834,
1874,
1964,
3823,
22737,
3879,
11424,
1162,
3392,
1271,
156,
17162,
6451,
17112,
1105,
1615,
17392,
4807,
3879,
11424,
1162,
3392,
170,
13834,
1874,
1964,
1398,
3879,
11424,
1162,
3392,
1271,
1398,
16752,
16718,
3879,
11424,
1162,
3392,
170,
13834,
1874,
1964,
3823,
10424,
3879,
11424,
1162,
3392,
1271,
151,
1200,
11944,
3910,
20012,
1116,
9108,
11424,
1162,
13196,
9108,
24000,
2190,
9108,
24000,
9108,
24000,
25021,
141,
7629,
7629,
7629,
1568,
1604,
1477,
9108,
24000,
1858,
12860,
20284,
4559,
27801,
1179,
9108,
24000,
25021,
141,
7629,
7629,
17175,
17175,
1559,
9108,
24000,
1858,
157,
21571,
2572,
1233,
9108,
24000,
25021,
141,
7629,
7629,
7629,
20829,
1568,
9108,
24000,
1858,
9954,
21463,
5053,
6063,
9108,
24000,
25021,
141,
7629,
7629,
1568,
1580,
1580,
1545,
1545,
9108,
24000,
1858,
2926,
27801,
1605,
23632,
2042,
9108,
24000,
25021,
141,
7629,
7629,
1568,
25892,
14541,
9108,
24000,
1858,
12120,
2354,
7889,
23632,
14248,
9108,
24000,
25021,
141,
7629,
7629,
1568,
10973,
21336,
9108,
24000,
1858,
139,
4455,
12416,
2599,
2042,
9108,
13596,
2190,
9108,
13596,
9108,
13596,
25021,
141,
7629,
7629,
7629,
1559,
1559,
1580,
9108,
13596,
1858,
1760,
2556,
18994,
1116,
117,
5328,
9108,
13596,
25021,
141,
7629,
7629,
7629,
1559,
1559,
1559,
9108,
13596,
1858,
1760,
2556,
18994,
1116,
9108,
13596,
25021,
141,
7629,
7629,
1568,
19598,
1580,
1477,
9108,
13596,
1858,
1970,
151,
1200,
11944,
3910,
3177,
11135,
7418,
9108,
13596,
25021,
141,
7629,
7629,
21336,
11049,
1571,
9108,
13596,
1858,
7642,
6834,
19840,
20946,
23009,
1104,
26500,
9108,
13596,
25021,
141,
7629,
7629,
15292,
1545,
1604,
1580,
9108,
13596,
1858,
14895,
21484,
1183,
3910,
28052,
9108,
13596,
25021,
141,
7629,
7629,
15292,
26303,
1495,
9108,
13596,
1858,
14286,
9717,
4679,
1348,
151,
1200,
11944,
3910,
28052,
9108,
13596,
25021,
141,
7629,
7629,
15292,
1559,
11964,
9108,
13596,
1858,
9954,
21463,
5053,
6063,
117,
7922,
118,
11896,
19878,
14426,
9108,
13596,
25021,
141,
7629,
7629,
1571,
22392,
23493,
9108,
13596,
1858,
8329,
5005,
8127,
4724,
9108,
13596,
25021,
141,
7629,
7629,
7629,
20829,
1475,
9108,
13596,
1858,
9954,
21463,
5053,
6063,
117,
9126,
2660,
2386,
9108,
13596,
25021,
141,
7629,
7629,
1568,
1580,
26752,
1527,
9108,
13596,
1858,
11896,
19878,
24262,
9108,
13596,
25021,
141,
7629,
7629,
7629,
1580,
1559,
1604,
9108,
13596,
1858,
8329,
14967,
4935,
1320,
28052,
9108,
13596,
25021,
141,
7629,
7629,
15292,
1559,
25129,
9108,
13596,
1858,
8329,
118,
141,
6834,
4314,
18766,
1161,
28052,
9108,
13596,
25021,
141,
7629,
7629,
1568,
1580,
11964,
1571,
9108,
13596,
1858,
19569,
1116,
10536,
11336,
22731,
7418,
117,
1970,
9108,
13596,
25021,
141,
7629,
7629,
1568,
1580,
23435,
1571,
9108,
13596,
1858,
151,
8816,
4165,
1361,
11702,
28052,
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25021,
141,
7629,
7629,
10424,
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1545,
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5821,
8223,
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23415,
7376,
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25021,
141,
7629,
7629,
24400,
23493,
1559,
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1858,
12983,
2728,
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28052,
9108,
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25021,
141,
7629,
7629,
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24458,
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1858,
19569,
26996,
19764,
1665,
1760,
21365,
11153,
10047,
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25021,
141,
7629,
7629,
15292,
1545,
18910,
9108,
13596,
1858,
22964,
25167,
11007,
1760,
21365,
11153,
10047,
9108,
13596,
25021,
141,
7629,
7629,
15292,
1545,
1559,
1604,
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1858,
22964,
25167,
11007,
28052,
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25021,
141,
7629,
7629,
15292,
26303,
1559,
9108,
13596,
1858,
151,
8816,
3329,
4047,
6602,
25608,
1197,
28052,
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25021,
141,
7629,
7629,
21336,
11049,
1527,
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1858,
22175,
2508,
18546,
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1104,
7642,
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23388,
6605,
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25021,
141,
7629,
7629,
27677,
1545,
22392,
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1858,
27688,
2430,
1732,
11457,
153,
118,
10181,
140,
24772,
1477,
2064,
1545,
1130,
23034,
3864,
9108,
13596,
25021,
141,
7629,
7629,
27677,
16480,
1559,
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full study rank 61259 study protocol section identification module n c t id NCT04838795 org study id info org study id Sisonke (Together): OPEN LABEL organization org full name Wits Health Consortium (Pty) Ltd org class OTHER brief title Sisonke (Together): OPEN LABEL TRIAL COVID-19 official title Open-label, Single-arm Phase 3B Implementation Study to Monitor the Effectiveness of the Single-dose Ad26.COV2.S COVID-19 Vaccine Among Health Care Workers in South Africa (VAC31518COV3012) acronym Sisonke status module status verified date October 2021 overall status Completed expanded access info has expanded access No start date struct start date February 17, 2021 start date type Actual primary completion date struct primary completion date March 31, 2022 primary completion date type Actual completion date struct completion date March 31, 2022 completion date type Actual study first submit date February 17, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 29, 2022 last update post date struct last update post date August 1, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Wits Health Consortium (Pty) Ltd lead sponsor class OTHER collaborator list collaborator collaborator name National Department of Health of South Africa collaborator class UNKNOWN collaborator name National Institute for Communicable Diseases, South Africa collaborator class OTHER collaborator name KwaZulu-Natal Research Innovation and Sequencing Platform - KRISP collaborator class UNKNOWN collaborator name Fred Hutchinson Cancer Center collaborator class OTHER collaborator name Hutchinson Center Research Institute of South Africa (HCRISA) collaborator class UNKNOWN collaborator name Janssen Vaccines & Prevention B.V. collaborator class INDUSTRY collaborator name Bio Analytical Research Corporation collaborator class INDUSTRY collaborator name Dis-Chem Pharmacy collaborator class UNKNOWN collaborator name BioVac collaborator class UNKNOWN collaborator name Biocair collaborator class UNKNOWN collaborator name Right to Care collaborator class OTHER collaborator name Clinical Laboratory Services collaborator class UNKNOWN oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No is u s export No description module brief summary To monitor the effectiveness of the single-dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) in South Africa detailed description Purpose To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) as compared to the general unvaccinated population in South Africa
Study design Open-label, single-arm phase 3B vaccine implementation study
Rationale South Africa is severely affected by the global COVID-19 epidemic, but currently no vaccine has been rolled out. The recent promising results of the 'ENSEMBLE' trial conducted by Janssen in South Africa, and the availability of a limited amount of vaccine doses, provide the rationale for a cohort study of vaccinated HCWs to inform the larger vaccine rollout.
Study participants Health Care workers age 18 and above working in the South African public and private health care sector (N=500 000) Study sites Department of Health Vaccine administration sites across South Africa supported by the Sisonke (Together) (VAC31518COV3012) trial Research Site Investigators and Study Staff
Study duration Participants will receive a single dose of vaccine at enrolment; to monitor outcomes the DATCOV surveillance system and NICD line list will be reviewed for up to 2 years post-vaccination.
A sub-cohort (approx. 850-1000 people) consisting of special sub-populations will be followed up at approx. 1, 3, 6 weeks and 6 months post vaccination. This group will also have outcomes monitored for up to a further 18 months, bringing their total follow-up duration to 2 years post-vaccination
Study products Ad26.COV2.S by Janssen administered as a single injection
Primary objectives • To assess the effectiveness of Ad26.COV2.S vaccine on severe COVID, hospitalizations and deaths in HCWs as compared with the general unvaccinated population in South Africa.
Secondary objectives • To estimate the incidence of symptomatic SARS CoV-2 infections in HCW
To estimate vaccine uptake among HCWs in South Africa
To monitor the genetic diversity of breakthrough SARS CoV-2 infections To monitor immunological responses (neutralising, non-neutralising antibodies and T cell responses) in HCWs with breakthrough infections
To measure baseline SARS CoV-2 antibody testing to evaluate pre-existing immunity in up to 100 000 HCWs.
In a subgroup of participants (approx. 850-1000 people) including representative sub-populations of interest, e.g. elderly, immune compromised:
To compare serum neutralization and immune responses before and after vaccination at 0, 6 weeks and up to 6 months.
To explore clotting parameters post vaccination at weeks 0, 1, 3.
To monitor for asymptomatic infection
Exploratory objectives To set up a comprehensive safety desk and establish a link between the national pharmacovigilance system to assist with monitoring safety and any unexpected adverse effects conditions module condition list condition SARS (Severe Acute Respiratory Syndrome) design module study type Interventional phase list phase Phase 3 design info design allocation N/A design intervention model Single Group Assignment design intervention model description Open-label, single-arm phase 3B vaccine implementation study design primary purpose Prevention design masking info design masking None (Open Label) enrollment info enrollment count 477102 enrollment type Actual arms interventions module intervention list intervention intervention type Biological intervention name To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine intervention description To monitor the effectiveness of the single dose Ad26.COV2.S COVID-19 vaccine among health care workers (HCW) as compared to the general unvaccinated population in South Africa outcomes module primary outcome list primary outcome primary outcome measure Number of severe COVID, hospitalizations and deaths in HCWs as compared with the general unvaccinated population in South Africa primary outcome description Rates of hospitalizations and deaths among vaccinated HCWs versus general unvaccinated population primary outcome time frame 24 Months secondary outcome list secondary outcome secondary outcome measure The number of symptomatic SARSCoV-2 infections among vaccinated HCWs secondary outcome description Incidence rate of SARS CoV-2 infection as indicated by self-report and validation in national laboratory records.
Rates of severe disease in HCW who are found to be RT-PCR positive at anytime up to 2 years post vaccination secondary outcome time frame 24 Months secondary outcome measure The measure of genetic diversity of breakthrough SARSCoV-2 infections secondary outcome description Genetic diversity of breakthrough infection virus as determined by whole genome sequencing. This will be recovered from national laboratories. secondary outcome time frame 24 months secondary outcome measure Monitoring for asymptomatic infection in a sub-set (10 000) of HCWs secondary outcome description Rates of asymptomatic infection at baseline and follow up using SARS CoV-2 virus and antibody testing. secondary outcome time frame 24 Months secondary outcome measure Monitor for safety and any unexpected adverse effects of the vaccine administration -pharmacovigilance secondary outcome description Conduct Pharmacovigilance to monitor for safety and adverse events Numbers of safety events and/or unexpected adverse effects reported to the study team Monitor pregnancies and pregnancy outcomes reported to safety desk. secondary outcome time frame 24 Months secondary outcome measure The vaccine uptake among HCWs in South Africa secondary outcome description Proportion of HCWs approached for study participation taking part in the study and receiving the vaccine secondary outcome time frame 12 Months other outcome list other outcome other outcome measure To monitor for safety and any unexpected adverse effects of the vaccine administration other outcome description To conduct pharmacovigilance to monitor for safety and any unexpected adverse effects of the vaccine administration other outcome time frame 24 Months eligibility module eligibility criteria Inclusion criteria
Age 18 and older
Health care worker in the private or public service
The President and Deputy President of South Africa* (The President and Deputy President of South Africa have been included in the protocol to address the issue of vaccine hesitancy. )
Willingness and ability to comply vaccination plan and other study procedures.
Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol.
Inclusion criteria for the sub-cohort
Age 18 and older
Health care worker in the private or public service
Willingness and ability to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures, with follow-up at an ENSEMBLE site.
Capable of giving electronic or personal signed informed consent as described in Appendix 5, which includes compliance with the requirements in this protocol.
Exclusion criteria
Any significant acute or chronic medical condition, situation or circumstance that in the opinion of the PI/designee makes the participant unsuitable for participation in the study, or jeopardises the safety or rights of the participant
Participant reports being pregnant at time of enrolment, planning conception within 3 months.
Participants who report breastfeeding at the time of enrolment will be excluded.
Current participation in any other research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the PI/designee.
History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.
Participants who have experienced major venous and arterial thrombosis occurring with thrombocytopenia following vaccination with any COVID-19 vaccine should not enrol in Sisonke.
Participants with a history of heparin-induced thrombocytopenia.
Note:
• Vaccination within 14-90 days with other COVID19 or non-specific vaccines are not exclusionary but should be discussed with study PI or designee.
Conditions of interest:
We note that international reports of VITT have not identified a risk factor, nor does there appear to be any prothrombotic state that indicates a risk factor for this immune response.
Nevertheless, the Sisonke study will enrol participants with chronic history of severe clotting disorders only after consultation and approval of the study Protocol Safety Review Team (PSRT).
We have identified certain specific conditions of special interest such as:
cerebral venous sinus thrombosis,
antiphospholipid syndrome
Individuals on therapeutic anticoagulants for current or previous arterial or venous thrombosis or embolism healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 105 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Glenda E Gray, MBChB overall official affiliation Non-Executive Director overall official role Principal Investigator location list location location facility Nelson Mandela Academic Clinical Research Unit (NeMACRU) location city Mthatha location state Eastern Cape location zip 5100 location country South Africa location facility PHOENIX Pharma Pty Ltd location city Port Elizabeth location state Eastern Cape location zip 6001 location country South Africa location facility Josha Research location city Bloemfontein location state Free State location zip 9300 location country South Africa location facility The Aurum Institute: Tembisa Clinical Research Centre location city Johannesburg location state Gauteng - South location zip 1632 location country South Africa location facility Perinatal HIV Research Unit Kliptown location city Johannesburg location state Gauteng - South location zip 1809 location country South Africa location facility CRISMO Research Centre, Dr Bhekithemba location city Germiston location state Gauteng location zip 1401 location country South Africa location facility Perinatal HIV Research Unit (PHRU), SOWETO location city Johannesburg location state Gauteng location zip 1862 location country South Africa location facility Wits RHI: Shandukani Research Centre location city Johannesburg location state Gauteng location zip 2001 location country South Africa location facility Themba Lethu HIV Research Unit (CHRU), Dr location city Johannesburg location state Gauteng location country South Africa location facility Synexus SA - Stanza Clinical Research Centre location city Pretoria location state Gauteng location zip 0122 location country South Africa location facility Setshaba Research Centre, location city Pretoria location state Gauteng location zip 0152 location country South Africa location facility Synexus Watermeyer Clinical Research Centre, location city Pretoria location state Gauteng location zip 0184 location country South Africa location facility Ndlovu Research Centre location city Pretoria location state Gauteng location country South Africa location facility Botha's Hill Clinical Research Site location city Bothas Hill location state KWA ZULU Natal location zip 3660 location country South Africa location facility CAPRISA eThekwini Clinical Research Site, Dr location city Durban location state KWA ZULU Natal location zip 4001 location country South Africa location facility Chatsworth Clinical Research Site location city Durban location state Kwa Zulu Natal location zip 4030 location country South Africa location facility CAPRISA Vulindlela Clinical Research Site, Dr location city Durban location state KWA ZULU Natal location country South Africa location facility Qhakaza Mbokodo Research Clinic location city Ladysmith location state KWA ZULU Natal location zip 3370 location country South Africa location facility Tongaat Clinical Research Site, Dr location city Tongaat location state Kwa Zulu Natal location zip 4400 location country South Africa location facility Mzansi Ethical Research Centre location city Middleburg location state Mpumalanga location zip 1050 location country South Africa location facility The Aurum Institute Klerksdorp Clinical Research Centre location city Klerksdorp location state North WEST Province location zip 2571 location country South Africa location facility FAMCRU (Family Clinical Research Unit), location city Cape Town location state Western Cape location zip 7505 location country South Africa location facility TASK Central location city Cape Town location state Western Cape location zip 7530 location country South Africa location facility TASK Clinical Research Centre location city Cape Town location state Western Cape location zip 7530 location country South Africa location facility Emavundleni Research Centre location city Cape Town location state Western CAPE location zip 7781 location country South Africa location facility Khayelitsha CRS, Dr Amy Ward / Dr Graeme Meintjes location city Cape Town location state Western CAPE location zip 7784 location country South Africa location facility Desmond Tutu Health Foundation CTU J52 Old Main Building Groote SchuurHospital location city Cape Town location state Western Cape location zip 7925 location country South Africa location facility Synexus Helderberg Clinical Research Centre, Dr Vera location city Somerset West location state Western CAPE location zip 7130 location country South Africa location facility South African Vaccine Initiative (SATVI), Dr Angelique Kany Kany location city Worcester location state Western Cape location zip 6850 location country South Africa location facility Desmond Tutu Health Foundation - Masiphumelele Research Office location city Cape Town location zip 7975 location country South Africa location facility The Aurum Institute: Rustenburg Clinical Research Centre, Dr Lawrence location city Rustenburg location zip 0299 location country South Africa references module reference list reference reference p m i d 35727802 reference type derived reference citation Takuva S, Takalani A, Seocharan I, Yende-Zuma N, Reddy T, Engelbrecht I, Faesen M, Khuto K, Whyte C, Bailey V, Trivella V, Peter J, Opie J, Louw V, Rowji P, Jacobson B, Groenewald P, Dorrington RE, Laubscher R, Bradshaw D, Moultrie H, Fairall L, Sanne I, Gail-Bekker L, Gray G, Goga A, Garrett N; Sisonke study team. Safety evaluation of the single-dose Ad26.COV2.S vaccine among healthcare workers in the Sisonke study in South Africa: A phase 3b implementation trial. PLoS Med. 2022 Jun 21;19(6):e1004024. doi: 10.1371/journal.pmed.1004024. eCollection 2022 Jun. reference p m i d 35305740 reference type derived reference citation Bekker LG, Garrett N, Goga A, Fairall L, Reddy T, Yende-Zuma N, Kassanjee R, Collie S, Sanne I, Boulle A, Seocharan I, Engelbrecht I, Davies MA, Champion J, Chen T, Bennett S, Mametja S, Semenya M, Moultrie H, de Oliveira T, Lessells RJ, Cohen C, Jassat W, Groome M, Von Gottberg A, Le Roux E, Khuto K, Barouch D, Mahomed H, Wolmarans M, Rousseau P, Bradshaw D, Mulder M, Opie J, Louw V, Jacobson B, Rowji P, Peter JG, Takalani A, Odhiambo J, Mayat F, Takuva S, Corey L, Gray GE; Sisonke Protocol Team; Sisonke Study Team. Effectiveness of the Ad26.COV2.S vaccine in health-care workers in South Africa (the Sisonke study): results from a single-arm, open-label, phase 3B, implementation study. Lancet. 2022 Mar 19;399(10330):1141-1153. doi: 10.1016/S0140-6736(22)00007-1. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000045169 condition mesh term Severe Acute Respiratory Syndrome condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf relevance low condition browse leaf id M24598 condition browse leaf name Severe Acute Respiratory Syndrome condition browse leaf as found Severe Acute Respiratory Syndrome condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id T5186 condition browse leaf name Severe Acute Respiratory Syndrome condition browse leaf as found Severe Acute Respiratory Syndrome condition browse leaf relevance high condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04838795 | [
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full study rank 61609 study protocol section identification module n c t id NCT04834245 org study id info org study id A12982019 organization org full name Beni-Suef University org class OTHER brief title Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing official title Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing: A Prospective Randomized Control Study status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date January 3, 2019 start date type Actual primary completion date struct primary completion date April 3, 2019 primary completion date type Actual completion date struct completion date December 30, 2019 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Magda Bayoumi responsible party investigator title Lecturer responsible party investigator affiliation Beni-Suef University lead sponsor lead sponsor name Magda Bayoumi lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Background: The wound dressings perform a crucial role in the cutaneous wounds' management due to their ability to protect wounds and promote dermal and epidermal tissue regeneration. Objective: the aim of the present study to evaluate the effectiveness of using hydrogel/nano silver-based dressing vs. traditional dressing on diabetic foot wound healing.
Approach: Sixty patients with type-2 diabetes hospitalized for diabetic foot wound treatment were recruited from selected Surgical departments at Kasr Al-Aini university hospital. detailed description Data Collection: The patients of group-I wounds were cleaned using normal saline; then, the wounds were closed firmly with hyderogel\nano silver dressing. The dressing was changed every two days according to dressing manufacture instruction. When the dressing was opened after three days, the wound was assessed for granulation tissue, wound, and discharge size.
The patients of group II wounds were dresses using a traditional method, cleaned by normal saline, use of betadine antiseptic; then they were secured with clean linen gauze. The dressing was changed once daily. The wound healing process of the two groups was then assessed for three consecutive weeks. conditions module condition list condition Diabetes Mellitus keyword list keyword Diabetic foot ulcer design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Supportive Care design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Actual arms interventions module arm group list arm group arm group label hydrogel/nano silver-based dressing arm group type Experimental arm group description hydrogel/nano silver-based dressing arm group intervention list arm group intervention name Procedure: Hydrogel/nano silver-based dressing intervention list intervention intervention type Procedure intervention name Hydrogel/nano silver-based dressing intervention description compare the effectiveness of using hydrogel/nano silver-based dressing vs. traditional dressing on diabetic foot wound healing. intervention arm group label list intervention arm group label hydrogel/nano silver-based dressing outcomes module primary outcome list primary outcome primary outcome measure the percentage of a reduction rate of the diabetic foot ulcer after intervention primary outcome description assess of diabetic foot ulcers size "sq mm" primary outcome time frame 3 Weeks eligibility module eligibility criteria Inclusion Criteria:
Diabetes Type I and Type II patient with diabetic foot ulcer age ranged 35-55 years old Willing to participate
Exclusion Criteria:
unwilling to participate. healthy volunteers No gender All minimum age 35 Years maximum age 55 Years std age list std age Adult contacts locations module location list location location facility Cairo University location city Cairo location country Egypt i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000017719 condition mesh term Diabetic Foot condition ancestor list condition ancestor condition ancestor id D000003925 condition ancestor term Diabetic Angiopathies condition ancestor id D000014652 condition ancestor term Vascular Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000016523 condition ancestor term Foot Ulcer condition ancestor id D000007871 condition ancestor term Leg Ulcer condition ancestor id D000012883 condition ancestor term Skin Ulcer condition ancestor id D000012871 condition ancestor term Skin Diseases condition ancestor id D000048909 condition ancestor term Diabetes Complications condition ancestor id D000003920 condition ancestor term Diabetes Mellitus condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000003929 condition ancestor term Diabetic Neuropathies condition browse leaf list condition browse leaf condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf relevance low condition browse leaf id M16358 condition browse leaf name Ulcer condition browse leaf relevance low condition browse leaf id M19085 condition browse leaf name Diabetic Foot condition browse leaf as found Diabetic Foot condition browse leaf relevance high condition browse leaf id M18071 condition browse leaf name Foot Ulcer condition browse leaf relevance low condition browse leaf id M6272 condition browse leaf name Diabetic Angiopathies condition browse leaf relevance low condition browse leaf id M16552 condition browse leaf name Vascular Diseases condition browse leaf relevance low condition browse leaf id M10035 condition browse leaf name Leg Ulcer condition browse leaf relevance low condition browse leaf id M14838 condition browse leaf name Skin Ulcer condition browse leaf relevance low condition browse leaf id M14826 condition browse leaf name Skin Diseases condition browse leaf relevance low condition browse leaf id M25157 condition browse leaf name Diabetes Complications condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M6276 condition browse leaf name Diabetic Neuropathies condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev BC17 condition browse branch name Skin and Connective Tissue Diseases condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases | NCT04834245 | [
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full study rank 61469 study protocol section identification module n c t id NCT04836065 org study id info org study id ESICMUNITE2020 organization org full name University Hospital, Ghent org class OTHER brief title ESICM UNITE COVID-19 Project (UNITE-COVID) official title European Society Of Intensive Care Medicine COVID-19 Project (UNITE-COVID) acronym UNITE-COVID status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date July 1, 2020 start date type Actual primary completion date struct primary completion date September 30, 2020 primary completion date type Actual completion date struct completion date December 31, 2020 completion date type Actual study first submit date June 25, 2020 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University Hospital, Ghent lead sponsor class OTHER collaborator list collaborator collaborator name European Society of Intensive Care Medicine collaborator class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary COVID-19 is arguably the biggest challenge critical care medicine has been confronted with since its conception. Critical care services around the world are flooded by patients presenting with severe respiratory failure who require prolonged treatment in the ICU. Despite the support provided, outcomes are poor, particularly in ventilated patients.
Many unanswered questions remain regarding the pathophysiology of COVID-19, particularly in severely ill patients. No evidence-based treatment is currently available, yet different often experimental therapies are administered to patients.
As experience grows, new phenotypes are recognized, and unreported complications are observed in the most severely ill patients. Although many registries are currently including patients, few of them focus on ICU patients and their specific treatments and newly observed complications and challenges.
Although the pandemic may appear on its return in many countries that are now easing the restrictions that were put in place to limit the spread of the disease, it can be expected that COVID-19 will be a continued challenge in ICUs globally until a safe and effective vaccine is found. Efforts to study the disease should continue in order to advance our understanding of the disease as well as improve treatment options. detailed description This is a multicenter, international, anonymized point prevalence study. Patients who were present in the ICU on the day in April 2020 with the highest number of COVID-19 patients in the unit. Data can be entered in the database until July 2020. Retrospective data collection and entry is allowed.
Subjects believed to fulfill all eligibility criteria, and none of the exclusion criteria, detailed in the relevant section of this protocol, will be included in the study.
Data will be entered in the database anonymously.
Data will consist of two core elements:
Center data (to be completed once)
Patient data
For different domains with specific, highly relevant and un(der)explored ICU research questions, an focused data set is to be completed. These domains include:
Respiratory
Coagulation and thrombo-embolic events
Infectious complications
Rehabilitation
Renal conditions module condition list condition COVID-19 Infection keyword list keyword Covid-19 Infection Inflammation respiratory distress coagulation thromboembolus rehabilitation renal cardiac mobilization design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 4995 enrollment type Actual outcomes module primary outcome list primary outcome primary outcome measure Number of patients admitted with confirmed COVID19 infection primary outcome description Number of patients in the ICU on the study day primary outcome time frame One day with 60 day follow-up primary outcome measure Mortality (ICU) primary outcome description Proportion of patients who have died at ICU discharge primary outcome time frame One day with 60 day follow-up primary outcome measure Mortality (60-day) primary outcome description Proportion of patients who have died at day 60 primary outcome time frame One day with 60 day follow-up secondary outcome list secondary outcome secondary outcome measure Duration of hospitalization in the ICU secondary outcome description Length of stay in the ICU secondary outcome time frame One day with 60 day follow-up secondary outcome measure Proportion of patients requiring invasive mechanical ventilation secondary outcome description Proportion of patients who require invasive mechanical ventilation during ICU stay versus all patients secondary outcome time frame One day with 60 day follow-up secondary outcome measure Proportion of patients developing infections during ICU stay secondary outcome description Proportion of patients who acquire an infection during their ICU stay versus all patients secondary outcome time frame One day with 60 day follow-up secondary outcome measure Proportion of patients developing thromboembolic events during ICU stay secondary outcome description Proportion of patients who develop any thromboembolic event during their ICU stay versus all patients secondary outcome time frame One day with 60 day follow-up secondary outcome measure Proportion of patients requiring tracheotomy during ICU stay secondary outcome description Proportion of patients who are require a tracheostomy versus all patients secondary outcome time frame One day with 60 day follow-up eligibility module eligibility criteria Inclusion Criteria:
Patient is present in an ICU or in any other place of the hospital under the care of the critical care team on the day between 15th February 2020 and 15th June 2020 with the highest number of COVID-19 patients in the unit. The exact date can be decided by the local investigator.
COVID-19 confirmed diagnosis through PCR or equivalent diagnostic technique
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study: SARS-CoV2 positive without COVID-19 healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult study population Patients with confirmed COVID-19 infection present in the ICUs of participating hospitals or in any other place of the hospital under the care of the critical care team on the day between 15th February 2020 and 15th June 2020 with the highest number of COVID-19 patients in the unit or in any other place of the hospital under the care of the critical care team (date to be decided by local investigator). sampling method Probability Sample contacts locations module overall official list overall official overall official name Jan DE WAELE overall official affiliation University of Gent Hospital overall official role Principal Investigator location list location location facility Ghent University Hospital location city Ghent location zip 9000 location country Belgium references module reference list reference reference p m i d 32353746 reference type background reference citation Lodigiani C, Iapichino G, Carenzo L, Cecconi M, Ferrazzi P, Sebastian T, Kucher N, Studt JD, Sacco C, Bertuzzi A, Sandri MT, Barco S; Humanitas COVID-19 Task Force. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020 Jul;191:9-14. doi: 10.1016/j.thromres.2020.04.024. Epub 2020 Apr 23. reference p m i d 32222812 reference type background reference citation Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28. reference p m i d 32167538 reference type background reference citation Grasselli G, Pesenti A, Cecconi M. Critical Care Utilization for the COVID-19 Outbreak in Lombardy, Italy: Early Experience and Forecast During an Emergency Response. JAMA. 2020 Apr 28;323(16):1545-1546. doi: 10.1001/jama.2020.4031. No abstract available. reference p m i d 32250385 reference type background reference citation Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394. Erratum in: JAMA. 2021 May 25;325(20):2120. reference p m i d 35922860 reference type derived reference citation Conway Morris A, Kohler K, De Corte T, Ercole A, De Grooth HJ, Elbers PWG, Povoa P, Morais R, Koulenti D, Jog S, Nielsen N, Jubb A, Cecconi M, De Waele J; ESICM UNITE COVID investigators. Co-infection and ICU-acquired infection in COIVD-19 ICU patients: a secondary analysis of the UNITE-COVID data set. Crit Care. 2022 Aug 3;26(1):236. doi: 10.1186/s13054-022-04108-8. Erratum in: Crit Care. 2022 Aug 17;26(1):249. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M9445 condition browse leaf name Inflammation condition browse leaf relevance low condition browse leaf id M15834 condition browse leaf name Thromboembolism condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases | NCT04836065 | [
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] |
full study rank 61366 study protocol section identification module n c t id NCT04837404 org study id info org study id 9343 organization org full name Maatschap Cardiologie Zwolle org class OTHER brief title Ultrasound Guided Transfemoral Complex Large-bore PCI Trial official title Ultrasound Guided Transfemoral Complex Large-bore PCI Trial acronym ULTRACOLOR status module status verified date July 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 9, 2021 start date type Actual primary completion date struct primary completion date May 1, 2024 primary completion date type Anticipated completion date struct completion date December 31, 2024 completion date type Anticipated study first submit date March 1, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 11, 2022 last update post date struct last update post date July 12, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Maatschap Cardiologie Zwolle lead sponsor class OTHER collaborator list collaborator collaborator name Diagram B.V. collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary ULTRACOLOR is a randomized multicentre investigator-initiated study to investigate if ultrasound guided femoral access is associated with less clinically relevant access site related bleeding and/or vascular complications requiring intervention as compared to the fluoroscopy guided method for complex PCI with large-bore access. detailed description ULTRACOLOR is a prospective, multicentre, randomized investigator-initiated trial designed to enroll 542 subjects with an indication for PCI for complex coronary lesions.
This study will investigate if ultrasound guided femoral access is associated with less clinically relevant access site related bleeding and/or vascular complications requiring intervention as compared to the fluoroscopy guided method for complex PCI with large-bore access. conditions module condition list condition Complex Coronary Lesions Percutaneous Coronary Intervention design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Prospective, multicentre, randomized investigator-initiated trial with a superiority design design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 542 enrollment type Anticipated arms interventions module arm group list arm group arm group label ultrasound guided femoral access arm group type Other arm group description Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Ultrasound guided femoral access will be used. arm group intervention list arm group intervention name Procedure: Ultrasound guided femoral access for complex PCI arm group label fluoroscopy guided femoral access arm group type Other arm group description Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Fluoroscopy guided femoral access will be used. arm group intervention list arm group intervention name Procedure: Fluoroscopy guided femoral access for complex PCI intervention list intervention intervention type Procedure intervention name Ultrasound guided femoral access for complex PCI intervention description Ultrasound guided femoral access for complex PCI intervention arm group label list intervention arm group label ultrasound guided femoral access intervention type Procedure intervention name Fluoroscopy guided femoral access for complex PCI intervention description Fluoroscopy guided femoral access for complex PCI intervention arm group label list intervention arm group label fluoroscopy guided femoral access outcomes module primary outcome list primary outcome primary outcome measure Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site during index hospitalization. primary outcome time frame up to discharge hospital, on average 24 hours secondary outcome list secondary outcome secondary outcome measure Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the secondary femoral or radial access site during index hospitalization. secondary outcome time frame up to discharge hospital, on average 24 hours secondary outcome measure Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site at 1 month. secondary outcome time frame 1 month secondary outcome measure Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the secondary femoral or radial access site at 1 month secondary outcome time frame 1 month secondary outcome measure Proportion of patients with MACE secondary outcome time frame up to discharge hospital (on average 24 hours) and at 1 month secondary outcome measure Procedural duration secondary outcome time frame during PCI procedure secondary outcome measure Incidence of first pass puncture secondary outcome time frame during PCI procedure secondary outcome measure Number of access attempts secondary outcome time frame during PCI procedure secondary outcome measure Incidence of.accidental venipuncture secondary outcome time frame during PCI procedure secondary outcome measure Incidence of access below the femoral artery bifurcation (ileofemoral angiogram) secondary outcome time frame during PCI procedure secondary outcome measure Incidence of vascular complication not requiring intervention of the primary femoral access site secondary outcome time frame up to discharge hospital (on average 24 hours) and at 1 month secondary outcome measure Incidence of vascular complication not requiring intervention of the secondary femoral or radial access site secondary outcome time frame up to discharge hospital (on average 24 hours) and at 1 month eligibility module eligibility criteria Inclusion Criteria:
Use of the femoral artery for primary or secondary access with ≥ 7 Fr guiding catheter as indication for complex PCI, according to the expertise of the treating physician.
Age 18 years or older.
Exclusion Criteria:
Inability to obtain informed consent
Contra-indication for femoral access
Cardiogenic shock
ST elevation myocardial infarction healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jolanda Pol-van der Velde, MSc central contact role Contact central contact phone +31 (0)38 426 2999 central contact e mail jo.pol@diagram-zwolle.nl overall official list overall official overall official name Maarten van Leeuwen, MD, PhD overall official affiliation Isala overall official role Principal Investigator location list location location facility Isala Hospital location status Recruiting location city Zwolle location zip 8025 AB location country Netherlands location contact list location contact location contact name Maarten van Leeuwen, MD, PhD location contact role Contact location contact phone +31 38 424 50 00 location contact e mail m.a.h.van.leeuwen@isala.nl location contact name Maarten van Leeuwen, MD, PhD location contact role Principal Investigator location contact name Tom Meijers, MD location contact role Sub-Investigator derived section misc info module version holder December 02, 2022 | NCT04837404 | [
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full study rank 61644 study protocol section identification module n c t id NCT04833790 org study id info org study id 1R01DK126049-01A1 org study id type U.S. NIH Grant/Contract org study id link https://reporter.nih.gov/quickSearch/1R01DK126049-01A1 organization org full name RAND org class OTHER brief title What Drives Poor Care for Child Diarrhea: A Standardized Patient Experiment official title What Drives Poor Care for Child Diarrhea: A Standardized Patient Experiment status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 5, 2022 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2023 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date May 6, 2022 last update post date struct last update post date May 12, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Zachary Wagner responsible party investigator title Professor of Policy Analysis responsible party investigator affiliation RAND lead sponsor lead sponsor name RAND lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Diarrhea is the second leading cause of death for children around the world, although nearly all of these deaths could be prevented with an inexpensive and simple treatment: oral rehydration salts (ORS). Many children with diarrhea do not receive ORS when they seek treatment and this study uses a field experiment to examine why this occurs. We will use anonymous standardized patients combined with a randomized ORS supply intervention to isolate the causal effect of several potential reasons for why children do not receive ORS when they seek care: 1) caretakers prefer ORS alternatives, 2) providers have a financial incentives to prescribe ORS alternatives, and 3) ORS is often out of stock. detailed description Diarrhea is the second leading cause of death for children around the world. This is true despite the fact that nearly all such deaths could be prevented with a simple and inexpensive solution: oral rehydration salts (ORS). Private health care providers, who treat the majority of childhood illness in low- and middle-income countries (LMICs), are particularly unlikely to dispense ORS to children with diarrhea. Instead, providers often dispense antibiotics inappropriately. Recognizing this significant challenge, several international organizations (including USAID) have invested heavily in trying to increase ORS dispensing in the private sector. In the absence of evidence on why ORS is so inconsistently dispensed by private providers, however, several interventions to promote private sector ORS dispensing have been ineffective. Clearly, a critical and urgent next step is to examine the key drivers of underprescription of ORS and overprescription of antibiotics in the private sector in order to inform efforts to improve diarrhea care. In this study, we examine several leading explanations for poor quality of care for child diarrhea in the private sector. First, patient preferences for ORS alternatives (e.g., an antibiotic) could be driving underprescription of ORS. We will identify the causal effect of patient preferences (Aim 1) by having anonymous standardized patients (SPs) pose as caretakers of children with diarrhea and express different (randomly assigned) preferences for treatment (ask for ORS, ask for antibiotics, or let provider decide). Second, private providers could be responding to financial incentives to sell more profitable alternatives to ORS (e.g., an antibiotic). To estimate the causal effect of financial incentives (Aim 2), we will instruct a subset of SPs to inform providers that they can get discounted treatments at a relative's drug shop. This eliminates the provider's financial incentive to recommend a given treatment and allows us to estimate the effect of such incentives. Finally, private providers might not directly distribute ORS or could have frequent stock-outs. To estimate the causal effect of stock-outs (Aim 3), we will randomly assign half of the providers to receive a three-month supply of ORS. This generates exogenous variation in stock outs and thus enables us to isolate the causal effect of stock outs on ORS and antibiotic prescribing. Combining, (a) causal estimates of the impact of each factor on prescribing, and (b) population estimates of the prevalence of each factor, will allow us to estimate the population level impact of implementing interventions that address each factor (Aim 4). This study will provide the most comprehensive evidence to date on why one of the most important health technologies in history is often not prescribed. The results will inform the design of interventions aimed at increasing ORS dispensing and reducing antibiotic dispensing. If such interventions are targeted appropriately, millions of young lives could be saved. conditions module condition list condition Child Diarrhea design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Crossover Assignment design intervention model description The two interventions are patient type (4 types) and free distribution of treatment for child diarrhea (2 groups). These will be cross-randomized creating 8 study arms. design primary purpose Treatment design masking info design masking Triple design masking description The study participants are private health care providers in India who treat child diarrhea. Providers will be masked to which type of patient they are assigned to but not whether they receive free treatment for child diarrhea. Outcomes will assessed by anonymous standardized patients and these will be blind to whether the provider received free treatment for child diarrhea. design who masked list design who masked Participant Care Provider Outcomes Assessor enrollment info enrollment count 2000 enrollment type Anticipated arms interventions module arm group list arm group arm group label Free distribution of ORS + standardized patient with ORS preference arm group type Experimental arm group description Providers assigned to this arm will receive 3 months supply of ORS. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates a preference for ORS. arm group intervention list arm group intervention name Behavioral: Free distribution of ORS Behavioral: Standardized patient with ORS preference arm group label Free distribution of ORS + standardized patient with Antibiotic preference arm group type Experimental arm group description Providers assigned to this arm will receive 3 months supply of ORS. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates a preference for Antibiotics. arm group intervention list arm group intervention name Behavioral: Free distribution of ORS Behavioral: Standardized patient with Antibiotic preference arm group label Free distribution of ORS + standardized patient with no preference arm group type Experimental arm group description Providers assigned to this arm will receive 3 months supply of ORS. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates no preference for treatment. arm group intervention list arm group intervention name Behavioral: Free distribution of ORS Behavioral: Standardized patient with no preference arm group label Free distribution of ORS + standardized patient with no preference + no financial incentive arm group type Experimental arm group description Providers assigned to this arm will receive 3 months supply of ORS. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates no preference for treatment and indicates that they will purchase whatever the provider recommends from a relative's drug shop. arm group intervention list arm group intervention name Behavioral: Free distribution of ORS Behavioral: Standardized patient with no preference + no financial incentive arm group label Status quo ORS supply + standardized patient with ORS preference arm group type Experimental arm group description Providers assigned to this arm will have status who ORS supply. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates a preference for ORS. arm group intervention list arm group intervention name Behavioral: Standardized patient with ORS preference arm group label Status quo ORS supply + standardized patient with Antibiotic preference arm group type Experimental arm group description Providers assigned to this arm will have status who ORS supply. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates a preference for Antibiotics. arm group intervention list arm group intervention name Behavioral: Standardized patient with Antibiotic preference arm group label Status quo ORS supply + standardized patient with no preference arm group type Experimental arm group description Providers assigned to this arm will have status who ORS supply. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates no preference for treatment. arm group intervention list arm group intervention name Behavioral: Standardized patient with no preference arm group label Status quo ORS supply + standardized patient with no preference + no financial incentive arm group type Experimental arm group description Providers assigned to this arm will have status who ORS supply. Roughly 4 weeks later, they will receive a visit from a standardized patient (outcomes assessor) who poses as a caretaker for their child with diarrhea and indicates no preference for treatment and indicates that they will purchase whatever the provider recommends from a relative's drug shop. arm group intervention list arm group intervention name Behavioral: Standardized patient with no preference + no financial incentive intervention list intervention intervention type Behavioral intervention name Free distribution of ORS intervention description Provides will receive 3 months supply of ORS at the beginning of the study to dispense to their patients. They will be asked to dispense the ORS at the market rate and not to give it away to other providers. intervention arm group label list intervention arm group label Free distribution of ORS + standardized patient with Antibiotic preference Free distribution of ORS + standardized patient with ORS preference Free distribution of ORS + standardized patient with no preference Free distribution of ORS + standardized patient with no preference + no financial incentive intervention type Behavioral intervention name Standardized patient with ORS preference intervention description Providers will receive a visit from an anonymous standardize patient posing a caretaker for a child with diarrhea who requests ORS to treat their child's diarrhea. intervention arm group label list intervention arm group label Free distribution of ORS + standardized patient with ORS preference Status quo ORS supply + standardized patient with ORS preference intervention type Behavioral intervention name Standardized patient with Antibiotic preference intervention description Providers will receive a visit from an anonymous standardize patient posing a caretaker for a child with diarrhea who requests Antibiotics to treat their child's diarrhea. intervention arm group label list intervention arm group label Free distribution of ORS + standardized patient with Antibiotic preference Status quo ORS supply + standardized patient with Antibiotic preference intervention type Behavioral intervention name Standardized patient with no preference intervention description Providers will receive a visit from an anonymous standardize patient posing a caretaker for a child with diarrhea who does not request anything specific to treat their child's diarrhea. intervention arm group label list intervention arm group label Free distribution of ORS + standardized patient with no preference Status quo ORS supply + standardized patient with no preference intervention type Behavioral intervention name Standardized patient with no preference + no financial incentive intervention description Providers will receive a visit from an anonymous standardize patient posing a caretaker for a child with diarrhea who does not request anything specific to treat their child's diarrhea. In addition they will inform the provider that they are not going to purchase anything from the provider because they have an uncle with a drug shop where they can get a discount. intervention arm group label list intervention arm group label Free distribution of ORS + standardized patient with no preference + no financial incentive Status quo ORS supply + standardized patient with no preference + no financial incentive outcomes module primary outcome list primary outcome primary outcome measure Received or prescribed ORS primary outcome description Standardized patients will record whether the provider either dispensed or prescribed ORS for their child's diarrhea . primary outcome time frame 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur. primary outcome measure Received or prescribed antibiotic primary outcome description Standardized patients will record whether the provider either dispensed or prescribed antibiotics for their child's diarrhea. primary outcome time frame 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur. secondary outcome list secondary outcome secondary outcome measure Received or prescribed zinc secondary outcome description Standardized patients will record whether the provider either dispensed or prescribed zinc for their child's diarrhea. secondary outcome time frame 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur. secondary outcome measure Received or prescribed zinc+ORS secondary outcome description Standardized patients will record whether the provider either dispensed or prescribed zinc and ORS (the gold standard treatment) for their child's diarrhea. secondary outcome time frame 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur. secondary outcome measure Received or prescribed ORS and no antibiotics secondary outcome description Standardized patients will record whether the provider either dispensed or prescribed ORS and no antibiotics for their child's diarrhea. secondary outcome time frame 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur. secondary outcome measure Received or prescribed ORS + zinc and no antibiotics secondary outcome description Standardized patients will record whether the provider either dispensed or prescribed ORS and zinc with no antibiotics for their child's diarrhea. secondary outcome time frame 4 weeks after the ORS supply is dispensed. Same time as standardize patient visits occur. eligibility module eligibility criteria Inclusion Criteria:
Eligible providers will be private providers over 18 years old in our sampled villages that treat at least one case of child diarrhea per week
Exclusion Criteria:
Providers in villages where there are no other providers will be excluded for confidentiality concerns healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility Indian Institute of Management Bangalore location status Recruiting location city Bangalore location state Karnataka location country India location contact list location contact location contact name Arnab Mukherji, PhD location contact role Contact location contact phone 5415173447 location contact e mail arnab@iimb.ac.in i p d sharing statement module i p d sharing Undecided i p d sharing description We plan on making individual underlying data available for replication purposes but this plan needs to be finalized with our IRB derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003967 condition mesh term Diarrhea condition ancestor list condition ancestor condition ancestor id D000012817 condition ancestor term Signs and Symptoms, Digestive condition browse leaf list condition browse leaf condition browse leaf id M6311 condition browse leaf name Diarrhea condition browse leaf as found Diarrhea condition browse leaf relevance high condition browse leaf id M14774 condition browse leaf name Signs and Symptoms, Digestive condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000000900 intervention mesh term Anti-Bacterial Agents intervention ancestor list intervention ancestor intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M3374 intervention browse leaf name Anti-Bacterial Agents intervention browse leaf as found Negative intervention browse leaf relevance high intervention browse leaf id M3376 intervention browse leaf name Antibiotics, Antitubercular intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04833790 | [
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1195,
1209,
19729,
27430,
1544,
1104,
1103,
12263,
1106,
3531,
170,
1210,
118,
2370,
3880,
1104,
23066,
1708,
119,
1188,
21241,
4252,
19790,
2285,
8516,
1107,
4482,
24046,
1105,
2456,
13267,
1366,
1106,
1110,
14995,
1103,
11019,
25034,
2629,
1104,
4482,
24046,
1113,
23066,
1708,
1105,
2848,
22400,
3073,
1116,
27362,
119,
3291,
12913,
16534,
117,
113,
170,
114,
11019,
25034,
10777,
1104,
1103,
3772,
1104,
1296,
5318,
1113,
3073,
1116,
27362,
117,
1105,
113,
171,
114,
1416,
10777,
1104,
1103,
22760,
1104,
1296,
5318,
117,
1209,
2621,
1366,
1106,
10301,
1103,
1416,
1634,
3772,
1104,
16381,
22496,
1115,
4134,
1296,
5318,
113,
19294,
1306,
125,
114,
119,
1188,
2025,
1209,
2194,
1103,
1211,
8232,
2554,
1106,
2236,
1113,
1725,
1141,
1104,
1103,
1211,
1696,
2332,
7951,
1107,
1607,
1110,
1510,
1136,
17421,
119,
1109,
2686,
1209,
12862,
1103,
1902,
1104,
22496,
5850,
1120,
4138,
23066,
1708,
4267,
20080,
5026,
1158,
1105,
7914,
2848,
22400,
4267,
20080,
5026,
1158,
119,
1409,
1216,
22496,
1132,
9271,
26620,
117,
9215,
1104,
1685,
2491,
1180,
1129,
4987,
119,
2975,
13196,
3879,
2190,
3879,
6405,
12120,
1813,
1197,
13836,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
3156,
5909,
1249,
19638,
1880,
1902,
9108,
2235,
6136,
1109,
1160,
22496,
1132,
5351,
2076,
113,
125,
3322,
114,
1105,
1714,
3735,
1104,
3252,
1111,
2027,
4267,
1813,
1197,
13836,
113,
123,
2114,
114,
119,
1636,
1209,
1129,
2771,
118,
7091,
2200,
3780,
129,
2025,
1739,
119,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
9457,
1902,
7739,
1158,
6136,
1109,
2025,
6635,
1132,
2029,
2332,
1920,
12263,
1107,
1726,
1150,
7299,
2027,
4267,
1813,
1197,
13836,
119,
5096,
22650,
1733,
1209,
1129,
19970,
1106,
1134,
2076,
1104,
5351,
1152,
1132,
3346,
1106,
1133,
1136,
2480,
1152,
3531,
1714,
3252,
1111,
2027,
4267,
1813,
1197,
13836,
119,
3929,
19191,
1116,
1209,
14758,
1118,
12631,
18013,
4420,
1105,
1292,
1209,
1129,
7198,
1106,
2480,
1103,
11482,
1460,
1714,
3252,
1111,
2027,
4267,
1813,
1197,
13836,
119,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
4539,
27989,
10224,
1204,
8396,
5096,
22650,
1197,
3929,
19191,
1116,
1249,
8830,
21484,
10803,
23992,
10803,
5099,
1539,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
4299,
3735,
1104,
23066,
1708,
116,
18013,
5351,
1114,
23066,
1708,
12629,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
5096,
22650,
1733,
3346,
1106,
1142,
1981,
1209,
3531,
124,
1808,
3880,
1104,
23066,
1708,
119,
19479,
1193,
125,
2277,
1224,
117,
1152,
1209,
3531,
170,
3143,
1121,
170,
18013,
5351,
113,
13950,
15187,
1766,
114,
1150,
25366,
1112,
170,
20893,
1111,
1147,
2027,
1114,
4267,
1813,
1197,
13836,
1105,
6653,
170,
12629,
1111,
23066,
1708,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
4299,
3735,
1104,
23066,
1708,
4108,
2328,
17564,
1348,
131,
6433,
2200,
5351,
1114,
23066,
1708,
12629,
1981,
1372,
3107,
4299,
3735,
1104,
23066,
1708,
116,
18013,
5351,
1114,
8329,
22400,
12629,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
5096,
22650,
1733,
3346,
1106,
1142,
1981,
1209,
3531,
124,
1808,
3880,
1104,
23066,
1708,
119,
19479,
1193,
125,
2277,
1224,
117,
1152,
1209,
3531,
170,
3143,
1121,
170,
18013,
5351,
113,
13950,
15187,
1766,
114,
1150,
25366,
1112,
170,
20893,
1111,
1147,
2027,
1114,
4267,
1813,
1197,
13836,
1105,
6653,
170,
12629,
1111,
8329,
25523,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
4299,
3735,
1104,
23066,
1708,
4108,
2328,
17564,
1348,
131,
6433,
2200,
5351,
1114,
8329,
22400,
12629,
1981,
1372,
3107,
4299,
3735,
1104,
23066,
1708,
116,
18013,
5351,
1114,
1185,
12629,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
5096,
22650,
1733,
3346,
1106,
1142,
1981,
1209,
3531,
124,
1808,
3880,
1104,
23066,
1708,
119,
19479,
1193,
125,
2277,
1224,
117,
1152,
1209,
3531,
170,
3143,
1121,
170,
18013,
5351,
113,
13950,
15187,
1766,
114,
1150,
25366,
1112,
170,
20893,
1111,
1147,
2027,
1114,
4267,
1813,
1197,
13836,
1105,
6653,
1185,
12629,
1111,
3252,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
4299,
3735,
1104,
23066,
1708,
4108,
2328,
17564,
1348,
131,
6433,
2200,
5351,
1114,
1185,
12629,
1981,
1372,
3107,
4299,
3735,
1104,
23066,
1708,
116,
18013,
5351,
1114,
1185,
12629,
116,
1185,
2798,
23692,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
5096,
22650,
1733,
3346,
1106,
1142,
1981,
1209,
3531,
124,
1808,
3880,
1104,
23066,
1708,
119,
19479,
1193,
125,
2277,
1224,
117,
1152,
1209,
3531,
170,
3143,
1121,
170,
18013,
5351,
113,
13950,
15187,
1766,
114,
1150,
25366,
1112,
170,
20893,
1111,
1147,
2027,
1114,
4267,
1813,
1197,
13836,
1105,
6653,
1185,
12629,
1111,
3252,
1105,
6653,
1115,
1152,
1209,
4779,
3451,
1103,
11482,
18029,
1116,
1121,
170,
5236,
112,
188,
3850,
4130,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
4299,
3735,
1104,
23066,
1708,
4108,
2328,
17564,
1348,
131,
6433,
2200,
5351,
1114,
1185,
12629,
116,
1185,
2798,
23692,
1981,
1372,
3107,
22130,
186,
11848,
23066,
1708,
3880,
116,
18013,
5351,
1114,
23066,
1708,
12629,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
5096,
22650,
1733,
3346,
1106,
1142,
1981,
1209,
1138,
2781,
1150,
23066,
1708,
3880,
119,
19479,
1193,
125,
2277,
1224,
117,
1152,
1209,
3531,
170,
3143,
1121,
170,
18013,
5351,
113,
13950,
15187,
1766,
114,
1150,
25366,
1112,
170,
20893,
1111,
1147,
2027,
1114,
4267,
1813,
1197,
13836,
1105,
6653,
170,
12629,
1111,
23066,
1708,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
6433,
2200,
5351,
1114,
23066,
1708,
12629,
1981,
1372,
3107,
22130,
186,
11848,
23066,
1708,
3880,
116,
18013,
5351,
1114,
8329,
22400,
12629,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
5096,
22650,
1733,
3346,
1106,
1142,
1981,
1209,
1138,
2781,
1150,
23066,
1708,
3880,
119,
19479,
1193,
125,
2277,
1224,
117,
1152,
1209,
3531,
170,
3143,
1121,
170,
18013,
5351,
113,
13950,
15187,
1766,
114,
1150,
25366,
1112,
170,
20893,
1111,
1147,
2027,
1114,
4267,
1813,
1197,
13836,
1105,
6653,
170,
12629,
1111,
8329,
25523,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
6433,
2200,
5351,
1114,
8329,
22400,
12629,
1981,
1372,
3107,
22130,
186,
11848,
23066,
1708,
3880,
116,
18013,
5351,
1114,
1185,
12629,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
5096,
22650,
1733,
3346,
1106,
1142,
1981,
1209,
1138,
2781,
1150,
23066,
1708,
3880,
119,
19479,
1193,
125,
2277,
1224,
117,
1152,
1209,
3531,
170,
3143,
1121,
170,
18013,
5351,
113,
13950,
15187,
1766,
114,
1150,
25366,
1112,
170,
20893,
1111,
1147,
2027,
1114,
4267,
1813,
1197,
13836,
1105,
6653,
1185,
12629,
1111,
3252,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
6433,
2200,
5351,
1114,
1185,
12629,
1981,
1372,
3107,
22130,
186,
11848,
23066,
1708,
3880,
116,
18013,
5351,
1114,
1185,
12629,
116,
1185,
2798,
23692,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
5096,
22650,
1733,
3346,
1106,
1142,
1981,
1209,
1138,
2781,
1150,
23066,
1708,
3880,
119,
19479,
1193,
125,
2277,
1224,
117,
1152,
1209,
3531,
170,
3143,
1121,
170,
18013,
5351,
113,
13950,
15187,
1766,
114,
1150,
25366,
1112,
170,
20893,
1111,
1147,
2027,
1114,
4267,
1813,
1197,
13836,
1105,
6653,
1185,
12629,
1111,
3252,
1105,
6653,
1115,
1152,
1209,
4779,
3451,
1103,
11482,
18029,
1116,
1121,
170,
5236,
112,
188,
3850,
4130,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
6433,
2200,
5351,
1114,
1185,
12629,
116,
1185,
2798,
23692,
9108,
2190,
9108,
9108,
2076,
4108,
2328,
17564,
1348,
9108,
1271,
4299,
3735,
1104,
23066,
1708,
9108,
6136,
5096,
22650,
1116,
1209,
3531,
124,
1808,
3880,
1104,
23066,
1708,
1120,
1103,
2150,
1104,
1103,
2025,
1106,
4267,
21643,
1106,
1147,
4420,
119,
1220,
1209,
1129,
1455,
1106,
4267,
21643,
1103,
23066,
1708,
1120,
1103,
2319,
2603,
1105,
1136,
1106,
1660,
1122,
1283,
1106,
1168,
12263,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
4299,
3735,
1104,
23066,
1708,
116,
18013,
5351,
1114,
8329,
22400,
12629,
4299,
3735,
1104,
23066,
1708,
116,
18013,
5351,
1114,
23066,
1708,
12629,
4299,
3735,
1104,
23066,
1708,
116,
18013,
5351,
1114,
1185,
12629,
4299,
3735,
1104,
23066,
1708,
116,
18013,
5351,
1114,
1185,
12629,
116,
1185,
2798,
23692,
9108,
2076,
4108,
2328,
17564,
1348,
9108,
1271,
6433,
2200,
5351,
1114,
23066,
1708,
12629,
9108,
6136,
5096,
22650,
1733,
1209,
3531,
170,
3143,
1121,
1126,
12631,
2530,
3708,
5351,
23614,
170,
20893,
1111,
170,
2027,
1114,
4267,
1813,
1197,
13836,
1150,
11458,
23066,
1708,
1106,
7299,
1147,
2027,
112,
188,
4267,
1813,
1197,
13836,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
4299,
3735,
1104,
23066,
1708,
116,
18013,
5351,
1114,
23066,
1708,
12629,
22130,
186,
11848,
23066,
1708,
3880,
116,
18013,
5351,
1114,
23066,
1708,
12629,
9108,
2076,
4108,
2328,
17564,
1348,
9108,
1271,
6433,
2200,
5351,
1114,
8329,
22400,
12629,
9108,
6136,
5096,
22650,
1733,
1209,
3531,
170,
3143,
1121,
1126,
12631,
2530,
3708,
5351,
23614,
170,
20893,
1111,
170,
2027,
1114,
4267,
1813,
1197,
13836,
1150,
11458,
8329,
25523,
1106,
7299,
1147,
2027,
112,
188,
4267,
1813,
1197,
13836,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
4299,
3735,
1104,
23066,
1708,
116,
18013,
5351,
1114,
8329,
22400,
12629,
22130,
186,
11848,
23066,
1708,
3880,
116,
18013,
5351,
1114,
8329,
22400,
12629,
9108,
2076,
4108,
2328,
17564,
1348,
9108,
1271,
6433,
2200,
5351,
1114,
1185,
12629,
9108,
6136,
5096,
22650,
1733,
1209,
3531,
170,
3143,
1121,
1126,
12631,
2530,
3708,
5351,
23614,
170,
20893,
1111,
170,
2027,
1114,
4267,
1813,
1197,
13836,
1150,
1674,
1136,
4566,
1625,
2747,
1106,
7299,
1147,
2027,
112,
188,
4267,
1813,
1197,
13836,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
4299,
3735,
1104,
23066,
1708,
116,
18013,
5351,
1114,
1185,
12629,
22130,
186,
11848,
23066,
1708,
3880,
116,
18013,
5351,
1114,
1185,
12629,
9108,
2076,
4108,
2328,
17564,
1348,
9108,
1271,
6433,
2200,
5351,
1114,
1185,
12629,
116,
1185,
2798,
23692,
9108,
6136,
5096,
22650,
1733,
1209,
3531,
170,
3143,
1121,
1126,
12631,
2530,
3708,
5351,
23614,
170,
20893,
1111,
170,
2027,
1114,
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full study rank 61805 study protocol section identification module n c t id NCT04831697 org study id info org study id R21DK123720 org study id type U.S. NIH Grant/Contract org study id link https://reporter.nih.gov/quickSearch/R21DK123720 organization org full name Medical College of Wisconsin org class OTHER brief title Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden official title Community-Based Intervention to Improve Diabetes Outcomes in Older African American Women With Multi-Caregiving Burden acronym MCGR21 status module status verified date April 2022 overall status Recruiting expanded access info has expanded access No start date struct start date December 14, 2021 start date type Actual primary completion date struct primary completion date May 31, 2023 primary completion date type Anticipated completion date struct completion date May 31, 2023 completion date type Anticipated study first submit date March 25, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 6, 2022 last update post date struct last update post date April 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Joni Williams responsible party investigator title Associate Professor responsible party investigator affiliation Medical College of Wisconsin lead sponsor lead sponsor name Medical College of Wisconsin lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary This is a two arm, pilot randomized control trial (RCT) in which 60 African American women (AAW), 40-64 years of age, with HbA1c ≥8% and multi-caregiving responsibilities will be recruited from communities in Milwaukee, Wisconsin and randomized to either: 1) an individual-based, social support, health educator-facilitated intervention to address multi-caregiving responsibilities (n=30), or 2) individual-based, health educator-facilitated diabetes education and skills training and general health education (n=30). All sessions will be delivered via telephone (i.e., landline, mobile device, smart device, etc.) by a health educator (i.e., nurse, social worker, Master's trained health educator) and is comprised of 12 weekly sessions and 3 booster sessions. Each session will last up to 60min. All study assessments will be administered by a Program Assistant at baseline, 3-months, and 6-months. detailed description The investigators propose to test the feasibility and preliminary efficacy of this multi-caregiving intervention on improving outcomes among AAW, ages 40-64 years with type 2 diabetes (T2DM) and multi-caregiving responsibilities using a pilot randomized design compared to diabetes enhanced usual care. The goals of the study will be assessed under the following specific aims:
Aim 1: To determine the feasibility of the multi-caregiving intervention as measured by recruitment, session attendance, retention, and treatment adherence in AAW with T2DM
Aim 2: To test the preliminary efficacy of the multi-caregiving intervention on glycemic and blood pressure control in AAW with T2DM compared to individual-delivered, health-educator led diabetes enhanced usual care at 6 months Hypothesis 1: AAW who receive the multi-caregiving intervention will have significant reductions in hemoglobin A1c at 6 months compared to AAW who receive diabetes enhanced usual care Hypothesis 2: AAW who receive the multi-caregiving intervention will have significant reductions in blood pressure at 6 months compared to AAW who receive diabetes enhanced usual care
Aim 3: To test the preliminary efficacy of the multi-caregiving intervention on self-care behaviors and quality of life in AAW with T2DM compared to individual-delivered, health educator led diabetes enhanced usual care at 6 months Hypothesis 1: AAW who receive the multi-caregiving intervention will have significant improvements in self-care behaviors (diet, physical activity, medication adherence, and blood glucose monitoring) at 6 months compared to AAW who receive diabetes enhanced usual care Hypothesis 2: AAW who receive the multi-caregiving intervention will have significant improvements in quality of life (SF-12 scores) at 6 months compared to AAW who receive diabetes enhanced usual care
In the final 6-month assessment, study participants will be asked to participate in 30 to 40-minute, semi-structured interviews by telephone. Findings will help refine the intervention and emphasize elements that enhance participant uptake and motivation for sustained behavior change for the future R01. conditions module condition list condition Type 2 Diabetes design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Health Services Research design masking info design masking Double design who masked list design who masked Investigator Outcomes Assessor enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Multi-Caregiving Intervention arm group type Experimental arm group description The multi-caregiving intervention consists of individual-based, social support, and health-educator facilitation and includes: a. Storytelling/sharing of experiences (5 minutes); social support and problem solving (15 minutes); Coping strategies (15minutes); and Structured Diabetes Education and Skills Training (15 minutes). The final 5min will be used for debriefing/reviewing goals. arm group intervention list arm group intervention name Behavioral: Multi-Caregiving Intervention arm group label Diabetes Enhanced Usual Care Intervention arm group type Active Comparator arm group description This is composed of individual-based, health educator-facilitated diabetes education and skills training and general health education and will receive structured diabetes education and skills training as described above (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes). arm group intervention list arm group intervention name Behavioral: Diabetes Enhanced Usual Care Intervention intervention list intervention intervention type Behavioral intervention name Multi-Caregiving Intervention intervention description The multi-caregiving intervention consists of individual-based, social support, and health educator facilitation and includes: a. Storytelling/sharing of experiences (5 minutes); social support and problem solving (15 minutes); Coping strategies (15 minutes); and Structured Diabetes Education and Skills Training (15 minutes). The last 5 minutes will be used to debrief and review goals. intervention arm group label list intervention arm group label Multi-Caregiving Intervention intervention type Behavioral intervention name Diabetes Enhanced Usual Care Intervention intervention description This is composed of individual-based, health educator-facilitated diabetes education and skills training and general health education and will receive structured diabetes education and skills training as described above (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes). intervention arm group label list intervention arm group label Diabetes Enhanced Usual Care Intervention outcomes module primary outcome list primary outcome primary outcome measure Change in Glycemic Control from Baseline to 6 months primary outcome description Trained personnel will collect a blood specimen via finger stick (using a Point-of-Care device) or via venipuncture to collect 10cc of blood to measure HbA1c. All collections will be performed in the community at a location convenient to the study participant. At the screening visit, the HbA1c must be 8% or greater to be eligible for participation. primary outcome time frame Screening/Baseline, 3-months, 6-months secondary outcome list secondary outcome secondary outcome measure Change in Diet from Baseline to 6 months secondary outcome description Diet will be measured by the 26-item Dietary Screener Questionnaire (DSQ) used in the National Health and Nutrition Examination Survey. Responses are used to estimate individual dietary intake for fruits, vegetables, dairy, added sugars, whole grains, fiber, adn calcium. secondary outcome time frame Screening/Baseline, 3-months, 6-months secondary outcome measure Change in Physical Activity from Baseline to 6 months secondary outcome description Physical activity will be measured using the 7-item International Physical Activity Questionnaire that asks about physical activities over the last 7 days. secondary outcome time frame Screening/Baseline, 3-months, 6-months secondary outcome measure Change in Blood Pressure Control from Baseline to 6 months secondary outcome description Blood pressure measurements will be obtained by the nurse/health educator using an automated BP monitor with participants seated comfortably for 5 minutes prior to the measurements. secondary outcome time frame Screening/Baseline, 3-months, 6-months secondary outcome measure Change in Blood Glucose Monitoring from Baseline to 6 months secondary outcome description Blood glucose monitoring will be assessed with the previously validated Summary of Diabetes Self-Care Activities (SDSCA) scale, where scores are calculated for each of the five areas assessed by the SDSCA over the past 7 days: diet, exercise, blood glucose monitoring, foot care, and smoking status. Higher scores mean more engagement in self-care behaviors. secondary outcome time frame Screening/Baseline, 3-months, 6-months secondary outcome measure Change in Medication Adherence from Baseline to 6 months secondary outcome description Medication adherence will be measured with the 6-item validated self-report Brooks Medication Adherence Scale. Each question asks yes-no questions about adherence, where a "no" response indicates better adherence. secondary outcome time frame Screening/Baseline, 3-months, 6-months secondary outcome measure Change in Health Related Quality of Life from Baseline to 6 months secondary outcome description The SF-12 is a valid and reliable instrument to measure functional status and yields summary physical (PCS-12) and mental health (MCS-12) outcome scores. Summary scores range from 0 to 100 where higher scores mean better quality of life. secondary outcome time frame Screening/Baseline, 3-months, 6-months eligibility module eligibility criteria Inclusion criteria:
Age 40-64 years
Self-identifies as female
Self-identifies as African American or Non-Hispanic Black
Self-reports multi-caregiving responsibilities
Clinical diagnosis of T2DM based on HbA1c≥8% at the screening/baseline assessment
Able to communicate in English
Access to a telephone (i.e., landline, mobile device, smart device, etc.)
Exclusion criteria:
Mental confusion at screening/baseline assessment suggesting significant dementia, active psychosis, or acute mental disorder
Participation in other diabetes trials
Life expectancy <6 months based on screening questionnaire healthy volunteers No gender Female minimum age 40 Years maximum age 64 Years std age list std age Adult contacts locations module central contact list central contact central contact name Joni Williams, MD, MPH central contact role Contact central contact phone 414-955-8827 central contact e mail jswilliams@mcw.edu overall official list overall official overall official name Joni Williams, MD, MPH overall official affiliation Medical College of Wisconsin overall official role Principal Investigator location list location location facility Medical College of Wisconsin location status Recruiting location city Milwaukee location state Wisconsin location zip 53226 location country United States location contact list location contact location contact name Joni Williams, MD, MPH location contact role Contact location contact phone 414-955-8827 location contact e mail jswilliams@mcw.edu derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003920 condition mesh term Diabetes Mellitus condition mesh id D000084802 condition mesh term Caregiver Burden condition ancestor list condition ancestor condition ancestor id D000044882 condition ancestor term Glucose Metabolism Disorders condition ancestor id D000008659 condition ancestor term Metabolic Diseases condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000013315 condition ancestor term Stress, Psychological condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition browse leaf list condition browse leaf condition browse leaf id M6271 condition browse leaf name Diabetes Mellitus, Type 2 condition browse leaf relevance low condition browse leaf id M6267 condition browse leaf name Diabetes Mellitus condition browse leaf as found Diabetes condition browse leaf relevance high condition browse leaf id M2481 condition browse leaf name Caregiver Burden condition browse leaf as found Caregiving Burden condition browse leaf relevance high condition browse leaf id M10791 condition browse leaf name Metabolic Diseases condition browse leaf relevance low condition browse leaf id M24556 condition browse leaf name Glucose Metabolism Disorders condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M15257 condition browse leaf name Stress, Psychological condition browse leaf relevance low condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC18 condition browse branch name Nutritional and Metabolic Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders | NCT04831697 | [
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3576,
119,
114,
1118,
170,
2332,
12102,
113,
178,
119,
174,
119,
117,
7439,
117,
1934,
7589,
117,
3257,
112,
188,
3972,
2332,
12102,
114,
1105,
1110,
11561,
1104,
1367,
5392,
6887,
1105,
124,
14112,
1200,
6887,
119,
2994,
4912,
1209,
1314,
1146,
1106,
2539,
7937,
119,
1398,
2025,
25451,
1209,
1129,
8318,
1118,
170,
4659,
5414,
1120,
2259,
2568,
117,
124,
118,
1808,
117,
1105,
127,
118,
1808,
119,
6448,
6136,
1109,
17718,
17794,
1106,
2774,
1103,
175,
14517,
7706,
1105,
9889,
23891,
1104,
1142,
4321,
118,
1920,
5389,
3970,
9108,
1113,
9248,
13950,
1621,
10419,
2924,
117,
6776,
1969,
118,
3324,
1201,
1114,
2076,
123,
17972,
113,
157,
1477,
20002,
114,
1105,
4321,
118,
1920,
5389,
3970,
10239,
1606,
170,
3955,
7091,
2200,
1902,
3402,
1106,
17972,
9927,
4400,
1920,
119,
1109,
2513,
1104,
1103,
2025,
1209,
1129,
14758,
1223,
1103,
1378,
2747,
8469,
131,
19294,
1306,
122,
131,
1706,
4959,
1103,
175,
14517,
7706,
1104,
1103,
4321,
118,
1920,
5389,
3970,
9108,
1112,
7140,
1118,
17964,
117,
4912,
7794,
117,
23406,
117,
1105,
3252,
8050,
21634,
1107,
10419,
2924,
1114,
157,
1477,
20002,
19294,
1306,
123,
131,
1706,
2774,
1103,
9889,
23891,
1104,
1103,
4321,
118,
1920,
5389,
3970,
9108,
1113,
176,
1193,
2093,
7257,
1105,
1892,
2997,
1654,
1107,
10419,
2924,
1114,
157,
1477,
20002,
3402,
1106,
2510,
118,
4653,
117,
2332,
118,
12102,
1521,
17972,
9927,
4400,
1920,
1120,
127,
1808,
145,
1183,
11439,
22063,
122,
131,
10419,
2924,
1150,
3531,
1103,
4321,
118,
1920,
5389,
3970,
9108,
1209,
1138,
2418,
7234,
1116,
1107,
23123,
8032,
2858,
7939,
18967,
1665,
1120,
127,
1808,
3402,
1106,
10419,
2924,
1150,
3531,
17972,
9927,
4400,
1920,
145,
1183,
11439,
22063,
123,
131,
10419,
2924,
1150,
3531,
1103,
4321,
118,
1920,
5389,
3970,
9108,
1209,
1138,
2418,
7234,
1116,
1107,
1892,
2997,
1120,
127,
1808,
3402,
1106,
10419,
2924,
1150,
3531,
17972,
9927,
4400,
1920,
19294,
1306,
124,
131,
1706,
2774,
1103,
9889,
23891,
1104,
1103,
4321,
118,
1920,
5389,
3970,
9108,
1113,
2191,
118,
1920,
16711,
1105,
3068,
1104,
1297,
1107,
10419,
2924,
1114,
157,
1477,
20002,
3402,
1106,
2510,
118,
4653,
117,
2332,
12102,
1521,
17972,
9927,
4400,
1920,
1120,
127,
1808,
145,
1183,
11439,
22063,
122,
131,
10419,
2924,
1150,
3531,
1103,
4321,
118,
1920,
5389,
3970,
9108,
1209,
1138,
2418,
8313,
1107,
2191,
118,
1920,
16711,
113,
10211,
117,
2952,
3246,
117,
15683,
8050,
21634,
117,
1105,
1892,
20636,
9437,
114,
1120,
127,
1808,
3402,
1106,
10419,
2924,
1150,
3531,
17972,
9927,
4400,
1920,
145,
1183,
11439,
22063,
123,
131,
10419,
2924,
1150,
3531,
1103,
4321,
118,
1920,
5389,
3970,
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1209,
1138,
2418,
8313,
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3068,
1104,
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113,
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118,
1367,
7432,
114,
1120,
127,
1808,
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1106,
10419,
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1150,
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9927,
4400,
1920,
1130,
1103,
1509,
127,
118,
2370,
8670,
117,
2025,
6635,
1209,
1129,
1455,
1106,
4868,
1107,
1476,
1106,
1969,
118,
2517,
117,
3533,
118,
15695,
7397,
1118,
7314,
119,
18036,
1116,
1209,
1494,
1231,
24191,
1103,
9108,
1105,
19291,
3050,
1115,
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14031,
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13482,
1105,
15710,
1111,
8505,
4658,
1849,
1111,
1103,
2174,
155,
24400,
119,
2975,
13196,
3879,
2190,
3879,
6902,
123,
12120,
22377,
3052,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
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1233,
1249,
19638,
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1902,
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3007,
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2713,
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7739,
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2190,
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1150,
19970,
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3121,
25524,
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3929,
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1249,
8830,
21484,
10803,
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10803,
5099,
2539,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
18447,
118,
8396,
5389,
3970,
11300,
21987,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1109,
4321,
118,
1920,
5389,
3970,
9108,
2923,
1104,
2510,
118,
1359,
117,
1934,
1619,
117,
1105,
2332,
118,
12102,
175,
7409,
18575,
7984,
1105,
2075,
131,
170,
119,
5145,
7854,
1979,
120,
6303,
1104,
5758,
113,
126,
1904,
114,
132,
1934,
1619,
1105,
2463,
15097,
113,
1405,
1904,
114,
132,
3291,
2624,
10700,
113,
1405,
7937,
20311,
114,
132,
1105,
25341,
1181,
12120,
22377,
3052,
2531,
1105,
26210,
5513,
113,
1405,
1904,
114,
119,
1109,
1509,
126,
7937,
1209,
1129,
1215,
1111,
1260,
27647,
11470,
1158,
120,
19730,
2513,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
18447,
118,
8396,
5389,
3970,
11300,
21987,
1981,
1372,
3107,
12120,
22377,
3052,
13832,
3822,
9650,
11155,
4746,
8396,
11300,
21987,
1981,
1372,
2076,
17244,
3291,
8223,
4626,
2772,
1981,
1372,
6136,
1188,
1110,
2766,
1104,
2510,
118,
1359,
117,
2332,
12102,
118,
21582,
17972,
1972,
1105,
4196,
2013,
1105,
1704,
2332,
1972,
1105,
1209,
3531,
15695,
17972,
1972,
1105,
4196,
2013,
1112,
1758,
1807,
113,
1476,
1904,
114,
1105,
1126,
2509,
6145,
1113,
1704,
2332,
7662,
113,
178,
119,
174,
119,
117,
1171,
2489,
117,
173,
6834,
3186,
3491,
1465,
117,
3576,
119,
114,
113,
1476,
1904,
114,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
12120,
22377,
3052,
13832,
3822,
9650,
11155,
4746,
8396,
11300,
21987,
9108,
2190,
9108,
9108,
2076,
4108,
2328,
17564,
1348,
9108,
1271,
18447,
118,
8396,
5389,
3970,
11300,
21987,
9108,
6136,
1109,
4321,
118,
1920,
5389,
3970,
9108,
2923,
1104,
2510,
118,
1359,
117,
1934,
1619,
117,
1105,
2332,
12102,
175,
7409,
18575,
7984,
1105,
2075,
131,
170,
119,
5145,
7854,
1979,
120,
6303,
1104,
5758,
113,
126,
1904,
114,
132,
1934,
1619,
1105,
2463,
15097,
113,
1405,
1904,
114,
132,
3291,
2624,
10700,
113,
1405,
1904,
114,
132,
1105,
25341,
1181,
12120,
22377,
3052,
2531,
1105,
26210,
5513,
113,
1405,
1904,
114,
119,
1109,
1314,
126,
1904,
1209,
1129,
1215,
1106,
1260,
27647,
11470,
1105,
3189,
2513,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
18447,
118,
8396,
5389,
3970,
11300,
21987,
9108,
2076,
4108,
2328,
17564,
1348,
9108,
1271,
12120,
22377,
3052,
13832,
3822,
9650,
11155,
4746,
8396,
11300,
21987,
9108,
6136,
1188,
1110,
2766,
1104,
2510,
118,
1359,
117,
2332,
12102,
118,
21582,
17972,
1972,
1105,
4196,
2013,
1105,
1704,
2332,
1972,
1105,
1209,
3531,
15695,
17972,
1972,
1105,
4196,
2013,
1112,
1758,
1807,
113,
1476,
1904,
114,
1105,
1126,
2509,
6145,
1113,
1704,
2332,
7662,
113,
178,
119,
174,
119,
117,
1171,
2489,
117,
173,
6834,
3186,
3491,
1465,
117,
3576,
119,
114,
113,
1476,
1904,
114,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
12120,
22377,
3052,
13832,
3822,
9650,
11155,
4746,
8396,
11300,
21987,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
9091,
1107,
144,
1193,
2093,
7257,
6342,
1121,
14562,
2042,
1106,
127,
1808,
2425,
9386,
6136,
9791,
1174,
4675,
1209,
7822,
170,
1892,
11678,
2258,
3602,
6166,
113,
1606,
170,
4221,
118,
1104,
118,
8396,
4442,
114,
1137,
2258,
1396,
2605,
16091,
26405,
5332,
1106,
7822,
1275,
19515,
1104,
1892,
1106,
4929,
145,
1830,
1592,
1475,
1665,
119,
1398,
6286,
1209,
1129,
1982,
1107,
1103,
1661,
1120,
170,
2450,
14785,
1106,
1103,
2025,
14031,
119,
1335,
1103,
11954,
3143,
117,
1103,
145,
1830,
1592,
1475,
1665,
1538,
1129,
129,
110,
1137,
3407,
1106,
1129,
7408,
1111,
6251,
119,
2425,
9386,
1159,
4207,
15652,
1158,
120,
14562,
2042,
117,
124,
118,
1808,
117,
127,
118,
1808,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
9091,
1107,
22327,
1121,
14562,
2042,
1106,
127,
1808,
3718,
9386,
6136,
22327,
1209,
1129,
7140,
1118,
1103,
1744,
118,
8926,
22327,
3113,
15652,
1200,
22171,
24730,
113,
18448,
4880,
114,
1215,
1107,
1103,
1305,
3225,
1105,
151,
23016,
26947,
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119,
24187,
1116,
1132,
1215,
1106,
10301,
2510,
10211,
3113,
14741,
1111,
11669,
117,
11872,
117,
14874,
117,
1896,
6656,
1116,
117,
2006,
19707,
117,
12753,
117,
8050,
1179,
15355,
119,
3718,
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1159,
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1158,
120,
14562,
2042,
117,
124,
118,
1808,
117,
127,
118,
1808,
3718,
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4929,
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1107,
10618,
2173,
6366,
1121,
14562,
2042,
1106,
127,
1808,
3718,
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6136,
10618,
3246,
1209,
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1606,
1103,
128,
118,
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10618,
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24730,
1115,
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2952,
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1103,
1314,
128,
1552,
119,
3718,
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1159,
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1158,
120,
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2042,
117,
124,
118,
1808,
117,
127,
118,
1808,
3718,
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1121,
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2042,
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127,
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1103,
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120,
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126,
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1103,
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119,
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117,
124,
118,
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117,
127,
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1103,
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1104,
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118,
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113,
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117,
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1111,
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1103,
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1763,
128,
1552,
131,
10211,
117,
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117,
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117,
2555,
1920,
117,
1105,
9987,
2781,
119,
7715,
7432,
1928,
1167,
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1107,
2191,
118,
1920,
16711,
119,
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1159,
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120,
14562,
2042,
117,
124,
118,
1808,
117,
127,
118,
1808,
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127,
1808,
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1103,
127,
118,
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118,
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24930,
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119,
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2304,
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118,
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21634,
117,
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170,
107,
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107,
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119,
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120,
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2042,
117,
124,
118,
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117,
127,
118,
1808,
3718,
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127,
1808,
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118,
1367,
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1105,
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1105,
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14940,
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113,
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1708,
118,
1367,
114,
1105,
4910,
2332,
113,
12029,
1708,
118,
1367,
114,
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7432,
119,
15463,
12917,
1616,
7432,
2079,
1121,
121,
1106,
1620,
1187,
2299,
7432,
1928,
1618,
3068,
1104,
1297,
119,
3718,
9386,
1159,
4207,
15652,
1158,
120,
14562,
2042,
117,
124,
118,
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full study rank 61823 study protocol section identification module n c t id NCT04831463 org study id info org study id 2019-91 organization org full name Ondokuz Mayıs University org class OTHER brief title The Effect of the Program on the Health Perceptions and Responsibilities of Immigrant Men on Utiling Healthcare Services official title The Effect of Increasising Health Awareness Program on Health Perceptıons and Responsıbılıtıes of Immıgrant Men (IHAP) on Perceived Stress Levels, Attitudes Towards Utiling Healthcare Services and Coping Strategies acronym IHAP status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date March 15, 2020 start date type Actual primary completion date struct primary completion date November 20, 2020 primary completion date type Actual completion date struct completion date March 15, 2021 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 26, 2021 last update post date struct last update post date April 28, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Ilknur Aydin Avci responsible party investigator title Head of Nursing Department responsible party investigator affiliation Ondokuz Mayıs University lead sponsor lead sponsor name Ondokuz Mayıs University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Aims The study aims to examine the effect of "IHAPIM" program on health perceptions, health responsibilities, perceived stress level, attitudes towards utiling health care services and the types of coping strategies of immigrant men.
Design This study is a two centre, double-blind, randomized controlled trial. Methods We attempt to report this randomized controlled trial to comply with the SPIRIT. The study population consist of 95 immigrant men live at north of Turkey. The study, between March 2020-March 2021 were held in the two district predominantly immigrants. The participants were randomly divided into experimental and control group. The experimental (N = 49) received a short-term IHAPIM program (5 week, 1 hr per week, 10 hr in total). Measurements were obtained during pre- and post-test from experimental and control group (N = 46). In this study, participants and statistician who conducted the research blinded.
Discussion The efficacy of health promotion interventions are known. However, the health promotion interventions for immigrants men performed by public health nurse are not available. At the same time, the effect of health promotion interventions for immigrants men are unknown.
Impact This study is expected to provide a piece of credible evidence of the the health promotion interventions for immigrants men performed by public health nurse and efficacy of health perceptions, health responsibilities, perceived stress level, attitudes towards utiling health care services and the types of coping strategies in immigrant men group. It is assumed that health promotion interventions specific to male health and sensitive to the language of immigrants lead to a beneficial results on health perceptions, health responsibilities, perceived stress level, attitudes towards utiling health care services and the types of coping strategies in immigrant men. If "IHAPIM" program perform in practice by public heath nurse. It can be effectively improve immigrant men's health variables such as health perceptions, health responsibilities, perceived stress level, attitudes towards utiling health care services and the types of coping strategies. detailed description This study was carried out in order to examine the effect of the "Increasising Health Awareness Program for Immigrant Men " (IHAPIM), which was prepared based on the Transition Theory of Meleis, on the health perceptions, health responsibilities, perceived stress levels, attitudes towards utiling health care services and the types of coping strategies of immigrant men.
This study, which was planned in accordance with the principles of a randomized controlled double-blind pre-test post-test control group experimental study, was conducted with immigrant males between the ages of 18 and 50, living in Canik and İlkadım districts of Samsun, where immigrants live mainly. The randomized clinical trial was based on the guidelines proposed by the SPIRIT 2013 Statement. The data of the study were collected in Samsun / Ilkadım and Canık District between May 2020 and November 2020. Randomization an experimental group and a control group formed using the research randomizer software. the program used random numbers to select participants and randomly assign them to the experimental or control group (total 95 immigrant men). In this study, immigrant men do not know that they are in the experimental or control group, and the statistician who conducted the research does not know which data belong to which group. Blinding is done in this way. The study was completed with 49 men in the experimental group and 46 men in the control group. The experimental (N = 49) received a short-term IHAPIM program by one-on-one interview (5 week, 1 hr per week). The data of the study were collected using personal information form, health perception scale, health responsibility sub-dimension of healthy lifestyle behaviors scale, perceived stress scale, stress coping methods scale and the scale of determining the attitudes of immigrants towards using health services.
personal information form; the form was developed by the researcher and consists of questions involving sociodemographic characteristics (age, marital status, education status, etc.) health perception scale; Health perceptions of immigrant men were evaluated with a visual number scale. There is a question on the scale. Information on how to fill the scale as parentheses information at the end of the question scored between 1-10, which is easy to understand, which immigrant men can answer on their own ('0' on this scale indicates that you evaluate your questioned situation very badly, the increase of the score is improving your assessment of your questioned situation, and the '10' score is shows that your assessment of your situation is very good).
health responsibility sub-dimension of healthy lifestyle behaviors scale; In measuring the level of responsibility for an individual's health, the healthy lifestyle behaviors scale, which was developed by Walker, Sechrist and Pender in 1987 and adapted to Arabic in 1998 by Hadad et al. is the scale that determines the extent to which they participate in health. All items of the healthy lifestyle behaviors scale are positive. There is no reverse matter. Marking is done on 4 Likert type scales. A score of 1 is given for an answer "Never", 2 points for an answer "Sometimes", 3 points for an answer "Often" and 4 points for an answer "Regularly". Health responsibility sub-dimension of healthy lifestyle behaviors scale 2, 7, 15,20,28,31,33,42,43,46. It consisted of a total of 10 items including items. The lowest score is 10, the highest score is 40. The reliability coefficients of the scale are α 0.90.
perceived stress scale; The Perceived Stress Scale, developed by Cohen, Kamarc and Mermelstein (1983), is the most commonly used tool of this type. Chaaya et al. In 2010, its validity and reliability in Arabic was made. The scale consists of 10 items. It was developed to evaluate to what extent the individual perceived his life as unpredictable, uncontrollable or overloaded in the last month. The scale is in the 5-point Likert type (1- never, 2- almost never, 3- sometimes, 4- often 5- very often), and its four items are reverse (4th, 5th, 7th, 8th items), six of its articles are plainly worded (1st, 2nd, 3rd, 6th, 9th, 10th items). The lowest score that can be obtained from the scale is 0, and the highest score is 40. The scale is evaluated over the total score, and the higher the scores indicate that the stress is perceived high. The Arabic reliability coefficients of the scale are α 0.87.
types of coping strategies; The study of the "Ways of Coping Inventory" scale developed by Folkman and Lazarus (1980) in order to determine the ways individuals use to deal with general or significant stress situations, the Arabic validity and reliability was conducted by Alghamdi (2020). The "Coping with Stress Scale" consists of two groups, 14 sub-dimensions and 28 items, as compatible and incompatible. Harmonious coping methods; active coping, positive reframing, planning, acceptance, religion, humor, using emotional social support support), using useful social support (using instrumental support), incompatible coping methods; behavioral disengagement, denial, substance use, focusing on the problem and venting, mental self-distraction, self-blame. The Likert-type scale scored between 1 and 4 does not have a total score. Arabic validity and reliability study of the scale was conducted in 2018 and the reliability coefficient was found to be α 0.80 in the Arabic version of the scale.
the scale of determining the attitudes towards utiling health care services; Developed in Arabic by Avci and Korkmaz in 2019 in order to determine the attitudes of immigrants towards using health services, the scale for determining the attitudes of immigrants towards using health services consists of 26 items. The scale consists of 4 sub-dimensions: health awareness, factors affecting admission to health services, delivery of health services, and access to health services. Answers given to each statement in the scale are in 5-point Likert type and all statements are positive. Scores obtained from sub-dimensions: between 4-20 points for health awareness sub-dimension; Between 4-20 points for the factors affecting the application to health services sub-dimension; It ranges between 5-25 points for the sub-dimension of the way health services are provided and 5-25 points for the sub-dimension of access to health services. The total scores obtained from the scale range from 18 to 90 points. The fact that the scores obtained from the scale subscale and the total score are high indicates that the immigrants have a good attitude towards using health services. Cronbach's alphas in the validity and reliability study of the scale are as follows: Cronbach's Alpha reliability coefficient of the health awareness sub-dimension (0.63), the Cronbach's Alpha reliability coefficient (0.73) of the factors affecting admission to health services, the Cronbach's Alpha reliability coefficient of the sub-dimension of how health services are provided (0.60), and Cronbach's Alpha reliability coefficient of access to health services sub-dimension is (0.71). The total Cronbach's alpha reliability coefficient of the scale for determining the attitudes of immigrants towards using health services is 0.72.
Evaluation of Data SPSS 23.0 statistical package program (Statistical Package for the Social Sciences, Chicago, Illinois) was used for statistical analysis and evaluation of the data. Whether the data showed normal distribution was checked with the Kolmogorov-Smirnov test. Mann Whitney U test were used to compare data between groups according to normality test. Wilcoxon test were used to compare the pre-test and post-test values within the group. The Chi-square test and two ratio tests were used to analyze categorical data. Significance level was taken as p <0.05.
Funding: Financial support of the research provided by the Project Management Office of Ondokuz Mayis University. PYO.SBF.1904.20.002.
Ethical aspects: Study approval was given by Ondokuz Mayıs University Ethıcs Commıttee For Socıal And Humanıtıes Research. (Decision No: 2019-91). All participants were informed about tis study and obtained orat-written informed consents. conditions module condition list condition Health Care Utilization Men keyword list keyword Immigrant Health, Men's Health, Health Promotion design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized controlled experimental design design primary purpose Prevention design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 100 enrollment type Actual arms interventions module arm group list arm group arm group label experimental group arm group type Experimental arm group description The experimental (N = 49) received a short-term IHAPIM program by one-on-one interview (5 week, 1 hr per week, 10 hr in total). arm group intervention list arm group intervention name Behavioral: Increasising Health Awareness Program for Immigrant Men arm group label control group arm group type No Intervention arm group description Firstly, Pre-tests were applied to the men in the control group. No intervention was applied to this group. Post-tests were made 3 months after finished intervention which applied to experimental group. intervention list intervention intervention type Behavioral intervention name Increasising Health Awareness Program for Immigrant Men intervention description The IHAPIM program is a health promotion intervention. The aim of intervention improve health perception and responsibilitiy intervention arm group label list intervention arm group label experimental group outcomes module primary outcome list primary outcome primary outcome measure Increasing health perception and responsibility of immigrant men primary outcome description After health promotion intervention (IHAPIM) this outcome will obtained primary outcome time frame 3 month eligibility module eligibility criteria Inclusion Criteria:
Volunteering to participate in the study
Be between the ages of 18 and 50
Being a male
No communication barriers
Being a immigrant
To be able to read and write Arabic language
Exclusion Criteria:
Being younger than 18 or over 50
Be woman
Inability to communicate with any problem such as hearing problem, speech impediment
Living undocumented
Refusing to participate in the study healthy volunteers Accepts Healthy Volunteers gender Male gender based Yes gender description The utiling of healthcare services by immigrant men is lower than immigrant women. Only men were recruited. minimum age 18 Years maximum age 55 Years std age list std age Adult contacts locations module overall official list overall official overall official name İlknur Aydin AVCI, Prof. overall official affiliation Ondokuz Mayıs University overall official role Study Director overall official name Metin Yılmaz, Prof. overall official affiliation Ondokuz Mayıs University overall official role Study Chair location list location location facility Ondokuz Mayis University location city Samsun location country Turkey derived section misc info module version holder December 02, 2022 | NCT04831463 | [
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6026,
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2076,
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122,
117,
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186,
172,
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122,
117,
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188,
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126,
117,
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117,
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23055,
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138,
19429,
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138,
1964,
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3763,
1104,
15192,
1951,
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13494,
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12262,
1116,
1239,
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170,
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175,
173,
170,
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14940,
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2629,
1104,
107,
146,
11612,
23203,
2107,
107,
1788,
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1116,
117,
2332,
10239,
117,
8367,
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1634,
117,
15149,
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190,
19621,
1158,
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1920,
1826,
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1103,
3322,
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4800,
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2642,
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2702,
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20569,
1116,
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1103,
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119,
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118,
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1103,
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119,
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134,
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114,
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170,
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118,
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146,
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113,
126,
1989,
117,
122,
177,
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1989,
117,
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177,
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114,
119,
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3073,
118,
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118,
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113,
151,
134,
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114,
119,
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117,
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188,
19756,
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1103,
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119,
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1988,
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1227,
119,
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117,
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1982,
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119,
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1103,
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117,
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1104,
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1111,
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119,
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170,
2727,
1104,
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1104,
1103,
1103,
2332,
4166,
22496,
1111,
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1441,
1982,
1118,
1470,
2332,
7439,
1105,
23891,
1104,
2332,
11170,
1116,
117,
2332,
10239,
117,
8367,
6600,
1634,
117,
15149,
2019,
190,
19621,
1158,
2332,
1920,
1826,
1105,
1103,
3322,
1104,
9947,
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119,
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1103,
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170,
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1113,
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11170,
1116,
117,
2332,
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117,
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117,
15149,
2019,
190,
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1920,
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1103,
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119,
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119,
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112,
188,
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11170,
1116,
117,
2332,
10239,
117,
8367,
6600,
1634,
117,
15149,
2019,
190,
19621,
1158,
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1920,
1826,
1105,
1103,
3322,
1104,
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1158,
10700,
119,
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1103,
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1103,
107,
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138,
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146,
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114,
117,
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1103,
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1988,
9560,
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117,
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1103,
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1116,
117,
2332,
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117,
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3001,
117,
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190,
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1920,
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1103,
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1104,
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2025,
117,
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1103,
6551,
1104,
170,
7091,
2200,
4013,
2702,
118,
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3073,
118,
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2112,
118,
2774,
1654,
1372,
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2025,
117,
1108,
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1206,
1103,
6776,
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1105,
1851,
117,
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300,
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117,
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120,
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1968,
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119,
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119,
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113,
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114,
119,
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117,
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146,
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1989,
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1989,
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2019,
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2007,
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1972,
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132,
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full study rank 61298 study protocol section identification module n c t id NCT04838288 org study id info org study id 201108 organization org full name Vanderbilt University Medical Center org class OTHER brief title Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XR™ official title Cognitive Outcomes and Quality of Life in Stable Renal Transplant Patients Switched fromTwice-Daily Tacrolimus to Envarsus XR™ acronym OPERATOR status module status verified date August 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 22, 2021 start date type Actual primary completion date struct primary completion date December 31, 2023 primary completion date type Anticipated completion date struct completion date December 31, 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date August 23, 2022 last update post date struct last update post date August 24, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Anthony Langone responsible party investigator title Associate Professor responsible party investigator affiliation Vanderbilt University Medical Center lead sponsor lead sponsor name Vanderbilt University Medical Center lead sponsor class OTHER collaborator list collaborator collaborator name Veloxis Pharmaceuticals collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export No description module brief summary The purpose of this study is to assess cognitive outcome and quality of life in stable renal transplant patients treated with twice daily tacrolimus at baseline and after switching to Envarsus XL. The study is designed to see if switching patients from Tacrolimus to Envarsus treatment improves cognitive function. detailed description Patients with chronic kidney disease most commonly show cognitive impairments involving attention, memory, executive functions, and mental processing speed. Although data have demonstrated improvements in cognition following kidney transplant and the reversibility of the memory problems evidenced in dialysis, neurotoxicity in transplant patients occurs in >40-50% of the patients treated with tacrolimus. Attention and working memory impairment have been observed in patients treated with sirolimus or tacrolimus, while cyclosporine-treated patients demonstrated performance similar to that of healthy volunteer controls, which may indicate that the cognitive deficit found was partly related to treatment. ENVARSUS XR is a new FDA-approved formulation of tacrolimus. A hallmark difference between ENVARSUS XR and other forms of once- and twice-daily tacrolimus products is the unique, proprietary MeltDose® drug delivery technology (Veloxis Pharmaceuticals, Hørsholm, Denmark) which reduces tacrolimus' particle size to a molecular level. The decreased surface area of the drug particles results in complete absorption and increased bioavailability in a once-daily dosing formulation. In stable kidney transplant patients, ENVARSUS XR pharmacokinetics are characterized by a steadier and more consistent concentration time profile over 24 hours, reduced peak and peak-to-trough fluctuations and similar exposure while benefiting from ~ 20% less total daily dose than twice daily tacrolimus. This open-label, prospective phase clinical trial is designed to evaluate whether switching patients from TAC-IR to ENVARSUS XR treatment improves cognitive function. conditions module condition list condition Renal Transplant keyword list keyword cognitive function Quality of life design module study type Interventional phase list phase Phase 4 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label Change from Prograf to Envarsus arm group type Experimental arm group description All participants will be switched from Prograf to Envarsus arm group intervention list arm group intervention name Drug: Change from Prograf to Envarsus XR intervention list intervention intervention type Drug intervention name Change from Prograf to Envarsus XR intervention description Change from Tacrolimus taken twice a day to Envarsus XR taken once a day intervention arm group label list intervention arm group label Change from Prograf to Envarsus intervention other name list intervention other name Change from Tacrolimus to Envarsus XR outcomes module primary outcome list primary outcome primary outcome measure Change in cognitive function-Global on RBANS primary outcome description Measured by the Global Composite Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Total score can range from 40 to 160. Low score indicates cognitive impairment. primary outcome time frame Baseline to month 4 primary outcome measure Change in cognitive function-Global on Covid-19 telephone battery primary outcome description Measured by the global composite score of the Covid-19 Telephone Battery, should that be the primary outcome battery that we employ due to COVID limitation. Total score can range from 40 to 160. Low score indicates cognitive impairment. primary outcome time frame Baseline to month 4 secondary outcome list secondary outcome secondary outcome measure Change in cognitive function on Trail making part A secondary outcome description Measured by Trail making Part A. Maximum time given for TMT A is 150 seconds. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. secondary outcome time frame Baseline to month 4 secondary outcome measure Change in cognitive function on Trail making part B secondary outcome description Measured by Trail making Part B. Maximum time given for TMT B is 300 seconds. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. secondary outcome time frame Baseline to month 4 secondary outcome measure Change in quality of life secondary outcome description Change in quality of life measured by WHODAS. The total score of WHODAS is the sum of all the 12 sub-scores and ranges from 0 to 48, with lower scores indicating better functioning. Total scores of 1-4 belong to mild disability, 5-9 to moderate disability, and 10-48 to severe disability secondary outcome time frame Baseline to Month 4 secondary outcome measure Impression of Improvement by PGI secondary outcome description measured by PGI-I (Patient's Global Impression of Improvement). The PGI-I measures change since initiating a medication and is assessed on a 7-point Likert-type scale ranging from very much better (1) to very much worse (7) secondary outcome time frame baseline to month 4 secondary outcome measure Impression of Improvement by CGI secondary outcome description measured by CGI-I (Clinical Global Impression of Improvement). The CGI-I measures change since initiating a medication and is assessed on a 7-point Likert-type scale ranging from very much improved (1) to very much worse (7). secondary outcome time frame baseline to month 4 secondary outcome measure Change of quality of sleep secondary outcome description measured by PIRS-20 (Pittsburgh Insomnia Rating Scale). The PIRS-20 total score is the sum of all items and ranges from 0 (good sleep) to 60 (bad sleep).3 secondary outcome time frame Baseline to month 4 eligibility module eligibility criteria Inclusion Criteria:
Patients must be able to understand English and provide written informed consent;
Males and females between 18 and 70 years of age;
Recipients of a primary or secondary kidney transplant 4 weeks to 10 years prior to screening;
Patients receiving a stable dose (i.e., no dose adjustments) of TAC-IR for a minimum of 4-7 days at screening;
Patients with a screening TAC-IR trough level of 3-9 ng/mL, measured between Day -7 to 0;
Women of childbearing potential must have a negative urine pregnancy test at screening;
Patients must be willing to commit to and comply with the schedule of study visits.
The patient is not scheduled to begin any new medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food supplements (including grapefruit and pomegranate products), or medications listed in Appendix 1.
Exclusion Criteria:
Recipients of any transplanted organ other than kidney;
Patients with an estimated glomerular filtration rate (eGFR) (MDRD4) < 25 mL/min at screening;
Patients with significant visual impairments affecting their ability to complete the study requirements and assessments: patient's vision is 20/200 or worse;
Patients with significant hearing impairments affecting their ability to complete the study requirements and assessments, based on Investigator discretion;
Patients with any severe medical condition (including infection) requiring acute or chronic treatment that in the Investigator's opinion would interfere with study participation;
Patients who have a history of any of the following, based on documentation of clinical conditions and concomitant medications in the medical records:
Cognitive decline secondary to stroke, per Investigator discretion
Dementia
Resected or existing brain tumor
Acute or chronic bipolar psychosis or schizophrenia per Investigator discretion
Mental retardation
Moderate or severe traumatic brain injury
Failure of any major organ other than the kidneys (e.g., end-stage liver disease)
Known non-adherence (defined as documentation in the patient chart of multiple missed visits and/or medication doses) which in the Investigator's opinion would interfere with the objectives of the study
Patients with medical history of hypertension or diabetes which is unmanageable by medically approved intervention (e.g., medication/diet) as assessed by the Investigator;
Patients with acute or chronic depression, corresponding to a score of ≥20 (corresponding to moderate depression) on the BDI-II at screening;
Patients who are taking any acute or chronic medications that may impact reaction time, memory, or sleep habits, based on Investigator discretion;
Patients on concurrent immunosuppression with MMF (CellCept) or MPS delayed release tablets (Myfortic), or generic versions of these medications, as per SOC, who have not been on stable doses (i.e., no dose adjustments or formulation change) for at least 4-7 days prior to screening;
Patients receiving prednisone or equivalent >10 mg/day;
Patients with an episode of biopsy-proven or suspected acute rejection that requires treatment within 3 months of screening;
Patients who are being actively treated for cancer (with the exception of non-invasive basal cell or cutaneous squamous cell carcinoma);
Patients known to be human immunodeficiency virus (HIV) positive;
Patients with any form of current drug or alcohol abuse as assessed by the Investigator;
Patients who were treated with any other investigational agent within 1 month prior to screening;
Pregnant or nursing women or women planning to become pregnant, where pregnancy is defined as a state of the female patient after conception and until the termination of gestation, confirmed by a positive urine laboratory test; women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC birth control method; UNLESS they are:
Women whose career, lifestyle, or sexual orientation preclude intercourse with a partner
Women whose partners have been sterilized by medically approved means healthy volunteers No gender All minimum age 18 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Mohammed Sika, PhD central contact role Contact central contact phone 6159361179 central contact e mail mohammed.sika@vumc.org overall official list overall official overall official name Anthonny Langone, MD overall official affiliation VUMC overall official role Principal Investigator location list location location facility VUMC location status Recruiting location city Nashville location state Tennessee location zip 37232 location country United States location contact list location contact location contact name Mohammed Sika, PhD location contact role Contact location contact phone 615-936-2630 location contact e mail mohammed.sika@vumc.org i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000016559 intervention mesh term Tacrolimus intervention ancestor list intervention ancestor intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000065095 intervention ancestor term Calcineurin Inhibitors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention browse leaf list intervention browse leaf intervention browse leaf id M18102 intervention browse leaf name Tacrolimus intervention browse leaf as found Hyperthermic Intraperitoneal Chemotherapy intervention browse leaf relevance high intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse leaf id M29605 intervention browse leaf name Calcineurin Inhibitors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04838288 | [
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177,
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23826,
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17713,
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16430,
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24767,
1227,
1106,
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1769,
13280,
13601,
2728,
2007,
23622,
7942,
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3442,
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7414,
17516,
12480,
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131,
2453,
2133,
1578,
117,
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117,
1137,
3785,
10592,
3073,
1665,
12906,
26864,
1114,
170,
3547,
2453,
2133,
6449,
1138,
1151,
188,
2083,
15892,
1118,
2657,
1193,
4092,
2086,
8071,
8118,
1302,
5772,
1398,
5867,
1425,
1407,
5848,
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1425,
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1204,
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1425,
11635,
26694,
11635,
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4541,
13196,
2129,
3232,
2190,
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2129,
3232,
1271,
12811,
14159,
1968,
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7735,
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24367,
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2179,
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1571,
1580,
22997,
14541,
1559,
1580,
2129,
3232,
174,
6346,
182,
10559,
2312,
4611,
119,
27466,
1968,
137,
191,
1818,
1665,
119,
8916,
2905,
2078,
2190,
2905,
2078,
2905,
2078,
1271,
1760,
1582,
1320,
3382,
12431,
4798,
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159,
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1968,
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8916,
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173,
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178,
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1162,
7404,
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full study rank 61685 study protocol section identification module n c t id NCT04833257 org study id info org study id 2020-FXY-484 organization org full name Sun Yat-sen University org class OTHER brief title Neoadjuvant Therapy of GP Chemotherapy Combined With Tislelizumab in Locoregionally Advanced NPC official title Efficacy and Safety of of GP Chemotherapy Combined With Tislelizumab Neoadjuvant Therapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: a Single-arm, Phase 2 Trial status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 14, 2021 start date type Actual primary completion date struct primary completion date November 30, 2025 primary completion date type Anticipated completion date struct completion date November 30, 2026 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 15, 2021 last update post date struct last update post date April 19, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Hai-Qiang Mai,MD,PhD responsible party investigator title Director of the Department of Nasopharyngeal Carcinoma responsible party investigator affiliation Sun Yat-sen University lead sponsor lead sponsor name Sun Yat-sen University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The purpose of this study is to explore the efficacy and safety of a combination of GP chemotherapy and tislelizumab in neoadjuvant therapy of locoregionally advanced nasopharyngeal carcinoma patients. detailed description Platinum-based concurrent chemoradiotherapy is the standard of care for patients with locoregionally advanced nasopharyngeal carcinoma(NPC). Gemcitabine plus cisplatin(GP) has been demonstrated an effective chemotherapy regimen for NPC patients in previous studies. The results of GP combined with concurrent chemoradiotherapy in the treatment of locoregionally advanced nasopharyngeal carcinoma showed 10% of locoregionally advanced NPC patients had complete response after three cycles of GP neoadjuvant chemotherapy, and GP neoadjuvant chemotherapy added to chemoradiotherapy significantly improved recurrence-free survival (85.3% vs 76.5%) and overall survival (94.6% vs 90.3%) among locoregionally advanced NPC patients , as compared with chemoradiotherapy alone. Therefore, GP regimen has been established as the highest level of evidence-based neoadjuvant chemotherapy in the 2020 National Comprehensive Cancer Network (NCCN) guidelines. Recently, immune checkpoint inhibitors, such as anti-programmed cell death-1 (PD-1)monoclonal antibody has shown promising efficacy in the treatment of tumor patients. Clinical trials have shown objective response rates of 20.5%-34% in patients with recurrent or metastatic NPC patients receiving anti PD-1 monoclonal antibody immunotherapy including pembrolizumab, nivolumab, camrelizumab, and toripalimab. The current NCCN guidelines recommend anti PD-1 monoclonal antibody as a second-line treatment for recurrent or metastatic NPC. More and more evidence show that immunotherapy combined with chemotherapy has a synergistic effect in treating tumors. GP chemotherapy combined with anti PD-1 antibody has achieved the initial effect in NPC. Phase 1 trials have shown the combination of camrelizumab plus GP chemotherapy in recurrent or metastatic NPC led to a proportion of 91% patients achieving an objective response. Tislelizumab, approved by the National Medical Products Administration in China, is an anti-PD-1 monoclonal IgG4 antibody with higher affinity to PD-1 than pembrolizumab and nivolumab and was engineered to minimize binding to FcγR on macrophages in order to abrogate antibody-dependent phagocytosis, a mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. Multiple clinical trials have shown strong anti-neoplastic activity of tislelizumab in various tumors including NPC. Clinical trial has shown an objective response rates of 43% in patients with recurrent metastatic nasopharyngeal carcinoma treated with tirelizumab, which is superior to other anti PD-1 monoclonal antibodys. So we hypothesize that GP neoadjuvant chemotherapy combined with tislelizumab could further improve survival of patients with locaregionally advanced NPC. Based on this, this study aims to evaluate the efficacy and safety of gemcitabine plus cisplatin chemotherapy combined with tislelizumab neoadjuvant therapy, followed by cisplatin based concurrent chemoradiotherapy in the patients with locoregionally advanced nasopharyngeal carcinoma, to provide new evidence for individualized comprehensive treatment in NPC. conditions module condition list condition Nasopharyngeal Carcinoma design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 63 enrollment type Anticipated arms interventions module arm group list arm group arm group label GP combine with Tislelizumab neoadjuvant therapy+CCRT arm group type Experimental arm group description Patients receive neoadjuvant therapy with gemcitabine(1000mg per square meter on day 1,8) , cisplatin (80mg per square meter on day 1) and tislelizumab(200mg) every three weeks for three cycles before radiotherapy, then followed by concurrent IMRT and cisplatin (100mg per square meter) concurrent every three weeks during radiotherapy (D1,D22,D43 of RT) . arm group intervention list arm group intervention name Drug: GP combine with Tislelizumab neoadjuvant therapy+CCRT intervention list intervention intervention type Drug intervention name GP combine with Tislelizumab neoadjuvant therapy+CCRT intervention description chemotherapy combine with anti-PD-1 targeted immunotherapy+concurrent chemotherapy intervention arm group label list intervention arm group label GP combine with Tislelizumab neoadjuvant therapy+CCRT outcomes module primary outcome list primary outcome primary outcome measure Complete Response primary outcome description CR assessed by independent reviewers, according to the Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the neoadjuvant therapy. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) . primary outcome time frame 9 weeks secondary outcome list secondary outcome secondary outcome measure Pathological Complete Response secondary outcome description Pathological complete response defined as the complete disappearance of the tumor cells in biopsy tissue of nasopharynx after neoadjuvant therapy . secondary outcome time frame 9 weeks secondary outcome measure Overall Survival(OS) secondary outcome description The OS was defined as the duration from the date of registration to the date of death from any cause or censored at the date of the last follow-up. secondary outcome time frame 2 years secondary outcome measure Progress-free survival(PFS) secondary outcome description Progress-free survival is calculated from the date of registration to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up secondary outcome time frame 2 years secondary outcome measure Locoregional failure-free survival(LRRFS) secondary outcome description The LRRFS is evaluated and calculated from the date of registration until the day of first locoregional relapse or until the date of the last follow-up visit. secondary outcome time frame 2 years secondary outcome measure Distant metastasis-free survival(DMFS) secondary outcome description The DMFS is evaluated and calculated from the date of registration until the day of first distant metastases or until the date of the last follow-up visit. secondary outcome time frame 2 years secondary outcome measure Incidence rate of adverse events (AEs) secondary outcome description Analysis of treatment-related AEs (trAEs) and immune-related AEs (irAEs) are evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. secondary outcome time frame 2 years secondary outcome measure PD-L1 expression level of tumor cell secondary outcome time frame 2 years secondary outcome measure tumor-infiltrating lymphocytes (TILs) secondary outcome time frame 2 year eligibility module eligibility criteria Inclusion Criteria:
Voluntary participation with Written informed consent.
Age ≥ 18 years and ≤ 70 years, male or non-pregnant female.
Histologically or cytologically confirmed with Nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III).
Original clinical staged as III-IVa (according to the 8th AJCC edition), Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
White blood cell count (WBC)≥4.0×109 /L, Hemoglobin ≥ 90g/L, Platelet count ≥100×109/L.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN),serum total bilirubin (TBIL) ≤2.0 times the upper limit of normal (ULN) .
Adequate renal function: creatinine clearance rate≥60 ml/min .
Exclusion Criteria:
Patients with recurrent or metastatic nasopharyngeal carcinoma.
Histologically or cytologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.
Prior therapy with Systemic chemotherapy.
Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures.
Seropositivity for human immunodeficiency virus (HIV).
Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
Prior exposure to immune checkpoint inhibitors,including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies.
Patients with immunodeficiency disease or a history of organ transplantation.
Received large doses of glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressants within 4 weeks.
Patients with severe dysfunction of heart, liver, lung, kidney or marrow.
Patients with severe, uncontrolled disease or infections.
Received other research drugs or in other clinical trials at the same time.
Refuse or fail to sign the informed consent .
Patients with other treatment contraindications.
Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.
Hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV deoxyribonucleic acid (HBV DNA) ≥1000cps/ml.
Patients with positive HCV antibody test will only be enrolled in this study if the PCR test for HCV RNA is negative. healthy volunteers No gender All minimum age 18 Years maximum age 70 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Hai qiang Mai central contact role Contact central contact phone 86-20-87343380 central contact e mail maihq@sysucc.org.cn central contact name Lin quan Tang central contact role Contact central contact phone 86-20-87343380 central contact e mail tanglq@sysucc.org.cn overall official list overall official overall official name Su LI, MD overall official affiliation GCP center overall official role Study Chair location list location location facility Sun Yat-sen University Cancer Center location status Recruiting location city Guangzhou location state Guangdong location zip 510060 location country China location contact list location contact location contact name Hai-Qiang Mai, MD location contact role Contact location contact e mail maihq@sysucc.org.cn references module reference list reference reference p m i d 28837405 reference type background reference citation Hsu C, Lee SH, Ejadi S, Even C, Cohen RB, Le Tourneau C, Mehnert JM, Algazi A, van Brummelen EMJ, Saraf S, Thanigaimani P, Cheng JD, Hansen AR. Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1-Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study. J Clin Oncol. 2017 Dec 20;35(36):4050-4056. doi: 10.1200/JCO.2017.73.3675. Epub 2017 Aug 24. reference p m i d 28848660 reference type background reference citation Economopoulou P, Kotsantis I, Psyrri A. The promise of immunotherapy in head and neck squamous cell carcinoma: combinatorial immunotherapy approaches. ESMO Open. 2017 Feb 13;1(6):e000122. doi: 10.1136/esmoopen-2016-000122. eCollection 2016. Review. reference p m i d 32540858 reference type background reference citation Desai J, Deva S, Lee JS, Lin CC, Yen CJ, Chao Y, Keam B, Jameson M, Hou MM, Kang YK, Markman B, Lu CH, Rau KM, Lee KH, Horvath L, Friedlander M, Hill A, Sandhu S, Barlow P, Wu CY, Zhang Y, Liang L, Wu J, Paton V, Millward M. Phase IA/IB study of single-agent tislelizumab, an investigational anti-PD-1 antibody, in solid tumors. J Immunother Cancer. 2020 Jun;8(1). pii: e000453. doi: 10.1136/jitc-2019-000453. reference p m i d 32561638 reference type background reference citation Shen L, Guo J, Zhang Q, Pan H, Yuan Y, Bai Y, Liu T, Zhou Q, Zhao J, Shu Y, Huang X, Wang S, Wang J, Zhou A, Ye D, Sun T, Gao Y, Yang S, Wang Z, Li J, Wu YL. Tislelizumab in Chinese patients with advanced solid tumors: an open-label, non-comparative, phase 1/2 study. J Immunother Cancer. 2020 Jun;8(1). pii: e000437. doi: 10.1136/jitc-2019-000437. Erratum in: J Immunother Cancer. 2020 Jul;8(2):. reference p m i d 27567279 reference type result reference citation Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, Peng P, Wu X, Lin Q, Xi X, Peng J, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Oct 15;388(10054):1883-1892. doi: 10.1016/S0140-6736(16)31388-5. Epub 2016 Aug 23. Erratum In: Lancet. 2016 Oct 15;388(10054):1882. reference p m i d 31150573 reference type result reference citation Zhang Y, Chen L, Hu GQ, Zhang N, Zhu XD, Yang KY, Jin F, Shi M, Chen YP, Hu WH, Cheng ZB, Wang SY, Tian Y, Wang XC, Sun Y, Li JG, Li WF, Li YH, Tang LL, Mao YP, Zhou GQ, Sun R, Liu X, Guo R, Long GX, Liang SQ, Li L, Huang J, Long JH, Zang J, Liu QD, Zou L, Su QF, Zheng BM, Xiao Y, Guo Y, Han F, Mo HY, Lv JW, Du XJ, Xu C, Liu N, Li YQ, Chua MLK, Xie FY, Sun Y, Ma J. Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma. N Engl J Med. 2019 Sep 19;381(12):1124-1135. doi: 10.1056/NEJMoa1905287. Epub 2019 May 31. reference p m i d 25702326 reference type result reference citation Zhang J, Fang W, Qin T, Yang Y, Hong S, Liang W, Ma Y, Zhao H, Huang Y, Xue C, Huang P, Hu Z, Zhao Y, Zhang L. Co-expression of PD-1 and PD-L1 predicts poor outcome in nasopharyngeal carcinoma. Med Oncol. 2015 Mar;32(3):86. doi: 10.1007/s12032-015-0501-6. Epub 2015 Feb 22. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000077274 condition mesh term Nasopharyngeal Carcinoma condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000009303 condition ancestor term Nasopharyngeal Neoplasms condition ancestor id D000010610 condition ancestor term Pharyngeal Neoplasms condition ancestor id D000010039 condition ancestor term Otorhinolaryngologic Neoplasms condition ancestor id D000006258 condition ancestor term Head and Neck Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009302 condition ancestor term Nasopharyngeal Diseases condition ancestor id D000010608 condition ancestor term Pharyngeal Diseases condition ancestor id D000009057 condition ancestor term Stomatognathic Diseases condition ancestor id D000010038 condition ancestor term Otorhinolaryngologic Diseases condition browse leaf list condition browse leaf condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf as found Carcinoma condition browse leaf relevance high condition browse leaf id M1730 condition browse leaf name Nasopharyngeal Carcinoma condition browse leaf as found Nasopharyngeal Carcinoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M11406 condition browse leaf name Nasopharyngeal Neoplasms condition browse leaf relevance low condition browse leaf id M12669 condition browse leaf name Pharyngeal Neoplasms condition browse leaf relevance low condition browse leaf id M12114 condition browse leaf name Otorhinolaryngologic Neoplasms condition browse leaf relevance low condition browse leaf id M8500 condition browse leaf name Head and Neck Neoplasms condition browse leaf relevance low condition browse leaf id M11405 condition browse leaf name Nasopharyngeal Diseases condition browse leaf relevance low condition browse leaf id M12667 condition browse leaf name Pharyngeal Diseases condition browse leaf relevance low condition browse leaf id M11169 condition browse leaf name Stomatognathic Diseases condition browse leaf relevance low condition browse leaf id M12113 condition browse leaf name Otorhinolaryngologic Diseases condition browse leaf relevance low condition browse leaf id T4047 condition browse leaf name Nasopharyngeal Carcinoma condition browse leaf as found Nasopharyngeal Carcinoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC07 condition browse branch name Mouth and Tooth Diseases condition browse branch abbrev BC09 condition browse branch name Ear, Nose, and Throat Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M5334 intervention browse leaf name Cisplatin intervention browse leaf relevance low intervention browse leaf id M113169 intervention browse leaf name Gemcitabine intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents | NCT04833257 | [
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15175,
114,
1144,
1151,
7160,
1126,
3903,
22572,
5521,
20939,
6716,
1179,
1111,
151,
15270,
4420,
1107,
2166,
2527,
119,
1109,
2686,
1104,
15175,
3490,
1114,
19522,
22572,
5521,
6533,
13447,
8420,
11478,
1183,
1107,
1103,
3252,
1104,
25338,
9475,
16680,
2716,
3682,
9468,
7301,
20695,
15023,
2176,
1348,
1610,
16430,
7903,
2799,
1275,
110,
1104,
25338,
9475,
16680,
2716,
3682,
151,
15270,
4420,
1125,
2335,
2593,
1170,
1210,
13874,
1104,
15175,
15242,
3556,
9380,
14194,
22572,
5521,
20939,
117,
1105,
15175,
15242,
3556,
9380,
14194,
22572,
5521,
20939,
1896,
1106,
22572,
5521,
6533,
13447,
8420,
11478,
1183,
5409,
4725,
1231,
10182,
21629,
118,
1714,
8115,
113,
4859,
119,
124,
110,
5016,
5465,
119,
126,
110,
114,
1105,
2905,
8115,
113,
5706,
119,
127,
110,
5016,
3078,
119,
124,
110,
114,
1621,
25338,
9475,
16680,
2716,
3682,
151,
15270,
4420,
117,
1112,
3402,
1114,
22572,
5521,
6533,
13447,
8420,
11478,
1183,
2041,
119,
6589,
117,
15175,
6716,
1179,
1144,
1151,
1628,
1112,
1103,
2439,
1634,
1104,
2554,
118,
1359,
15242,
3556,
9380,
14194,
22572,
5521,
20939,
1107,
1103,
12795,
1305,
25187,
11558,
3998,
113,
14056,
1658,
2249,
114,
13112,
119,
15088,
117,
11650,
4031,
7587,
27558,
1116,
117,
1216,
1112,
2848,
118,
18693,
2765,
1473,
118,
122,
113,
27802,
118,
122,
114,
19863,
13335,
4934,
1348,
2848,
14637,
1144,
2602,
10480,
23891,
1107,
1103,
3252,
1104,
14601,
4420,
119,
15961,
7356,
1138,
2602,
7649,
2593,
5600,
1104,
1406,
119,
126,
110,
118,
3236,
110,
1107,
4420,
1114,
1231,
21754,
1137,
27154,
27372,
151,
15270,
4420,
4172,
2848,
27802,
118,
122,
19863,
13335,
4934,
1348,
2848,
14637,
13280,
13601,
12512,
4679,
11478,
1183,
1259,
185,
5521,
12725,
2646,
10337,
1918,
1830,
117,
11437,
6005,
7776,
6639,
117,
11019,
1306,
9261,
9368,
10161,
1830,
117,
1105,
1106,
16669,
10584,
1918,
1830,
119,
1109,
1954,
14056,
1658,
2249,
13112,
18029,
2848,
27802,
118,
122,
19863,
13335,
4934,
1348,
2848,
14637,
1112,
170,
1248,
118,
1413,
3252,
1111,
1231,
21754,
1137,
27154,
27372,
151,
15270,
119,
3046,
1105,
1167,
2554,
1437,
1115,
13280,
13601,
12512,
4679,
11478,
1183,
3490,
1114,
22572,
5521,
20939,
1144,
170,
188,
10941,
10805,
5562,
2629,
1107,
12770,
24309,
119,
15175,
22572,
5521,
20939,
3490,
1114,
2848,
27802,
118,
122,
2848,
14637,
1144,
3890,
1103,
3288,
2629,
1107,
151,
15270,
119,
12278,
122,
7356,
1138,
2602,
1103,
4612,
1104,
11019,
1306,
9261,
9368,
10161,
1830,
4882,
15175,
22572,
5521,
20939,
1107,
1231,
21754,
1137,
27154,
27372,
151,
15270,
1521,
1106,
170,
10807,
1104,
5539,
110,
4420,
11190,
1126,
7649,
2593,
119,
157,
1548,
1513,
2646,
10337,
1918,
1830,
117,
4092,
1118,
1103,
1305,
3875,
16818,
4918,
1107,
1975,
117,
1110,
1126,
2848,
118,
27802,
118,
122,
19863,
13335,
4934,
1348,
146,
1403,
2349,
1527,
2848,
14637,
1114,
2299,
18859,
1106,
27802,
118,
122,
1190,
185,
5521,
12725,
2646,
10337,
1918,
1830,
1105,
11437,
6005,
7776,
6639,
1105,
1108,
16419,
1106,
20220,
7861,
1106,
143,
1665,
28340,
2069,
1113,
23639,
12736,
19911,
1116,
1107,
1546,
1106,
170,
12725,
4948,
2848,
14637,
118,
7449,
185,
2328,
2758,
3457,
26156,
117,
170,
6978,
1104,
157,
118,
2765,
16443,
1105,
3209,
4789,
1106,
2848,
118,
27802,
118,
122,
7606,
119,
17476,
7300,
7356,
1138,
2602,
2012,
2848,
118,
15242,
1643,
20519,
3246,
1104,
189,
1548,
1513,
2646,
10337,
1918,
1830,
1107,
1672,
24309,
1259,
151,
15270,
119,
15961,
3443,
1144,
2602,
1126,
7649,
2593,
5600,
1104,
3887,
110,
1107,
4420,
1114,
1231,
21754,
27154,
27372,
9468,
7301,
20695,
15023,
2176,
1348,
1610,
16430,
7903,
5165,
1114,
15269,
2646,
10337,
1918,
1830,
117,
1134,
1110,
7298,
1106,
1168,
2848,
27802,
118,
122,
19863,
13335,
4934,
1348,
2848,
14637,
1116,
119,
1573,
1195,
177,
1183,
11439,
16090,
3708,
1115,
15175,
15242,
3556,
9380,
14194,
22572,
5521,
20939,
3490,
1114,
189,
1548,
1513,
2646,
10337,
1918,
1830,
1180,
1748,
4607,
8115,
1104,
4420,
1114,
25338,
23340,
16680,
2716,
3682,
151,
15270,
119,
7457,
1113,
1142,
117,
1142,
2025,
8469,
1106,
17459,
1103,
23891,
1105,
3429,
1104,
176,
5521,
6617,
1777,
16405,
4882,
172,
1548,
1643,
16236,
1394,
22572,
5521,
20939,
3490,
1114,
189,
1548,
1513,
2646,
10337,
1918,
1830,
15242,
3556,
9380,
14194,
7606,
117,
1723,
1118,
172,
1548,
1643,
16236,
1394,
1359,
19522,
22572,
5521,
6533,
13447,
8420,
11478,
1183,
1107,
1103,
4420,
1114,
25338,
9475,
16680,
2716,
3682,
9468,
7301,
20695,
15023,
2176,
1348,
1610,
16430,
7903,
117,
1106,
2194,
1207,
2554,
1111,
2510,
2200,
8232,
3252,
1107,
151,
15270,
119,
2975,
13196,
3879,
2190,
3879,
11896,
7301,
20695,
15023,
2176,
1348,
8185,
16430,
7903,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
12278,
123,
1902,
23992,
1902,
18205,
151,
120,
138,
1902,
9108,
2235,
8353,
1990,
1249,
19638,
1880,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
7330,
113,
3353,
20943,
114,
10803,
23992,
10803,
5099,
5519,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
15175,
12479,
1114,
157,
1548,
1513,
2646,
10337,
1918,
1830,
15242,
3556,
9380,
14194,
7606,
116,
21362,
10460,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
7195,
24767,
3531,
15242,
3556,
9380,
14194,
7606,
1114,
176,
5521,
6617,
1777,
16405,
113,
6087,
1306,
1403,
1679,
1961,
8227,
1113,
1285,
122,
117,
129,
114,
117,
172,
1548,
1643,
16236,
1394,
113,
2908,
1306,
1403,
1679,
1961,
8227,
1113,
1285,
122,
114,
1105,
189,
1548,
1513,
2646,
10337,
1918,
1830,
113,
2363,
1306,
1403,
114,
1451,
1210,
2277,
1111,
1210,
13874,
1196,
2070,
8420,
11478,
1183,
117,
1173,
1723,
1118,
19522,
146,
21148,
1942,
1105,
172,
1548,
1643,
16236,
1394,
113,
1620,
1306,
1403,
1679,
1961,
8227,
114,
19522,
1451,
1210,
2277,
1219,
2070,
8420,
11478,
1183,
113,
141,
1475,
117,
141,
20581,
117,
141,
25631,
1104,
155,
1942,
114,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
15175,
12479,
1114,
157,
1548,
1513,
2646,
10337,
1918,
1830,
15242,
3556,
9380,
14194,
7606,
116,
21362,
10460,
9108,
2190,
9108,
9108,
2076,
13982,
9108,
1271,
15175,
12479,
1114,
157,
1548,
1513,
2646,
10337,
1918,
1830,
15242,
3556,
9380,
14194,
7606,
116,
21362,
10460,
9108,
6136,
22572,
5521,
20939,
12479,
1114,
2848,
118,
27802,
118,
122,
9271,
13280,
13601,
12512,
4679,
11478,
1183,
116,
19522,
22572,
5521,
20939,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
15175,
12479,
1114,
157,
1548,
1513,
2646,
10337,
1918,
1830,
15242,
3556,
9380,
14194,
7606,
116,
21362,
10460,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
12735,
24187,
2425,
9386,
6136,
15531,
14758,
1118,
2457,
19475,
117,
2452,
1106,
1103,
24187,
27845,
140,
10587,
3464,
1107,
20375,
17037,
26271,
1116,
113,
155,
8231,
6258,
1942,
114,
1121,
1103,
1305,
11558,
2024,
113,
14056,
2240,
114,
119,
20012,
2593,
17428,
1170,
1103,
6026,
1104,
1103,
15242,
3556,
9380,
14194,
7606,
119,
12735,
2593,
3393,
1112,
1103,
2335,
14158,
1104,
1103,
4010,
1105,
1664,
118,
4010,
8241,
1988,
113,
188,
114,
3626,
1120,
2259,
2568,
1170,
2070,
7810,
10540,
1118,
7085,
19975,
11336,
2142,
3923,
146,
26772,
113,
25827,
2240,
114,
119,
2425,
9386,
1159,
4207,
130,
2277,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
17392,
7542,
12735,
24187,
3718,
9386,
6136,
17392,
7542,
2335,
2593,
3393,
1112,
1103,
2335,
14158,
1104,
1103,
14601,
3652,
1107,
25128,
12685,
7918,
1104,
9468,
7301,
20695,
15023,
1775,
1170,
15242,
3556,
9380,
14194,
7606,
119,
3718,
9386,
1159,
4207,
130,
2277,
3718,
9386,
4929,
8007,
26849,
113,
11570,
114,
3718,
9386,
6136,
1109,
11570,
1108,
3393,
1112,
1103,
9355,
1121,
1103,
2236,
1104,
9630,
1106,
1103,
2236,
1104,
1473,
1121,
1251,
2612,
1137,
172,
5026,
13841,
1120,
1103,
2236,
1104,
1103,
1314,
2812,
118,
1146,
119,
3718,
9386,
1159,
4207,
123,
1201,
3718,
9386,
4929,
12798,
118,
1714,
8115,
113,
153,
17691,
114,
3718,
9386,
6136,
12798,
118,
1714,
8115,
1110,
10056,
1121,
1103,
2236,
1104,
9630,
1106,
1103,
2236,
1104,
1103,
1148,
5070,
1120,
1251,
1751,
1137,
1473,
1121,
1251,
2612,
1137,
172,
5026,
13841,
1120,
1103,
2236,
1104,
1103,
1314,
2812,
118,
1146,
3718,
9386,
1159,
4207,
123,
1201,
3718,
9386,
4929,
10605,
9475,
16680,
1348,
4290,
118,
1714,
8115,
113,
149,
2069,
2069,
17691,
114,
3718,
9386,
6136,
1109,
149,
2069,
2069,
17691,
1110,
17428,
1105,
10056,
1121,
1103,
2236,
1104,
9630,
1235,
1103,
1285,
1104,
1148,
25338,
9475,
16680,
1348,
1231,
16046,
2217,
1137,
1235,
1103,
2236,
1104,
1103,
1314,
2812,
118,
1146,
3143,
119,
3718,
9386,
1159,
4207,
123,
1201,
3718,
9386,
4929,
12120,
16566,
27154,
8419,
4863,
118,
1714,
8115,
113,
141,
18586,
1708,
114,
3718,
9386,
6136,
1109,
141,
18586,
1708,
1110,
17428,
1105,
10056,
1121,
1103,
2236,
1104,
9630,
1235,
1103,
1285,
1104,
1148,
6531,
27154,
8419,
8830,
1137,
1235,
1103,
2236,
1104,
1103,
1314,
2812,
118,
1146,
3143,
119,
3718,
9386,
1159,
4207,
123,
1201,
3718,
9386,
4929,
3561,
26859,
2093,
2603,
1104,
16798,
1958,
113,
138,
27485,
114,
3718,
9386,
6136,
12504,
1104,
3252,
118,
2272,
138,
27485,
113,
189,
1197,
1592,
27485,
114,
1105,
11650,
118,
2272,
138,
27485,
113,
178,
1197,
1592,
27485,
114,
1132,
17428,
1113,
3142,
1104,
6869,
12008,
9019,
4559,
6360,
140,
10587,
3464,
1111,
24930,
10840,
17437,
113,
16899,
11356,
2036,
114,
126,
119,
121,
9173,
119,
3718,
9386,
1159,
4207,
123,
1201,
3718,
9386,
4929,
27802,
118,
149,
1475,
2838,
1634,
1104,
14601,
2765,
3718,
9386,
1159,
4207,
123,
1201,
3718,
9386,
4929,
14601,
118,
1107,
8702,
6066,
7969,
181,
25698,
26431,
113,
157,
17656,
1116,
114,
3718,
9386,
1159,
4207,
123,
1214,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
5713,
19529,
1616,
6251,
1114,
13404,
6189,
9635,
119,
4936,
864,
1407,
1201,
1105,
863,
3102,
1201,
117,
2581,
1137,
1664,
118,
6391,
2130,
119,
1230,
2430,
7810,
1193,
1137,
172,
25669,
7542,
1193,
3659,
1114,
7922,
4188,
11745,
2605,
6185,
1610,
16430,
7903,
1104,
1103,
9468,
7301,
20695,
15023,
1775,
113,
27840,
1137,
5576,
11093,
9014,
14964,
2913,
2076,
117,
23750,
1563,
1137,
2684,
114,
119,
7267,
7300,
9645,
1112,
2684,
118,
4191,
1161,
113,
2452,
1106,
1103,
5192,
22078,
12096,
2596,
114,
117,
2882,
22892,
1212,
12241,
1990,
113,
16028,
2346,
2349,
114,
2099,
2781,
113,
12727,
114,
121,
1137,
122,
119,
2061,
1892,
2765,
5099,
113,
160,
9428,
114,
864,
1527,
119,
121,
28193,
10424,
1580,
120,
149,
117,
1124,
3702,
1403,
2858,
7939,
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3078,
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full study rank 61651 study protocol section identification module n c t id NCT04833699 org study id info org study id MUGLA-3 organization org full name Erzincan Military Hospital org class OTHER brief title The Effect of Hot Pack Application on Postoperative Ileus Undergoing Surgery for Gynecologic Malignancies official title The Effect of Hot Pack Application of Umbilical Region on Postoperative Ileus in Patients Undergoing Surgery for Gynecologic Malignancies: a Randomized Controlled Trial status module status verified date October 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 5, 2021 start date type Actual primary completion date struct primary completion date December 30, 2022 primary completion date type Anticipated completion date struct completion date March 30, 2023 completion date type Anticipated study first submit date March 27, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date October 2, 2022 last update post date struct last update post date October 4, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Kemal GUNGORDUK responsible party investigator title KG responsible party investigator affiliation Muğla Sıtkı Koçman University lead sponsor lead sponsor name Erzincan Military Hospital lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Postoperative ileus (POI), is an extensively known complication characterized by an impairment of normal gastrointestinal motor activity after abdominal surgery and may also occur after surgery at other sites due to non-mechanical causes. [1]. This clinical asset has been linked to prominent perioperative morbidity with the following financial burden owing to extended hospitalization [1]. Furthermore, POI can postpone adjuvant treatments, such as chemotherapy in patients who went through surgery for cancers.
Abdominal tenderness and distension, nausea and vomiting, delay in the passage of flatus and stool, and intolerance to solid food are the prime symptoms of POI [1-3]. It is generally transient, but if prolonged, can cause surgical incision dehiscence, intestinal anastomotic fistula, abdominal cavity infection, intestinal ischemia, aspiration pneumonia, and other serious complications [4-6]. Hence, many clinicians have focused on averting POI. Many studies have analyzed preventive methods, such as preoperative mobilization of the patient, adequate pain control, gum chewing, epidural anesthesia, coffee consumption, and motility agents such as metoclopramide and alvimopan [7-15]. For all the manifold remedy approaches, POI maintains a difficult clinical challenge that compromises the rapid improvement of patients who underwent abdominal surgery.
Recently, thermal attempts have been employs for several situations such as inflammatory bowel disease, chronic pelvic pain, and abdominal pain [16]. It may be used in two different ways; whole body or local. Local thermal therapy can be carried out by hot pack or paraffin [17]. It has been demonstrated that local thermotherapy abate myotonia, enhances circulation, and eases pain by expediting the removal of the pain-producing substance. Local thermal therapy is widely used for a number of conditions such as pain, nausea, vomiting, and some bowel diseases in traditional Chinese medicine [18].
Only one study has shown that hot pack therapy at the postoperative period has a positive effect on bowel motility. However, this study has a lot of weaknesses. Moreover, until now, no study has specifically investigated the effect of the hot pack on gynecological oncology surgery. The investigators hypothesized that using a hot pack during the early postoperative period would accelerate the return of gastrointestinal motility. Therefore, investigators performed a randomized controlled trial (RCT) to assess whether using hot pack whips up the recovery of gut function after gynecological oncology surgery conditions module condition list condition Postoperative Ileus design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Prevention design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 130 enrollment type Anticipated arms interventions module arm group list arm group arm group label Control arm group type No Intervention arm group description Group A served as the control group who did not receive any intervention except our clinical standard postoperative care arm group label Study arm group type Experimental arm group description Group B served as the hot pack group that warm water (80 C) was put in a hot pack (Fig 1) and then placed on the patients umbilicus at 6, 12, and 18 h after the operation for 45 minutes in addition to clinical standard postoperative care. arm group intervention list arm group intervention name Other: rubber water bag intervention list intervention intervention type Other intervention name rubber water bag intervention description hot pack group that 1200 cc warm water (50-550 c) was put in a rubber water bag (Fig 1) and then covered with a cloth and placed on the patients umbilicus at 6, 12, and 18 h after the operation for 30 minutes in addition to clinical standard postoperative care. intervention arm group label list intervention arm group label Study outcomes module primary outcome list primary outcome primary outcome measure time to the first passage of flatus after surgery primary outcome description Patients were checked hourly for bowel sounds by auscultation and were asked to note the time of first flatus and defecation and to inform the clinical nurses or an assistant. primary outcome time frame up to 72 hours secondary outcome list secondary outcome secondary outcome measure The time to tolerate a solid diet secondary outcome description The time to tolerate a solid diet was measured from the end of operation, referred to the time when the patient awoke from anesthesia, until the patient tolerated intake of solid food (any food that required chewing) without vomiting secondary outcome time frame Up to 7 days secondary outcome measure The time to the first bowel movement secondary outcome description The time to the first bowel movement was referred to the time to the first audible bowel sound during routine postoperative care. Patients were checked hourly for bowel sounds by auscultation and were asked to note the time of first flatus and defecation and to inform the clinical nurses or an assistant. secondary outcome time frame up to 72 hours eligibility module eligibility criteria Inclusion Criteria:
patiens aith aged ≥18 years olds
patients undergoing elective exhaustive staging surgery (total hysterectomy (Type A-C2), systematic pelvic para-aortic lymphadenectomy ± bilateral salpingo-oophorectomy and ± omentectomy by abdominal approach containing either open or laparoscopic surgery.
Exclusion Criteria:
ASA score >3,
chronic constipation (defined as ≤2 bowel movements per week),
inflammatory bowel disease,
irritable bowel syndrome,
compromised liver function,
clinically significant cardiac arrhythmia,
a thyroid disorder,
a history of abdominal bowel surgery,
previous abdominal irradiation,
previous neoadjuvant chemotherapy or hyperthermic intraperitoneal chemotherapy,
the use of an upper abdominal multi-visceral surgical approach for debulking surgery
The covid-19 positive test result,
early post-operative complications in the first week after surgery (re-laparotomy, massive blood transfusion),
a need for intensive care for >24 hours post-operatively,
bowel anastomosis. healthy volunteers No gender Female minimum age 18 Years maximum age 90 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Kemal Güngördük, MD central contact role Contact central contact phone 05057465266 central contact e mail drkemalgungorduk@gmail.com location list location location facility Mugla Sıtkı Kocman University Education and Research Hospital location status Recruiting location city Mugla location zip 48000 location country Turkey location contact list location contact location contact name Mugla Sıtkı Kocman University Education and R Hospital location contact role Contact location contact phone +905054921766 location contact e mail drkemalgungorduk@gmail.com i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000045823 condition mesh term Ileus condition ancestor list condition ancestor condition ancestor id D000007415 condition ancestor term Intestinal Obstruction condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition browse leaf list condition browse leaf condition browse leaf id M24738 condition browse leaf name Ileus condition browse leaf as found Ileus condition browse leaf relevance high condition browse leaf id M9601 condition browse leaf name Intestinal Obstruction condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions | NCT04833699 | [
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24767,
2831,
25251,
17910,
1111,
144,
10941,
2528,
13791,
1596,
17168,
12149,
9885,
131,
170,
19441,
2200,
6342,
2433,
12819,
2781,
13196,
2781,
22480,
2236,
1357,
17881,
1477,
2905,
2781,
11336,
1665,
27975,
1158,
3631,
2469,
23992,
1144,
3631,
2469,
1302,
1838,
2236,
188,
23055,
1838,
2236,
1364,
126,
117,
17881,
1475,
1838,
2236,
2076,
2173,
4746,
2425,
6026,
2236,
188,
23055,
2425,
6026,
2236,
1382,
1476,
117,
17881,
1477,
2425,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
6026,
2236,
188,
23055,
6026,
2236,
1345,
1476,
117,
17881,
1495,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
2025,
1148,
12295,
2236,
1345,
1765,
117,
17881,
1475,
2025,
1148,
12295,
186,
172,
2236,
1364,
123,
117,
17881,
1475,
2025,
1148,
2112,
2236,
188,
23055,
2025,
1148,
2112,
2236,
1364,
127,
117,
17881,
1475,
2025,
1148,
2112,
2236,
2076,
2173,
4746,
1314,
11984,
12295,
2236,
1357,
123,
117,
17881,
1477,
1314,
11984,
2112,
2236,
188,
23055,
1314,
11984,
2112,
2236,
1357,
125,
117,
17881,
1477,
1314,
11984,
2112,
2236,
2076,
2173,
4746,
10767,
24146,
13196,
2784,
1710,
2784,
1710,
2076,
8013,
1130,
5710,
3121,
25524,
1766,
2784,
1710,
17805,
1554,
1271,
26835,
7435,
144,
27370,
2349,
9565,
2137,
2591,
2428,
2784,
1710,
17805,
1641,
148,
2349,
2784,
1710,
17805,
13494,
19569,
28223,
1742,
156,
12262,
1204,
1377,
12262,
19892,
28201,
1399,
1239,
1730,
10767,
1730,
10767,
1271,
142,
11819,
1394,
7804,
4012,
3355,
1730,
10767,
1705,
152,
24162,
9637,
20051,
13196,
1110,
175,
173,
170,
12521,
3850,
1302,
1110,
175,
173,
170,
12521,
4442,
1302,
6136,
13196,
4094,
14940,
3799,
19807,
5838,
14596,
12963,
113,
153,
2346,
2240,
114,
117,
1110,
1126,
7620,
1227,
3254,
15534,
6858,
1118,
1126,
24034,
8341,
1880,
1104,
2999,
3245,
8005,
10879,
2556,
14196,
5968,
3246,
1170,
24716,
6059,
1105,
1336,
1145,
4467,
1170,
6059,
1120,
1168,
3911,
1496,
1106,
1664,
118,
6676,
4680,
119,
164,
122,
166,
119,
1188,
7300,
13274,
1144,
1151,
5128,
1106,
3289,
1679,
2660,
3365,
5838,
182,
1766,
14598,
1785,
1114,
1103,
1378,
2798,
11904,
13412,
1106,
2925,
2704,
2734,
164,
122,
166,
119,
7282,
117,
153,
2346,
2240,
1169,
2112,
5674,
1673,
8050,
9380,
14194,
14115,
117,
1216,
1112,
22572,
5521,
20939,
1107,
4420,
1150,
1355,
1194,
6059,
1111,
4182,
1116,
119,
22358,
18882,
7050,
8886,
1757,
1105,
4267,
15874,
8427,
117,
22882,
1105,
26979,
1158,
117,
8513,
1107,
1103,
5885,
1104,
3596,
1361,
1105,
15631,
117,
1105,
1154,
2879,
3923,
1106,
4600,
2094,
1132,
1103,
5748,
8006,
1104,
153,
2346,
2240,
164,
122,
118,
124,
166,
119,
1135,
1110,
2412,
14715,
9080,
117,
1133,
1191,
16639,
117,
1169,
2612,
13467,
1107,
16073,
1260,
27516,
14797,
117,
1107,
13053,
14196,
1126,
12788,
18445,
2941,
7374,
5886,
117,
24716,
19421,
8974,
117,
1107,
13053,
14196,
1110,
4386,
8191,
117,
1112,
22631,
20673,
117,
1105,
1168,
3021,
13522,
164,
125,
118,
127,
166,
119,
13615,
117,
1242,
12257,
5895,
1138,
3378,
1113,
170,
12986,
1158,
153,
2346,
2240,
119,
2408,
2527,
1138,
17689,
3843,
2109,
4069,
117,
1216,
1112,
3073,
19807,
5838,
13221,
15100,
1104,
1103,
5351,
117,
12373,
2489,
1654,
117,
19956,
19791,
117,
174,
25786,
12602,
1126,
2556,
27300,
117,
3538,
8160,
117,
1105,
182,
3329,
13378,
5789,
1216,
1112,
1899,
13335,
13200,
4515,
3269,
1105,
2393,
5086,
3702,
10224,
164,
128,
118,
1405,
166,
119,
1370,
1155,
1103,
22502,
23615,
8015,
117,
153,
2346,
2240,
9032,
170,
2846,
7300,
4506,
1115,
13018,
1116,
1103,
6099,
8331,
1104,
4420,
1150,
9315,
24716,
6059,
119,
15088,
117,
10735,
4021,
1138,
1151,
13856,
1111,
1317,
7832,
1216,
1112,
22653,
7125,
1883,
3653,
117,
13306,
185,
1883,
15901,
2489,
117,
1105,
24716,
2489,
164,
1479,
166,
119,
1135,
1336,
1129,
1215,
1107,
1160,
1472,
3242,
132,
2006,
1404,
1137,
1469,
119,
5328,
10735,
7606,
1169,
1129,
2446,
1149,
1118,
2633,
5246,
1137,
18311,
16274,
164,
1542,
166,
119,
1135,
1144,
1151,
7160,
1115,
1469,
1103,
9019,
20939,
170,
13859,
1139,
12355,
5813,
117,
11778,
1116,
9097,
117,
1105,
7166,
1116,
2489,
1118,
4252,
3537,
21412,
1103,
8116,
1104,
1103,
2489,
118,
4411,
9556,
119,
5328,
10735,
7606,
1110,
3409,
1215,
1111,
170,
1295,
1104,
2975,
1216,
1112,
2489,
117,
22882,
117,
26979,
1158,
117,
1105,
1199,
7125,
1883,
8131,
1107,
2361,
1922,
5182,
164,
1407,
166,
119,
2809,
1141,
2025,
1144,
2602,
1115,
2633,
5246,
7606,
1120,
1103,
2112,
19807,
5838,
1669,
1144,
170,
3112,
2629,
1113,
7125,
1883,
182,
3329,
13378,
119,
1438,
117,
1142,
2025,
1144,
170,
1974,
1104,
24417,
119,
9841,
117,
1235,
1208,
117,
1185,
2025,
1144,
4418,
10788,
1103,
2629,
1104,
1103,
2633,
5246,
1113,
176,
10941,
23388,
1113,
12241,
6059,
119,
1109,
17718,
177,
1183,
11439,
16090,
2200,
1115,
1606,
170,
2633,
5246,
1219,
1103,
1346,
2112,
19807,
5838,
1669,
1156,
26872,
1103,
1862,
1104,
3245,
8005,
10879,
2556,
14196,
182,
3329,
13378,
119,
6589,
117,
17718,
1982,
170,
7091,
2200,
4013,
3443,
113,
25157,
1942,
114,
1106,
15187,
2480,
1606,
2633,
5246,
15005,
1116,
1146,
1103,
7593,
1104,
9691,
3053,
1170,
176,
10941,
23388,
1113,
12241,
6059,
2975,
13196,
3879,
2190,
3879,
3799,
19807,
5838,
9190,
12963,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
18461,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8353,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
3929,
19191,
1116,
1249,
8830,
21484,
10803,
23992,
10803,
5099,
7029,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
6342,
1981,
1372,
2076,
1302,
11300,
21987,
1981,
1372,
6136,
1990,
138,
1462,
1112,
1103,
1654,
1372,
1150,
1225,
1136,
3531,
1251,
9108,
2589,
1412,
7300,
2530,
2112,
19807,
5838,
1920,
1981,
1372,
3107,
8690,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1990,
139,
1462,
1112,
1103,
2633,
5246,
1372,
1115,
3258,
1447,
113,
2908,
140,
114,
1108,
1508,
1107,
170,
2633,
5246,
113,
17355,
1403,
122,
114,
1105,
1173,
1973,
1113,
1103,
4420,
15276,
15197,
14191,
1120,
127,
117,
1367,
117,
1105,
1407,
177,
1170,
1103,
2805,
1111,
2532,
1904,
1107,
1901,
1106,
7300,
2530,
2112,
19807,
5838,
1920,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
9579,
1447,
3821,
9108,
2190,
9108,
9108,
2076,
2189,
9108,
1271,
9579,
1447,
3821,
9108,
6136,
2633,
5246,
1372,
1115,
15508,
14402,
3258,
1447,
113,
1851,
118,
13592,
172,
114,
1108,
1508,
1107,
170,
9579,
1447,
3821,
113,
17355,
1403,
122,
114,
1105,
1173,
2262,
1114,
170,
8217,
1105,
1973,
1113,
1103,
4420,
15276,
15197,
14191,
1120,
127,
117,
1367,
117,
1105,
1407,
177,
1170,
1103,
2805,
1111,
1476,
1904,
1107,
1901,
1106,
7300,
2530,
2112,
19807,
5838,
1920,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
8690,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
1159,
1106,
1103,
1148,
5885,
1104,
3596,
1361,
1170,
6059,
2425,
9386,
6136,
7195,
24767,
1127,
6488,
24308,
1111,
7125,
1883,
3807,
1118,
12686,
1116,
10182,
23934,
2116,
1105,
1127,
1455,
1106,
3805,
1103,
1159,
1104,
1148,
3596,
1361,
1105,
19353,
25534,
2116,
1105,
1106,
12862,
1103,
7300,
13318,
1137,
1126,
3109,
119,
2425,
9386,
1159,
4207,
1146,
1106,
5117,
2005,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
1109,
1159,
1106,
21073,
170,
4600,
10211,
3718,
9386,
6136,
1109,
1159,
1106,
21073,
170,
4600,
10211,
1108,
7140,
1121,
1103,
1322,
1104,
2805,
117,
2752,
1106,
1103,
1159,
1165,
1103,
5351,
21167,
1121,
1126,
2556,
27300,
117,
1235,
1103,
5351,
21073,
1181,
14741,
1104,
4600,
2094,
113,
1251,
2094,
1115,
2320,
19791,
114,
1443,
26979,
1158,
3718,
9386,
1159,
4207,
3725,
1106,
128,
1552,
3718,
9386,
4929,
1109,
1159,
1106,
1103,
1148,
7125,
1883,
2230,
3718,
9386,
6136,
1109,
1159,
1106,
1103,
1148,
7125,
1883,
2230,
1108,
2752,
1106,
1103,
1159,
1106,
1103,
1148,
22395,
7125,
1883,
1839,
1219,
9285,
2112,
19807,
5838,
1920,
119,
7195,
24767,
1127,
6488,
24308,
1111,
7125,
1883,
3807,
1118,
12686,
1116,
10182,
23934,
2116,
1105,
1127,
1455,
1106,
3805,
1103,
1159,
1104,
1148,
3596,
1361,
1105,
19353,
25534,
2116,
1105,
1106,
12862,
1103,
7300,
13318,
1137,
1126,
3109,
119,
3718,
9386,
1159,
4207,
1146,
1106,
5117,
2005,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
26227,
23461,
170,
7088,
4079,
864,
15292,
1201,
25343,
4420,
15819,
11797,
2109,
16287,
2109,
16772,
6059,
113,
1703,
177,
21878,
10294,
18778,
1183,
113,
6902,
138,
118,
140,
1477,
114,
117,
12818,
185,
1883,
15901,
18311,
118,
170,
12148,
1596,
181,
25698,
6397,
21032,
18574,
212,
20557,
21718,
1233,
2624,
1186,
118,
184,
4184,
18443,
5822,
18574,
1105,
212,
184,
1880,
10294,
18778,
1183,
1118,
24716,
3136,
4051,
1719,
1501,
1137,
4443,
14452,
21442,
6059,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
15278,
1592,
2794,
135,
124,
117,
13306,
14255,
2050,
9717,
1891,
113,
3393,
1112,
863,
1477,
7125,
1883,
5172,
1679,
1989,
114,
117,
22653,
7125,
1883,
3653,
117,
178,
14791,
8637,
7125,
1883,
9318,
117,
22485,
11911,
3053,
117,
7300,
1193,
2418,
17688,
170,
11096,
7889,
1582,
8191,
117,
170,
21153,
16219,
8936,
117,
170,
1607,
1104,
24716,
7125,
1883,
6059,
117,
2166,
24716,
178,
10582,
25971,
117,
2166,
15242,
3556,
9380,
14194,
22572,
5521,
20939,
1137,
177,
24312,
8420,
7257,
1107,
4487,
3365,
8383,
25362,
1233,
22572,
5521,
20939,
117,
1103,
1329,
1104,
1126,
3105,
24716,
4321,
118,
191,
1548,
14840,
1348,
13467,
3136,
1111,
1260,
27515,
4419,
6059,
1109,
1884,
18312,
118,
1627,
3112,
2774,
1871,
117,
1346,
2112,
118,
13035,
13522,
1107,
1103,
1148,
1989,
1170,
6059,
113,
1231,
118,
4443,
14452,
18778,
1183,
117,
4672,
1892,
14715,
17149,
114,
117,
170,
1444,
1111,
12885,
1920,
1111,
135,
1572,
2005,
2112,
118,
13035,
1193,
117,
7125,
1883,
1126,
12788,
18445,
4863,
119,
8071,
8118,
1302,
5772,
9714,
5867,
1425,
1407,
5848,
4177,
1425,
3078,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2129,
3232,
2190,
2129,
3232,
2129,
3232,
1271,
26835,
7435,
144,
17176,
2118,
19593,
2956,
17176,
1377,
117,
9292,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
4991,
1568,
1571,
1559,
23435,
1571,
25129,
1545,
2129,
3232,
174,
6346,
173,
4661,
14494,
1233,
11652,
18791,
7641,
1377,
137,
176,
14746,
119,
3254,
2450,
2190,
2450,
2450,
3695,
19569,
1403,
1742,
156,
12262,
1204,
1377,
12262,
19892,
1665,
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full study rank 61747 study protocol section identification module n c t id NCT04832451 org study id info org study id 56786525-050.04.04-6988 organization org full name Ankara University org class OTHER brief title Effects of Interpersonal Relational Role Analysis official title Effects of Interpersonal Relational Role Analysis on Nursing Students' Depressive Symptoms and Coping Styles status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date November 6, 2018 start date type Actual primary completion date struct primary completion date January 24, 2019 primary completion date type Actual completion date struct completion date April 24, 2019 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 1, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Yasemin Cekic responsible party investigator title Research Assistant Dr. responsible party investigator affiliation Ankara University lead sponsor lead sponsor name Ankara University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Introduction: Interpersonal Relational Role Analysis (IRRA) is a psychosocial group intervention that allows individuals to see the problems they experience in interpersonal relationships and interactions in the group environment and to be handled together with group members.
Aim: The present study aims to investigate the effects of IRRA on nursing students' depressive symptoms and coping styles.
Method: This study was conducted with randomized controlled, pre-test-post-test control group design and follow-up test patterns. Students with depressive symptoms were randomly assigned to control (n=10) or intervention groups (n=10). Intervention group students received 21 weeks of IRRA intervention.
Results: It was determined that IRRA had a positive effect on nursing students' depressive symptoms and coping styles.
Discussion: This study is the first to evaluate the effects of IRRA on depressive symptoms and coping styles. Our study provides evidence on the effectiveness of IRRA in reducing the depressive symptoms of nursing students and in managing stress.
Implications for Practice: IRRA is a practical and useful intervention that mental health nurses can incorporate and use in their clinical practice while helping individuals to become aware of problems in relationships and roles that may impair their mental health. detailed description Aim and Design Aiming to investigate the effects of Interpersonal Relational Role Analysis (IRRA) on nursing students' depressive symptoms and coping styles, this study was conducted with randomized controlled, pre-test-post-test control group design and follow-up test patterns.
Research population and sample The study was conducted in the 2018-2019 academic year (November 2018 - April 2019). The research population comprised second-year nursing students studying at two different state universities in the 2018-2019 academic year (n=385). Since the researcher had an instructional relationship with the first-, third-, and fourth-year students, the study was performed with the second-year students. The number of people to be included in the groups was calculated in the G*Power (3.1.9.2) package program based on a research. As a result of the power analysis with an effect size of 0.7, a power of 80%, and an alpha level (probability of making a type I error) of 0.05, the sample size was calculated as a total of 16 students (8 in the intervention and 8 in the control group). Considering the possibility of drop-outs during the study, the research was conducted with a total of 20 students (10 in the intervention and 10 in the control group). Effective implementation of IRRA requires interaction among the group members; therefore, the intervention group was composed of students studying in the same class. To prevent interaction between the control group and the intervention group, the control group was composed of students studying at a different state university in the same city with the same education program. The students who met the inclusion criteria and agreed to participate in the study were assigned to the intervention and control groups with the Research Randomizer program. Randomization was performed by a researcher who was not included in the research. To make the study a single-blind study, students were not informed about the group to which they were assigned.
Inclusion/exclusion criteria Inclusion criteria were as follows: (a) being a nursing student at the university during the research (November 2018-April 2019), (b) not having any disability that would cause difficulties in filling in the data collection tools or during sessions, (c) scoring scores indicating mild to moderate depression from the Beck Depression Inventory, (d) agreeing to participate in the research, and (e) being over 18 years old. Exclusion criteria were as follows: (a) scoring scores indicating severe depression from the Beck Depression Inventory (severe depression requires psychopharmacological treatment).
Data Collection Tools Sociodemographic Characteristics Form This form, developed by the researchers, contains questions about students' sociodemographic characteristics such as age, gender, marital status, economic status, and parental educational status.
Beck Depression Inventory (BDI) The inventory consists of 21 self-report items that allow evaluating the severity of depressive symptoms rather than the diagnosis of depression. The total score obtained from the scale is evaluated, each item is scored between 0 and 3, and there are no reverse-scored items on the scale. 0-9 points indicate probably no depression, 10-16 points mild depression levels, 17-24 points moderate depression levels, and 25 and above points severe depression. The above-mentioned classification was used in this study. Cronbach's alpha reliability coefficient of the scale was calculated as 0.74.
Coping Styles Inventory (CSI) The scale has 30 items and five sub-dimensions rated on a four-point Likert-type scale. To calculate the score from the "seeking social support" sub-dimension, the first and ninth items are reversely scored. The scores of the sub-dimensions are calculated by dividing the total scores obtained from the items by the total number of items. High scores from the self-confident approach, optimistic approach, and seeking social support sub-dimensions indicate that effective methods are used to cope with stress whereas high scores from the helpless approach and submissive approach sub-dimensions indicate that ineffective methods are used to cope with stress. Cronbach's alpha reliability coefficient was calculated as 0.69 for the self-confident approach sub-dimension, 0.63 for the optimistic approach sub-dimension, 0.72 for the seeking social support sub-dimension, 0.67 for the helpless approach sub-dimension, and 0.68 for the submissive approach sub-dimension.
Implementation First, the BDI (inclusion criteria) was applied face to face to the students who constituted the population (n=385) (06-08 November 2018). After the BDI scores were evaluated, the students who met the inclusion criteria were randomly assigned to the intervention and control groups.
In a preliminary interview held with the 10 students in the intervention group, they were informed in a confidential manner about the subject of the research, the duration and content of the implementation process, what was expected from the participants, session rules, the place where the sessions would be held, and that sessions would be audio-recorded. Also, informed consent forms were obtained from them, and pre-tests (BDI, CSI) were applied (14 November 2018). Likewise, the students in the control group were informed about the research, informed consents were obtained from them, and pre-tests were applied to them (15 November 2018).
A total of 21 90-minute IRRA sessions (two sessions a week) were held with the 10 students in the intervention group between 16.11.2018 and 20.01.2019. The sessions were chaired by a group administrator (the researcher) and two observers (faculty members in the field of mental health nursing). The group administrator received IRRA training from faculty members who developed the IRRA model. Before the sessions, warm-up exercises were performed in order to develop a sense of trust and to increase rapport and interaction among the members. In the first session, an "acquaintance activity" was held, and the session rules, about which the participants were informed in the preliminary interview, were again presented for everyone's approval. In the following sessions, after the warm-up exercises, an agenda-setting round (a process devoted to setting the agenda) was carried out with the participation of each member. At this stage, each member was asked whether they experienced an important event they wanted to share with other members, and then each member summarized which IRRA step they were in and determined on which step they would work throughout that day's session. After this stage, the members who wanted to work in the group in that day's session worked on the IRRA steps. In each session, 45-50 minutes were allocated to examining the IRRA steps. During this time, participants were given opportunities to express themselves, and the IRRA steps of 2-3 members were discussed in each session, depending on the progress of the group members. Due to individual differences, some members made rapid progress through the IRRA steps, while it took others longer to complete the steps. At the end of each session, a 15-20 minute evaluation round was held with the participation of the observers. During the evaluation, the group administrator summarized what was discussed in the session. Participants were asked how they felt during the session, their negative feelings were studied, and it was ensured that no members left the session with negative feelings. The group administrator and observers gave empathic and positive feedback to each member due to their efforts to improve and change themselves. Similarities between the experiences and feelings of the participants were emphasized. The members thanked each other for confiding in each other. In the last session, a "separation activity" was held, where the members shared the positive aspects they discovered about each other, as well as their feelings and thoughts about the ending of the group.
While 21 sessions of IRRA were applied to the intervention group, no intervention was applied to the control group. Once the IRRA sessions were completed, post-tests (BDI, CSI) were applied to the intervention and control groups (January 21-24, 2019). Three months later (April 2019), a follow-up test (BDI, CSI) was applied to both groups. After the follow-up test, the participants in the control group were referred to the psychological support unit of the university.
Data Analysis Data were analysed using the Statistical Package for Social Sciences 22.0. In the evaluation of the data, the Kolmogorov-Smirnov test was applied to determine whether the data had a normal distribution or not, regarding the steepness and skewness. As a result of the analysis, it was found out that the significance value of the Kolmogorov-Smirnov test was higher than 0.05, the steepness and skewness values were between the range of -1 and +1, and the data had a normal distribution. The independent samples t test and chi-square test were used to examine the homogeneity of participant characteristics and outcome variables between the intervention and control group at baseline.
The versatile variance analysis was performed for the comparison of the group, time, and group×time interaction among means of BDI and CSI subscale score in the intervention and control groups. To compare the mean scores among the groups one-way variance analysis in repeated measurements was used, and "the Bonferroni-adjusted t test for dependent samples" was used to compare the measurements.
Ethical approval This study was approved by a research ethics committee (56786525-050.04.04-6988). Written and verbal consent was obtained from the students who agreed to participate in the study. conditions module condition list condition Depressive Symptoms Coping Skills keyword list keyword coping styles depressive symptoms interpersonal relational role analysis nursing students stress design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Single Group Assignment design intervention model description randomized controlled, pre-test-post-test control group design and follow-up test patterns design primary purpose Prevention design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 385 enrollment type Actual arms interventions module arm group list arm group arm group label Intervention Group arm group type Experimental arm group description The Beck Depression Inventory[BDI] (inclusion criteria) was applied face to face to the students who constituted the population (n=385). After the BDI scores were evaluated, the students who met the inclusion criteria were randomly assigned to the intervention and control groups.
In a preliminary interview held with the intervention group (n=10), they were informed about the subject of the research, the duration and content of the implementation process, session rules, and that sessions would be audio-recorded. Informed consent forms were obtained from them, and pre-tests (BDI, Coping Styles Inventory[CSI]) were applied.
A total of 21 90-minute Interpersonal Relational Role Analysis (IRRA) sessions (two sessions a week) were held with the intervention group.
21 sessions of IRRA were applied to the intervention group, once the sessions were completed, post-tests (BDI, CSI) were applied. Three months later, a follow-up test (BDI, CSI) was applied to intervention group. arm group intervention list arm group intervention name Behavioral: Interpersonal Relational Role Analysis arm group label Control Group arm group type No Intervention arm group description The students in the control group were informed about the research, informed consents were obtained from them, and pre-tests (Beck Depression Inventory, Coping Styles Inventory) were applied to them. No intervention was applied to the control group (n=10). Once the Interpersonal Relational Role Analysis sessions were completed, post-tests (Beck Depression Inventory, Coping Styles Inventory) were applied to the control group. Three months later, a follow-up test (Beck Depression Inventory, Coping Styles Inventory) was applied to control groups. After the follow-up test, the participants in the control group were referred to the psychological support unit of the university. intervention list intervention intervention type Behavioral intervention name Interpersonal Relational Role Analysis intervention description Interpersonal Relational Role Analysis (IRRA) is a psychosocial group intervention that allows individuals to see the problems they experience in interpersonal relationships and interactions in the group environment and to be handled together with group members.
Similar to Yalom's interactional group therapy model, IRRA sessions comprise warm up, the stages of setting the agenda, working, evaluating, and getting feedback from observers, which are based on the 'here and now' principle. IRRA helps to safely examine the roles in which group members are "stuck," in a group environment which is a small example of social life, and these roles are addressed in six steps. intervention arm group label list intervention arm group label Intervention Group outcomes module primary outcome list primary outcome primary outcome measure Beck Depression Inventory primary outcome description The Turkish validity and reliability study of the inventory, which was developed by Beck et al. (1961), was conducted by Hisli (1989). The inventory consists of 21 self-report items that allow evaluating the severity of depressive symptoms rather than the diagnosis of depression. The total score obtained from the scale is evaluated, each item is scored between 0 and 3, and there are no reverse-scored items on the scale. 0-9 points indicate probably no depression, 10-16 points mild depression levels, 17-24 points moderate depression levels, and 25 and above points severe depression. The above-mentioned classification was used in this study. Cronbach's alpha reliability coefficient of the scale was calculated as 0.74 (Hisli, 1989). primary outcome time frame 5 months secondary outcome list secondary outcome secondary outcome measure Coping Styles Inventory secondary outcome description The Turkish validity and reliability study of the scale, which was developed by Folkman and Lazarus (1980) to determine the ways to cope with stressful situations, was conducted by Sahin and Durak (1995). The scale has 30 items and five sub-dimensions rated on a four-point Likert-type scale. To calculate the score from the "seeking social support" sub-dimension, the first and ninth items are reversely scored. The scores of the sub-dimensions are calculated by dividing the total scores obtained from the items by the total number of items. Cronbach's alpha reliability coefficient was calculated as 0.69 for the self-confident approach sub-dimension, 0.63 for the optimistic approach sub-dimension, 0.72 for the seeking social support sub-dimension, 0.67 for the helpless approach sub-dimension, and 0.68 for the submissive approach sub-dimension (Sahin & Durak, 1995). secondary outcome time frame 5 months eligibility module eligibility criteria Inclusion Criteria:
being a nursing student at the university during the research (November 2018-April 2019),
not having any disability that would cause difficulties in filling in the data collection tools or during sessions,
scoring scores indicating mild to moderate depression from the Beck Depression Inventory,
agreeing to participate in the research,
being over 18 years old.
Exclusion Criteria:
scoring scores indicating severe depression from the Beck Depression Inventory (severe depression requires psychopharmacological treatment). healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Gülsüm ANÇEL, PhD overall official affiliation Ankara University overall official role Study Director location list location location facility Ankara University Faculty of Nursing location city Ankara location zip 06230 location country Turkey i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003863 condition mesh term Depression condition ancestor list condition ancestor condition ancestor id D000001526 condition ancestor term Behavioral Symptoms condition browse leaf list condition browse leaf condition browse leaf id M6210 condition browse leaf name Depression condition browse leaf as found Depressive Symptoms condition browse leaf relevance high condition browse leaf id M6213 condition browse leaf name Depressive Disorder condition browse leaf relevance low condition browse leaf id M3970 condition browse leaf name Behavioral Symptoms condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions | NCT04832451 | [
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1142,
2016,
117,
1103,
1484,
1150,
1458,
1106,
1250,
1107,
1103,
1372,
1107,
1115,
1285,
112,
188,
4912,
1589,
1113,
1103,
146,
2069,
9664,
3343,
119,
1130,
1296,
4912,
117,
2532,
118,
1851,
1904,
1127,
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1106,
13766,
1103,
146,
2069,
9664,
3343,
119,
1507,
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6635,
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6848,
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123,
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124,
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1103,
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6099,
5070,
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146,
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1639,
2039,
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1103,
3343,
119,
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1103,
1322,
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1296,
4912,
117,
170,
1405,
118,
1406,
2517,
10540,
1668,
1108,
1316,
1114,
1103,
6251,
1104,
1103,
15793,
119,
1507,
1103,
10540,
117,
1103,
1372,
11065,
25172,
1184,
1108,
6352,
1107,
1103,
4912,
119,
4539,
27989,
21868,
1127,
1455,
1293,
1152,
1464,
1219,
1103,
4912,
117,
1147,
4366,
4681,
1127,
2376,
117,
1105,
1122,
1108,
17349,
1115,
1185,
1484,
1286,
1103,
4912,
1114,
4366,
4681,
119,
1109,
1372,
11065,
1105,
15793,
1522,
9712,
21745,
1105,
3112,
13032,
1106,
1296,
1420,
1496,
1106,
1147,
3268,
1106,
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1105,
1849,
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4233,
1206,
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5758,
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1103,
6635,
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119,
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1484,
16490,
1296,
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1111,
14255,
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3408,
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1296,
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119,
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1103,
1314,
4912,
117,
170,
107,
8865,
3246,
107,
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1316,
117,
1187,
1103,
1484,
3416,
1103,
3112,
5402,
1152,
2751,
1164,
1296,
1168,
117,
1112,
1218,
1112,
1147,
4681,
1105,
3578,
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1103,
3830,
1104,
1103,
1372,
119,
1799,
1626,
6887,
1104,
146,
2069,
9664,
1127,
3666,
1106,
1103,
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1372,
117,
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1108,
3666,
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1103,
1654,
1372,
119,
2857,
1103,
146,
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9664,
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117,
2112,
118,
5715,
113,
139,
17243,
117,
25011,
114,
1127,
3666,
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1103,
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1105,
1654,
2114,
113,
1356,
1626,
118,
1572,
117,
10351,
114,
119,
2677,
1808,
1224,
113,
1364,
10351,
114,
117,
170,
2812,
118,
1146,
2774,
113,
139,
17243,
117,
25011,
114,
1108,
3666,
1106,
1241,
2114,
119,
1258,
1103,
2812,
118,
1146,
2774,
117,
1103,
6635,
1107,
1103,
1654,
1372,
1127,
2752,
1106,
1103,
9189,
1619,
2587,
1104,
1103,
2755,
119,
7154,
12504,
7154,
1127,
24443,
6834,
1174,
1606,
1103,
12121,
14667,
2553,
1111,
3563,
4052,
1659,
119,
121,
119,
1130,
1103,
10540,
1104,
1103,
2233,
117,
1103,
19892,
13505,
26205,
12316,
118,
156,
15191,
15847,
2774,
1108,
3666,
1106,
4959,
2480,
1103,
2233,
1125,
170,
2999,
3735,
1137,
1136,
117,
4423,
1103,
9458,
1757,
1105,
188,
2391,
6540,
5800,
119,
1249,
170,
1871,
1104,
1103,
3622,
117,
1122,
1108,
1276,
1149,
1115,
1103,
7467,
2860,
1104,
1103,
19892,
13505,
26205,
12316,
118,
156,
15191,
15847,
2774,
1108,
2299,
1190,
121,
119,
4991,
117,
1103,
9458,
1757,
1105,
188,
2391,
6540,
5800,
4718,
1127,
1206,
1103,
2079,
1104,
118,
122,
1105,
116,
122,
117,
1105,
1103,
2233,
1125,
170,
2999,
3735,
119,
1109,
2457,
8025,
189,
2774,
1105,
22572,
1182,
118,
1961,
2774,
1127,
1215,
1106,
11755,
1103,
16358,
3702,
27054,
1785,
1104,
14031,
5924,
1105,
9386,
10986,
1206,
1103,
9108,
1105,
1654,
1372,
1120,
2259,
2568,
119,
1109,
27133,
26717,
3622,
1108,
1982,
1111,
1103,
7577,
1104,
1103,
1372,
117,
1159,
117,
1105,
1372,
28193,
4974,
8234,
1621,
2086,
1104,
139,
17243,
1105,
25011,
4841,
26996,
1513,
2794,
1107,
1103,
9108,
1105,
1654,
2114,
119,
1706,
14133,
1103,
1928,
7432,
1621,
1103,
2114,
1141,
118,
1236,
26717,
3622,
1107,
4892,
12307,
1108,
1215,
117,
1105,
107,
1103,
17182,
6732,
3484,
1182,
118,
10491,
189,
2774,
1111,
7449,
8025,
107,
1108,
1215,
1106,
14133,
1103,
12307,
119,
142,
26610,
5684,
1188,
2025,
1108,
4092,
1118,
170,
1844,
13438,
3914,
113,
4376,
1559,
22392,
1571,
17600,
118,
4991,
1568,
119,
5129,
119,
5129,
118,
5691,
1604,
1604,
114,
119,
13404,
1105,
14093,
9635,
1108,
3836,
1121,
1103,
1651,
1150,
2675,
1106,
4868,
1107,
1103,
2025,
119,
2975,
13196,
3879,
2190,
3879,
3177,
16568,
156,
17162,
6451,
17112,
3291,
2624,
26210,
2501,
12565,
2190,
2501,
12565,
9947,
1158,
6739,
1260,
16568,
8006,
9455,
14359,
1348,
6796,
1348,
1648,
3622,
11138,
1651,
6600,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
8353,
1990,
1249,
19638,
1880,
1902,
9108,
2235,
6136,
7091,
2200,
4013,
117,
3073,
118,
2774,
118,
2112,
118,
2774,
1654,
1372,
1902,
1105,
2812,
118,
1146,
2774,
6692,
1902,
2425,
3007,
18461,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8353,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
4539,
27989,
10224,
1204,
10803,
23992,
10803,
5099,
27462,
10803,
2076,
2173,
4746,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
11300,
21987,
1990,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1109,
10429,
11442,
1130,
14850,
4649,
164,
139,
17243,
166,
113,
10838,
9173,
114,
1108,
3666,
1339,
1106,
1339,
1106,
1103,
1651,
1150,
12810,
1103,
1416,
113,
183,
134,
27462,
114,
119,
1258,
1103,
139,
17243,
7432,
1127,
17428,
117,
1103,
1651,
1150,
1899,
1103,
10838,
9173,
1127,
19729,
3346,
1106,
1103,
9108,
1105,
1654,
2114,
119,
1130,
170,
9889,
3669,
1316,
1114,
1103,
9108,
1372,
113,
183,
134,
1275,
114,
117,
1152,
1127,
6189,
1164,
1103,
2548,
1104,
1103,
1844,
117,
1103,
9355,
1105,
3438,
1104,
1103,
7249,
1965,
117,
4912,
2995,
117,
1105,
1115,
6887,
1156,
1129,
6056,
118,
1802,
119,
1130,
17747,
9635,
2769,
1127,
3836,
1121,
1172,
117,
1105,
3073,
118,
5715,
113,
139,
17243,
117,
3291,
2624,
27881,
1130,
14850,
4649,
164,
25011,
166,
114,
1127,
3666,
119,
138,
1703,
1104,
1626,
3078,
118,
2517,
11300,
14359,
1348,
11336,
6840,
1348,
17094,
12504,
113,
146,
2069,
9664,
114,
6887,
113,
1160,
6887,
170,
1989,
114,
1127,
1316,
1114,
1103,
9108,
1372,
119,
1626,
6887,
1104,
146,
2069,
9664,
1127,
3666,
1106,
1103,
9108,
1372,
117,
1517,
1103,
6887,
1127,
2063,
117,
2112,
118,
5715,
113,
139,
17243,
117,
25011,
114,
1127,
3666,
119,
2677,
1808,
1224,
117,
170,
2812,
118,
1146,
2774,
113,
139,
17243,
117,
25011,
114,
1108,
3666,
1106,
9108,
1372,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
4108,
2328,
17564,
1348,
131,
11300,
14359,
1348,
11336,
6840,
1348,
17094,
12504,
1981,
1372,
3107,
6342,
1990,
1981,
1372,
2076,
1302,
11300,
21987,
1981,
1372,
6136,
1109,
1651,
1107,
1103,
1654,
1372,
1127,
6189,
1164,
1103,
1844,
117,
6189,
9635,
1116,
1127,
3836,
1121,
1172,
117,
1105,
3073,
118,
5715,
113,
10429,
11442,
1130,
14850,
4649,
117,
3291,
2624,
27881,
1130,
14850,
4649,
114,
1127,
3666,
1106,
1172,
119,
1302,
9108,
1108,
3666,
1106,
1103,
1654,
1372,
113,
183,
134,
1275,
114,
119,
2857,
1103,
11300,
14359,
1348,
11336,
6840,
1348,
17094,
12504,
6887,
1127,
2063,
117,
2112,
118,
5715,
113,
10429,
11442,
1130,
14850,
4649,
117,
3291,
2624,
27881,
1130,
14850,
4649,
114,
1127,
3666,
1106,
1103,
1654,
1372,
119,
2677,
1808,
1224,
117,
170,
2812,
118,
1146,
2774,
113,
10429,
11442,
1130,
14850,
4649,
117,
3291,
2624,
27881,
1130,
14850,
4649,
114,
1108,
3666,
1106,
1654,
2114,
119,
1258,
1103,
2812,
118,
1146,
2774,
117,
1103,
6635,
1107,
1103,
1654,
1372,
1127,
2752,
1106,
1103,
9189,
1619,
2587,
1104,
1103,
2755,
119,
9108,
2190,
9108,
9108,
2076,
4108,
2328,
17564,
1348,
9108,
1271,
11300,
14359,
1348,
11336,
6840,
1348,
17094,
12504,
9108,
6136,
11300,
14359,
1348,
11336,
6840,
1348,
17094,
12504,
113,
146,
2069,
9664,
114,
1110,
170,
15604,
21155,
22354,
12562,
1372,
9108,
1115,
3643,
2833,
1106,
1267,
1103,
2645,
1152,
2541,
1107,
9455,
14359,
1348,
6085,
1105,
10393,
1107,
1103,
1372,
3750,
1105,
1106,
1129,
8630,
1487,
1114,
1372,
1484,
119,
12250,
1106,
14680,
2858,
1306,
112,
188,
8234,
1348,
1372,
7606,
2235,
117,
146,
2069,
9664,
6887,
16722,
3258,
1146,
117,
1103,
5251,
1104,
3545,
1103,
12932,
117,
1684,
117,
27698,
117,
1105,
2033,
13032,
1121,
15793,
117,
1134,
1132,
1359,
1113,
1103,
112,
1303,
1105,
1208,
112,
6708,
119,
146,
2069,
9664,
6618,
1106,
9510,
11755,
1103,
3573,
1107,
1134,
1372,
1484,
1132,
107,
5342,
117,
107,
1107,
170,
1372,
3750,
1134,
1110,
170,
1353,
1859,
1104,
1934,
1297,
117,
1105,
1292,
3573,
1132,
7894,
1107,
1565,
3343,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
11300,
21987,
1990,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
10429,
11442,
1130,
14850,
4649,
2425,
9386,
6136,
1109,
4229,
17782,
1105,
17104,
2025,
1104,
1103,
14952,
117,
1134,
1108,
1872,
1118,
10429,
3084,
2393,
119,
113,
2920,
114,
117,
1108,
3303,
1118,
1230,
2646,
113,
2056,
114,
119,
1109,
14952,
2923,
1104,
1626,
2191,
118,
2592,
4454,
1115,
2621,
27698,
1103,
20997,
1104,
1260,
16568,
8006,
1897,
1190,
1103,
12645,
1104,
7560,
119,
1109,
1703,
2794,
3836,
1121,
1103,
3418,
1110,
17428,
117,
1296,
8926,
1110,
2297,
1206,
121,
1105,
124,
117,
1105,
1175,
1132,
1185,
7936,
118,
2297,
4454,
1113,
1103,
3418,
119,
121,
118,
130,
1827,
5057,
1930,
1185,
7560,
117,
1275,
118,
1479,
1827,
10496,
7560,
3001,
117,
1542,
118,
1572,
1827,
8828,
7560,
3001,
117,
1105,
1512,
1105,
1807,
1827,
5199,
7560,
119,
1109,
1807,
118,
3025,
5393,
1108,
1215,
1107,
1142,
2025,
119,
140,
3484,
6396,
112,
188,
11164,
17104,
21130,
1104,
1103,
3418,
1108,
10056,
1112,
121,
119,
5692,
113,
1230,
2646,
117,
2056,
114,
119,
2425,
9386,
1159,
4207,
126,
1808,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
3291,
2624,
27881,
1130,
14850,
4649,
3718,
9386,
6136,
1109,
4229,
17782,
1105,
17104,
2025,
1104,
1103,
3418,
117,
1134,
1108,
1872,
1118,
12539,
1399,
1105,
26501,
113,
2253,
114,
1106,
4959,
1103,
3242,
1106,
16743,
1114,
6600,
2365,
7832,
117,
1108,
3303,
1118,
17784,
8265,
1105,
12786,
16971,
113,
1876,
114,
119,
1109,
3418,
1144,
1476,
4454,
1105,
1421,
4841,
118,
10082,
6317,
1113,
170,
1300,
118,
1553,
2409,
3740,
118,
2076,
3418,
119,
1706,
20446,
1103,
2794,
1121,
1103,
107,
5788,
1934,
1619,
107,
4841,
118,
11025,
117,
1103,
1148,
1105,
6948,
4454,
1132,
7936,
1193,
2297,
119,
1109,
7432,
1104,
1103,
4841,
118,
10082,
1132,
10056,
1118,
18699,
1103,
1703,
7432,
3836,
1121,
1103,
4454,
1118,
1103,
1703,
1295,
1104,
4454,
119,
140,
3484,
6396,
112,
188,
11164,
17104,
21130,
1108,
10056,
1112,
121,
119,
5691,
1111,
1103,
2191,
118,
9588,
3136,
4841,
118,
11025,
117,
121,
119,
5519,
1111,
1103,
24876,
3136,
4841,
118,
11025,
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full study rank 61335 study protocol section identification module n c t id NCT04837807 org study id info org study id IRB-30007063 organization org full name University of Alabama at Birmingham org class OTHER brief title Digital Device Users Who Are Treated With Systane Hydration PF official title Understanding Quality of Life in High Digital Device Users Who Are Treated With Systane Hydration PF status module status verified date October 2022 overall status Completed expanded access info has expanded access No start date struct start date August 18, 2021 start date type Actual primary completion date struct primary completion date November 19, 2021 primary completion date type Actual completion date struct completion date November 19, 2021 completion date type Actual study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual results first submit date March 7, 2022 results first submit q c date October 6, 2022 results first post date struct results first post date October 10, 2022 results first post date type Actual results first posted q c comments date struct results first posted q c comments date April 1, 2022 results first posted q c comments date type Actual last update submit date October 6, 2022 last update post date struct last update post date October 10, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Andrew Pucker responsible party investigator title Assistant Professor responsible party investigator affiliation University of Alabama at Birmingham lead sponsor lead sponsor name University of Alabama at Birmingham lead sponsor class OTHER collaborator list collaborator collaborator name Alcon Research collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary Systane Hydration PF is a recently released preservative-free artificial tear that is able to supplement the ocular surface's moisture while simultaneously soothing the eye. While Systane Hydration PF should in theory improve the symptoms and subsequently the quality of life of patients who have DES, this clinical application has yet to be tested. This drop furthermore is available in both unit-dose and multi-dose options; however, it is unclear if patient perceive a difference between the two dispensing methods. Therefore, the primary purpose of this study is to recruit patients who have DES and to treat them with Systane Hydration PF and determine how regular use of this drop impacts a patient's ocular surface symptoms and overall quality of life. This study will secondarily compare the two dispensing methods to determine if patients prefer one method over the other. detailed description Extensive computer use is no longer an employment-specific challenge. Use of digital devices in work, home, and leisure settings is now the norm, and it is now socially expected. While the introduction of high-powered computers and digital devices have greatly improved many aspects of modern life, the pervasive use of digital devices has caused some patients to develop a condition known as Digital Eye Strain (DES). DES has been reported to be as high as 93% the population depending upon how the condition is defined, and its severity has been found to increase with increased digital device time. DES is a condition where patients experience symptoms such as glare, accommodative dysfunction, defocus, fatigue, discomfort, and dryness from digital device use, and these dry eye symptoms may also result in decreased quality of life. While dryness symptoms in DES are likely multifactorial (e.g., contact lens use, systemic disease status), much of the dryness symptoms in DES are probably due to tear film evaporation secondary to having a reduced number of blinks per minute while using digital devices. Since much of the ocular symptoms associated with DES stem from excessive tear evaporation, artificial tears have become an accepted DES treatment
Systane Hydration PF is a recently released preservative-free artificial tear that is able to supplement the ocular surface's moisture while simultaneously soothing the eye. Systane Hydration PF has HydroBoost technology, which is thought to enhance the drop's effectiveness by incorporating ingredients that increase drop retention. While Systane Hydration PF should in theory improve the symptoms and subsequently the quality of life of patients who have DES, this clinical application has yet to be tested. This drop furthermore is available in both unit-dose and multi-dose options; however, it is unclear if patient perceive a difference between the two dispensing methods. Therefore, the primary purpose of this study is to recruit patients who have DES and to treat them with Systane Hydration PF and determine how regular use of this drop impacts a patient's ocular surface symptoms and overall quality of life. This study will secondarily compare the two dispensing methods to determine if patients prefer one method over the other. conditions module condition list condition Dry Eye keyword list keyword Digital Eye Strain Dry Eye Artificial Tears Eye Comfort design module study type Interventional phase list phase Phase 4 design info design allocation Randomized design intervention model Crossover Assignment design intervention model description All subjects will be treated with Systane Hydration PF. Half will start with the unit-dose version and half with start with the multi-dose version. Subjects will switch to the other dosing option in the middle of the study. design primary purpose Treatment design masking info design masking Single design masking description Investigators will be masked to the dosage group. Subjects will not be masked because it is not possible with the dosage interventions. design who masked list design who masked Participant enrollment info enrollment count 30 enrollment type Actual arms interventions module arm group list arm group arm group label Unit Dose First, Then Multi-Dose arm group type Experimental arm group description Subjects randomized to this group will apply the unit-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. arm group intervention list arm group intervention name Drug: Systane Hydration PF arm group label Multi Dose, Then Unit Dose arm group type Experimental arm group description Subjects randomized to this group will apply multi-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. arm group intervention list arm group intervention name Drug: Systane Hydration PF intervention list intervention intervention type Drug intervention name Systane Hydration PF intervention description This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. intervention arm group label list intervention arm group label Multi Dose, Then Unit Dose Unit Dose First, Then Multi-Dose outcomes module primary outcome list primary outcome primary outcome measure IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection primary outcome description Impact of Dry Eye on Daily Life (IDEEL) Work questions will be self-administered electronically to understand how treatment with Systane Hydration PF helps a patient's ability to work (0-100 scale with 100 being worst and 0 being best). primary outcome time frame 2 weeks secondary outcome list secondary outcome secondary outcome measure Drop Dispensing Method Preference secondary outcome description Subjects will report whether they preferred the unit-dose dispensing method or the multi-dose dispensing method via a forced choice questionnaire (forced choice with patient being required to pick if they like the unit-dose dispensing method or the multi-dose better). secondary outcome time frame Between groups at 2 weeks secondary outcome measure Ocular Surface Disease Index (OSDI) Questionnaire secondary outcome description The Ocular Surface Disease Index (OSDI) will be self-administered electronically to understand how treatment with Systane Hydration PF helps a patient's ability to work (0-100 scale with 100 being worst and 0 being best). secondary outcome time frame 2 weeks eligibility module eligibility criteria Inclusion Criteria:
18 years or older
Using digital devices 8 or more hours per day
Eyes that are dry, irritated, itchy or burn while using a digital screen, like a computer or smartphone
Eye fatigue from digital screen use
Impact of Dry Eye on Daily Life (IDEEL) Work score ≤80
Ocular Surface Disease Index (OSDI) score between 13 and 32 (inclusive)
Willing to discontinue current artificial tears for at least 24 hours before enrollment
Exclusion Criteria:
Pregnant or breastfeeding
Are currently using isotretinoin-derivatives or other ocular medications
Having any active ocular infection or inflammation
History of severe ocular trauma
Ocular surgery within the past 12 months
Having any known systemic health conditions that are thought to alter tear film physiology (e.g., Sjögren's syndrome
Using a dry eye treatment other than artificial tears
Currently using artificial tears more than 4 times per day
Contact lens wear within the past week healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility University of Alabama at Birmingham location city Birmingham location state Alabama location zip 35294 location country United States i p d sharing statement module i p d sharing No results section participant flow module flow group list flow group flow group id FG000 flow group title Unit Dose, Then Multi-dose flow group description The participants first received the unit dose version of Systane Hydrataion PF, there was a one day washout period, and then they received the multi-dose version of Systane Hydration PF. flow group id FG001 flow group title Multi Dose, Then Unit Dose flow group description The participants first received the multi-dose version of Systane Hydrataion PF, there was a one day washout period, and then they received the unit-dose version of Systane Hydration PF. flow period list flow period flow period title First Sequence (Week 1) flow milestone list flow milestone flow milestone type STARTED flow milestone comment This was a crossover study, so all subject got both treatments. flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 15 flow achievement group id FG001 flow achievement num subjects 15 flow milestone type Received Sequence flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 15 flow achievement group id FG001 flow achievement num subjects 15 flow milestone type COMPLETED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 15 flow achievement group id FG001 flow achievement num subjects 14 flow milestone type NOT COMPLETED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 0 flow achievement group id FG001 flow achievement num subjects 1 flow drop withdraw list flow drop withdraw flow drop withdraw type Withdrawal by Subject flow reason list flow reason flow reason group id FG000 flow reason num subjects 0 flow reason group id FG001 flow reason num subjects 1 flow period title Washout 1 Day flow milestone list flow milestone flow milestone type STARTED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 15 flow achievement group id FG001 flow achievement num subjects 14 flow milestone type COMPLETED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 14 flow achievement group id FG001 flow achievement num subjects 14 flow milestone type NOT COMPLETED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 1 flow achievement group id FG001 flow achievement num subjects 0 flow period title Second Sequence (Week 2) flow milestone list flow milestone flow milestone type STARTED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 14 flow achievement group id FG001 flow achievement num subjects 14 flow milestone type COMPLETED flow milestone comment Person dropped out prior to the crossover. flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 14 flow achievement group id FG001 flow achievement num subjects 14 flow milestone type NOT COMPLETED flow achievement list flow achievement flow achievement group id FG000 flow achievement num subjects 0 flow achievement group id FG001 flow achievement num subjects 0 baseline characteristics module baseline group list baseline group baseline group id BG000 baseline group title All Participants baseline group description Subjects were randomized to either a multi dose group or a unit dose group, each group used either a multi dose or unit does in order to apply Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain. After 1 week subjects were switched from their starting group to the other group to determine which dispensing method was preferred.
Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. baseline denom list baseline denom baseline denom units Participants baseline denom count list baseline denom count baseline denom count group id BG000 baseline denom count value 30 baseline measure list baseline measure baseline measure title Age, Categorical baseline measure param type Count of Participants baseline measure unit of measure Participants baseline class list baseline class baseline class denom list baseline class denom baseline class denom units Participants baseline class denom count list baseline class denom count baseline class denom count group id BG000 baseline class denom count value 30 baseline category list baseline category baseline category title <=18 years baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 0 baseline category title Between 18 and 65 years baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 30 baseline category title >=65 years baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 0 baseline measure title Age, Continuous baseline measure param type Median baseline measure dispersion type Standard Deviation baseline measure unit of measure Years baseline class list baseline class baseline class denom list baseline class denom baseline class denom units Participants baseline class denom count list baseline class denom count baseline class denom count group id BG000 baseline class denom count value 30 baseline category list baseline category baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 28.6 baseline measurement spread 12 baseline measure title Sex: Female, Male baseline measure population description This project featured a total of 30 participants, each participant received both treatments, however one patient was lost to follow up, and thus was not part of the crossover total. baseline measure param type Count of Participants baseline measure unit of measure Participants baseline class list baseline class baseline class denom list baseline class denom baseline class denom units Participants baseline class denom count list baseline class denom count baseline class denom count group id BG000 baseline class denom count value 30 baseline category list baseline category baseline category title Female baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 21 baseline category title Male baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 9 baseline measure title Race and Ethnicity Not Collected baseline measure population description Race and Ethnicity were not collected from any participant. baseline measure param type Count of Participants baseline measure unit of measure Participants baseline class list baseline class baseline class denom list baseline class denom baseline class denom units Participants baseline class denom count list baseline class denom count baseline class denom count group id BG000 baseline class denom count value 0 baseline measure title Region of Enrollment baseline measure population description The project features only 30 participants, all participants got both treatments however one subject dropped out prior to the crossover and thus was not counted in the crossover total. baseline measure param type Number baseline measure unit of measure participants baseline class list baseline class baseline class title United States baseline class denom list baseline class denom baseline class denom units Participants baseline class denom count list baseline class denom count baseline class denom count group id BG000 baseline class denom count value 30 baseline category list baseline category baseline measurement list baseline measurement baseline measurement group id BG000 baseline measurement value 30 outcome measures module outcome measure list outcome measure outcome measure type Primary outcome measure title IDEEL (Impact of Dry Eye on Daily Life) Quality of Life - Work Subsection outcome measure description Impact of Dry Eye on Daily Life (IDEEL) Work questions will be self-administered electronically to understand how treatment with Systane Hydration PF helps a patient's ability to work (0-100 scale with 100 being worst and 0 being best). outcome measure population description While we had 30 total subjects enroll we lost one person due to lack of interest in the study. As such she was not switched over to the next group and thus no scores other than baseline were collected. outcome measure reporting status Posted outcome measure param type Median outcome measure dispersion type Standard Deviation outcome measure unit of measure score on a scale outcome measure time frame 2 weeks outcome group list outcome group outcome group id OG000 outcome group title Unit Dose outcome group description Subjects randomized to this group will apply the unit-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain.
Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. outcome group id OG001 outcome group title Multi Dose outcome group description Subjects randomized to this group will apply multi-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain.
Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. outcome denom list outcome denom outcome denom units Participants outcome denom count list outcome denom count outcome denom count group id OG000 outcome denom count value 30 outcome denom count group id OG001 outcome denom count value 30 outcome class list outcome class outcome category list outcome category outcome measurement list outcome measurement outcome measurement group id OG000 outcome measurement value 81.4 outcome measurement spread 12.7 outcome measurement group id OG001 outcome measurement value 81.4 outcome measurement spread 12.7 outcome analysis list outcome analysis outcome analysis group id list outcome analysis group id OG000 OG001 outcome analysis group description Each participant in the study was asked to complete the IDEEL work at their baseline, week 1 and week 2 visits. The IDEEL work is graded on a scale to 100 with higher numbers being deemed as "better" scores thus representing more comfort than previous weeks. outcome analysis non inferiority type Superiority outcome analysis p value <0.05 outcome analysis statistical method ANOVA outcome analysis statistical comment This was a cross-over study, so there is really 30 subjects per group that was analyzed. outcome analysis param type Mean Difference (Final Values) outcome analysis param value 22.4 outcome analysis c i num sides 2-Sided outcome analysis dispersion type Standard Deviation outcome analysis dispersion value 12.8 outcome measure type Secondary outcome measure title Drop Dispensing Method Preference outcome measure description Subjects will report whether they preferred the unit-dose dispensing method or the multi-dose dispensing method via a forced choice questionnaire (forced choice with patient being required to pick if they like the unit-dose dispensing method or the multi-dose better). outcome measure population description One person discontinued after the baseline visit and thus did not crossover between groups. outcome measure reporting status Posted outcome measure param type Count of Participants outcome measure unit of measure Participants outcome measure time frame Between groups at 2 weeks outcome group list outcome group outcome group id OG000 outcome group title Unit Dose outcome group description Subjects randomized to this group will apply the unit-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain.
Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. outcome group id OG001 outcome group title Multi Dose outcome group description Subjects randomized to this group will apply multi-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain.
Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. outcome denom list outcome denom outcome denom units Participants outcome denom count list outcome denom count outcome denom count group id OG000 outcome denom count value 29 outcome denom count group id OG001 outcome denom count value 29 outcome class list outcome class outcome category list outcome category outcome measurement list outcome measurement outcome measurement group id OG000 outcome measurement value 16 outcome measurement group id OG001 outcome measurement value 13 outcome measure type Secondary outcome measure title Ocular Surface Disease Index (OSDI) Questionnaire outcome measure description The Ocular Surface Disease Index (OSDI) will be self-administered electronically to understand how treatment with Systane Hydration PF helps a patient's ability to work (0-100 scale with 100 being worst and 0 being best). outcome measure population description One subject was lost after the baseline visit. Thus OSDI scores for the week 1 and 2 visit could not be calculated for that individual. outcome measure reporting status Posted outcome measure param type Mean outcome measure dispersion type Standard Deviation outcome measure unit of measure score on a scale outcome measure time frame 2 weeks outcome group list outcome group outcome group id OG000 outcome group title Unit Dose outcome group description Subjects randomized to this group will apply the unit-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain.
Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. outcome group id OG001 outcome group title Multi Dose outcome group description Subjects randomized to this group will apply multi-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain.
Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. outcome denom list outcome denom outcome denom units Participants outcome denom count list outcome denom count outcome denom count group id OG000 outcome denom count value 29 outcome denom count group id OG001 outcome denom count value 30 outcome class list outcome class outcome category list outcome category outcome measurement list outcome measurement outcome measurement group id OG000 outcome measurement value 14.3 outcome measurement spread 8.6 outcome measurement group id OG001 outcome measurement value 14.3 outcome measurement spread 8.6 outcome analysis list outcome analysis outcome analysis group id list outcome analysis group id OG000 OG001 outcome analysis non inferiority type Superiority outcome analysis non inferiority comment OSDI scores were obtained across all three visits, baseline, week 1 and week 2. Lower OSDI scores indicate better eye health. outcome analysis p value <0.05 outcome analysis statistical method ANOVA outcome analysis statistical comment This was a cross-over study, so there is really 30 subjects per group that was analyzed. outcome analysis param type Mean Difference (Final Values) outcome analysis param value 10.5 outcome analysis c i num sides 2-Sided outcome analysis dispersion type Standard Deviation outcome analysis dispersion value 7.3 adverse events module events frequency threshold 0 events time frame 1 month. event group list event group event group id EG000 event group title Unit Dose event group description Subjects randomized to this group will apply the unit-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain.
Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. event group deaths num affected 0 event group deaths num at risk 30 event group serious num affected 0 event group serious num at risk 30 event group other num affected 0 event group other num at risk 30 event group id EG001 event group title Multi Dose event group description Subjects randomized to this group will apply multi-dose version of Systane Hydration PF to determine if it helps alleviate symptoms associated with digital eye strain.
Systane Hydration PF: This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies. event group deaths num affected 0 event group deaths num at risk 30 event group serious num affected 0 event group serious num at risk 30 event group other num affected 0 event group other num at risk 30 more info module certain agreement agreement p i sponsor employee No agreement restrictive agreement No point of contact point of contact title Dr. Andrew Pucker point of contact organization The University of Alabama at Birmingham point of contact e mail apucker@uab.edu point of contact phone 920-579-2900 document section large document module large doc list large doc large doc type abbrev Prot_SAP_ICF large doc has protocol Yes large doc has s a p Yes large doc has i c f Yes large doc label Study Protocol, Statistical Analysis Plan, and Informed Consent Form large doc date November 19, 2021 large doc upload date 02/04/2022 14:35 large doc filename Prot_SAP_ICF_000.pdf derived section misc info module version holder December 02, 2022 submission tracking condition browse module condition mesh list condition mesh condition mesh id D000015352 condition mesh term Dry Eye Syndromes condition ancestor list condition ancestor condition ancestor id D000007766 condition ancestor term Lacrimal Apparatus Diseases condition ancestor id D000005128 condition ancestor term Eye Diseases condition browse leaf list condition browse leaf condition browse leaf id M17192 condition browse leaf name Dry Eye Syndromes condition browse leaf as found Dry Eye condition browse leaf relevance high condition browse leaf id M9816 condition browse leaf name Keratoconjunctivitis Sicca condition browse leaf relevance low condition browse leaf id M14393 condition browse leaf name Rupture condition browse leaf relevance low condition browse leaf id M3707 condition browse leaf name Asthenopia condition browse leaf relevance low condition browse leaf id M21938 condition browse leaf name Lacerations condition browse leaf relevance low condition browse leaf id M15507 condition browse leaf name Syndrome condition browse leaf relevance low condition browse leaf id M9938 condition browse leaf name Lacrimal Apparatus Diseases condition browse leaf relevance low condition browse leaf id M7423 condition browse leaf name Eye Diseases condition browse leaf relevance low condition browse leaf id T6034 condition browse leaf name Quality of Life condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC11 condition browse branch name Eye Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M29659 intervention browse leaf name Lubricant Eye Drops intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04837807 | [
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2025,
25021,
146,
22672,
118,
11975,
20829,
1545,
1495,
2369,
8916,
1554,
1271,
1239,
1104,
5359,
1120,
5836,
8916,
1705,
152,
24162,
9637,
4094,
1641,
6082,
15545,
2093,
24222,
2627,
2372,
157,
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1181,
1556,
156,
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145,
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153,
2271,
2078,
1641,
21300,
14801,
1104,
2583,
1107,
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6082,
15545,
2093,
24222,
2627,
2372,
157,
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1181,
1556,
156,
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145,
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153,
2271,
2781,
13196,
2781,
22480,
2236,
1357,
17881,
1477,
2905,
2781,
12735,
1181,
3631,
2469,
23992,
1144,
3631,
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1302,
1838,
2236,
188,
23055,
1838,
2236,
1360,
1407,
117,
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1475,
1838,
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2076,
2173,
4746,
2425,
6026,
2236,
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2425,
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2236,
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117,
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1475,
2425,
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2076,
2173,
4746,
6026,
2236,
188,
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6026,
2236,
1379,
1627,
117,
17881,
1475,
6026,
2236,
2076,
2173,
4746,
2025,
1148,
12295,
2236,
1364,
127,
117,
17881,
1475,
2025,
1148,
12295,
186,
172,
2236,
1364,
127,
117,
17881,
1475,
2025,
1148,
2112,
2236,
188,
23055,
2025,
1148,
2112,
2236,
1364,
129,
117,
17881,
1475,
2025,
1148,
2112,
2236,
2076,
2173,
4746,
2686,
1148,
12295,
2236,
1345,
128,
117,
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1477,
2686,
1148,
12295,
186,
172,
2236,
1357,
127,
117,
17881,
1477,
2686,
1148,
2112,
2236,
188,
23055,
2686,
1148,
2112,
2236,
1357,
1275,
117,
17881,
1477,
2686,
1148,
2112,
2236,
2076,
2173,
4746,
2686,
1148,
6310,
186,
172,
7640,
2236,
188,
23055,
2686,
1148,
6310,
186,
172,
7640,
2236,
1364,
122,
117,
17881,
1477,
2686,
1148,
6310,
186,
172,
7640,
2236,
2076,
2173,
4746,
1314,
11984,
12295,
2236,
1357,
127,
117,
17881,
1477,
1314,
11984,
2112,
2236,
188,
23055,
1314,
11984,
2112,
2236,
1357,
1275,
117,
17881,
1477,
1314,
11984,
2112,
2236,
2076,
2173,
4746,
10767,
24146,
13196,
2784,
1710,
2784,
1710,
2076,
8013,
1130,
5710,
3121,
25524,
1766,
2784,
1710,
17805,
1554,
1271,
3217,
153,
8474,
1200,
2784,
1710,
17805,
1641,
5414,
2986,
2784,
1710,
17805,
13494,
1239,
1104,
5359,
1120,
5836,
1730,
10767,
1730,
10767,
1271,
1239,
1104,
5359,
1120,
5836,
1730,
10767,
1705,
152,
24162,
9637,
20715,
2190,
20715,
20715,
1271,
2586,
7235,
2713,
20715,
1705,
15969,
2137,
13329,
23313,
3663,
20051,
13196,
20051,
1144,
173,
182,
172,
1302,
1110,
175,
173,
170,
12521,
3850,
2160,
1110,
175,
173,
170,
12521,
4442,
1302,
1110,
190,
188,
10107,
2160,
6136,
13196,
4094,
14940,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
1110,
170,
3055,
1308,
3073,
6906,
26465,
2109,
118,
1714,
8246,
7591,
1115,
1110,
1682,
1106,
15491,
1103,
184,
11702,
2473,
112,
188,
15164,
1229,
7344,
18059,
1103,
2552,
119,
1799,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
1431,
1107,
2749,
4607,
1103,
8006,
1105,
2886,
1103,
3068,
1104,
1297,
1104,
4420,
1150,
1138,
18581,
1708,
117,
1142,
7300,
4048,
1144,
1870,
1106,
1129,
7289,
119,
1188,
3968,
1748,
4982,
1110,
1907,
1107,
1241,
2587,
118,
13753,
1105,
4321,
118,
13753,
6665,
132,
1649,
117,
1122,
1110,
10527,
1191,
5351,
25784,
170,
3719,
1206,
1103,
1160,
4267,
20080,
5026,
1158,
4069,
119,
6589,
117,
1103,
2425,
3007,
1104,
1142,
2025,
1110,
1106,
14240,
4420,
1150,
1138,
18581,
1708,
1105,
1106,
7299,
1172,
1114,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
1105,
4959,
1293,
2366,
1329,
1104,
1142,
3968,
15791,
170,
5351,
112,
188,
184,
11702,
2473,
8006,
1105,
2905,
3068,
1104,
1297,
119,
1188,
2025,
1209,
1248,
18206,
14133,
1103,
1160,
4267,
20080,
5026,
1158,
4069,
1106,
4959,
1191,
4420,
9353,
1141,
3442,
1166,
1103,
1168,
119,
6448,
6136,
16409,
27291,
2775,
1329,
1110,
1185,
2039,
1126,
6233,
118,
2747,
4506,
119,
11696,
1104,
3539,
5197,
1107,
1250,
117,
1313,
117,
1105,
17036,
11106,
1110,
1208,
1103,
18570,
117,
1105,
1122,
1110,
1208,
15315,
2637,
119,
1799,
1103,
4784,
1104,
1344,
118,
5605,
7565,
1105,
3539,
5197,
1138,
5958,
4725,
1242,
5402,
1104,
2030,
1297,
117,
1103,
1679,
25007,
1329,
1104,
3539,
5197,
1144,
2416,
1199,
4420,
1106,
3689,
170,
3879,
1227,
1112,
6082,
9329,
1457,
11098,
113,
18581,
1708,
114,
119,
18581,
1708,
1144,
1151,
2103,
1106,
1129,
1112,
1344,
1112,
5429,
110,
1103,
1416,
5763,
1852,
1293,
1103,
3879,
1110,
3393,
117,
1105,
1157,
20997,
1144,
1151,
1276,
1106,
2773,
1114,
2569,
3539,
4442,
1159,
119,
18581,
1708,
1110,
170,
3879,
1187,
4420,
2541,
8006,
1216,
1112,
11043,
117,
170,
14566,
6262,
16848,
3946,
173,
6834,
26420,
117,
19353,
13335,
1361,
117,
18418,
117,
19614,
117,
1105,
3712,
1757,
1121,
3539,
4442,
1329,
117,
1105,
1292,
3712,
2552,
8006,
1336,
1145,
1871,
1107,
10558,
3068,
1104,
1297,
119,
1799,
3712,
1757,
8006,
1107,
18581,
1708,
1132,
2620,
4321,
8057,
9363,
2916,
113,
174,
119,
176,
119,
117,
3232,
11039,
1329,
117,
27410,
3653,
2781,
114,
117,
1277,
1104,
1103,
3712,
1757,
8006,
1107,
18581,
1708,
1132,
1930,
1496,
1106,
7591,
1273,
174,
2497,
18876,
1891,
3718,
1106,
1515,
170,
3549,
1295,
1104,
14119,
1116,
1679,
2517,
1229,
1606,
3539,
5197,
119,
1967,
1277,
1104,
1103,
184,
11702,
8006,
2628,
1114,
18581,
1708,
8175,
1121,
12177,
7591,
174,
2497,
18876,
1891,
117,
8246,
3632,
1138,
1561,
1126,
3134,
18581,
1708,
3252,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
1110,
170,
3055,
1308,
3073,
6906,
26465,
2109,
118,
1714,
8246,
7591,
1115,
1110,
1682,
1106,
15491,
1103,
184,
11702,
2473,
112,
188,
15164,
1229,
7344,
18059,
1103,
2552,
119,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
1144,
145,
19694,
2064,
26459,
1204,
2815,
117,
1134,
1110,
1354,
1106,
11778,
1103,
3968,
112,
188,
12949,
1118,
14239,
13288,
1115,
2773,
3968,
23406,
119,
1799,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
1431,
1107,
2749,
4607,
1103,
8006,
1105,
2886,
1103,
3068,
1104,
1297,
1104,
4420,
1150,
1138,
18581,
1708,
117,
1142,
7300,
4048,
1144,
1870,
1106,
1129,
7289,
119,
1188,
3968,
1748,
4982,
1110,
1907,
1107,
1241,
2587,
118,
13753,
1105,
4321,
118,
13753,
6665,
132,
1649,
117,
1122,
1110,
10527,
1191,
5351,
25784,
170,
3719,
1206,
1103,
1160,
4267,
20080,
5026,
1158,
4069,
119,
6589,
117,
1103,
2425,
3007,
1104,
1142,
2025,
1110,
1106,
14240,
4420,
1150,
1138,
18581,
1708,
1105,
1106,
7299,
1172,
1114,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
1105,
4959,
1293,
2366,
1329,
1104,
1142,
3968,
15791,
170,
5351,
112,
188,
184,
11702,
2473,
8006,
1105,
2905,
3068,
1104,
1297,
119,
1188,
2025,
1209,
1248,
18206,
14133,
1103,
1160,
4267,
20080,
5026,
1158,
4069,
1106,
4959,
1191,
4420,
9353,
1141,
3442,
1166,
1103,
1168,
119,
2975,
13196,
3879,
2190,
3879,
18112,
9329,
2501,
12565,
2190,
2501,
12565,
6082,
9329,
1457,
11098,
18112,
9329,
2051,
19814,
2916,
9846,
9329,
3291,
1306,
11088,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
12278,
125,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
3156,
5909,
1249,
19638,
1880,
1902,
9108,
2235,
6136,
1398,
5174,
1209,
1129,
5165,
1114,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
119,
8636,
1209,
1838,
1114,
1103,
2587,
118,
13753,
1683,
1105,
1544,
1114,
1838,
1114,
1103,
4321,
118,
13753,
1683,
119,
12859,
26394,
1209,
6878,
1106,
1103,
1168,
18463,
1158,
5146,
1107,
1103,
2243,
1104,
1103,
2025,
119,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8353,
1902,
7739,
1158,
6136,
1130,
5710,
3121,
25524,
3864,
1209,
1129,
19970,
1106,
1103,
18463,
2553,
1372,
119,
12859,
26394,
1209,
1136,
1129,
19970,
1272,
1122,
1110,
1136,
1936,
1114,
1103,
18463,
2553,
22496,
119,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
4539,
27989,
10224,
1204,
10803,
23992,
10803,
5099,
1476,
10803,
2076,
2173,
4746,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
6115,
2091,
2217,
1752,
117,
1599,
18447,
118,
2091,
2217,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
12859,
26394,
7091,
2200,
1106,
1142,
1372,
1209,
6058,
1103,
2587,
118,
13753,
1683,
1104,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
1106,
4959,
1191,
1122,
6618,
27295,
8006,
2628,
1114,
3539,
2552,
10512,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
1981,
1372,
3107,
18447,
2091,
2217,
117,
1599,
6115,
2091,
2217,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
12859,
26394,
7091,
2200,
1106,
1142,
1372,
1209,
6058,
4321,
118,
13753,
1683,
1104,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
1106,
4959,
1191,
1122,
6618,
27295,
8006,
2628,
1114,
3539,
2552,
10512,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
9108,
2190,
9108,
9108,
2076,
13982,
9108,
1271,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
9108,
6136,
1188,
1110,
1126,
1166,
118,
1103,
118,
4073,
3073,
6906,
26465,
2109,
1714,
8246,
7591,
1115,
1169,
1129,
3310,
1120,
1211,
6989,
4822,
1105,
185,
7111,
1918,
9805,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
18447,
2091,
2217,
117,
1599,
6115,
2091,
2217,
6115,
2091,
2217,
1752,
117,
1599,
18447,
118,
2091,
2217,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
10999,
27073,
2162,
113,
13788,
1104,
18112,
9329,
1113,
5732,
2583,
114,
14801,
1104,
2583,
118,
6955,
12859,
25461,
2425,
9386,
6136,
13788,
1104,
18112,
9329,
1113,
5732,
2583,
113,
10999,
27073,
2162,
114,
6955,
3243,
1209,
1129,
2191,
118,
8318,
4828,
2716,
1106,
2437,
1293,
3252,
1114,
156,
6834,
5108,
1162,
145,
19429,
6108,
153,
2271,
6618,
170,
5351,
112,
188,
2912,
1106,
1250,
113,
121,
118,
1620,
3418,
1114,
1620,
1217,
4997,
1105,
121,
1217,
1436,
114,
119,
2425,
9386,
1159,
4207,
123,
2277,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
19909,
12120,
20080,
5026,
1158,
20569,
11689,
16792,
3718,
9386,
6136,
12859,
26394,
1209,
2592,
2480,
1152,
6349,
1103,
2587,
118,
13753,
4267,
20080,
5026,
1158,
3442,
1137,
1103,
4321,
118,
13753,
4267,
20080,
5026,
1158,
3442,
2258,
170,
2257,
3026,
2304,
24730,
113,
2257,
3026,
1114,
5351,
1217,
2320,
1106,
3368,
1191,
1152,
1176,
1103,
2587,
118,
13753,
4267,
20080,
5026,
1158,
3442,
1137,
1103,
4321,
118,
13753,
1618,
114,
119,
3718,
9386,
1159,
4207,
3847,
2114,
1120,
123,
2277,
3718,
9386,
4929,
152,
11702,
22017,
20012,
10146,
113,
11570,
17243,
114,
22171,
24730,
3718,
9386,
6136,
1109,
152,
11702,
22017,
20012,
10146,
113,
11570,
17243,
114,
1209,
1129,
2191,
118,
8318,
4828,
2716,
1106,
2437,
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full study rank 61347 study protocol section identification module n c t id NCT04837651 org study id info org study id VA26843 organization org full name Dragonfly Research, LLC org class OTHER brief title Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab Treated With Ocrelizumab or Natalizumab official title A Real World, Prospective, Single-center, Observational Study Comparing Humoral and T-Cell Responses to COVID-19 Vaccination in Multiple Sclerosis Patients Treated With Ocrelizumab or Natalizumab acronym OCR-VAX status module status verified date July 2021 overall status Completed expanded access info has expanded access No start date struct start date March 2, 2021 start date type Actual primary completion date struct primary completion date July 1, 2021 primary completion date type Actual completion date struct completion date July 1, 2021 completion date type Actual study first submit date March 16, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 26, 2021 last update post date struct last update post date August 2, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Dragonfly Research, LLC lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device Yes description module brief summary The primary goal of this study is to provide additional data regarding B and T-cell mediated responses to COVID-19 vaccines in MS patients treated with OCR and to determine which clinical and paraclinical variables correlating with vaccine immunogenicity. B-cell mediated humoral responses and adaptive T-cell mediated cellular responses were measured in patients treated with OCR who received any of the available SARS-CoV-2 vaccines, 3-4 weeks after completion of vaccination. detailed description The purpose of this study is to see if patients on ocrelizumab (Ocrevus) produce a humoral and T-cell response to the coronavirus vaccine. Ocrelizumab depletes B-lymphocytes and has the potential to reduce the effectiveness of vaccines. The impact of ocrelizumab treatment on coronavirus vaccines is unknown.
Natalizumab (Tysabri) likely has a minimal impact the efficacy of vaccines. In this study the investigators will take blood samples in patients being treated with either ocrelizumab or natalizumab before and after vaccination with an FDA-authorized coronavirus (COVID-19) vaccine and compare the antibody response in both groups. conditions module condition list condition Multiple Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes keyword list keyword COVID-19 Natalizumab Ocrelizumab Ocrevus Tysabri Antibody Coronavirus Vaccine design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 48 enrollment type Actual arms interventions module arm group list arm group arm group label Ocrelizumab Treated Multiple Sclerosis Patients arm group intervention list arm group intervention name Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test Device: T-Detect COVID T-cell blood test arm group label Natalizumab Treated Multiple Sclerosis Patients arm group intervention list arm group intervention name Device: Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test Device: T-Detect COVID T-cell blood test intervention list intervention intervention type Device intervention name Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test intervention description Subjects will receive an Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test within 4 weeks of receiving their first COVID-19 injection. Within 3-4 weeks of receipt of their final COVID-19 vaccine dose, subjects will receive another Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test. intervention arm group label list intervention arm group label Natalizumab Treated Multiple Sclerosis Patients Ocrelizumab Treated Multiple Sclerosis Patients intervention type Device intervention name T-Detect COVID T-cell blood test intervention description A select number of subjects will also receive a qualitative SARS-CoV-2 t-cell immunity test, the T-Detect COVID test, within 3-4 weeks of receipt of their final COVID-19 vaccine dose. intervention arm group label list intervention arm group label Natalizumab Treated Multiple Sclerosis Patients Ocrelizumab Treated Multiple Sclerosis Patients outcomes module primary outcome list primary outcome primary outcome measure SARS-CoV-2 B-cell response primary outcome description Production of SARS-CoV-2 antibodies in response to the COVID-19 vaccine in patients receiving treatment with ocrelizumab or natalizumab. primary outcome time frame Measured within 3-4 weeks of final COVID-19 vaccine dose primary outcome measure SARS-CoV-2 T-cell response primary outcome description Production of SARS-CoV-2 T-cell response to the COVID-19 vaccine in patients receiving treatment with ocrelizumab or natalizumab. primary outcome time frame Measured within 3-4 weeks of final COVID-19 vaccine dose eligibility module eligibility criteria Inclusion Criteria
Age 18-55
Diagnosis of multiple sclerosis (as per the revised 2017 criteria)
EDSS score of 0-5.5 inclusive
Has initiated ocrelizumab or natalizumab at least 6 months prior to study enrollment
For women of childbearing potential: agreement to remain abstinent or to use a highly effective (99% efficacy or greater) contraceptive method
Individual must be able to provide consent, read/write/comprehend English language or must be able to provide a consistent translator
Exclusion Criteria
Previous infection with COVID-19, confirmed by FDA approved testing
Cognitive impairment limiting the ability to consent or complete study procedures
Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding
Any prior use of immunosuppressive or chemotherapy treatment (including, but not limited to, cladribine, alemtuzumab, mycophenolate mofetil, cyclophosphamide, methotrexate, azathioprine)
Prior treatment with a B-cell depleting therapy other than ocrelizumab within 12 months of first on-study infusion excluding standard ocrelizumab pre-treatment therapy
Use of systemic corticosteroid therapy within 12 weeks of screening (excluding corticosteroid treatment given concurrently with ocrelizumab)
History of allergic reactions to vaccines healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years maximum age 55 Years std age list std age Adult study population Adult Multiple Sclerosis patients receiving treatment with natalizumab or ocrelizumab at the Elliot Lewis MS Center. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Joshua Katz, M.D. overall official affiliation Dragonfly Research, LLC overall official role Principal Investigator location list location location facility Dragonfly Research, LLC location city Wellesley location state Massachusetts location zip 02481 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000009103 condition mesh term Multiple Sclerosis condition mesh id D000009422 condition mesh term Nervous System Diseases condition mesh id D000003711 condition mesh term Demyelinating Diseases condition mesh id D000020274 condition mesh term Autoimmune Diseases of the Nervous System condition mesh id D000020278 condition mesh term Demyelinating Autoimmune Diseases, CNS condition mesh id D000001327 condition mesh term Autoimmune Diseases condition mesh id D000007154 condition mesh term Immune System Diseases condition mesh id D000012598 condition mesh term Sclerosis condition mesh id D000010335 condition mesh term Pathologic Processes condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition ancestor id D000056784 condition ancestor term Leukoencephalopathies condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition browse leaf list condition browse leaf condition browse leaf id M11212 condition browse leaf name Multiple Sclerosis condition browse leaf as found Multiple Sclerosis condition browse leaf relevance high condition browse leaf id M14567 condition browse leaf name Sclerosis condition browse leaf as found Sclerosis condition browse leaf relevance high condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M3781 condition browse leaf name Autoimmune Diseases condition browse leaf as found Autoimmune Diseases condition browse leaf relevance high condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf as found Immune System Diseases condition browse leaf relevance high condition browse leaf id M6061 condition browse leaf name Demyelinating Diseases condition browse leaf as found Demyelinating Diseases condition browse leaf relevance high condition browse leaf id M21247 condition browse leaf name Autoimmune Diseases of the Nervous System condition browse leaf as found Autoimmune Diseases of the Nervous System condition browse leaf relevance high condition browse leaf id M21251 condition browse leaf name Demyelinating Autoimmune Diseases, CNS condition browse leaf as found Demyelinating Autoimmune Diseases, CNS condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse leaf id M27744 condition browse leaf name Leukoencephalopathies condition browse leaf relevance low condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id D000000906 intervention mesh term Antibodies intervention ancestor list intervention ancestor intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M9336 intervention browse leaf name Immunoglobulins intervention browse leaf relevance low intervention browse leaf id M3377 intervention browse leaf name Antibodies intervention browse leaf as found Period intervention browse leaf relevance high intervention browse leaf id M16512 intervention browse leaf name Vaccines intervention browse leaf relevance low intervention browse leaf id M288912 intervention browse leaf name Ocrelizumab intervention browse leaf relevance low intervention browse leaf id M411 intervention browse leaf name Natalizumab intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04837651 | [
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full study rank 61602 study protocol section identification module n c t id NCT04834336 org study id info org study id 5883-GOA organization org full name Dokuz Eylul University org class OTHER brief title Inspiratory Muscle Training in Acute Decompensated Heart Failure official title Effects of Inspiratory Muscle Training in Patients With Acute Decompensated Heart Failure status module status verified date October 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date January 15, 2023 start date type Anticipated primary completion date struct primary completion date April 1, 2023 primary completion date type Anticipated completion date struct completion date April 1, 2024 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 30, 2022 last update post date struct last update post date November 1, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Aylin Tanriverdi responsible party investigator title Research assistant responsible party investigator affiliation Dokuz Eylul University lead sponsor lead sponsor name Dokuz Eylul University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Hospitalized patients with acute decompensated heart failure (ADHF) present a high prevalence of inspiratory muscle weakness on admission and discharge. Inspiratory muscle training has been reported as a beneficial approach in chronic heart failure. However, the effects of inspiratory muscle training in hospitalized patients with ADHF have been not known. The aim of this study is to investigate the safety, feasibility, and effects of inspiratory muscle training in hospitalized patients with ADHF. detailed description The participants will randomly be allocated into two groups: (1) Physical training plus inspiratory muscle training, (2) Physical training
Participants in the physical training plus inspiratory muscle training group will perform inspiratory muscle training and physical training. Inspiratory muscle training will be applied with an electronic device. Physical training will be implemented as balance, mobility, functional strength, endurance exercises. During the hospitalization, the inspiratory muscle training will be carried out twice a day with mild to moderate whereas physical training will be carried out once a day. The physical training group will perform only physical training. Physical training will be implemented as balance, mobility, functional strength, endurance exercises. During the hospitalization, physical training will be carried out once a day. For the safety and feasibility of inspiratory muscle training, data will be collected daily during the hospitalization. For effects of inspiratory muscle training, data will be collected at baseline and hospital discharge. conditions module condition list condition Acute Decompensated Heart Failure design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Participant enrollment info enrollment count 28 enrollment type Anticipated arms interventions module arm group list arm group arm group label Physical training plus inspiratory muscle training arm group type Experimental arm group description Inspiratory Muscle Training (IMT) will be implemented by using the Power Breathe® device. IMT training will begin with mild to moderate intensity of maximal inspiratory pressure. It will be performed 6 to 10 breaths, 4 sets, and twice daily during the hospitalization when as soon as hemodynamic stability is provided.
Physical Training will consist of each functional domain (balance, mobility, strength, and endurance) according to patients' functional levels. These will include static and dynamic balance training, mobility training, functional strength training focused on lower extremities, and endurance training as sustained walking. A daily 30 min session during the hospitalization will be performed with one-on-one supervision when as soon as hemodynamic stability is provided. arm group intervention list arm group intervention name Device: inspiratory muscle training device Other: Physical training arm group label Physical training arm group type Active Comparator arm group description Physical Training will consist of each functional domain (balance, mobility, strength, and endurance) according to patients' functional levels. These will include static and dynamic balance training, mobility training, functional strength training focused on lower extremities, and endurance training as sustained walking. A daily 30 min session during the hospitalization will be performed with one-on-one supervision when as soon as hemodynamic stability is provided. arm group intervention list arm group intervention name Other: Physical training intervention list intervention intervention type Device intervention name inspiratory muscle training device intervention description Inspiratory muscle training will be performed with an inspiratory muscle training device. intervention arm group label list intervention arm group label Physical training plus inspiratory muscle training intervention type Other intervention name Physical training intervention description Physical training will be performed with exercise including balance, mobility, functional strength, and endurance. intervention arm group label list intervention arm group label Physical training Physical training plus inspiratory muscle training outcomes module primary outcome list primary outcome primary outcome measure Maximal Inspiratory Pressure primary outcome description Maximal inspiratory pressure will be measured by an electronic mouth pressure device (cmH2O) primary outcome time frame baseline and hospital discharge, an average of 4 to 10 days secondary outcome list secondary outcome secondary outcome measure Adverse events secondary outcome description The number of adverse events resulting from the intervention will be noted. Adverse events include blood pressure greater than 170/100 mmHg, desaturation of oxygen greater than 4%, severe musculoskeletal and/or chest pain, dyspnea greater than 6 on the Borg scale, dizziness, nausea, vomiting, bleeding, loss or obstruction of the central or peripheral catheter. secondary outcome time frame During the hospitalization, daily, during an average of 4 to 10 days secondary outcome measure Recruitment rate secondary outcome description The number of participants divided by the total number of eligible patients (%) secondary outcome time frame During the hospitalization, daily, during an average of 4 to 10 days secondary outcome measure Adherence rate secondary outcome description The number of training sessions divided by the total number of potential sessions (%) secondary outcome time frame During the hospitalization, daily, during an average of 4 to 10 days secondary outcome measure Retention rate secondary outcome description The number of patients who complete the protocol divided by the total number of patients included in the study (%) secondary outcome time frame During the hospitalization, daily, during an average of 4 to 10 days secondary outcome measure New York Heart Association Functional Classification secondary outcome description Functional Classification will be assessed with New York Heart Association (NYHA) Functional Classification. The minimum value is 1 whereas the maximum value is 4. Higher scores indicate the lower functional class. secondary outcome time frame baseline and hospital discharge, an average of 4 to 10 days secondary outcome measure Dyspnea secondary outcome description Dyspnea will be assessed by using the Modified Medical Research Council Scale. It is a 5-item scale. Higher scores indicate higher dyspnea perception. secondary outcome time frame baseline and hospital discharge, an average of 4 to 10 days secondary outcome measure Hand Grip Strength secondary outcome description Hand grip strength will be measured by a dynamometer. secondary outcome time frame baseline and hospital discharge, an average of 4 to 10 days secondary outcome measure Physical Performance secondary outcome description Physical performance will be measured by Short Physical Performance Battery (SPPB). SPPB comprises 5 times sit-to-stand, standing balance and 4-m gait speed. The total score ranges from 0 to 12 and a higher score indicates better physical performance. secondary outcome time frame baseline and hospital discharge, an average of 4 to 10 days secondary outcome measure Frailty secondary outcome description Frailty will be assessed by using the Clinical Frailty Scale (CFS). CFS scores on a scale from 1 (very fit) to 9 (terminally ill). secondary outcome time frame baseline and hospital discharge, an average of 4 to 10 days secondary outcome measure Cardiac autonomic function secondary outcome description Cardiac autonomic function will be evaluated with heart rate variability analysis by using a SphygmoCor ® device. secondary outcome time frame baseline and hospital discharge, an average of 4 to 10 days secondary outcome measure Arterial Stiffness secondary outcome description Arterial stiffness will be measured by augmentation index using a SphygmoCor® device. secondary outcome time frame baseline and hospital discharge, an average of 4 to 10 days secondary outcome measure Disability secondary outcome description Disability will be assessed by using Barthel Index. It occurs 10 questions and the score ranges from 0 to 100. Higher scores indicate greater independence. secondary outcome time frame baseline and hospital discharge, an average of 4 to 10 days secondary outcome measure One-year mortality secondary outcome description The mortality rate during the first year following hospital discharge secondary outcome time frame one year after discharge eligibility module eligibility criteria Inclusion Criteria:
The management of a diagnosis of ADHF over 24 hours in a hospital setting
Hemodynamic stability
The independence of basic activities of daily life before admission
Exclusion Criteria:
Acute myocardial infarction
Congenital heart disease
Endocarditis, miyocarditis or pericarditis
Morbid obesity
Already participating in cardiac rehabilitation healthy volunteers No gender All minimum age 45 Years maximum age 85 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Aylin Tanriverdi central contact role Contact central contact phone +905352359989 central contact e mail tanrverdiaylin@gmail.com overall official list overall official overall official name Sema Savci, Prof overall official affiliation Dokuz Eylul University overall official role Study Director i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006333 condition mesh term Heart Failure condition ancestor list condition ancestor condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition browse leaf list condition browse leaf condition browse leaf id M8573 condition browse leaf name Heart Failure condition browse leaf as found Heart Failure condition browse leaf relevance high condition browse leaf id M26290 condition browse leaf name Respiratory Aspiration condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id T170 condition browse leaf name Acute Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases | NCT04834336 | [
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1302,
1838,
2236,
188,
23055,
1838,
2236,
1356,
1405,
117,
17881,
1495,
1838,
2236,
2076,
8329,
6617,
16963,
1181,
2425,
6026,
2236,
188,
23055,
2425,
6026,
2236,
1364,
122,
117,
17881,
1495,
2425,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
6026,
2236,
188,
23055,
6026,
2236,
1364,
122,
117,
17881,
1527,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
2025,
1148,
12295,
2236,
1364,
122,
117,
17881,
1475,
2025,
1148,
12295,
186,
172,
2236,
1364,
123,
117,
17881,
1475,
2025,
1148,
2112,
2236,
188,
23055,
2025,
1148,
2112,
2236,
1364,
129,
117,
17881,
1475,
2025,
1148,
2112,
2236,
2076,
2173,
4746,
1314,
11984,
12295,
2236,
1357,
1476,
117,
17881,
1477,
1314,
11984,
2112,
2236,
188,
23055,
1314,
11984,
2112,
2236,
1379,
122,
117,
17881,
1477,
1314,
11984,
2112,
2236,
2076,
2173,
4746,
10767,
24146,
13196,
2784,
1710,
2784,
1710,
2076,
8013,
1130,
5710,
3121,
25524,
1766,
2784,
1710,
17805,
1554,
1271,
138,
7777,
1394,
13880,
26999,
3309,
2784,
1710,
17805,
1641,
2713,
3109,
2784,
1710,
17805,
13494,
2091,
4786,
1584,
142,
7777,
4654,
1239,
1730,
10767,
1730,
10767,
1271,
2091,
4786,
1584,
142,
7777,
4654,
1239,
1730,
10767,
1705,
152,
24162,
9637,
20051,
13196,
1110,
175,
173,
170,
12521,
3850,
1302,
1110,
175,
173,
170,
12521,
4442,
1302,
6136,
13196,
4094,
14940,
3355,
2200,
4420,
1114,
12104,
1260,
8178,
11741,
28027,
1174,
1762,
4290,
113,
5844,
13561,
114,
1675,
170,
1344,
22760,
1104,
22233,
8508,
11412,
1183,
6484,
11477,
1113,
10296,
1105,
12398,
119,
1130,
20080,
5132,
6207,
6484,
2013,
1144,
1151,
2103,
1112,
170,
16250,
3136,
1107,
13306,
1762,
4290,
119,
1438,
117,
1103,
3154,
1104,
22233,
8508,
11412,
1183,
6484,
2013,
1107,
2704,
2200,
4420,
1114,
5844,
13561,
1138,
1151,
1136,
1227,
119,
1109,
6457,
1104,
1142,
2025,
1110,
1106,
8242,
1103,
3429,
117,
175,
14517,
7706,
117,
1105,
3154,
1104,
22233,
8508,
11412,
1183,
6484,
2013,
1107,
2704,
2200,
4420,
1114,
5844,
13561,
119,
6448,
6136,
1109,
6635,
1209,
19729,
1129,
11117,
1154,
1160,
2114,
131,
113,
122,
114,
10618,
2013,
4882,
22233,
8508,
11412,
1183,
6484,
2013,
117,
113,
123,
114,
10618,
2013,
4539,
27989,
21868,
1107,
1103,
2952,
2013,
4882,
22233,
8508,
11412,
1183,
6484,
2013,
1372,
1209,
3870,
22233,
8508,
11412,
1183,
6484,
2013,
1105,
2952,
2013,
119,
1130,
20080,
5132,
6207,
6484,
2013,
1209,
1129,
3666,
1114,
1126,
4828,
4442,
119,
10618,
2013,
1209,
1129,
7042,
1112,
5233,
117,
16178,
117,
8458,
3220,
117,
20655,
11536,
119,
1507,
1103,
2704,
2734,
117,
1103,
22233,
8508,
11412,
1183,
6484,
2013,
1209,
1129,
2446,
1149,
3059,
170,
1285,
1114,
10496,
1106,
8828,
6142,
2952,
2013,
1209,
1129,
2446,
1149,
1517,
170,
1285,
119,
1109,
2952,
2013,
1372,
1209,
3870,
1178,
2952,
2013,
119,
10618,
2013,
1209,
1129,
7042,
1112,
5233,
117,
16178,
117,
8458,
3220,
117,
20655,
11536,
119,
1507,
1103,
2704,
2734,
117,
2952,
2013,
1209,
1129,
2446,
1149,
1517,
170,
1285,
119,
1370,
1103,
3429,
1105,
175,
14517,
7706,
1104,
22233,
8508,
11412,
1183,
6484,
2013,
117,
2233,
1209,
1129,
4465,
3828,
1219,
1103,
2704,
2734,
119,
1370,
3154,
1104,
22233,
8508,
11412,
1183,
6484,
2013,
117,
2233,
1209,
1129,
4465,
1120,
2259,
2568,
1105,
2704,
12398,
119,
2975,
13196,
3879,
2190,
3879,
138,
23987,
13063,
4165,
11741,
28027,
1174,
4641,
143,
11922,
3313,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
8353,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
4539,
27989,
10224,
1204,
10803,
23992,
10803,
5099,
1743,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
10618,
2013,
4882,
22233,
8508,
11412,
1183,
6484,
2013,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1130,
20080,
5132,
6207,
19569,
1116,
10536,
5513,
113,
146,
13910,
114,
1209,
1129,
7042,
1118,
1606,
1103,
3794,
139,
18709,
1162,
28167,
4442,
119,
146,
13910,
2013,
1209,
3295,
1114,
10496,
1106,
8828,
7657,
1104,
12477,
23984,
22233,
8508,
11412,
1183,
2997,
119,
1135,
1209,
1129,
1982,
127,
1106,
1275,
13278,
117,
125,
3741,
117,
1105,
3059,
3828,
1219,
1103,
2704,
2734,
1165,
1112,
1770,
1112,
23123,
22320,
12881,
1596,
9397,
1110,
2136,
119,
10618,
5513,
1209,
8296,
1104,
1296,
8458,
5777,
113,
5233,
117,
16178,
117,
3220,
117,
1105,
20655,
114,
2452,
1106,
4420,
112,
8458,
3001,
119,
1636,
1209,
1511,
12182,
1105,
9652,
5233,
2013,
117,
16178,
2013,
117,
8458,
3220,
2013,
3378,
1113,
2211,
4252,
7877,
9084,
1905,
117,
1105,
20655,
2013,
1112,
8505,
3179,
119,
138,
3828,
1476,
11241,
4912,
1219,
1103,
2704,
2734,
1209,
1129,
1982,
1114,
1141,
118,
1113,
118,
1141,
10955,
1165,
1112,
1770,
1112,
23123,
22320,
12881,
1596,
9397,
1110,
2136,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
15545,
2093,
131,
22233,
8508,
11412,
1183,
6484,
2013,
4442,
2189,
131,
10618,
2013,
1981,
1372,
3107,
10618,
2013,
1981,
1372,
2076,
17244,
3291,
8223,
4626,
2772,
1981,
1372,
6136,
10618,
5513,
1209,
8296,
1104,
1296,
8458,
5777,
113,
5233,
117,
16178,
117,
3220,
117,
1105,
20655,
114,
2452,
1106,
4420,
112,
8458,
3001,
119,
1636,
1209,
1511,
12182,
1105,
9652,
5233,
2013,
117,
16178,
2013,
117,
8458,
3220,
2013,
3378,
1113,
2211,
4252,
7877,
9084,
1905,
117,
1105,
20655,
2013,
1112,
8505,
3179,
119,
138,
3828,
1476,
11241,
4912,
1219,
1103,
2704,
2734,
1209,
1129,
1982,
1114,
1141,
118,
1113,
118,
1141,
10955,
1165,
1112,
1770,
1112,
23123,
22320,
12881,
1596,
9397,
1110,
2136,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
10618,
2013,
9108,
2190,
9108,
9108,
2076,
15545,
2093,
9108,
1271,
22233,
8508,
11412,
1183,
6484,
2013,
4442,
9108,
6136,
1130,
20080,
5132,
6207,
6484,
2013,
1209,
1129,
1982,
1114,
1126,
22233,
8508,
11412,
1183,
6484,
2013,
4442,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
10618,
2013,
4882,
22233,
8508,
11412,
1183,
6484,
2013,
9108,
2076,
2189,
9108,
1271,
10618,
2013,
9108,
6136,
10618,
2013,
1209,
1129,
1982,
1114,
6730,
1259,
5233,
117,
16178,
117,
8458,
3220,
117,
1105,
20655,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
10618,
2013,
10618,
2013,
4882,
22233,
8508,
11412,
1183,
6484,
2013,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
25217,
1348,
1130,
20080,
5132,
6207,
2544,
3313,
2425,
9386,
6136,
25217,
1348,
22233,
8508,
11412,
1183,
2997,
1209,
1129,
7140,
1118,
1126,
4828,
1779,
2997,
4442,
113,
3975,
3048,
1477,
2346,
114,
2425,
9386,
1159,
4207,
2259,
2568,
1105,
2704,
12398,
117,
1126,
1903,
1104,
125,
1106,
1275,
1552,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
24930,
10840,
1958,
3718,
9386,
6136,
1109,
1295,
1104,
16798,
1958,
3694,
1121,
1103,
9108,
1209,
1129,
2382,
119,
24930,
10840,
1958,
1511,
1892,
2997,
3407,
1190,
10837,
120,
1620,
2608,
3048,
1403,
117,
3532,
2980,
23022,
1104,
7621,
3407,
1190,
125,
110,
117,
5199,
182,
1361,
10182,
8867,
13622,
21470,
1105,
120,
1137,
2229,
2489,
117,
173,
6834,
1643,
25362,
3407,
1190,
127,
1113,
1103,
9326,
10805,
3418,
117,
4267,
15284,
1757,
117,
22882,
117,
26979,
1158,
117,
9793,
117,
2445,
1137,
184,
4832,
17993,
1104,
1103,
2129,
1137,
17963,
5855,
4638,
2083,
119,
3718,
9386,
1159,
4207,
1507,
1103,
2704,
2734,
117,
3828,
117,
1219,
1126,
1903,
1104,
125,
1106,
1275,
1552,
3718,
9386,
4929,
11336,
1665,
27975,
1880,
2603,
3718,
9386,
6136,
1109,
1295,
1104,
6635,
3233,
1118,
1103,
1703,
1295,
1104,
7408,
4420,
113,
110,
114,
3718,
9386,
1159,
4207,
1507,
1103,
2704,
2734,
117,
3828,
117,
1219,
1126,
1903,
1104,
125,
1106,
1275,
1552,
3718,
9386,
4929,
24930,
21634,
2603,
3718,
9386,
6136,
1109,
1295,
1104,
2013,
6887,
3233,
1118,
1103,
1703,
1295,
1104,
3209,
6887,
113,
110,
114,
3718,
9386,
1159,
4207,
1507,
1103,
2704,
2734,
117,
3828,
117,
1219,
1126,
1903,
1104,
125,
1106,
1275,
1552,
3718,
9386,
4929,
11336,
5208,
2116,
2603,
3718,
9386,
6136,
1109,
1295,
1104,
4420,
1150,
2335,
1103,
11309,
3233,
1118,
1103,
1703,
1295,
1104,
4420,
1529,
1107,
1103,
2025,
113,
110,
114,
3718,
9386,
1159,
4207,
1507,
1103,
2704,
2734,
117,
3828,
117,
1219,
1126,
1903,
1104,
125,
1106,
1275,
1552,
3718,
9386,
4929,
1203,
1365,
4641,
1791,
16068,
17264,
19295,
3718,
9386,
6136,
16068,
17264,
19295,
1209,
1129,
14758,
1114,
1203,
1365,
4641,
1791,
113,
5883,
11612,
114,
16068,
17264,
19295,
119,
1109,
5867,
2860,
1110,
122,
6142,
1103,
4177,
2860,
1110,
125,
119,
7715,
7432,
5057,
1103,
2211,
8458,
1705,
119,
3718,
9386,
1159,
4207,
2259,
2568,
1105,
2704,
12398,
117,
1126,
1903,
1104,
125,
1106,
1275,
1552,
3718,
9386,
4929,
141,
6834,
1643,
25362,
3718,
9386,
6136,
141,
6834,
1643,
25362,
1209,
1129,
14758,
1118,
1606,
1103,
12556,
22293,
3875,
2713,
1761,
20334,
119,
1135,
1110,
170,
126,
118,
8926,
3418,
119,
7715,
7432,
5057,
2299,
173,
6834,
1643,
25362,
11170,
119,
3718,
9386,
1159,
4207,
2259,
2568,
1105,
2704,
12398,
117,
1126,
1903,
1104,
125,
1106,
1275,
1552,
3718,
9386,
4929,
9918,
144,
16669,
1457,
5123,
27116,
3718,
9386,
6136,
9918,
5688,
3220,
1209,
1129,
7140,
1118,
170,
173,
21880,
3702,
19401,
119,
3718,
9386,
1159,
4207,
2259,
2568,
1105,
2704,
12398,
117,
1126,
1903,
1104,
125,
1106,
1275,
1552,
3718,
9386,
4929,
10618,
6724,
3718,
9386,
6136,
10618,
2099,
1209,
1129,
7140,
1118,
6373,
10618,
6724,
11537,
113,
16625,
2101,
2064,
114,
119,
16625,
2101,
2064,
8302,
126,
1551,
3465,
118,
1106,
118,
2484,
117,
2288,
5233,
1105,
125,
118,
182,
176,
21263,
2420,
119,
1109,
1703,
2794,
9123,
1121,
121,
1106,
1367,
1105,
170,
2299,
2794,
6653,
1618,
2952,
2099,
119,
3718,
9386,
1159,
4207,
2259,
2568,
1105,
2704,
12398,
117,
1126,
1903,
1104,
125,
1106,
1275,
1552,
3718,
9386,
4929,
13359,
11922,
2340,
3718,
9386,
6136,
13359,
11922,
2340,
1209,
1129,
14758,
1118,
1606,
1103,
15961,
13359,
11922,
2340,
20334,
113,
18802,
1708,
114,
119,
18802,
1708,
7432,
1113,
170,
3418,
1121,
122,
113,
1304,
4218,
114,
1106,
130,
113,
6020,
1193,
5178,
114,
119,
3718,
9386,
1159,
4207,
2259,
2568,
1105,
2704,
12398,
117,
1126,
1903,
1104,
125,
1106,
1275,
1552,
3718,
9386,
4929,
10103,
12571,
12365,
2728,
7257,
3053,
3718,
9386,
6136,
10103,
12571,
12365,
2728,
7257,
3053,
1209,
1129,
17428,
1114,
1762,
2603,
15661,
26468,
3622,
1118,
1606,
170,
156,
22192,
1403,
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] |
full study rank 61793 study protocol section identification module n c t id NCT04831853 org study id info org study id RBHP 2020 MOISSET 2 secondary id info list secondary id info secondary id 2020-A02913-36 secondary id type Other Identifier secondary id domain ANSM organization org full name University Hospital, Clermont-Ferrand org class OTHER brief title Self- Versus Conventional-swabbing for COVID-19 Screening (COVISWAB) official title Comparison for Sensitivity and Tolerance of Self-swabbing and Conventional Nasopharyngeal Swabbing for SARS-CoV-2 Detection for Pain, Discomfort and Acceptability: a Randomized Controlled Non-inferiority Study acronym COVISWAB status module status verified date March 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 2021 start date type Anticipated primary completion date struct primary completion date October 2021 primary completion date type Anticipated completion date struct completion date December 2021 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name University Hospital, Clermont-Ferrand lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Self-swabbing requires less personal protective equipment and could allow to test more people and even to do quick self-diagnosis if antigenic tests are available.
In a preliminary study on 190 medical students, the investigators have shown that self and conventional swabbing were identically well-accepted with equivalent level of pain and discomfort induced by swabbing. In a sub-group of this sample, the investigators have shown that the quality of the 2 sampling methods were equivalent.
The goal of this large study in the general population is to confirm these findings in an adequately powered study. Such results would allow to develop self-swabbing for large screening campaigns and eventually self-diagnosis using antigenic tests. detailed description All consecutive subjects coming to the 2 dedicated centers for COVID-19 screening in Clermont-Ferrand University hospital (one for medical students and one for the general population) will be asked to be included in the present study. They will be randomly assigned to either supervised self-swabbing followed by conventional swabbing led by a healthcare professional or the other way round.
All the subjects will have to complete a brief questionnaire including demographical characteristics (age, sex, height, weight, eye color), potential symptoms (asthenia, fever, anosmia…) anticipated pain and discomfort and previous nasopharyngeal swabbing experience. Pain, discomfort and overall acceptability of the procedure will be completed just after completion of the swabbing. conditions module condition list condition Covid19 keyword list keyword SARS-CoV-2 COVID-19 Nasopharyngeal swabbing Self-swabbing pain Sensitivity design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design intervention model description Randomized sequence of supervised self-swabbing and conventional swabbing for SARS-CoV-2 screening design primary purpose Diagnostic design masking info design masking None (Open Label) enrollment info enrollment count 400 enrollment type Anticipated arms interventions module arm group list arm group arm group label Supervised self-swabbing followed by conventional swabbing arm group type Experimental arm group description the subjects will first benefit from a 5 minutes explanation on how to perform self-swabbing and will then performed the swabbing under the supervision of a trained healthcare professional arm group intervention list arm group intervention name Other: nasopharyngeal swabbing procedure (self swabbing first) arm group label Conventional swabbing followed by supervised self-swabbing arm group type Experimental arm group description the subject will undergo conventional nasopharyngeal swabbing performed by a trained healthcare professional first. arm group intervention list arm group intervention name Other: nasopharyngeal swabbing procedure (conventionnal swabbing first) intervention list intervention intervention type Other intervention name nasopharyngeal swabbing procedure (self swabbing first) intervention description Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing intervention arm group label list intervention arm group label Supervised self-swabbing followed by conventional swabbing intervention type Other intervention name nasopharyngeal swabbing procedure (conventionnal swabbing first) intervention description patient undergoes conventionnal swabbing first then realises the nasal swabbing himself intervention arm group label list intervention arm group label Conventional swabbing followed by supervised self-swabbing outcomes module primary outcome list primary outcome primary outcome measure Non-inferiority of self-swabbing compared to conventional swabbing concerning diagnosis sensitivity primary outcome description assessed using consistency of COVID-19 RT-PCR results for both sampling modalities (Self- swabbing versus conventional-swabbing). If non-inferiority is confirmed on this criterion, pain will be tested. primary outcome time frame 5 minutes after the end of the procedure of nasopharyngeal swabbing secondary outcome list secondary outcome secondary outcome measure Correlation between age, sex and swabbing-induced pain secondary outcome description Score on the pain numeric rating scale (0 to 10; higher scores meaning more pain) secondary outcome time frame 5 minutes after the end of the procedure secondary outcome measure Correlation between eye color and swabbing-induced pain secondary outcome description Eye-color self-reported by the subject on a validated 14 item scale and pain score on the numeric rating scale (NRS) (0 to 10; higher scores meaning more pain) secondary outcome time frame 5 minutes after the end of the procedure secondary outcome measure Correlation between eye color and swabbing-induced discomfort secondary outcome description Eye-color self-reported by the subject on a validated 14 item scale and discomfort score on numeric rating scale (0 to 10; higher scores meaning more discomfort) secondary outcome time frame 5 minutes after the end of the procedure secondary outcome measure Correlation between symptoms (fever, headache, asthenia, anosmia, agueusia, cough, dyspnea, muscle pain, sore throat, diarrhea) and swabbing-induced pain secondary outcome description symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain) secondary outcome time frame 5 minutes after the end of the procedure secondary outcome measure Correlation between body mass index and swabbing-induced pain secondary outcome description symptoms self-reported by the subject and pain score on numeric rating scale (0 to 10; higher scores meaning more pain) secondary outcome time frame 5 minutes after the end of the procedure secondary outcome measure Correlation between anticipated pain and actual pain secondary outcome description anticipated and actual pain self-reported on numeric rating scale (0 to 10; higher scores meaning more pain) secondary outcome time frame 5 minutes after the end of the procedure secondary outcome measure Correlation between anticipated discomfort and actual discomfort. secondary outcome description anticipated and actual discomfort self-reported on numeric rating scale (0 to 10; higher scores meaning more pain) secondary outcome time frame 5 minutes after the end of the procedure secondary outcome measure Richness assessment for respiratory cells secondary outcome description Ct value of beta-globin gene secondary outcome time frame Day 0 secondary outcome measure Non-inferiority of self-swabbing compared to conventional swabbing concerning pain secondary outcome description assessed using a Numerical Rating Scale (0 indicating no pain and 10 the worst imaginable pain). If non-inferiority is confirmed on this criterion, discomfort will be tested secondary outcome time frame 5 minutes after the end of the procedure of nasopharyngeal swabbing secondary outcome measure Non-inferiority of self-swabbing compared to conventional swabbing concerning pain discomfort secondary outcome description assessed using a Numerical Rating Scale (0 indicating no discomfort and 10 the worst imaginable discomfort). If non-inferiority is confirmed on this criterion, acceptability will be tested secondary outcome time frame 5 minutes after the end of the procedure of nasopharyngeal swabbing secondary outcome measure Non-inferiority of self-swabbing compared to conventional swabbing concerning acceptability secondary outcome description assessed using a Numerical Rating Scale (0 indicating that the procedure is not acceptable at all and 10 that the procedure is perfectly well accepted). secondary outcome time frame 5 minutes after the end of the procedure of nasopharyngeal swabbing eligibility module eligibility criteria Inclusion Criteria:
Any subject coming for nasopharyngeal swabbing for SARS-CoV-2 screening
Fluent in French (both oral and written)
Able to give an eclaired consent
Exclusion Criteria:
Contra-indication to nasopharyngeal swabbing
Refusal to participate
Pregnant women healthy volunteers Accepts Healthy Volunteers gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Lise LACLAUTRE central contact role Contact central contact phone +33473754963 central contact e mail promo_interne_drci@chu-clermontferrand.fr overall official list overall official overall official name Xavier MOISSET overall official affiliation University Hospital, Clermont-Ferrand overall official role Principal Investigator location list location location facility CHU de Clermont-Ferrand location city Clermont-Ferrand location zip 63000 location country France location contact list location contact location contact name Lise Laclautre location contact role Contact location contact phone +33473754963 location contact e mail promo_interne_drci@chu-clermontferrand.fr location contact name Xavier Moisset location contact role Principal Investigator location contact name Jean Beytout location contact role Sub-Investigator location contact name Cécile Henquell location contact role Sub-Investigator location contact name Laurent Gerbaud location contact role Sub-Investigator location contact name Claire Aumerand location contact role Sub-Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9170 condition browse leaf name Hypersensitivity condition browse leaf relevance low condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology | NCT04831853 | [
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full study rank 61559 study protocol section identification module n c t id NCT04834895 org study id info org study id 09.2019.1056 organization org full name Marmara University org class OTHER brief title Investigation of the Effectivenes of Digital Based Exercises in Patients With Neck Pain official title Investigation of the Effectivenes of Digital Based Exercises in Patients With Neck Pain status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date February 1, 2021 start date type Actual primary completion date struct primary completion date July 20, 2021 primary completion date type Anticipated completion date struct completion date July 30, 2021 completion date type Anticipated study first submit date February 21, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Eda Tonga responsible party investigator title Doctor of Philosopy responsible party investigator affiliation Marmara University lead sponsor lead sponsor name Marmara University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary In study, the researchers examine the effectiveness of digital-based exercises in patients with chronic neck pain.The planned study has 2 main objectives:
Increase exercise adherence with mhealth apps.
To reduce pain and disability of patients with chronic neck pain. detailed description Neck pain is one of the most common musculoskeletal diseases after low back pain in the community. The incidence of neck pain was reported as %37,2. Neck pain can be caused by trauma, poor posture, degenerative diseases, tumors, muscle stress, wiplash injuries, cervical myelopathy, cervical ligamentous instability, fracture, vascular insufficiency or systemic diseases. Neck pain is classified as acute (less than six weeks), subacute (six to twelve weeks) or chronic (lasting more than twelve weeks). While neck pain is treated in physiotherapy clinics, it is also supported by home exercises during and after treatment.
It is emphasized that home exercise programs for neck pain are effective, but exercise adherence is an important factor. Nowadays, with the rapid development of mobile healthcare applications, digital based exercise applications have started to be used in physiotherapy and rehabilitation. Although it has been shown to be useful in studies examining the effectiveness of mHealth applications for different musculoskeletal problems, these studies are quite limited. Several studies have identified the beneficial effects of digital-based exercises, but no clear evidence of superiority over written or oral home exercise programs. In 2019, a mobile exercise application (Neck Exercise) for neck pain patients was developed as a thesis study at Marmara University Health Sciences Institute. The availability of this mobile application is shown on healthy people. However, its efficacy has not been studied in patients with chronic neck pain. This mobile app includes for the neck spinal stabilization , posture, breathing exercises and exercises for scapula circumference. Each exercise is explained with video. In addition, this application gives reminder signals at user-defined time intervals. Participants with chronic neck pain aged between 18-65 years will be included in the study and randomly divided into two groups. One group will be given home exercises via brochure to the other group via mobile application. Participants will be asked to do home exercises 3 days a week for 6 weeks. Pain, disability and exercise adherence of the participants will be evaluated. The Nordic Musculoskeletal Questionnaire, VAS, neck disability index and exercise adherence scale will be used in the evaluation. Our thesis will be the first study examining the effect of a mobile application developed for neck pain on adherence to home exercises. As a result of study, the researchers aim to save paper by prescribing home exercise programs via mobile application and to promote a platform where users can better understand the exercises. conditions module condition list condition Neck Pain keyword list keyword Neck pain exercise digital health mHealth adherence design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Single design who masked list design who masked Outcomes Assessor enrollment info enrollment count 60 enrollment type Anticipated arms interventions module arm group list arm group arm group label mhealth exercise group arm group type Active Comparator arm group description home exercise program is given to patients via mobile application arm group intervention list arm group intervention name Other: mhealth exercise group arm group label brochure exercise group arm group type Experimental arm group description home exercise program is given to patients via brochure arm group intervention list arm group intervention name Other: brochure exercise group intervention list intervention intervention type Other intervention name mhealth exercise group intervention description Participants were asked to perform 18 exercises specially prepared for neck pain in the M.ü Neck Exercises application according to the number of repetitions specified in the application.Participants will be asked to do home exercises 3 days a week for 6 weeks intervention arm group label list intervention arm group label mhealth exercise group intervention type Other intervention name brochure exercise group intervention description Participants were asked to perform 18 exercises specially prepared for neck pain in the brochure according to the number of repetitions specified in the application.Participants will be asked to do home exercises 3 days a week for 6 weeks intervention arm group label list intervention arm group label brochure exercise group outcomes module primary outcome list primary outcome primary outcome measure Change from Visual Analog Scale (VAS) score at 6 Weeks primary outcome description VAS is the most commonly used method to assess pain intensity. The leftmost value in the 10 cm horizontal line used for VAS is scored between 0 cm (no pain) and the rightmost value is between 10 cm (unbearable pain) (Boonstra, Schiphorst Preuper et al. 2008). Measurements were recorded at the beginning and end of exercise training for both groups. primary outcome time frame Baseline and Week 6 primary outcome measure Change from Exercise Adherence Scale Points at 6 Weeks primary outcome description It consists of four yes / no questions.'Yes' answer is rated with 1 point, 'No' answer gets 0 point. Lesser scores indicate good exercise adherence. primary outcome time frame Baseline and Week 6 secondary outcome list secondary outcome secondary outcome measure Change from Neck Pain and Disability Index Points at 6 Weeks secondary outcome description Neck pain and disability balance consist of 20 items. Scoring of each item is done with a 10 cm visual analog scale and scored between 0 and 5 points. The Turkish version study of Biçer et al. Whose reliability and validity has been proven. It was made by (Biçer 2004). The items evaluate the severity of pain and the effect of pain on professional, recreational, social, daily life activities and their relationship with emotional factors. Thus, it measures the effects of neck pain on functionality, quality of life and disability. The total score is the sum of the points in each item and ranges from 0 to 100. The score evaluation was carried out as follows (Buko 2013).
0-4: no problem 5-14: mild severity problem 15-24: moderate severity problem 25-34: severe problem 35 and above: very severe problem secondary outcome time frame Baseline and Week 6 other outcome list other outcome other outcome measure Change from The Nordic Musculoskeletal Questionnaire at 6 Weeks other outcome description It is used to question musculoskeletal disorders. The Nordic Musculoskeletal Questionnaire, reliable information about the onset, prevalence and outcome of musculoskeletal pain in nine body areas (neck, shoulders, back, elbows, wrists / hands, waist, hips / thighs, knees, ankles / feet) Provider is a questionnaire that can be filled in by self or personal interview technique. The Nordic Musculoskeletal Questionnaire is a measure that can be used for musculoskeletal pain and related conditions in studies conducted in general and / or general communities. The Scandinavian musculoskeletal system query questions yes / no . other outcome time frame Baseline and Week 6 eligibility module eligibility criteria Inclusion Criteria:
Neck pain that has been going on for at least 3 months
Participant can use smart phone,
No problem affecting reading and answering survey questions
Exclusion Criteria:
Presence of visual and auditory problems that may prevent the use of the smartphone application
Torticollis
Vertigo
Pregnancy
Additional diseases such as vertebrobasilar insufficiency, heart failure, chronic heart disease and hypertension
Dementia
Inflammatory rheumatic disease
Psychosis and neurological disease diagnosis
Receiving another treatment or having surgery in 3 months
Exposure to any neck trauma in the past 6 months
A past or ongoing cancer history healthy volunteers No gender All minimum age 18 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Eda TONGA central contact role Contact central contact phone 90 216 330 20 70 central contact e mail eda.tonga@marmara.edu.tr location list location location facility Marmara University location status Recruiting location city Istanbul location country Turkey location contact list location contact location contact name Eda TONGA location contact role Contact location contact e mail eda.tonga@marmara.edu.tr derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000019547 condition mesh term Neck Pain condition ancestor list condition ancestor condition ancestor id D000010146 condition ancestor term Pain condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M20638 condition browse leaf name Neck Pain condition browse leaf as found Neck Pain condition browse leaf relevance high condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases | NCT04834895 | [
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full study rank 61546 study protocol section identification module n c t id NCT04835064 org study id info org study id CSPAC-4 organization org full name Fudan University org class OTHER brief title Pancreatic Cancer With Elevated Serum CA125 Were Compared With Those Who Did Not Receive Neoadjuvant Chemotherapy. official title A Phase III, Multicenter, Prospective, Randomized, Patients With Resectable Pancreatic Cancer With Elevated Serum CA125 Were Compared With Those Who Did Not Receive Neoadjuvant Chemotherapy. status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 1, 2021 start date type Anticipated primary completion date struct primary completion date April 1, 2024 primary completion date type Anticipated completion date struct completion date December 1, 2024 completion date type Anticipated study first submit date April 2, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Xian-Jun Yu responsible party investigator title President of Shanghai Pancreatic Cancer Institute responsible party investigator affiliation Fudan University lead sponsor lead sponsor name Fudan University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The main purpose of
To observe the overall survival of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy A secondary purpose
To observe relapse-free survival in patients with resectable pancreatic cancer with elevated serum CA125 versus without neoadjuvant chemotherapy
To observe the resectable rate of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy
To observe the safety parameters of patients with resectable pancreatic cancer with or without neoadjuvant chemotherapy with elevated serum CA125 detailed description This study is a prospective, multicenter, randomized, controlled Ⅲ period clinical trials.A total of 600 patients with resectable pancreatic cancer assessed by imaging and serum CA125≥35 U/mL were randomly assigned according to the ratio of 1:1 (300 cases: 300 cases) between the direct surgical resection group and the neoadjuvant chemotherapy group, to observe the efficacy and safety of patients with resectable pancreatic cancer with elevated serum CA125 with or without neoadjuvant chemotherapy.Neoadjuvant chemotherapy and adjuvant chemotherapy can use albumin-binding paclitaxel combined with gemcitabine (AG) regimen or mFOLFirinox (5-FU, calcium leucofolate [LV], irinotecan, oxaliplatin) regimen. AG regimen was given on day 1, 8, 15, and repeated every 4 weeks.The mFOLFIRINOX regimen was administered on days 1 and 15 and repeated every 4 weeks.Patients in the neoadjuvant chemotherapy group were treated with 4 courses of neoadjuvant chemotherapy (AG regimen or mFOLFIRINOX regimen) immediately after the pathologic diagnosis of pancreatic adenocarcinoma was confirmed by puncture.Patients receiving neoadjuvant chemotherapy will undergo surgical exploration to assess the resectability of the tumor.Four to eight weeks after radical resection, the patients were treated with adjuvant chemotherapy from the recovery of surgical trauma. The choice of adjuvant chemotherapy after surgery depended on the response to neoadjuvant chemotherapy.If neoadjuvant chemotherapy is effective, adjuvant chemotherapy will maintain the original regimen;If neoadjuvant chemotherapy is ineffective but radical surgery is still feasible, adjuvant chemotherapy will be used with a crossover regimen.Neoadjuvant chemotherapy group received adjuvant chemotherapy for 2 courses.In the direct surgical resection group, 6 courses of adjuvant chemotherapy were started 4 to 8 weeks after radical resection.Relevant examinations should be conducted before and after each course of medication to evaluate safety events. Imaging reexaminations should be conducted every 2 courses of medication, and imaging reexaminations should be conducted every 3 months during follow-up to evaluate disease recurrence. conditions module condition list condition Pancreatic Adenocarcinoma design module study type Interventional phase list phase Phase 3 design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Triple design who masked list design who masked Participant Care Provider Investigator enrollment info enrollment count 600 enrollment type Anticipated arms interventions module arm group list arm group arm group label Nab-paclitaxel and Gemcitabine arm group type Experimental arm group description Albumin combined with paclitaxel 125mg/m2 intravenous infusion, Day 1, 8, 15;Gemcitabine 1000 mg/m2 was given intravenously for more than 30min on days 1, 8, and 15, and repeated every 4 weeks. arm group intervention list arm group intervention name Drug: Nab paclitaxel Drug: Gemcitabine arm group label mFOLFIRINOX arm group type Experimental arm group description Oxaliplatin 85 mg/m2 intravenous infusion for 2 h, Day 1;LV 400 mg/m2 intravenous infusion for 2 h, Day 1;Irinotecan 150 mg/m2 was added 30 min after intravenous infusion for 90 min, day 1;This was immediately followed by a continuous intravenous infusion of 5-FU 2400 mg/m2 for 46 h.Repeat every 2 weeks. arm group intervention list arm group intervention name Drug: mFOLFIRINOX intervention list intervention intervention type Drug intervention name Nab paclitaxel intervention description Albumin combined with paclitaxel 125mg/m2 intravenous infusion, Day 1, 8, 15 intervention arm group label list intervention arm group label Nab-paclitaxel and Gemcitabine intervention other name list intervention other name Abraxane intervention type Drug intervention name Gemcitabine intervention description Intravenous infusion of 1000 mg/m2 was given for more than 30min on days 1, 8, and 15, and repeated every 4 weeks intervention arm group label list intervention arm group label Nab-paclitaxel and Gemcitabine intervention other name list intervention other name Gemzar intervention type Drug intervention name mFOLFIRINOX intervention description Oxaliplatin 85 mg/m2 intravenous infusion for 2 h, Day 1;LV 400 mg/m2 intravenous infusion for 2 h, Day 1;Irinotecan 150 mg/m2 was added 30 min after intravenous infusion for 90 min, day 1;This was immediately followed by a continuous intravenous infusion of 5-FU 2400 mg/m2 for 46 h.Repeat every 2 weeks. intervention arm group label list intervention arm group label mFOLFIRINOX intervention other name list intervention other name modified FOLFIRINOX regimen outcomes module primary outcome list primary outcome primary outcome measure overall survival primary outcome description • To observe the overall survival of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy primary outcome time frame from randomization to death, up to 36 months secondary outcome list secondary outcome secondary outcome measure Relapse-free survival secondary outcome description To observe the relapse-free survival of patients with resectable pancreatic cancer with elevated serum CA125 versus without neoadjuvant chemotherapy secondary outcome time frame from randomization to recurrence, up to 36 months secondary outcome measure Surgical excision rate secondary outcome description • To observe the resectable rate of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy secondary outcome time frame from randomization to recurrence, up to 36 months secondary outcome measure Incidence of adverse events secondary outcome description • To observe the Incidence of adverse events of patients with resectable pancreatic cancer with or without neoadjuvant chemotherapy with elevated serum CA125 secondary outcome time frame from randomization to recurrence, up to 36 months eligibility module eligibility criteria Inclusion Criteria:
Voluntarily participate and sign the informed consent;
Age ≥18 years old and ≤75 years old, no gender limitation;
ECOG score ≤1;
Imaging evaluation of resectable pancreatic cancer, serum CA125≥35 U/mL;
pancreatic adenocarcinoma confirmed by pathology after pancreatic puncture or surgery;
No distant metastasis, malignant abdominal effusion or pleural effusion before neoadjuvant chemotherapy;Postoperative baseline chest, abdomen and pelvis CT showed no tumor metastasis/recurrence.
Expected survival ≥3 months;
No serious hematopoietic dysfunction, abnormal functions of heart, lung, liver and kidney and immune deficiency were observed. The laboratory test results met the following criteria: blood routine indicators: white blood cell (WBC) ≥3×109/L;Absolute neutrophils count (ANC) ≥1.5×109/L;Platelet (PLT) ≥100×109/L;Hemoglobin (HGB) ≥9g/dL;Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤2.5× upper limit of normal value (ULN);Total bilirubin (TBil) ≤ULN;Serum creatinine (CRE) ≤1.5×ULN;Coagulation function: Prothrombin time (PT), international standardized ratio (INR) ≤1.5×ULN;
the willingness of women with potential fertility to use medically approved contraceptives in the trial;
Able to follow the research visit plan and other program requirements.
Exclusion Criteria:
Patients had received any type of anti-tumor therapy before enrolment, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy;
have central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other uncontrollable serious diseases;
Uncontrolled infection, bleeding, pancreatic leakage, bile leakage, or other postoperative complications at baseline;Acute and chronic metabolic acidosis (including ketoacidosis and lactic acidosis) cannot be corrected;
Have a history of other malignant tumor diseases;
Have a history of allergy to the study drug or similar drug structure;
Pregnant and lactating women;
Other reasons why the investigator considers it inappropriate to participate in the clinical study. healthy volunteers No gender All minimum age 18 Years maximum age 75 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Xian-Jun Jun, M.D., Ph.D. central contact role Contact central contact phone 86 21 64175590 central contact e mail xiahuanyu@fudanpci.org central contact name Wen-Quan Wang, M.D., Ph.D. central contact role Contact central contact phone +86 21 64175590 central contact e mail wangwenquan@fudanpci.org overall official list overall official overall official name Xian-Jun Jun, M.D., Ph.D. overall official affiliation Fudan University overall official role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M2737 condition browse leaf name Adenocarcinoma condition browse leaf relevance low condition browse leaf id M12262 condition browse leaf name Pancreatic Neoplasms condition browse leaf relevance low condition browse leaf id T4387 condition browse leaf name Pancreatic Cancer condition browse leaf as found Pancreatic Cancer condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id C000056507 intervention mesh term Gemcitabine intervention mesh id D000017239 intervention mesh term Paclitaxel intervention mesh id C000627770 intervention mesh term Folfirinox intervention ancestor list intervention ancestor intervention ancestor id D000000972 intervention ancestor term Antineoplastic Agents, Phytogenic intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention ancestor id D000050257 intervention ancestor term Tubulin Modulators intervention ancestor id D000050256 intervention ancestor term Antimitotic Agents intervention ancestor id D000050258 intervention ancestor term Mitosis Modulators intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention ancestor id D000000964 intervention ancestor term Antimetabolites, Antineoplastic intervention ancestor id D000000963 intervention ancestor term Antimetabolites intervention ancestor id D000000998 intervention ancestor term Antiviral Agents intervention ancestor id D000000890 intervention ancestor term Anti-Infective Agents intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention browse leaf list intervention browse leaf intervention browse leaf id M18689 intervention browse leaf name Paclitaxel intervention browse leaf as found From intervention browse leaf relevance high intervention browse leaf id M231 intervention browse leaf name Albumin-Bound Paclitaxel intervention browse leaf relevance low intervention browse leaf id M113169 intervention browse leaf name Gemcitabine intervention browse leaf as found Open- intervention browse leaf relevance high intervention browse leaf id M1674 intervention browse leaf name Oxaliplatin intervention browse leaf relevance low intervention browse leaf id M7752 intervention browse leaf name Fluorouracil intervention browse leaf relevance low intervention browse leaf id M1671 intervention browse leaf name Irinotecan intervention browse leaf relevance low intervention browse leaf id M271074 intervention browse leaf name Folfirinox intervention browse leaf as found Peer support intervention browse leaf relevance high intervention browse leaf id M25350 intervention browse leaf name Tubulin Modulators intervention browse leaf relevance low intervention browse leaf id M25349 intervention browse leaf name Antimitotic Agents intervention browse leaf relevance low intervention browse leaf id M3433 intervention browse leaf name Antimetabolites intervention browse leaf relevance low intervention browse leaf id M3466 intervention browse leaf name Antiviral Agents intervention browse leaf relevance low intervention browse leaf id M3366 intervention browse leaf name Anti-Infective Agents intervention browse leaf relevance low intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents | NCT04835064 | [
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8050,
9380,
14194,
22572,
5521,
20939,
1209,
1129,
1215,
1114,
170,
18847,
6716,
1179,
119,
14521,
3556,
9380,
14194,
22572,
5521,
20939,
1372,
1460,
8050,
9380,
14194,
22572,
5521,
20939,
1111,
123,
4770,
119,
1130,
1103,
2904,
13467,
1231,
25461,
1372,
117,
127,
4770,
1104,
8050,
9380,
14194,
22572,
5521,
20939,
1127,
1408,
125,
1106,
129,
2277,
1170,
8276,
1231,
25461,
119,
11336,
23403,
2861,
17865,
1431,
1129,
3303,
1196,
1105,
1170,
1296,
1736,
1104,
15683,
1106,
17459,
3429,
1958,
119,
146,
26772,
1231,
11708,
11787,
9199,
1116,
1431,
1129,
3303,
1451,
123,
4770,
1104,
15683,
117,
1105,
14377,
1231,
11708,
11787,
9199,
1116,
1431,
1129,
3303,
1451,
124,
1808,
1219,
2812,
118,
1146,
1106,
17459,
3653,
1231,
10182,
21629,
119,
2975,
13196,
3879,
2190,
3879,
6991,
13782,
7698,
17533,
13335,
1813,
16430,
7903,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
12278,
124,
1902,
23992,
1902,
18205,
7922,
118,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
9457,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
4539,
27989,
10224,
1204,
8396,
5096,
22650,
1197,
1130,
5710,
3121,
25524,
1766,
10803,
23992,
10803,
5099,
4372,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
11896,
1830,
118,
185,
7409,
12888,
7897,
1883,
1105,
144,
5521,
6617,
1777,
16405,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
6429,
1394,
3490,
1114,
185,
7409,
12888,
7897,
1883,
8347,
1306,
1403,
120,
182,
1477,
1107,
4487,
7912,
2285,
1107,
17149,
117,
2295,
122,
117,
129,
117,
1405,
132,
144,
5521,
6617,
1777,
16405,
6087,
17713,
120,
182,
1477,
1108,
1549,
1107,
4487,
7912,
9537,
1111,
1167,
1190,
1476,
7937,
1113,
1552,
122,
117,
129,
117,
1105,
1405,
117,
1105,
4892,
1451,
125,
2277,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
11896,
1830,
185,
7409,
12888,
7897,
1883,
13982,
131,
144,
5521,
6617,
1777,
16405,
1981,
1372,
3107,
182,
2271,
13901,
17675,
20595,
2249,
24569,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
152,
20192,
10913,
16236,
1394,
4859,
17713,
120,
182,
1477,
1107,
4487,
7912,
2285,
1107,
17149,
1111,
123,
177,
117,
2295,
122,
132,
149,
2559,
3434,
17713,
120,
182,
1477,
1107,
4487,
7912,
2285,
1107,
17149,
1111,
123,
177,
117,
2295,
122,
132,
146,
16987,
27560,
1179,
4214,
17713,
120,
182,
1477,
1108,
1896,
1476,
11241,
1170,
1107,
4487,
7912,
2285,
1107,
17149,
1111,
3078,
11241,
117,
1285,
122,
132,
1188,
1108,
2411,
1723,
1118,
170,
6803,
1107,
4487,
7912,
2285,
1107,
17149,
1104,
126,
118,
143,
2591,
11202,
1568,
17713,
120,
182,
1477,
1111,
3993,
177,
119,
20777,
13448,
1451,
123,
2277,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
13982,
131,
182,
2271,
13901,
17675,
20595,
2249,
24569,
9108,
2190,
9108,
9108,
2076,
13982,
9108,
1271,
11896,
1830,
185,
7409,
12888,
7897,
1883,
9108,
6136,
6429,
1394,
3490,
1114,
185,
7409,
12888,
7897,
1883,
8347,
1306,
1403,
120,
182,
1477,
1107,
4487,
7912,
2285,
1107,
17149,
117,
2295,
122,
117,
129,
117,
1405,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
11896,
1830,
118,
185,
7409,
12888,
7897,
1883,
1105,
144,
5521,
6617,
1777,
16405,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
138,
6766,
20192,
1673,
9108,
2076,
13982,
9108,
1271,
144,
5521,
6617,
1777,
16405,
9108,
6136,
1130,
4487,
7912,
2285,
1107,
17149,
1104,
6087,
17713,
120,
182,
1477,
1108,
1549,
1111,
1167,
1190,
1476,
7937,
1113,
1552,
122,
117,
129,
117,
1105,
1405,
117,
1105,
4892,
1451,
125,
2277,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
11896,
1830,
118,
185,
7409,
12888,
7897,
1883,
1105,
144,
5521,
6617,
1777,
16405,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
144,
5521,
8950,
9108,
2076,
13982,
9108,
1271,
182,
2271,
13901,
17675,
20595,
2249,
24569,
9108,
6136,
152,
20192,
10913,
16236,
1394,
4859,
17713,
120,
182,
1477,
1107,
4487,
7912,
2285,
1107,
17149,
1111,
123,
177,
117,
2295,
122,
132,
149,
2559,
3434,
17713,
120,
182,
1477,
1107,
4487,
7912,
2285,
1107,
17149,
1111,
123,
177,
117,
2295,
122,
132,
146,
16987,
27560,
1179,
4214,
17713,
120,
182,
1477,
1108,
1896,
1476,
11241,
1170,
1107,
4487,
7912,
2285,
1107,
17149,
1111,
3078,
11241,
117,
1285,
122,
132,
1188,
1108,
2411,
1723,
1118,
170,
6803,
1107,
4487,
7912,
2285,
1107,
17149,
1104,
126,
118,
143,
2591,
11202,
1568,
17713,
120,
182,
1477,
1111,
3993,
177,
119,
20777,
13448,
1451,
123,
2277,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
182,
2271,
13901,
17675,
20595,
2249,
24569,
9108,
1168,
1271,
2190,
9108,
1168,
1271,
5847,
143,
13901,
17675,
20595,
2249,
24569,
6716,
1179,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
2905,
8115,
2425,
9386,
6136,
794,
1706,
12326,
1103,
2905,
8115,
1104,
4420,
1114,
1231,
26338,
1895,
13316,
13782,
7698,
4182,
1114,
8208,
23651,
8784,
11964,
1571,
1114,
1105,
1443,
15242,
3556,
9380,
14194,
22572,
5521,
20939,
2425,
9386,
1159,
4207,
1121,
7091,
2734,
1106,
1473,
117,
1146,
1106,
3164,
1808,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
11336,
16046,
2217,
118,
1714,
8115,
3718,
9386,
6136,
1706,
12326,
1103,
1231,
16046,
2217,
118,
1714,
8115,
1104,
4420,
1114,
1231,
26338,
1895,
13316,
13782,
7698,
4182,
1114,
8208,
23651,
8784,
11964,
1571,
6055,
1443,
15242,
3556,
9380,
14194,
22572,
5521,
20939,
3718,
9386,
1159,
4207,
1121,
7091,
2734,
1106,
1231,
10182,
21629,
117,
1146,
1106,
3164,
1808,
3718,
9386,
4929,
17078,
20851,
4252,
16073,
2603,
3718,
9386,
6136,
794,
1706,
12326,
1103,
1231,
26338,
1895,
2603,
1104,
4420,
1114,
1231,
26338,
1895,
13316,
13782,
7698,
4182,
1114,
8208,
23651,
8784,
11964,
1571,
1114,
1105,
1443,
15242,
3556,
9380,
14194,
22572,
5521,
20939,
3718,
9386,
1159,
4207,
1121,
7091,
2734,
1106,
1231,
10182,
21629,
117,
1146,
1106,
3164,
1808,
3718,
9386,
4929,
3561,
26859,
2093,
1104,
16798,
1958,
3718,
9386,
6136,
794,
1706,
12326,
1103,
3561,
26859,
2093,
1104,
16798,
1958,
1104,
4420,
1114,
1231,
26338,
1895,
13316,
13782,
7698,
4182,
1114,
1137,
1443,
15242,
3556,
9380,
14194,
22572,
5521,
20939,
1114,
8208,
23651,
8784,
11964,
1571,
3718,
9386,
1159,
4207,
1121,
7091,
2734,
1106,
1231,
10182,
21629,
117,
1146,
1106,
3164,
1808,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
5713,
19529,
11486,
4868,
1105,
2951,
1103,
6189,
9635,
132,
4936,
864,
15292,
1201,
1385,
1105,
863,
26253,
1201,
1385,
117,
1185,
5772,
26802,
132,
16028,
2346,
2349,
2794,
863,
1475,
132,
146,
26772,
10540,
1104,
1231,
26338,
1895,
13316,
13782,
7698,
4182,
117,
23651,
8784,
11964,
1571,
28758,
19297,
158,
120,
182,
2162,
132,
13316,
13782,
7698,
8050,
26601,
8766,
16430,
7903,
3659,
1118,
3507,
4807,
1170,
13316,
13782,
7698,
23609,
26405,
5332,
1137,
6059,
132,
1302,
6531,
27154,
8419,
4863,
117,
12477,
2646,
15454,
24716,
174,
3101,
17268,
1137,
185,
1513,
12602,
174,
3101,
17268,
1196,
15242,
3556,
9380,
14194,
22572,
5521,
20939,
132,
3799,
19807,
5838,
2259,
2568,
2229,
117,
14701,
1105,
185,
1883,
9356,
16899,
2799,
1185,
14601,
27154,
8419,
4863,
120,
1231,
10182,
21629,
119,
16409,
26426,
1174,
8115,
864,
1495,
1808,
132,
1302,
3021,
23123,
10024,
5674,
22331,
1596,
173,
6834,
26420,
117,
22832,
4226,
1104,
1762,
117,
13093,
117,
11911,
1105,
16042,
1105,
11650,
21344,
1127,
4379,
119,
1109,
8087,
2774,
2686,
1899,
1103,
1378,
9173,
131,
1892,
9285,
24091,
131,
1653,
1892,
2765,
113,
160,
9428,
114,
864,
1495,
28193,
10424,
1580,
120,
149,
132,
138,
4832,
4063,
6140,
24928,
3818,
12736,
20473,
1116,
5099,
113,
23096,
1658,
114,
864,
1475,
119,
126,
28193,
10424,
1580,
120,
149,
132,
15930,
5765,
113,
153,
26909,
114,
864,
20150,
28193,
10424,
1580,
120,
149,
132,
1124,
3702,
1403,
2858,
7939,
113,
145,
13745,
114,
864,
1580,
1403,
120,
173,
2162,
132,
5657,
25128,
16710,
7448,
1279,
131,
15278,
1942,
113,
156,
2349,
14697,
114,
117,
18589,
1942,
113,
156,
17095,
1942,
114,
863,
1477,
119,
126,
28193,
3105,
5310,
1104,
2999,
2860,
113,
158,
2162,
2249,
114,
132,
8653,
16516,
2646,
5082,
7939,
113,
157,
2064,
2723,
114,
863,
2591,
2162,
2249,
132,
19536,
1818,
172,
11811,
6105,
2042,
113,
15531,
2036,
114,
863,
1475,
119,
126,
28193,
2591,
2162,
2249,
132,
3291,
28026,
6840,
3053,
131,
5096,
1582,
16071,
7939,
1159,
113,
22216,
114,
117,
1835,
18013,
6022,
113,
15969,
2069,
114,
863,
1475,
119,
126,
28193,
2591,
2162,
2249,
132,
1103,
21623,
1104,
1535,
1114,
3209,
20060,
1106,
1329,
2657,
1193,
4092,
14255,
4487,
17046,
1116,
1107,
1103,
3443,
132,
138,
2165,
1106,
2812,
1103,
1844,
3143,
2197,
1105,
1168,
1788,
5420,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
7195,
24767,
1125,
1460,
1251,
2076,
1104,
2848,
118,
14601,
7606,
1196,
4035,
13166,
1880,
117,
1259,
9108,
1348,
22572,
5521,
7745,
13685,
2646,
8569,
117,
170,
18075,
2116,
117,
2070,
8420,
11478,
1183,
117,
22572,
5521,
20939,
117,
1105,
9546,
9271,
7606,
132,
1138,
2129,
5604,
1449,
8131,
117,
4910,
8131,
117,
15443,
1126,
10533,
1161,
185,
20302,
1548,
117,
14255,
7562,
3946,
1762,
4290,
117,
5199,
170,
11096,
7889,
1582,
8191,
1105,
1168,
8362,
7235,
8005,
3848,
2165,
3021,
8131,
132,
12118,
7235,
8005,
11572,
8974,
117,
9793,
117,
13316,
13782,
7698,
19299,
2553,
117,
16516,
1513,
19299,
2553,
117,
1137,
1168,
2112,
19807,
5838,
13522,
1120,
2259,
2568,
132,
138,
23987,
1105,
13306,
25158,
5190,
11776,
113,
1259,
180,
20713,
7409,
12894,
4863,
1105,
2495,
11143,
5190,
11776,
114,
2834,
1129,
13808,
132,
4373,
170,
1607,
1104,
1168,
12477,
2646,
15454,
14601,
8131,
132,
4373,
170,
1607,
1104,
1155,
1200,
4873,
1106,
1103,
2025,
3850,
1137,
1861,
3850,
2401,
132,
11689,
15454,
1105,
2495,
5822,
3798,
1535,
132,
2189,
3672,
1725,
1103,
17805,
10500,
1122,
17073,
1106,
4868,
1107,
1103,
7300,
2025,
119,
8071,
8118,
1302,
5772,
1398,
5867,
1425,
1407,
5848,
4177,
1425,
3453,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
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2129,
3232,
2190,
2129,
3232,
2129,
3232,
1271,
20802,
1389,
118,
12865,
12865,
117,
150,
119,
141,
119,
117,
7642,
119,
141,
119,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
5942,
1626,
3324,
16770,
25491,
21500,
2129,
3232,
174,
6346,
193,
15963,
8734,
9379,
137,
175,
15798,
1179,
1643,
6617,
119,
8916,
2129,
3232,
1271,
23158,
118,
154,
8734,
7014,
117,
150,
119,
141,
119,
117,
7642,
119,
141,
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full study rank 61662 study protocol section identification module n c t id NCT04833556 org study id info org study id 005/2564 (IRB4) secondary id info list secondary id info secondary id 161/2021 secondary id type Registry Identifier secondary id domain Siriraj Institutional Review Board COA number organization org full name Mahidol University org class OTHER brief title Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery official title Clinical Characteristics and Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery status module status verified date September 2022 overall status Recruiting expanded access info has expanded access No start date struct start date April 22, 2021 start date type Actual primary completion date struct primary completion date December 31, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 4, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date September 11, 2022 last update post date struct last update post date September 13, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Mahidol University lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary Postpartum haemorrhage is the common cause of maternal death worldwide. The primary purpose of this study is to identify the maternal outcomes after PPH. The highlighted outcome is the anesthetic management including rate of blood transfusion and incidence of patient experiencing massive blood transfusion. The secondary purposes of this study are amount of blood loss, causes of PPH and other outcomes that related to PPH such as the rate of hysterectomy and postoperative outcome eg. congestive heart failure, acute kidney injury and TRALI etc. Additionally, incidence of PPH will be studied. Data collection will be made to identify the cause of PPH, anesthetic techniques that may related to the amount of hemorrhage, medical treatment for PPH and neonatal outcomes. We also aim to obtain the rate of ICU admission and revealed the factors involving the ICU admission in PPH patients underwent cesarean delivery. detailed description Postpartum hemorrhage (PPH) is the common cause of maternal death worldwide. It is interesting to note that PPH is the most common cause of death in developing country. Additionally, PPH is the common cause of maternal cardiac arrest. PPH defined as the amount of bleeding more than or equal to 500 ml after vaginal delivery and bleeding of more than or equal to 1,000 ml after cesarean delivery. The rate of PPH regardless any route of delivery was 2.9-3.2%. Rate of PPH in patients undergoing cesarean delivery was approximately 0.6% - 3.1%.
The difference in anesthetic techniques influence the rate of postpartum hemorrhage. Numerous studies showed the association between general anesthesia and postpartum hemorrhage in patient undergoing cesarean delivery. The outcome showed the odds of PPH in women who had cesarean delivery with general anesthesia were 8.15 times higher (95% CI 6.43-10.33) than for those who had CS with epidural anesthesia. Likewise, systematic review and meta-analysis revealed general anesthesia associated with higher amount of blood loss, but not the transfusion rate comparing with regional anesthesia. The decreasing of myometrial uterine tone from the usage of inhalational agents (halothane, enflurane, isofurane, sevoflurane, and desflurane) from general anesthesia explains this consequence.
Guidelines recommended the management of PPH after cesarean delivery were launched. World Health Organization (WHO) recommendation reported both surgical together with medical management (non-surgical) in patients with PPH, which published in the year 2012. The major role of anesthesiologists involving in treatment of PPH is medical treatment and blood and blood component administration. The novel medical treatment of PPH has been described in several literatures including the usage of tranexamic acid and fibrinogen concentrate. The World Maternal Antifibrinolytic trial (WOMAN trial) is the large-sample size randomized controlled trial publishing in the Lancet in the year 2017. WOMAN trial revealed the administration of tranexamic acid in patients with PPH after vaginal or cesarean delivery significantly reduced blood loss and decreased maternal mortality rate from bleeding. Likewise, Cochrane database systematic review concluded in the year 2018 that intravenous tranexamic acid reduced mortality rate due to bleeding in women with PPH, irrespective of mode of delivery. The WHO collaborator subsequently launched the update of recommendation including the administration of tranexamic acid 1 gram in PPH patients within 3 hours after birth.
Moreover, the rate of ICU admission after postpartum hemorrhage was studied revealing 15 of 21 patients (71.4%). Of which, 12 patients presented disseminated intravascular coagulation (DIC) and 2 cases death (9%). Critically-ill patients deriving from massive hemorrhage from PPH also transfusion-related acute lungs injury (TRALI), congestive heart failure, acute kidney injury and multiorgan failure.
In this study, we emphasize in patients underwent cesarean delivery with PPH (intraoperative estimated blood loss > 1,000 ml). The primary purpose is to identify the maternal outcomes after PPH. The highlighted outcome is the anesthetic management including rate of blood transfusion and incidence of patient experiencing massive blood transfusion. The secondary purposes of this study are amount of blood loss, causes of PPH and other outcomes that related to PPH such as the rate of hysterectomy and postoperative outcome eg. congestive heart failure, acute kidney injury and TRALI etc. Additionally, incidence of PPH will be studied. Data collection will be made to identify the cause of PPH, anesthetic techniques that may related to the amount of hemorrhage, medical treatment for PPH and neonatal outcomes. We also aim to obtain the rate of ICU admission and revealed the factors involving the ICU admission in PPH patients underwent cesarean delivery.
The detail of outcomes of PPH in cesarean delivered patients in Siriraj hospital is scared; and it has not yet been described in the literature. Therefore, the authors aim to collected the data and analyzed the outcomes associated with PPH, in order to report in the literatures as well as improving the anesthetic management of intraoperative PPH in our institute. conditions module condition list condition Cesarean Section Complications Postpartum Hemorrhage Anesthesia Complication Blood Transfusion Complication Uterine Atony With Hemorrhage keyword list keyword Cesarean section Postpartum haemorrhage Anesthesia complication Blood transfusion Intensive care unit admission design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Retrospective enrollment info enrollment count 420 enrollment type Anticipated arms interventions module arm group list arm group arm group label Postpartum haemorrhage arm group description Patients undergoing cesarean delivery with postpartum haemorrhage (blood loss more than or equal to 1,000 ml.) outcomes module primary outcome list primary outcome primary outcome measure Rate of blood transfusion primary outcome description Rate of blood transfusion in patients with postpartum haemorrhage primary outcome time frame In operating theatre to 24 hour postoperatively primary outcome measure Rate of ICU admission primary outcome description Patients with postpartum haemorrhage required admission in the ICU primary outcome time frame From 0-24 hours postoperatively secondary outcome list secondary outcome secondary outcome measure Amount of haemorrhage secondary outcome description Amount of blood loss after delivery secondary outcome time frame In operating theatre to 24 hour postoperatively secondary outcome measure Rate of hysterectomy secondary outcome description Rate of hysterectomy after postpartum hemorrhage secondary outcome time frame In operating theatre to 24 hour postoperatively secondary outcome measure Anesthetic technique secondary outcome description General anesthesia with endotracheal tube or regional anesthesia secondary outcome time frame In operating theatre to 24 hour postoperatively secondary outcome measure Rate of blood component administration secondary outcome description Rate of patients receiving FFP, cryoprecipitate or platelets secondary outcome time frame In operating theatre to 24 hour postoperatively secondary outcome measure Rate of Tranexamic acid administration secondary outcome description Rate of patients receiving Tranexamic acid secondary outcome time frame In operating theatre to 24 hour postoperatively secondary outcome measure Causes of postpartum hemorrhage secondary outcome description Identify causes of postpartum hemorrhage secondary outcome time frame In operating theatre to 24 hour postoperatively secondary outcome measure Factor associated ICU admission secondary outcome description Factor associated ICU admission after cesarean delivery with postpartum hemorrhage secondary outcome time frame In operating theatre to 24 hour postoperatively secondary outcome measure Rate of complications after postpartum haemorrhage secondary outcome description Rate of complications after postpartum haemorrhage eg. prolong intubation, congestive heart failure, acute kidney injury, transfusion-related acute lungs injury (TRALI) secondary outcome time frame 0-30 days postoperatively secondary outcome measure Maternal mortality rate secondary outcome description Report rate of maternal death secondary outcome time frame 0-30 days postoperatively secondary outcome measure Neonatal outcomes secondary outcome description Neonatal Apgar score secondary outcome time frame At 1 and 5 minutes after delivery eligibility module eligibility criteria Inclusion Criteria:
Patients underwent cesarean delivery with estimated blood loss equal or more than 1,000 ml
Exclusion Criteria:
Cesarean delivery at less than 24 weeks of gestation
Patient chart that not contained primary outcome data eg. absent of the anesthetic record healthy volunteers No gender Female std age list std age Child Adult Older Adult study population Female patients underwent cesarean delivery with estimated blood loss equal or more than 1,000 ml sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Patchareya Nivatpumin, M.D. central contact role Contact central contact phone +6689-666-2187 central contact e mail patchareya.niv@mahidol.ac.th central contact name Nattapon Sukcharoen, M.D. central contact role Contact central contact phone +6686-992-3739 central contact e mail nut154686644@gmail.com overall official list overall official overall official name Patchareya Nivatpumin, M.D. overall official affiliation Mahidol University overall official role Principal Investigator location list location location facility Faculty of Medicine Siriraj Hospital location status Recruiting location city Bangkok location zip 10700 location country Thailand location contact list location contact location contact name Patchareya Nivatpumin, M.D. location contact role Contact location contact phone +6689-666-2187 location contact e mail patchareya.niv@mahidol.ac.th location contact name Nattapon Sukcharoen, M.D. location contact role Contact location contact phone +6686-992-3739 location contact e mail nut154686644@gmail.com i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000006473 condition mesh term Postpartum Hemorrhage condition mesh id D000014593 condition mesh term Uterine Inertia condition mesh id D000065227 condition mesh term Transfusion Reaction condition mesh id D000006470 condition mesh term Hemorrhage condition ancestor list condition ancestor condition ancestor id D000010335 condition ancestor term Pathologic Processes condition ancestor id D000007744 condition ancestor term Obstetric Labor Complications condition ancestor id D000011248 condition ancestor term Pregnancy Complications condition ancestor id D000011644 condition ancestor term Puerperal Disorders condition ancestor id D000014592 condition ancestor term Uterine Hemorrhage condition ancestor id D000004420 condition ancestor term Dystocia condition ancestor id D000006402 condition ancestor term Hematologic Diseases condition ancestor id D000007154 condition ancestor term Immune System Diseases condition browse leaf list condition browse leaf condition browse leaf id M8708 condition browse leaf name Hemorrhage condition browse leaf as found Hemorrhage condition browse leaf relevance high condition browse leaf id M8711 condition browse leaf name Postpartum Hemorrhage condition browse leaf as found Postpartum Hemorrhage condition browse leaf relevance high condition browse leaf id M29643 condition browse leaf name Transfusion Reaction condition browse leaf as found Blood Transfusion Complication condition browse leaf relevance high condition browse leaf id M16493 condition browse leaf name Uterine Inertia condition browse leaf as found Uterine Atony condition browse leaf relevance high condition browse leaf id M9916 condition browse leaf name Obstetric Labor Complications condition browse leaf relevance low condition browse leaf id M13279 condition browse leaf name Pregnancy Complications condition browse leaf relevance low condition browse leaf id M13651 condition browse leaf name Puerperal Disorders condition browse leaf relevance low condition browse leaf id M16492 condition browse leaf name Uterine Hemorrhage condition browse leaf relevance low condition browse leaf id M6746 condition browse leaf name Dystocia condition browse leaf relevance low condition browse leaf id M8642 condition browse leaf name Hematologic Diseases condition browse leaf relevance low condition browse leaf id M9352 condition browse leaf name Immune System Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04833556 | [
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3393,
1112,
1103,
2971,
1104,
9793,
1167,
1190,
1137,
4463,
1106,
2260,
182,
1233,
1170,
191,
27547,
7050,
6779,
1105,
9793,
1104,
1167,
1190,
1137,
4463,
1106,
122,
117,
1288,
182,
1233,
1170,
172,
1279,
8836,
1389,
6779,
119,
1109,
2603,
1104,
27660,
3048,
8334,
1251,
2438,
1104,
6779,
1108,
123,
119,
130,
118,
124,
119,
123,
110,
119,
24442,
1104,
27660,
3048,
1107,
4420,
15819,
172,
1279,
8836,
1389,
6779,
1108,
2324,
121,
119,
127,
110,
118,
124,
119,
122,
110,
119,
1109,
3719,
1107,
1126,
2556,
18994,
4884,
2933,
1103,
2603,
1104,
2112,
17482,
8928,
23123,
1766,
1197,
19911,
119,
16663,
2527,
2799,
1103,
3852,
1206,
1704,
1126,
2556,
27300,
1105,
2112,
17482,
8928,
23123,
1766,
1197,
19911,
1107,
5351,
15819,
172,
1279,
8836,
1389,
6779,
119,
1109,
9386,
2799,
1103,
10653,
1104,
27660,
3048,
1107,
1535,
1150,
1125,
172,
1279,
8836,
1389,
6779,
1114,
1704,
1126,
2556,
27300,
1127,
129,
119,
1405,
1551,
2299,
113,
4573,
110,
140,
2240,
127,
119,
3887,
118,
1275,
119,
3081,
114,
1190,
1111,
1343,
1150,
1125,
24821,
1114,
174,
25786,
12602,
1126,
2556,
27300,
119,
18872,
117,
12818,
3189,
1105,
27154,
118,
3622,
3090,
1704,
1126,
2556,
27300,
2628,
1114,
2299,
2971,
1104,
1892,
2445,
117,
1133,
1136,
1103,
14715,
17149,
2603,
15089,
1114,
2918,
1126,
2556,
27300,
119,
1109,
18326,
1104,
1139,
6758,
19091,
1348,
190,
2083,
2042,
3586,
1121,
1103,
7991,
1104,
1107,
19456,
15937,
5789,
113,
5871,
7841,
15296,
117,
4035,
2087,
7535,
18194,
117,
1110,
10008,
4084,
1673,
117,
14516,
6005,
2087,
7535,
18194,
117,
1105,
3532,
2087,
7535,
18194,
114,
1121,
1704,
1126,
2556,
27300,
7155,
1142,
9547,
119,
7500,
10443,
6315,
1103,
2635,
1104,
27660,
3048,
1170,
172,
1279,
8836,
1389,
6779,
1127,
2536,
119,
1291,
3225,
6534,
113,
23750,
114,
13710,
2103,
1241,
13467,
1487,
1114,
2657,
2635,
113,
1664,
118,
13467,
114,
1107,
4420,
1114,
27660,
3048,
117,
1134,
1502,
1107,
1103,
1214,
1368,
119,
1109,
1558,
1648,
1104,
1126,
2556,
16090,
19840,
25976,
1116,
5336,
1107,
3252,
1104,
27660,
3048,
1110,
2657,
3252,
1105,
1892,
1105,
1892,
6552,
3469,
119,
1109,
2281,
2657,
3252,
1104,
27660,
3048,
1144,
1151,
1758,
1107,
1317,
3783,
1116,
1259,
1103,
7991,
1104,
189,
18194,
20192,
7257,
5190,
1105,
20497,
27647,
2728,
4915,
10191,
119,
1109,
1291,
25702,
10449,
1348,
8329,
8702,
27647,
2728,
1193,
2941,
3443,
113,
160,
13041,
14962,
3443,
114,
1110,
1103,
1415,
118,
6876,
2060,
7091,
2200,
4013,
3443,
5550,
1107,
1103,
11856,
1204,
1107,
1103,
1214,
1504,
119,
160,
13041,
14962,
3443,
3090,
1103,
3469,
1104,
189,
18194,
20192,
7257,
5190,
1107,
4420,
1114,
27660,
3048,
1170,
191,
27547,
7050,
1137,
172,
1279,
8836,
1389,
6779,
5409,
3549,
1892,
2445,
1105,
10558,
11476,
14471,
2603,
1121,
9793,
119,
18872,
117,
24763,
8539,
12818,
3189,
4803,
1107,
1103,
1214,
1857,
1115,
1107,
4487,
7912,
2285,
189,
18194,
20192,
7257,
5190,
3549,
14471,
2603,
1496,
1106,
9793,
1107,
1535,
1114,
27660,
3048,
117,
178,
11604,
16776,
1104,
5418,
1104,
6779,
119,
1109,
23750,
20715,
2886,
2536,
1103,
11984,
1104,
13710,
1259,
1103,
3469,
1104,
189,
18194,
20192,
7257,
5190,
122,
25968,
1107,
27660,
3048,
4420,
1439,
124,
2005,
1170,
3485,
119,
9841,
117,
1103,
2603,
1104,
146,
23520,
10296,
1170,
2112,
17482,
8928,
23123,
1766,
1197,
19911,
1108,
2376,
8387,
1405,
1104,
1626,
4420,
113,
5729,
119,
125,
110,
114,
119,
2096,
1134,
117,
1367,
4420,
2756,
4267,
11553,
23713,
1107,
4487,
11509,
11702,
1884,
28026,
6840,
113,
141,
9741,
114,
1105,
123,
2740,
1473,
113,
130,
110,
114,
119,
15247,
1193,
118,
5178,
4420,
4167,
21877,
1121,
4672,
23123,
1766,
1197,
19911,
1121,
27660,
3048,
1145,
14715,
17149,
118,
2272,
12104,
8682,
3773,
113,
157,
9664,
2162,
2240,
114,
117,
14255,
7562,
3946,
1762,
4290,
117,
12104,
16042,
3773,
1105,
4321,
1766,
3820,
4290,
119,
1130,
1142,
2025,
117,
1195,
19291,
1107,
4420,
9315,
172,
1279,
8836,
1389,
6779,
1114,
27660,
3048,
113,
1107,
4487,
19807,
5838,
3555,
1892,
2445,
135,
122,
117,
1288,
182,
1233,
114,
119,
1109,
2425,
3007,
1110,
1106,
6183,
1103,
11476,
13950,
1170,
27660,
3048,
119,
1109,
11634,
9386,
1110,
1103,
1126,
2556,
18994,
2635,
1259,
2603,
1104,
1892,
14715,
17149,
1105,
21014,
1104,
5351,
13992,
4672,
1892,
14715,
17149,
119,
1109,
3718,
4998,
1104,
1142,
2025,
1132,
2971,
1104,
1892,
2445,
117,
4680,
1104,
27660,
3048,
1105,
1168,
13950,
1115,
2272,
1106,
27660,
3048,
1216,
1112,
1103,
2603,
1104,
177,
21878,
10294,
18778,
1183,
1105,
2112,
19807,
5838,
9386,
174,
1403,
119,
14255,
7562,
3946,
1762,
4290,
117,
12104,
16042,
3773,
1105,
157,
9664,
2162,
2240,
3576,
119,
5533,
117,
21014,
1104,
27660,
3048,
1209,
1129,
2376,
119,
7154,
2436,
1209,
1129,
1189,
1106,
6183,
1103,
2612,
1104,
27660,
3048,
117,
1126,
2556,
18994,
4884,
1115,
1336,
2272,
1106,
1103,
2971,
1104,
23123,
1766,
1197,
19911,
117,
2657,
3252,
1111,
27660,
3048,
1105,
24762,
6575,
1233,
13950,
119,
1284,
1145,
6457,
1106,
6268,
1103,
2603,
1104,
146,
23520,
10296,
1105,
3090,
1103,
5320,
5336,
1103,
146,
23520,
10296,
1107,
27660,
3048,
4420,
9315,
172,
1279,
8836,
1389,
6779,
119,
1109,
6505,
1104,
13950,
1104,
27660,
3048,
1107,
172,
1279,
8836,
1389,
4653,
4420,
1107,
2203,
5132,
3361,
2704,
1110,
5528,
132,
1105,
1122,
1144,
1136,
1870,
1151,
1758,
1107,
1103,
3783,
119,
6589,
117,
1103,
5752,
6457,
1106,
4465,
1103,
2233,
1105,
17689,
1103,
13950,
2628,
1114,
27660,
3048,
117,
1107,
1546,
1106,
2592,
1107,
1103,
3783,
1116,
1112,
1218,
1112,
9248,
1103,
1126,
2556,
18994,
2635,
1104,
1107,
4487,
19807,
5838,
27660,
3048,
1107,
1412,
8918,
119,
2975,
13196,
3879,
2190,
3879,
24664,
9724,
7766,
6177,
3291,
8223,
20721,
1116,
3799,
17482,
8928,
1124,
26271,
1197,
19911,
1760,
2556,
27300,
3291,
8223,
20721,
5657,
13809,
17149,
3291,
8223,
20721,
158,
2083,
2042,
1335,
10031,
1556,
1124,
26271,
1197,
19911,
2501,
12565,
2190,
2501,
12565,
24664,
9724,
7766,
2237,
3799,
17482,
8928,
5871,
5521,
1766,
1197,
19911,
1760,
2556,
27300,
3254,
15534,
5657,
14715,
17149,
1130,
27291,
1920,
2587,
10296,
1902,
13196,
2025,
2076,
152,
4832,
1200,
11583,
1348,
5351,
25097,
1302,
1902,
23992,
1902,
8310,
1348,
2235,
2190,
1902,
8310,
1348,
2235,
9060,
118,
2809,
1902,
1159,
7281,
2190,
1902,
1159,
7281,
11336,
8005,
16776,
10803,
23992,
10803,
5099,
18650,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
3799,
17482,
8928,
5871,
5521,
1766,
1197,
19911,
1981,
1372,
6136,
7195,
24767,
15819,
172,
1279,
8836,
1389,
6779,
1114,
2112,
17482,
8928,
5871,
5521,
1766,
1197,
19911,
113,
1892,
2445,
1167,
1190,
1137,
4463,
1106,
122,
117,
1288,
182,
1233,
119,
114,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
24442,
1104,
1892,
14715,
17149,
2425,
9386,
6136,
24442,
1104,
1892,
14715,
17149,
1107,
4420,
1114,
2112,
17482,
8928,
5871,
5521,
1766,
1197,
19911,
2425,
9386,
1159,
4207,
1130,
3389,
4041,
1106,
1572,
2396,
2112,
19807,
5838,
1193,
2425,
9386,
4929,
24442,
1104,
146,
23520,
10296,
2425,
9386,
6136,
7195,
24767,
1114,
2112,
17482,
8928,
5871,
5521,
1766,
1197,
19911,
2320,
10296,
1107,
1103,
146,
23520,
2425,
9386,
1159,
4207,
1622,
121,
118,
1572,
2005,
2112,
19807,
5838,
1193,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
7277,
6094,
2227,
1104,
5871,
5521,
1766,
1197,
19911,
3718,
9386,
6136,
7277,
6094,
2227,
1104,
1892,
2445,
1170,
6779,
3718,
9386,
1159,
4207,
1130,
3389,
4041,
1106,
1572,
2396,
2112,
19807,
5838,
1193,
3718,
9386,
4929,
24442,
1104,
177,
21878,
10294,
18778,
1183,
3718,
9386,
6136,
24442,
1104,
177,
21878,
10294,
18778,
1183,
1170,
2112,
17482,
8928,
23123,
1766,
1197,
19911,
3718,
9386,
1159,
4207,
1130,
3389,
4041,
1106,
1572,
2396,
2112,
19807,
5838,
1193,
3718,
9386,
4929,
1760,
2556,
18994,
5531,
3718,
9386,
6136,
1615,
1126,
2556,
27300,
1114,
1322,
3329,
19366,
13836,
1233,
7159,
1137,
2918,
1126,
2556,
27300,
3718,
9386,
1159,
4207,
1130,
3389,
4041,
1106,
1572,
2396,
2112,
19807,
5838,
1193,
3718,
9386,
4929,
24442,
1104,
1892,
6552,
3469,
3718,
9386,
6136,
24442,
1104,
4420,
4172,
26834,
2101,
117,
5354,
4184,
1874,
6617,
18965,
2193,
1137,
4885,
9585,
3718,
9386,
1159,
4207,
1130,
3389,
4041,
1106,
1572,
2396,
2112,
19807,
5838,
1193,
3718,
9386,
4929,
24442,
1104,
157,
18194,
20192,
7257,
5190,
3469,
3718,
9386,
6136,
24442,
1104,
4420,
4172,
157,
18194,
20192,
7257,
5190,
3718,
9386,
1159,
4207,
1130,
3389,
4041,
1106,
1572,
2396,
2112,
19807,
5838,
1193,
3718,
9386,
4929,
20111,
1116,
1104,
2112,
17482,
8928,
23123,
1766,
1197,
19911,
3718,
9386,
6136,
146,
11951,
6120,
4680,
1104,
2112,
17482,
8928,
23123,
1766,
1197,
19911,
3718,
9386,
1159,
4207,
1130,
3389,
4041,
1106,
1572,
2396,
2112,
19807,
5838,
1193,
3718,
9386,
4929,
15926,
2628,
146,
23520,
10296,
3718,
9386,
6136,
15926,
2628,
146,
23520,
10296,
1170,
172,
1279,
8836,
1389,
6779,
1114,
2112,
17482,
8928,
23123,
1766,
1197,
19911,
3718,
9386,
1159,
4207,
1130,
3389,
4041,
1106,
1572,
2396,
2112,
19807,
5838,
1193,
3718,
9386,
4929,
24442,
1104,
13522,
1170,
2112,
17482,
8928,
5871,
5521,
1766,
1197,
19911,
3718,
9386,
6136,
24442,
1104,
13522,
1170,
2112,
17482,
8928,
5871,
5521,
1766,
1197,
19911,
174,
1403,
119,
5250,
9851,
1107,
25098,
1891,
117,
14255,
7562,
3946,
1762,
4290,
117,
12104,
16042,
3773,
117,
14715,
17149,
118,
2272,
12104,
8682,
3773,
113,
157,
9664,
2162,
2240,
114,
3718,
9386,
1159,
4207,
121,
118,
1476,
1552,
2112,
19807,
5838,
1193,
3718,
9386,
4929,
25702,
10449,
1348,
14471,
2603,
3718,
9386,
6136,
7178,
2603,
1104,
11476,
1473,
3718,
9386,
1159,
4207,
121,
118,
1476,
1552,
2112,
19807,
5838,
1193,
3718,
9386,
4929,
14521,
24226,
1348,
13950,
3718,
9386,
6136,
14521,
24226,
1348,
138,
1643,
5526,
2794,
3718,
9386,
1159,
4207,
1335,
122,
1105,
126,
1904,
1170,
6779,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
7195,
24767,
9315,
172,
1279,
8836,
1389,
6779,
1114,
3555,
1892,
2445,
4463,
1137,
1167,
1190,
122,
117,
1288,
182,
1233,
16409,
1665,
17855,
140,
10587,
3464,
131,
24664,
9724,
7766,
6779,
1120,
1750,
1190,
1572,
2277,
1104,
176,
16144,
2116,
7195,
9080,
3481,
1115,
1136,
4049,
2425,
9386,
2233,
174,
1403,
119,
10040,
1104,
1103,
1126,
2556,
18994,
1647,
8071,
8118,
1302,
5772,
9714,
188,
1204,
1181,
1425,
2190,
188,
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full study rank 61824 study protocol section identification module n c t id NCT04831450 org study id info org study id 20200543 organization org full name University of Miami org class OTHER brief title Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC) official title Phase II Trial of Maintenance Cemiplimab-rwlc After Concurrent Chemoradiotherapy (CRT) in Intermediate and High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC) status module status verified date August 2022 overall status Withdrawn why stopped Investigator Decision expanded access info has expanded access No start date struct start date July 2022 start date type Anticipated primary completion date struct primary completion date July 15, 2022 primary completion date type Actual completion date struct completion date July 15, 2022 completion date type Actual study first submit date April 1, 2021 study first submit q c date April 1, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date August 1, 2022 last update post date struct last update post date August 4, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Chukwuemeka Ikpeazu responsible party investigator title Associate Professor of Clinical responsible party investigator affiliation University of Miami lead sponsor lead sponsor name University of Miami lead sponsor class OTHER collaborator list collaborator collaborator name Regeneron Pharmaceuticals collaborator class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No is u s export No description module brief summary The purpose of this study is to evaluate the experimental immunotherapy agent cemiplimab-rwlc when given after completion of chemotherapy and radiation treatment and determine if it will improve progression free survival and cure rates in patients with PD-L1 positive locally advanced head and neck cancer. conditions module condition list condition Head and Neck Squamous Cell Carcinoma HNSCC Squamous Cell Carcinoma of the Larynx Squamous Cell Carcinoma of the Oral Cavity Squamous Cell Carcinoma of Hypopharynx design module study type Interventional phase list phase Phase 2 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 0 enrollment type Actual arms interventions module arm group list arm group arm group label Cemiplimab After CRT in HNSCC arm group type Experimental arm group description Participants will receive Cemiplimab for 6 consecutive months (a total of 8 cycles) 14-42 days after completion of standard of care CRT. arm group intervention list arm group intervention name Drug: Cemiplimab-Rwlc intervention list intervention intervention type Drug intervention name Cemiplimab-Rwlc intervention description 350 mg Cemiplimab administered via intravenous infusion over 30 minutes on Day 1 of a 21-day cycle. intervention arm group label list intervention arm group label Cemiplimab After CRT in HNSCC intervention other name list intervention other name REGN2810 outcomes module primary outcome list primary outcome primary outcome measure Progression-Free Survival (PFS) primary outcome description Progression-Free Survival (PFS) is defined as the elapsed time from the date of starting maintenance treatment until disease progression or death (whichever occurs first). Patients who have not had an event will be censored at the date of last disease assessment documenting the patient was free of progression. Progression will be assessed using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. primary outcome time frame Up to 2 years secondary outcome list secondary outcome secondary outcome measure PFS Rate secondary outcome description PFS is defined as the elapsed time from the date of starting maintenance treatment until disease progression or death (whichever occurs first). Patients who have not had an event will be censored at the date of last disease assessment documenting the patient was free of progression. Progression will be assessed using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. secondary outcome time frame Up to 1 year secondary outcome measure Overall Survival (OS) secondary outcome description Overall survival (OS) will be defined as the elapsed time from the date of starting maintenance treatment (Cycle 1 Day 1) until death. Alive patients will be censored at the date of last known to be alive. secondary outcome time frame Up to 2 years secondary outcome measure Incidence of Treatment-Related Toxicity and Adverse Events secondary outcome description Safety of the intervention will be reported as the incidence of treatment-related toxicity, including serious adverse events (SAEs) and adverse events (AEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion. secondary outcome time frame Up to 9 months eligibility module eligibility criteria Inclusion Criteria:
Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
Intermediate or high-risk disease defined by the following:
Squamous Cell Carcinoma of the oral cavity, larynx or hypopharynx American Joint Committee on Cancer (AJCC) 8th Stage III-IVB
p16-Negative oropharynx SCC, AJCC 8th Stage III-IVB
p16--positive oropharyngeal SCC, AJCC 8th stage II-III
Tumor must have documented Programmed Death (PD) Ligand (L) -1 Combined Positive Score (CPS) PD-L1 CPS ≥ 1 by immunohistochemistry (IHC).
Prior therapy for advanced stage HNSCC with definitive Standard of Care (SoC) CRT Intensity Modulated Radiation Therapy (IMRT (66-70 Gy) with concurrent Cisplatin with curative intent. Patients must have received a total cumulative dose of cisplatin of ≥ 200 mg/m2 or equivalent carboplatin plus taxanes combination per investigator criteria during concurrent treatment.
No clinical or radiographic evidence of progressive disease at the time of enrollment.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
Adequate bone marrow function, including:
Absolute Neutrophil Count (ANC) ≥ 1,000/µL or ≥ 1.0 x 10^9/L.
Platelets ≥ 75,000/µL or ≥ 100 x 10^9/L.
Hemoglobin ≥ 8 g/dL (may have been transfused).
Adequate renal function, as determined by an estimated creatinine clearance ≥ 30 mL/min as calculated using the Cockcroft- Gault.
Adequate liver function, including:
Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
Aspartate and alanine aminotransferase (AST and ALT) < 2.5 x ULN.
Pregnancy test (for patients of childbearing potential) negative at screening.
Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use two methods of contraception (at least one of which is considered to be highly effective throughout the study and for at least 3 months after the last dose of cemiplimab-rwlc.
Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative, as allowed by local guideline/practice) has been informed of all pertinent aspects of the study.
Exclusion Criteria:
Prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T lymphocyte Associated (CTLA)-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
Major surgery ≤ 4 weeks prior to enrollment.
Prior malignancy (other than the current Head and Neck cancer or in situ disease) requiring tumor-directed therapy within the last 2 years prior to enrollment, or concurrent malignancy associated with clinical instability. Exceptions for disease within the 2 years are superficial esophageal cancer (TIS or T1a) fully resected by endoscopy, prostate cancer (Gleason score ≤6) either curatively treated or deemed to not require treatment, ductal in situ carcinoma of the breast that has completed curative treatment, adequately treated basal cell or squamous cell skin cancer.
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
Active infection requiring systemic therapy.
Use of immunosuppressive medication at time of enrollment, except the following:
Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent
Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
Prior organ transplantation including allogenic stem-cell transplantation.
Diagnosis of prior immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA [ribonucleic acid] if anti-HCV antibody screening test positive).
Pregnant female patients, breastfeeding female patients, and male patients able to father children and female patients of childbearing potential who are unwilling or unable to use 2 methods of contraception (at least one of which is considered to be highly effective) for at least 3 months after the last dose of cemiplimab-rwlc.
Patients with impaired decision-making capacity. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Chukwuemeka Ikpeazu, MD overall official affiliation University of Miami overall official role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 removed country list removed country United States condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000002294 condition mesh term Carcinoma, Squamous Cell condition mesh id D000077195 condition mesh term Squamous Cell Carcinoma of Head and Neck condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000018307 condition ancestor term Neoplasms, Squamous Cell condition ancestor id D000006258 condition ancestor term Head and Neck Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition browse leaf list condition browse leaf condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf as found Carcinoma condition browse leaf relevance high condition browse leaf id M4702 condition browse leaf name Carcinoma, Squamous Cell condition browse leaf as found Squamous Cell Carcinoma condition browse leaf relevance high condition browse leaf id M9987 condition browse leaf name Laryngeal Diseases condition browse leaf relevance low condition browse leaf id M1689 condition browse leaf name Squamous Cell Carcinoma of Head and Neck condition browse leaf as found Head and Neck Squamous Cell Carcinoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M19604 condition browse leaf name Neoplasms, Squamous Cell condition browse leaf relevance low condition browse leaf id M8500 condition browse leaf name Head and Neck Neoplasms condition browse leaf relevance low condition browse leaf id T4267 condition browse leaf name Oral Squamous Cell Carcinoma condition browse leaf as found Squamous Cell Carcinoma of the Oral Cavity condition browse leaf relevance high condition browse leaf id T3311 condition browse leaf name Laryngeal Cancer condition browse leaf as found Carcinoma of the larynx condition browse leaf relevance high condition browse leaf id T2952 condition browse leaf name Hypopharyngeal Cancer condition browse leaf as found Carcinoma of Hypopharynx condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC09 condition browse branch name Ear, Nose, and Throat Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention mesh list intervention mesh intervention mesh id C000627974 intervention mesh term Cemiplimab intervention ancestor list intervention ancestor intervention ancestor id D000074322 intervention ancestor term Antineoplastic Agents, Immunological intervention ancestor id D000000970 intervention ancestor term Antineoplastic Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M302600 intervention browse leaf name Cemiplimab intervention browse leaf as found College intervention browse leaf relevance high intervention browse leaf id M1346 intervention browse leaf name Antineoplastic Agents, Immunological intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev ANeo intervention browse branch name Antineoplastic Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04831450 | [
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full study rank 61448 study protocol section identification module n c t id NCT04836338 org study id info org study id GSX 1401 organization org full name Verathon org class INDUSTRY brief title GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations official title Assessment of the GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations: Pilot Manikin Study status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date January 21, 2016 start date type Actual primary completion date struct primary completion date February 9, 2016 primary completion date type Actual completion date struct completion date October 1, 2020 completion date type Actual study first submit date December 18, 2020 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Verathon lead sponsor class INDUSTRY collaborator list collaborator collaborator name University of Texas Southwestern Medical Center collaborator class OTHER oversight module is f d a regulated drug No is f d a regulated device Yes description module brief summary The overall purpose of this study is to assess the functionality & impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models. detailed description The overall purpose of this study is to assess the functionality & impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope blades and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models. The hypothesis is that the Spectrum laryngoscope blades and stylet can improve the time and/or success of orotracheal intubation in a manikin.
Secondary aims of this study include assessing the impact of Spectrum pediatric video laryngoscope blades under simulated normal and difficult airway conditions on glottic view grade, mouth space, ease of blade insertion, ease of tracheal tube insertion, mechanisms of tracheal tube insertion impediment, and perceived overall clinical & functional usefulness in airways with predictors of difficult intubation. conditions module condition list condition Pediatric ALL design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 50 enrollment type Actual arms interventions module arm group list arm group arm group label Participants arm group description Anesthesia and emergency medicine providers who perform pediatric orotracheal intubations arm group intervention list arm group intervention name Device: orotracheal intubation intervention list intervention intervention type Device intervention name orotracheal intubation intervention description orotracheal intubation intervention arm group label list intervention arm group label Participants outcomes module primary outcome list primary outcome primary outcome measure Time to intubate primary outcome description Time to intubate on each of 3 attempts per blade, on each manikin type. primary outcome time frame 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. primary outcome measure First pass success rate primary outcome description First pass success rate on each of 3 attempts per blade, on each manikin type. First pass success (FPS) is defined as the ability to place a tracheal tube below a patient's vocal cords on the first attempt without removing the video laryngoscope from the patient's mouth. primary outcome time frame 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. primary outcome measure Overall performance and clinical utility using a 5-point Likert Scale primary outcome description Overall performance and clinical utility of single-use pediatric stylet; Using a 5-point LIKERT SCALE, participants will grade the following statements with regards to the use of the single-use pediatric stylet
= strongly disagree
= disagree
= neutral
= agree
= strongly agree
e.g. - Participants will assign a number to the following statements:
The pediatric style was easy to insert into the mouth of the when used with normal neonate manikin
The pediatric style was easy to insert into the mouth of the when used with the difficult neonate manikin
The pediatric style was easy to insert into the mouth of the when used with normal pediatric manikin primary outcome time frame 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. secondary outcome list secondary outcome secondary outcome measure Failed intubation attempt secondary outcome description The time taken for an intubation attempt that ultimately fails proper tube placement, or exceeds the allowed time for intubation under this protocol. Failed intubation attempt is defined as an attempt to intubate that does not result in tube placement, that is longer than 120 seconds, or results in a wrong placement of endotracheal tube (For example: Esophageal intubation, etc.). secondary outcome time frame 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. secondary outcome measure Intubation success on first attempt secondary outcome description Cumulative measure of intubation success on first attempt over 3 successive uses of the pediatric video laryngoscope, per blade, on each manikin type. secondary outcome time frame 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. other outcome list other outcome other outcome measure Glottic view grade other outcome description Glottic view grade on each of 3 attempts per blade, on each manikin type using the Cormack & Lehane grading scale:
Grade 1 = Full view of vocal cords
Grade 2a = Partial view of vocal cords
Grade 2b = Only arytenoids/posterior part of vocal cords
Grade 3 = Only epiglottis visible, no view of glottis or arytenoids
Grade 4 = Neither glottis nor epiglottis visible other outcome time frame 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. other outcome measure Time to visualize glottis other outcome description Time to visualize the glottis on each of 3 attempts per blade, on each manikin type. other outcome time frame 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. other outcome measure Assessment of clinical utility and performance using a Lickert scale other outcome description Assessment of the clinical utility and performance of the pediatric blades using a 5-point Lickert scale, where 1 = strongly disagree, 2 = disagree, 3= neutral, 4 = agree, 5 = strongly agree.
Ease of the pediatric video laryngoscope blade insertion when attempting to insert the pediatric video laryngoscope blade into manikin's mouth for each blade type and manikin type.
Ease of tracheal intubation when attempting to pass a tracheal tube below manikin's vocal cords using each of the pediatric video laryngoscope blades on each manikin type.
Assessment of the comfort of each blade handle during neonate/pediatric intubations.
Assessment of the blade and cable connection during neonate/pediatric intubation with each blade type.
Assessment of potential cable interference during neonate/pediatric intubation with each blade type. other outcome time frame 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. other outcome measure Observational description of features causing impediments other outcome description Participant self-reported observational description of potential features causing intubation impediments to tracheal tube insertion (e.g., tube hitting the epiglottis or tube hitting the arytenoid). Recorded by the study subject at the time of attempt at placing a tracheal tube below a patient's vocal cords using each of the pediatric video laryngoscope blades. other outcome time frame 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. other outcome measure Overall clinical usefulness other outcome description Recorded as excellent, good, fair, or inadequate by the study subject when using the pediatric video laryngoscope and stylet to place a tracheal tube below a patient's vocal cords. other outcome time frame 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. other outcome measure Overall satisfaction of operator other outcome description Recorded as excellent, good, fair, or inadequate by the study subject when using each of the pediatric video laryngoscope blades and stylet to place a tracheal tube below manikin's vocal cords. other outcome time frame 120 seconds - This is the maximum time allowed. After this time, it will be recorded as a failed attempt. eligibility module eligibility criteria Inclusion Criteria:
Anesthesia and emergency medicine providers who perform pediatric orotracheal intubations
Able to give voluntary consent to participate in the study
Are experienced with orotracheal intubation (> 50 times) using direct laryngoscopy or video laryngoscopy
Exclusion Criteria:
Volunteers who are < 18 years of age
Volunteers unable to read or understand English
Unable to physically meet the demands of orotracheal intubation or those who have heart, wrist, or low back disease. Are not experienced with pediatric orotracheal intubations gender All minimum age 18 Years std age list std age Adult Older Adult study population Clinicians, anesthesia, and emergency medicine providers who perform pediatric intubations. Participants will be recruited from Children's Medical Center, Dallas. sampling method Non-Probability Sample contacts locations module overall official list overall official overall official name Patrick Olomu, MD overall official affiliation University of Texas Southwestern Medical Center overall official role Principal Investigator location list location location facility University of Texas Southwestern Medical Center location city Dallas location state Texas location zip 75235 location country United States derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id T1134 condition browse leaf name Childhood Acute Lymphoblastic Leukemia condition browse leaf as found Pediatric ALL condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev Rare condition browse branch name Rare Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04836338 | [
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2236,
188,
23055,
1314,
11984,
2112,
2236,
1364,
129,
117,
17881,
1475,
1314,
11984,
2112,
2236,
2076,
2173,
4746,
10767,
24146,
13196,
2784,
1710,
2784,
1710,
2076,
156,
5674,
27035,
1197,
1730,
10767,
1730,
10767,
1271,
13050,
1582,
1320,
1730,
10767,
1705,
15969,
2137,
13329,
23313,
3663,
20715,
2190,
20715,
20715,
1271,
1239,
1104,
2245,
22557,
3875,
1945,
20715,
1705,
152,
24162,
9637,
20051,
13196,
1110,
175,
173,
170,
12521,
3850,
1302,
1110,
175,
173,
170,
12521,
4442,
2160,
6136,
13196,
4094,
14940,
1109,
2905,
3007,
1104,
1142,
2025,
1110,
1106,
15187,
1103,
16354,
111,
3772,
1104,
1103,
1329,
1104,
1103,
3599,
2011,
144,
18498,
1708,
16260,
22046,
185,
24795,
1888,
2495,
15023,
12443,
16260,
1105,
1947,
1204,
1111,
1103,
1137,
3329,
19366,
13836,
1233,
1107,
25098,
1891,
1104,
24762,
5430,
1105,
185,
24795,
4420,
117,
19105,
1299,
12635,
1179,
3584,
119,
6448,
6136,
1109,
2905,
3007,
1104,
1142,
2025,
1110,
1106,
15187,
1103,
16354,
111,
3772,
1104,
1103,
1329,
1104,
1103,
3599,
2011,
144,
18498,
1708,
16260,
22046,
185,
24795,
1888,
2495,
15023,
12443,
16260,
11939,
1105,
1947,
1204,
1111,
1103,
1137,
3329,
19366,
13836,
1233,
1107,
25098,
1891,
1104,
24762,
5430,
1105,
185,
24795,
4420,
117,
19105,
1299,
12635,
1179,
3584,
119,
1109,
11066,
1110,
1115,
1103,
22046,
2495,
15023,
12443,
16260,
11939,
1105,
1947,
1204,
1169,
4607,
1103,
1159,
1105,
120,
1137,
2244,
1104,
1137,
3329,
19366,
13836,
1233,
1107,
25098,
1891,
1107,
170,
1299,
12635,
1179,
119,
7934,
8469,
1104,
1142,
2025,
1511,
23529,
1103,
3772,
1104,
22046,
185,
24795,
1888,
2495,
15023,
12443,
16260,
11939,
1223,
27210,
2999,
1105,
2846,
1586,
2787,
2975,
1113,
176,
7841,
2941,
2458,
3654,
117,
1779,
2000,
117,
7166,
1104,
6275,
27914,
117,
7166,
1104,
189,
19366,
13836,
1233,
7159,
27914,
117,
10748,
1104,
189,
19366,
13836,
1233,
7159,
27914,
24034,
1174,
27439,
117,
1105,
8367,
2905,
7300,
111,
8458,
5616,
1757,
1107,
1586,
8520,
1114,
17163,
3864,
1104,
2846,
1107,
25098,
1891,
119,
2975,
13196,
3879,
2190,
3879,
153,
24795,
18589,
2162,
1902,
13196,
2025,
2076,
152,
4832,
1200,
11583,
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5351,
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1902,
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10803,
23992,
10803,
5099,
1851,
10803,
2076,
2173,
4746,
1739,
22496,
13196,
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1372,
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1981,
1372,
1981,
1372,
3107,
4539,
27989,
21868,
1981,
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6136,
1760,
2556,
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1981,
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15545,
2093,
131,
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1233,
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1981,
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2425,
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2425,
9386,
4929,
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2614,
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1107,
25098,
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1113,
1296,
1104,
124,
4021,
1679,
6275,
117,
1113,
1296,
1299,
12635,
1179,
2076,
119,
2425,
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118,
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1258,
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117,
1122,
1209,
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1802,
1112,
170,
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2661,
119,
2425,
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4929,
1752,
2789,
2244,
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2425,
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2244,
2603,
1113,
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1104,
124,
4021,
1679,
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117,
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1296,
1299,
12635,
1179,
2076,
119,
1752,
2789,
2244,
113,
143,
10197,
114,
1110,
3393,
1112,
1103,
2912,
1106,
1282,
170,
189,
19366,
13836,
1233,
7159,
2071,
170,
5351,
112,
188,
5563,
13408,
1116,
1113,
1103,
1148,
2661,
1443,
9305,
1103,
1888,
2495,
15023,
12443,
16260,
1121,
1103,
5351,
112,
188,
1779,
119,
2425,
9386,
1159,
4207,
5356,
3071,
118,
1188,
1110,
1103,
4177,
1159,
2148,
119,
1258,
1142,
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117,
1122,
1209,
1129,
1802,
1112,
170,
2604,
2661,
119,
2425,
9386,
4929,
8007,
2099,
1105,
7300,
10345,
1606,
170,
126,
118,
1553,
2409,
3740,
20334,
2425,
9386,
6136,
8007,
2099,
1105,
7300,
10345,
1104,
1423,
118,
1329,
185,
24795,
1947,
1204,
132,
7993,
170,
126,
118,
1553,
149,
2240,
22441,
10460,
9314,
12507,
2036,
117,
6635,
1209,
3654,
1103,
1378,
8477,
1114,
12747,
1106,
1103,
1329,
1104,
1103,
1423,
118,
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24795,
1947,
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134,
23423,
134,
8795,
134,
5340,
134,
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5340,
174,
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176,
119,
118,
4539,
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27430,
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8477,
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1779,
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1299,
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1103,
1165,
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2846,
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1299,
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140,
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4929,
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117,
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6136,
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7841,
2941,
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3654,
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1104,
124,
4021,
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1296,
1299,
12635,
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2076,
1606,
1103,
3291,
10841,
2158,
111,
3180,
15296,
176,
23857,
3418,
131,
6318,
122,
134,
8896,
2458,
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5563,
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6318,
123,
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134,
4539,
2916,
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5563,
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6318,
123,
1830,
134,
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170,
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5208,
18093,
120,
16530,
1226,
1104,
5563,
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6318,
124,
134,
2809,
174,
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1403,
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6620,
5085,
117,
1185,
2458,
1104,
176,
7841,
6620,
1137,
170,
1616,
5208,
18093,
6318,
125,
134,
8853,
176,
7841,
6620,
4040,
174,
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1403,
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6620,
5085,
1168,
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1103,
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1122,
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2604,
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3708,
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6620,
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6620,
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7300,
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5255,
8638,
1204,
3418,
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19721,
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7300,
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1105,
2099,
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1103,
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24795,
11939,
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126,
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1553,
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8638,
1204,
3418,
117,
1187,
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134,
5473,
23423,
117,
123,
134,
23423,
117,
124,
134,
8795,
117,
125,
134,
5340,
117,
126,
134,
5473,
5340,
119,
142,
6530,
1104,
1103,
185,
24795,
1888,
2495,
15023,
12443,
16260,
6275,
27914,
1165,
6713,
1106,
22884,
1103,
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1802,
1112,
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2661,
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full study rank 61216 study protocol section identification module n c t id NCT04839354 org study id info org study id STUDY00002344 secondary id info list secondary id info secondary id PECARN Protocol Number 050 secondary id type Other Identifier secondary id domain Pediatric Emergency Care Applied Research Network secondary id UG3HL148560 secondary id type U.S. NIH Grant/Contract secondary id link https://reporter.nih.gov/quickSearch/UG3HL148560 organization org full name Emory University org class OTHER brief title Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial official title Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial acronym STArT status module status verified date January 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 21, 2021 start date type Actual primary completion date struct primary completion date April 2027 primary completion date type Anticipated completion date struct completion date April 2027 completion date type Anticipated study first submit date April 8, 2021 study first submit q c date April 8, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date January 12, 2022 last update post date struct last update post date January 13, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Claudia R. Morris MD responsible party investigator title Principal Investigator responsible party investigator affiliation Emory University lead sponsor lead sponsor name Emory University lead sponsor class OTHER collaborator list collaborator collaborator name National Heart, Lung, and Blood Institute (NHLBI) collaborator class NIH oversight module oversight has d m c Yes is f d a regulated drug Yes is f d a regulated device No is u s export No description module brief summary The trial of IV arginine therapy in children with Vaso-occlusive painful episodes (VOE) in sickle cell disease (SCD) is designed to further knowledge on efficacy and safety of the therapy. detailed description The trial is designed as a double-blind, placebo controlled, randomized, phase 3, multi-center trial of IV arginine therapy in children with Vaso-occlusive painful episodes (VOE) in sickle cell disease (SCD) to further knowledge on efficacy and safety of the therapy. The exploratory objective is to more fully characterize the arginine metabolome in children with SCD during VOE, and evaluate the effects of arginine therapy on global arginine bioavailability and mitochondrial function together with important clinical outcomes (time to VOE resolution, pain scores, total parenteral opioid use, Patient-Reported Outcomes (PROs), and hospital length of stay in children with SCD and VOE. conditions module condition list condition Sickle Cell Disease keyword list keyword Arginine Therapy Pain management design module study type Interventional phase list phase Phase 3 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 360 enrollment type Anticipated arms interventions module arm group list arm group arm group label Arginine Hydrochloride arm group type Experimental arm group description Arginine is a nutritional supplement in parenteral form arm group intervention list arm group intervention name Drug: Arginine Hydrochloride arm group label Placebo arm group type Placebo Comparator arm group description Normal saline arm group intervention list arm group intervention name Other: Normal saline intervention list intervention intervention type Drug intervention name Arginine Hydrochloride intervention description One-time L-arginine loading dose (200 mg/kg IV) + standard dose (100 mg/kg IV TID) intervention arm group label list intervention arm group label Arginine Hydrochloride intervention type Other intervention name Normal saline intervention description Placebo (normal saline) loading dose (2ml/kg IV) + 1ml/kg IV TID intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Change in time-to-crisis resolution primary outcome description Time in hours from study drug delivery to time of last dose of parenteral opioid delivery primary outcome time frame Date and time of first study drug administration and last IV opioid treatment - up to 2 months secondary outcome list secondary outcome secondary outcome measure Change in total parenteral opioid use secondary outcome description Total parenteral opioid use (morphine equivalents, mg/kg) secondary outcome time frame Time of IV placement, opioid monitoring up to 2 months secondary outcome measure Change in pain scores secondary outcome description Daily highest and lowest pain scores will be recorded. 0-10 scale, 10 is strongest pain secondary outcome time frame Time of IV placement, and on the day of discharge up to 2 months secondary outcome measure Change in PROMIS Pain Interference score secondary outcome description PROMIS: pain Interference (8 items). PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured (e.g., more pain). secondary outcome time frame Within 12 hours of study drug delivery, and on the day of discharge up to 2 months secondary outcome measure Change in PROMIS Pain Behavior score secondary outcome description PROMIS: pain behavior (8 items). PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured (e.g., more pain) secondary outcome time frame Within 12 hours of study drug delivery, and on the day of discharge up to 2 months secondary outcome measure Change in PROMIS Fatigue score secondary outcome description PROMIS: fatigue (8 items). PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured (e.g., more fatigue). secondary outcome time frame Within 12 hours of study drug delivery, and on the day of discharge up to 2 months other outcome list other outcome other outcome measure Change in Medication Quantification Score (MQS) other outcome description Medication Quantification Score (MQS) is a tool to objectively quantify pain. It computes a single numeric value for a patient's pain medication profile. This number is used to track pain levels through a treatment course. other outcome time frame Pre-dose and on day of discharge up to 2 months other outcome measure Hospital length of stay in children other outcome description Hospital length of stay in children (days) will be recorded. other outcome time frame Up to 6 months other outcome measure Change in Pediatric PROMIS score other outcome description Pediatric PROMIS: (35 items) To be completed by patients ages 8-17 years of age and parents of children ages 5-17 years of age: (a)pain behavior (8 items), (b)pain interference (8 items), (c)pain intensity (1 item), (d)physical stress experiences (8 items), (e)fatigue (10 items). PROMIS measures are scored on the T-score metric. High scores mean more of the concept being measured (e.g., more fatigue). other outcome time frame Within 12 hours of study drug delivery, and on the day of discharge up to 2 months other outcome measure Change in Pediatric QL SCD score other outcome description Peds QL SCD module (19 items) to be completed by children ages 5-17 years of age and parents of children ages 3-17 years of age: (a)Pain and Hurt (9 items), (b)Pain Impact (10 items) other outcome time frame Within 12 hours of study drug delivery, and on the day of discharge up to 2 months other outcome measure Change in Arginine bioavailability other outcome description Pharmacokinetic study will measure peak plasma arginine concentration other outcome time frame Prior to study drug delivery (pre-Dose), on day 2 and prior to discharge up to 2 months other outcome measure Change in mitochondrial function other outcome description Mitochondrial respiratory complex activities will be measured to estimate mitochondrial function other outcome time frame Prior to study drug delivery (pre-Dose), on day 2 and prior to discharge up to 2 months eligibility module eligibility criteria Inclusion Criteria:
Age 3-21 years of age, inclusive; AND
Established diagnosis of sickle cell disease (any genotype); AND
Pain requiring medical care in an acute care setting (ED, hospital ward, day hospital, clinic) not attributable to non-sickle cell causes, treated with parenteral opioids.
Exclusion Criteria:
Responds to 2 doses of IV opioids sufficiently for outpatient management
Greater than 12 hours from first dose of intravenous opioids to treat current pain in acute care setting
Hemoglobin less than 5 gm/dL or emergent need for red blood cell transfusion for hemodynamically unstable patient; OR
Ketamine use in the emergency department for treatment of VOE; OR
Glutamine within 30 days; OR
New SCD drug use < 3 months (e.g. Hydroxyurea, voxelotor, crizanlizumab, etc) OR
Acute mental status or neurological changes; OR
Acute stroke or clinical concern for stroke; OR
Three or more ED visits for sickle cell related pain receiving parenteral opioids in previous 7 days (not including current ED visit); OR
Hospital discharge within previous 7 days; OR
Hypotension requiring clinical intervention; hemodynamic instability; septic shock; OR
Previous randomization in this arginine phase 3 RCT; OR
Use of inhaled nitric oxide, sildenafil or arginine within the last month; OR
Non-English or non-Spanish speaking; OR
pregnancy; OR
Allergy to arginine; OR
PI/clinical team concerns for compliance/issues that may adversely impact study participation/outcome; OR
Adults 18 years or older who lack medical decision-making capacity to consent healthy volunteers No gender All minimum age 3 Years maximum age 21 Years std age list std age Child Adult contacts locations module central contact list central contact central contact name Claudia Morris, MD central contact role Contact central contact phone 404-785-7141 central contact e mail claudia.r.morris@emory.edu overall official list overall official overall official name Claudia Morris, MD overall official affiliation Emory University overall official role Principal Investigator location list location location facility Children's Hospital Los Angeles location status Recruiting location city Los Angeles location state California location zip 90027 location country United States location facility UCSF Benioff Children's Hospital location status Recruiting location city San Francisco location state California location zip 94158 location country United States location facility Children's National Medical Center location status Recruiting location city Washington location state District of Columbia location zip 20010 location country United States location facility Children's Healthcare of Atlanta at Hughes Spalding location status Recruiting location city Atlanta location state Georgia location zip 03322 location country United States location facility Children's Healthcare of Atlanta at Egleston location status Recruiting location city Atlanta location state Georgia location zip 30322 location country United States location contact list location contact location contact name Claudia Morris, MD location contact role Contact location contact phone 404-785-7141 location contact e mail claudia.r.morris@emory.edu location facility Washington University/St. Louis Children's Hospital location status Recruiting location city Saint Louis location state Missouri location zip 63110 location country United States location facility Nationwide Children's Hospital location status Recruiting location city Columbus location state Ohio location zip 43205 location country United States location facility Children's Hospital of Philadelphia location status Recruiting location city Philadelphia location state Pennsylvania location zip 19104 location country United States location facility Texas Children's Hospital/Baylor College of Medicine location status Recruiting location city Houston location state Texas location zip 77030 location country United States location facility Medical College of Wisconsin/Wisconsin Children's Hospital location status Recruiting location city Wauwatosa location state Wisconsin location zip 53226 location country United States i p d sharing statement module i p d sharing Yes i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) i p d sharing time frame Will be available starting 2029 i p d sharing access criteria No restrictions derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000755 condition mesh term Anemia, Sickle Cell condition ancestor list condition ancestor condition ancestor id D000000745 condition ancestor term Anemia, Hemolytic, Congenital condition ancestor id D000000743 condition ancestor term Anemia, Hemolytic condition ancestor id D000000740 condition ancestor term Anemia condition ancestor id D000006402 condition ancestor term Hematologic Diseases condition ancestor id D000006453 condition ancestor term Hemoglobinopathies condition ancestor id D000030342 condition ancestor term Genetic Diseases, Inborn condition browse leaf list condition browse leaf condition browse leaf id M3237 condition browse leaf name Anemia, Sickle Cell condition browse leaf as found Sickle Cell Disease condition browse leaf relevance high condition browse leaf id M12218 condition browse leaf name Pain condition browse leaf relevance low condition browse leaf id M3222 condition browse leaf name Anemia condition browse leaf relevance low condition browse leaf id M8699 condition browse leaf name Hemolysis condition browse leaf relevance low condition browse leaf id M3225 condition browse leaf name Anemia, Hemolytic condition browse leaf relevance low condition browse leaf id M3227 condition browse leaf name Anemia, Hemolytic, Congenital condition browse leaf relevance low condition browse leaf id M8642 condition browse leaf name Hematologic Diseases condition browse leaf relevance low condition browse leaf id M8691 condition browse leaf name Hemoglobinopathies condition browse leaf relevance low condition browse leaf id M22839 condition browse leaf name Genetic Diseases, Inborn condition browse leaf relevance low condition browse leaf id T5229 condition browse leaf name Sickle Cell Anemia condition browse leaf as found Sickle Cell Disease condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC15 condition browse branch name Blood and Lymph Conditions condition browse branch abbrev BC16 condition browse branch name Diseases and Abnormalities at or Before Birth condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id T1 intervention browse leaf name Arginine intervention browse leaf as found Adderall intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev AA intervention browse branch name Amino Acids intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04839354 | [
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] |
full study rank 61233 study protocol section identification module n c t id NCT04839133 org study id info org study id MyoSuit Feasibility Trial organization org full name German Heart Institute org class OTHER brief title Robotic-assisted Exercise Training in Heart Failure official title Feasibility of Robotic Assisted Exercise Training in Patients With Advanced Heart Failure or Advanced Pulmonary Diseases status module status verified date November 2021 overall status Completed expanded access info has expanded access No start date struct start date March 31, 2021 start date type Actual primary completion date struct primary completion date July 30, 2021 primary completion date type Actual completion date struct completion date July 31, 2021 completion date type Actual study first submit date March 29, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date November 16, 2021 last update post date struct last update post date November 24, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name German Heart Institute lead sponsor class OTHER collaborator list collaborator collaborator name ETH Zurich collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Background:
Regular physical activity is an evidence-based adjuvant therapy of chronic heart failure or chronic lung diseases. Structured exercise training is safe, increases exercise capacity and quality of life, relieves symptoms and reduces hospitalization rates. Even a trend towards reduction of mortality has been identified. However, dyspnea and fatigue, typical symptoms of heart or lung failure, force patients to physical inactivity which fatally aggravates deconditioning and exercise intolerance, leading to an increased risk of hospitalization and a loss of independence and quality of life. To break through this vicious circle physical activity must be restored, since exercise intolerance can be successfully improved by physical training.
Purpose:
This study will address the challenging task of remobilizing patients with advanced chronic lung or heart failure in a functional New York Heart Association class III-IV by using an externally physically-supported exosuit movement therapy. This soft, wearable robot (fig. 1) assists mobilization according to individual needs by activating neuromuscular feedback systems, promoting physical activity and preventing early physical exhaustion. The investigators hypotheses that an exosuit-supported training increases exercise capacity and quality of life in a greater degree than non-supported training.
Methods:
The study will consist of two parts investigating i) the feasibility, tolerance and safety (n= 30) and ii) the efficacy of an exosuit device-supported training (n=30). In i) patients will perform a walking test and a set of everyday life skills or participate in a standardized rehabilitation sports program. In ii) patients will be randomized in a 2:1 ratio for an exosuit-supported or non-supported exercise training protocol, training 3 units per week for 8 weeks. Assessment of outcome will be performed by various functional, mobility and endurance tests, questionnaires and clinical parameters. Furthermore, the transfer of regained motor and balance skills to everyday life will be analyzed. conditions module condition list condition Heart Failure, Systolic Pulmonary Disease keyword list keyword Exercise training Robotic training Exosuit training design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 30 enrollment type Actual arms interventions module arm group list arm group arm group label Feasibility study group arm group type Other arm group intervention list arm group intervention name Device: MyoSuitFeasibility intervention list intervention intervention type Device intervention name MyoSuitFeasibility intervention description Participants will absolve feasibility tests with and without wearing a MyoSuit. intervention arm group label list intervention arm group label Feasibility study group outcomes module primary outcome list primary outcome primary outcome measure Incidence of Treatment-Emergent Falls - Safety of the MyoSuit primary outcome description Patients with advanced heart or pulmonary failure will perform 6-minute walking tests and activities of daily life both with and without wearing a MyoSuit. Outcome is measured by documenting number of falls. primary outcome time frame 1 hour primary outcome measure Incidence of Treatment-Emergent Adverse Events - Safety of the MyoSuit primary outcome description Patients with advanced heart or pulmonary failure will perform 6-minute walking tests and activities of daily life both with and without wearing a MyoSuit. Outcome is measured by documenting adverse events. primary outcome time frame 1 hour primary outcome measure Exercise can be performed when wearing a MyoSuit - Feasibility and Tolerability of walking test, activities of daily life, rehabilitation exercise group. primary outcome description Patients with advanced heart or pulmonary failure will perform a 6 minute walking test, activities of daily life and a cardiac rehabilitation exercise unit. Outcome is measured dichotomously (yes/no) according to its feasibility. primary outcome time frame 1 hour primary outcome measure Necessity of assistance in exercising when wearing a MyoSuit - Feasibility and Tolerability primary outcome description Patients with advanced heart or pulmonary failure will perform a 6 minute walking test, activities of daily lif and a cardiac rehabilitation exercise unit. Outcome is measured according to a scale of assistance needed (1=no assistance, 2=little assistance, 3=much assistance, 4=not possible). 1 is minimum, 4 is maximum. The higher the score, the worse the outcome. primary outcome time frame 1 hour primary outcome measure MyoSuit assistance leads to changes in walking distance in patients with advanced heart or pulmonary failure assessed by 6-minute walking test. primary outcome description Change of 6minute walk distance in meters will be assessed with and without MyoSuit in every participant. primary outcome time frame 30 minutes eligibility module eligibility criteria Inclusion Criteria:
>17 years old
written informed consent
chronic end-stage systolic heart failure without ventricular assist device, LVEF ≤ 45% OR chronic advanced pulmonary diseases
clinically stable for at least 6 weeks
ability to mobilize into standing and walking of at least 10 meters with or without rollator
ability to get up from a chair without rotating the upper body >45° sagittally
Exclusion Criteria:
addictions or other illnesses that impact the ability to understand the nature, scope and consequences of the trial
lack of knowledge of German to fully understand study information
pregnancy, pre-menopausal women
contraindications of cardiopulmonary exercising
BMI > 35 kg/m², waist size > 135 cm.
Height <150 cm, >195 cm
Weight<45 kg, >110 kg
Functional Reach Test <15,24 cm
Flexion contracture in the knee/hip joint >10°
Chronic colonization or active infection with multi-resistant pathogens healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module location list location location facility German Heart Center location city Berlin location zip 13353 location country Germany location facility German Heart Institute location city Berlin location zip 13353 location country Germany references module reference list reference reference p m i d 35320878 reference type derived reference citation Just IA, Fries D, Loewe S, Falk V, Cesarovic N, Edelmann F, Feuerstein A, Haufe FL, Xiloyannis M, Riener R, Schoenrath F. Movement therapy in advanced heart failure assisted by a lightweight wearable robot: a feasibility pilot study. ESC Heart Fail. 2022 Jun;9(3):1643-1650. doi: 10.1002/ehf2.13903. Epub 2022 Mar 23. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000008171 condition mesh term Lung Diseases condition mesh id D000006333 condition mesh term Heart Failure condition mesh id D000054143 condition mesh term Heart Failure, Systolic condition ancestor list condition ancestor condition ancestor id D000006331 condition ancestor term Heart Diseases condition ancestor id D000002318 condition ancestor term Cardiovascular Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M8573 condition browse leaf name Heart Failure condition browse leaf as found Heart Failure condition browse leaf relevance high condition browse leaf id M26732 condition browse leaf name Heart Failure, Systolic condition browse leaf as found Heart Failure, Systolic condition browse leaf relevance high condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf as found Pulmonary Disease condition browse leaf relevance high condition browse leaf id M26736 condition browse leaf name Systolic Murmurs condition browse leaf relevance low condition browse leaf id M8571 condition browse leaf name Heart Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC14 condition browse branch name Heart and Blood Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology | NCT04839133 | [
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8458,
1203,
1365,
4641,
1791,
1705,
2684,
118,
4191,
1118,
1606,
1126,
6298,
1193,
8027,
118,
2726,
4252,
2155,
10950,
2230,
7606,
119,
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2991,
117,
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113,
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119,
122,
114,
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11955,
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117,
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119,
1109,
17718,
177,
1183,
11439,
18769,
1115,
1126,
4252,
2155,
10950,
118,
2726,
2013,
6986,
6730,
3211,
1105,
3068,
1104,
1297,
1107,
170,
3407,
2178,
1190,
1664,
118,
2726,
2013,
119,
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1116,
131,
1109,
2025,
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1104,
1160,
2192,
11950,
178,
114,
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175,
14517,
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117,
15745,
1105,
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113,
183,
134,
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114,
1105,
25550,
114,
1103,
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2013,
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183,
134,
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114,
119,
1130,
178,
114,
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170,
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170,
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119,
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114,
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131,
122,
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1111,
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118,
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118,
2726,
6730,
2013,
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117,
2013,
124,
2338,
1679,
1989,
1111,
129,
2277,
119,
19721,
1104,
9386,
1209,
1129,
1982,
1118,
1672,
8458,
117,
16178,
1105,
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5715,
117,
2304,
24730,
1116,
1105,
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119,
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117,
1103,
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153,
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2013,
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2013,
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9538,
2165,
1902,
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1902,
18205,
151,
120,
138,
1902,
9108,
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1990,
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19638,
1880,
1902,
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114,
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23992,
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1476,
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2076,
2173,
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22496,
13196,
1981,
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1981,
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1981,
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11907,
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1981,
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1981,
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1981,
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175,
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119,
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1981,
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2025,
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118,
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1200,
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118,
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170,
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122,
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170,
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119,
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1110,
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1958,
119,
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9386,
1159,
4207,
122,
2396,
2425,
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4929,
16409,
1200,
14636,
1169,
1129,
1982,
1165,
3351,
170,
1422,
1186,
1708,
10950,
118,
11907,
17506,
5474,
1105,
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119,
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127,
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113,
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120,
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114,
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175,
14517,
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119,
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122,
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151,
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1200,
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1158,
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170,
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10950,
118,
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1105,
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2425,
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1209,
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170,
127,
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117,
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181,
8914,
1105,
170,
17688,
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6730,
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119,
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122,
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117,
123,
134,
1376,
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117,
124,
134,
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117,
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134,
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1936,
114,
119,
122,
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5867,
117,
125,
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4177,
119,
1109,
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1103,
2794,
117,
1103,
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1103,
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119,
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1159,
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122,
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127,
118,
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119,
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127,
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14031,
119,
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11768,
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140,
10587,
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131,
135,
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1322,
118,
2016,
188,
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21828,
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117,
149,
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2271,
863,
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110,
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1193,
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127,
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1106,
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1105,
3179,
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1106,
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1121,
170,
2643,
1443,
14362,
1103,
3105,
1404,
135,
2532,
7259,
21718,
24632,
6163,
1193,
16409,
1665,
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140,
10587,
3464,
131,
15658,
1116,
1137,
1168,
6946,
1279,
1115,
3772,
1103,
2912,
1106,
2437,
1103,
2731,
117,
9668,
1105,
8421,
1104,
1103,
3443,
2960,
1104,
3044,
1104,
1528,
1106,
3106,
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2025,
1869,
10203,
117,
3073,
118,
1441,
4184,
25134,
1348,
1535,
14255,
4487,
24704,
4578,
6126,
1104,
3621,
2660,
16091,
13505,
7637,
1616,
4252,
1200,
21349,
1158,
139,
14038,
135,
2588,
4023,
120,
6450,
117,
5111,
2060,
135,
11498,
3975,
119,
21621,
133,
4214,
3975,
117,
135,
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3975,
25589,
133,
2532,
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117,
135,
6745,
4023,
16068,
17264,
26836,
5960,
133,
1405,
117,
1572,
3975,
143,
21729,
1988,
2329,
3313,
1107,
1103,
5656,
120,
5110,
4091,
135,
1275,
7259,
20394,
26003,
23204,
1137,
2327,
8974,
1114,
4321,
118,
13676,
3507,
19790,
1116,
8071,
8118,
1302,
5772,
1398,
5867,
1425,
1407,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2450,
2190,
2450,
2450,
3695,
1528,
4641,
1945,
2450,
1331,
3206,
2450,
195,
9717,
15118,
24239,
2450,
1583,
1860,
2450,
3695,
1528,
4641,
2024,
2450,
1331,
3206,
2450,
195,
9717,
15118,
24239,
2450,
1583,
1860,
7732,
13196,
3835,
2190,
3835,
3835,
185,
182,
178,
173,
2588,
17101,
1568,
1604,
1559,
1604,
3835,
2076,
4408,
3835,
19548,
2066,
146,
1592,
117,
13359,
1905,
141,
117,
10605,
5773,
1162,
156,
117,
143,
23074,
159,
117,
24664,
9724,
3292,
1596,
151,
117,
5316,
1883,
4119,
143,
117,
11907,
10232,
7879,
138,
117,
11679,
16205,
1162,
23485,
117,
20802,
26179,
11657,
1548,
150,
117,
155,
8584,
1200,
155,
117,
20452,
10061,
1179,
7625,
1324,
143,
119,
6257,
7606,
1107,
3682,
1762,
4290,
6842,
1118,
170,
14939,
4330,
1895,
10975,
131,
170,
175,
14517,
7706,
3955,
2025,
119,
142,
10844,
4641,
143,
11922,
119,
17881,
1477,
12865,
132,
130,
113,
124,
114,
131,
19290,
1495,
118,
24182,
119,
9465,
131,
1275,
119,
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120,
19563,
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119,
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119,
142,
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9751,
1695,
119,
178,
185,
173,
6303,
4195,
13196,
178,
185,
173,
6303,
12118,
2007,
16388,
1174,
4408,
2237,
1940,
1116,
1665,
23992,
13196,
1683,
10266,
1382,
5507,
117,
17881,
1477,
3879,
11424,
1162,
13196,
3879,
24000,
2190,
3879,
24000,
3879,
24000,
25021,
141,
7629,
7629,
1568,
1604,
16770,
1475,
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1858,
14557,
2118,
20012,
1116,
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24000,
25021,
141,
7629,
7629,
1568,
1545,
23493,
1495,
3879,
24000,
1858,
4641,
143,
11922,
3313,
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24000,
25021,
141,
7629,
7629,
1571,
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25631,
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1858,
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143,
11922,
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117,
156,
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141,
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141,
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1858,
10103,
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141,
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11964,
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1858,
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157,
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11424,
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2190,
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11424,
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25021,
150,
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25319,
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117,
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117,
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170,
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1964,
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170,
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1964,
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170,
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1964,
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113,
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139,
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114,
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full study rank 61197 study protocol section identification module n c t id NCT04839601 org study id info org study id NP10014 organization org full name NeuroPace org class INDUSTRY brief title RNS System RESPONSE Study official title RNS® System Responsive Stimulation for Adolescents With Epilepsy Study acronym RESPONSE status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date October 27, 2021 start date type Actual primary completion date struct primary completion date July 1, 2026 primary completion date type Anticipated completion date struct completion date December 31, 2027 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date November 11, 2022 last update post date struct last update post date November 14, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name NeuroPace lead sponsor class INDUSTRY oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device Yes description module brief summary To demonstrate that the RNS System is safe and effective as an adjunctive therapy in individuals age 12 through 17 years with medically refractory partial onset epilepsy. detailed description NeuroPace is sponsoring the RESPONSE Study with the RNS System in individuals age 12 through 17 with partial (focal) onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures. For the purposes of this study, disabling seizures are defined as motor partial seizures, complex partial seizures, and/or secondarily generalized seizures. The RNS System is currently approved by the FDA for use in patients 18 years and older with hard-to-treat partial-onset seizures. The same device will be used in the RESPONSE Study.
The study is a prospective open label single arm pivotal study and participants will be followed for 2 years after placement of the RNS System. The study will enroll a maximum of 200 subjects within the United States to ensure that at least 150 subjects are implanted with the RNS System.
The study design includes one interim analysis which will occur after the 75th implanted patient reaches 12 months post-implant. If the study achieves its primary safety and effectiveness endpoint goals at the interim analysis, the study will be considered successful and enrollment will be stopped.
If the interim analysis does not achieve the primary safety and effectiveness endpoint goals, the study will continue enrolling up to the maximum of 200 patients. A final analysis will be conducted after the 150th implanted patient reaches 12 months post-implant. conditions module condition list condition Epilepsy Partial Seizure Neurostimulator; Complications Drug Resistant Epilepsy Focal Epilepsy keyword list keyword Adolescent Medically refractory Responsive neurostimulation Focal onset seizures RNS System design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 200 enrollment type Anticipated arms interventions module arm group list arm group arm group label Evaluation Group (stimulation ON) arm group type Experimental arm group description Group of participants that have an RNS System implanted and are being treated with responsive stimulation. arm group intervention list arm group intervention name Device: RNS System intervention list intervention intervention type Device intervention name RNS System intervention description The RNS System provides closed loop responsive brain stimulation. The Neurostimulator monitors the electrical activity of the brain to detect abnormal activity that could lead to a seizure. If abnormal activity is detected, the neurostimulator delivers electrical stimulation to the brain through the leads to help prevent the seizure before it occurs. intervention arm group label list intervention arm group label Evaluation Group (stimulation ON) outcomes module primary outcome list primary outcome primary outcome measure Short-term chronic serious adverse device effect (SADE) rate primary outcome description The primary safety endpoint is the percent of subjects with serious device-related adverse events at 84 days (12 weeks) post-implant. primary outcome time frame 84-days post-implant primary outcome measure Responder rate at 12 months post implant primary outcome description 12 months post-implant primary outcome time frame The primary effectiveness endpoint is the percent of subjects with a ≥ 50% reduction in seizures at 12 months post-implant compared to the pre-implant baseline. other outcome list other outcome other outcome measure Device-related Serious Adverse Event (SADE) event rate other outcome description The annual SADE event rate over time in subjects age 12 - 17 years implanted with the neurostimulator and/or leads during study participation will be calculated other outcome time frame Implant through 2 years post-implant other outcome measure Event rate of Serious Adverse Events (SAEs) of particular relevance other outcome description The annual event rate of SAEs of particular relevance (device-related or not) will be calculated over time in subjects age 12 - 17 years implanted with the neurostimulator and/or leads during study participation.
SAEs of particular relevance include those related to:
infection
intracranial hemorrhage
new more disabling seizure types
suicidality other outcome time frame Implant through 2 years post-implant other outcome measure Affective status as measured by the Beck Depression Inventory other outcome description Affective status (by summary scores from the Beck Depression Inventory (BDI), either the BDI-II or Beck Youth Inventory (BYI-II), depending on age at time of the initial clinic appointment) will be described pre-implant, as well as for the post-implant months 3, 6, 9, 12 and then every four months. other outcome time frame Implant through 2 years post-implant other outcome measure Neuropsychological functioning as assessed by a sub-set of tests in the NIH Toolbox Cognition Battery other outcome description Neuropsychological functioning as assessed by neuropsychological testing with pediatric validated, standardized inventories to assess 3 domains that include attention, memory, and vocabulary (Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, and Picture Vocabulary Test, respectively). These inventories are taken from the NIH Toolbox Cognition Battery and will be described by presenting summary scores for the pre-neurostimulator implant period, as well as for the annual appointments. other outcome time frame Implant through 2 years post-implant other outcome measure Percentage change in seizure frequency other outcome description The percentage change in seizure frequency will be summarized and reported by medians and responder rates for each 3-month interval beginning 4 months post-implant. other outcome time frame Implant through 2 years post-implant other outcome measure Quality of life as assessed by the Quality of Life in Epilepsy Inventory (QOLIE) other outcome description Quality of life [by summary scores from the QOLIE-AD-48 (validated for ages 12 - 17 years) or QOLIE-31-P (validated for ages 18 and older), depending on age at time of assessment] will be described pre-neurostimulator implant, as well as at yearly time points. other outcome time frame Implant through 2 years post-implant eligibility module eligibility criteria Inclusion Criteria:
Subject has disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair functional ability in domains including employment, psychosocial education and mobility.
Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the investigator, by the subject or parent/caregiver.
Subject had an average of three or more disabling motor simple partial seizures, complex partial seizures and/or secondarily generalized seizures over the two most recent consecutive 30-day periods, with no 30-day period with less than two seizures per subject and/or parent/caregiver report.
Subject failed treatment with a minimum of two anti-seizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment, as determined by the investigator.
Subject has undergone diagnostic testing as part of his/her standard care that has identified no more than two epileptogenic regions.
Subject is male or a female of childbearing potential using a reliable method of contraception (hormonal, barrier method, surgical or abstention).
Subject is age 12 or older but will be less than age 18 (has not reached 18th birthday) at the time of implantation with the RNS System.
Subject is able to maintain an electronic diary alone or with the assistance of a competent individual.
Subject is able to attend clinic appointments in accordance with the study schedule.
Subject and/or parent/guardian must be willing and able to provide informed consent and assent when appropriate.
Subject is not currently implanted with an RNS Neurostimulator or NeuroPace Leads.
In the investigator's opinion, subject is able to tolerate a neurosurgical procedure.
Exclusion Criteria:
Subject has been diagnosed with primarily generalized seizures.
Subject requires procedures that are contraindicated based on current RNS System labeling.
In the opinion of the investigator, the subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive central nervous system disease.
Subject has been diagnosed with active psychosis, major depression or suicidal ideation in the preceding year. Subjects with post-ictal psychiatric symptoms need not be excluded.
Subject is pregnant.
Subject is participating in a therapeutic investigational drug or other device study.
Subject is implanted with an electronic medical device that delivers electrical energy to the brain.
Subject has been diagnosed with psychogenic or non-epileptic seizures.
Subject has experienced unprovoked status epilepticus in the preceding year.
Subject is taking chronic anticoagulants.
Note: For contraindications, refer to current physician labeling (manuals) for the RNS System available at the NeuroPace website (www.neuropace.com). healthy volunteers No gender All minimum age 12 Years maximum age 17 Years std age list std age Child contacts locations module central contact list central contact central contact name Kerry Flynn central contact role Contact central contact phone 650-793-5277 central contact e mail kflynn@neuropace.com central contact name Tracy Courtney central contact role Contact central contact e mail tcourtney@neuropace.com overall official list overall official overall official name Martha Morrell, MD overall official affiliation NeuroPace, Inc. overall official role Principal Investigator location list location location facility Children's Health of Orange County location status Recruiting location city Orange location state California location zip 92868 location country United States location contact list location contact location contact name Angelyque Lorenzana location contact role Contact location contact phone 714-509-8972 location contact phone ext 18972 location contact e mail Angelyque.Lorenzana@choc.org location contact name Joffre Olaya location contact role Principal Investigator location facility Nicklaus Children's Hospital location status Recruiting location city Miami location state Florida location zip 33155 location country United States location contact list location contact location contact name Mari Vega location contact role Contact location contact e mail marinellie.vega@nicklaushealth.org location contact name Marytery Fajardo location contact role Principal Investigator location facility University of Chicago location status Withdrawn location city Chicago location state Illinois location zip 60637 location country United States location facility Spectrum Health System location status Recruiting location city Grand Rapids location state Michigan location zip 49503 location country United States location contact list location contact location contact name Jacquelyn Davis-Dudka location contact role Contact location contact e mail Jacquelyn.davis-dudka@spectrumhealth.org location contact name Anastasia Luniova, MD location contact role Principal Investigator location facility Mayo Clinic location status Recruiting location city Rochester location state Minnesota location zip 55905 location country United States location contact list location contact location contact name Brian Lundstrom, MD, PhD location contact role Contact location facility Westchester Medical Center location status Recruiting location city Hawthorne location state New York location zip 10532 location country United States location contact list location contact location contact name Donika Zogejani location contact role Contact location contact phone 914-768-3970 location contact e mail dzogejan@nymc.edu location contact name Steve Wolf location contact role Principal Investigator location facility Cohen Children's Medical Center location status Withdrawn location city Lake Success location state New York location zip 11042 location country United States location facility Mount Sinai Hospital location status Withdrawn location city New York location state New York location zip 10029 location country United States location facility Le Bonheur Children's Foundation Research Institute location status Withdrawn location city Memphis location state Tennessee location zip 38105 location country United States references module reference list reference reference p m i d 32690786 reference type result reference citation Nair DR, Laxer KD, Weber PB, Murro AM, Park YD, Barkley GL, Smith BJ, Gwinn RP, Doherty MJ, Noe KH, Zimmerman RS, Bergey GK, Anderson WS, Heck C, Liu CY, Lee RW, Sadler T, Duckrow RB, Hirsch LJ, Wharen RE Jr, Tatum W, Srinivasan S, McKhann GM, Agostini MA, Alexopoulos AV, Jobst BC, Roberts DW, Salanova V, Witt TC, Cash SS, Cole AJ, Worrell GA, Lundstrom BN, Edwards JC, Halford JJ, Spencer DC, Ernst L, Skidmore CT, Sperling MR, Miller I, Geller EB, Berg MJ, Fessler AJ, Rutecki P, Goldman AM, Mizrahi EM, Gross RE, Shields DC, Schwartz TH, Labar DR, Fountain NB, Elias WJ, Olejniczak PW, Villemarette-Pittman NR, Eisenschenk S, Roper SN, Boggs JG, Courtney TA, Sun FT, Seale CG, Miller KL, Skarpaas TL, Morrell MJ; RNS System LTT Study. Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy. Neurology. 2020 Sep 1;95(9):e1244-e1256. doi: 10.1212/WNL.0000000000010154. Epub 2020 Jul 20. i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000004827 condition mesh term Epilepsy condition mesh id D000012640 condition mesh term Seizures condition mesh id D000069279 condition mesh term Drug Resistant Epilepsy condition mesh id D000004828 condition mesh term Epilepsies, Partial condition ancestor list condition ancestor condition ancestor id D000001927 condition ancestor term Brain Diseases condition ancestor id D000002493 condition ancestor term Central Nervous System Diseases condition ancestor id D000009422 condition ancestor term Nervous System Diseases condition ancestor id D000009461 condition ancestor term Neurologic Manifestations condition browse leaf list condition browse leaf condition browse leaf id M7135 condition browse leaf name Epilepsy condition browse leaf as found Epilepsy condition browse leaf relevance high condition browse leaf id M14604 condition browse leaf name Seizures condition browse leaf as found Seizures condition browse leaf relevance high condition browse leaf id M7136 condition browse leaf name Epilepsies, Partial condition browse leaf as found Focal Epilepsy condition browse leaf relevance high condition browse leaf id M369 condition browse leaf name Drug Resistant Epilepsy condition browse leaf as found Drug Resistant Epilepsy condition browse leaf relevance high condition browse leaf id M4356 condition browse leaf name Brain Diseases condition browse leaf relevance low condition browse leaf id M4894 condition browse leaf name Central Nervous System Diseases condition browse leaf relevance low condition browse leaf id M11556 condition browse leaf name Neurologic Manifestations condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC10 condition browse branch name Nervous System Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology | NCT04839601 | [
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1193,
1231,
27476,
9363,
1183,
11336,
20080,
4199,
2109,
24928,
11955,
2050,
4060,
6856,
143,
13335,
1348,
15415,
20752,
1116,
155,
12412,
3910,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
151,
120,
138,
1902,
9108,
2235,
8353,
1990,
1249,
19638,
1880,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
7330,
113,
3353,
20943,
114,
10803,
23992,
10803,
5099,
2363,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
27845,
1990,
113,
23842,
21748,
114,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
1990,
1104,
6635,
1115,
1138,
1126,
155,
12412,
3910,
24034,
16999,
1105,
1132,
1217,
5165,
1114,
1231,
20080,
4199,
2109,
23842,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
15545,
2093,
131,
155,
12412,
3910,
9108,
2190,
9108,
9108,
2076,
15545,
2093,
9108,
1271,
155,
12412,
3910,
9108,
6136,
1109,
155,
12412,
3910,
2790,
1804,
7812,
1231,
20080,
4199,
2109,
3575,
23842,
119,
1109,
151,
8816,
15540,
4060,
19410,
16884,
1103,
6538,
3246,
1104,
1103,
3575,
1106,
11552,
22832,
3246,
1115,
1180,
1730,
1106,
170,
20752,
119,
1409,
22832,
3246,
1110,
11168,
117,
1103,
24928,
11955,
2050,
4060,
19410,
19603,
6538,
23842,
1106,
1103,
3575,
1194,
1103,
4501,
1106,
1494,
3843,
1103,
20752,
1196,
1122,
4365,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
27845,
1990,
113,
23842,
21748,
114,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
6373,
118,
1858,
13306,
3021,
16798,
4442,
2629,
113,
13411,
20427,
114,
2603,
2425,
9386,
6136,
1109,
2425,
3429,
1322,
7587,
1110,
1103,
3029,
1104,
5174,
1114,
3021,
4442,
118,
2272,
16798,
1958,
1120,
5731,
1552,
113,
1367,
2277,
114,
2112,
118,
24034,
9180,
119,
2425,
9386,
1159,
4207,
5731,
118,
1552,
2112,
118,
24034,
9180,
2425,
9386,
4929,
11336,
20080,
16838,
1200,
2603,
1120,
1367,
1808,
2112,
24034,
9180,
2425,
9386,
6136,
1367,
1808,
2112,
118,
24034,
9180,
2425,
9386,
1159,
4207,
1109,
2425,
12949,
1322,
7587,
1110,
1103,
3029,
1104,
5174,
1114,
170,
864,
1851,
110,
7234,
1107,
20752,
1116,
1120,
1367,
1808,
2112,
118,
24034,
9180,
3402,
1106,
1103,
3073,
118,
24034,
9180,
2259,
2568,
119,
1168,
9386,
2190,
1168,
9386,
1168,
9386,
4929,
15545,
2093,
118,
2272,
19536,
4179,
24930,
10840,
16223,
113,
13411,
20427,
114,
1856,
2603,
1168,
9386,
6136,
1109,
2683,
13411,
20427,
1856,
2603,
1166,
1159,
1107,
5174,
1425,
1367,
118,
1542,
1201,
24034,
16999,
1114,
1103,
24928,
11955,
2050,
4060,
19410,
1105,
120,
1137,
4501,
1219,
2025,
6251,
1209,
1129,
10056,
1168,
9386,
1159,
4207,
146,
8223,
9180,
1194,
123,
1201,
2112,
118,
24034,
9180,
1168,
9386,
4929,
16223,
2603,
1104,
19536,
4179,
24930,
10840,
17437,
113,
13411,
27485,
114,
1104,
2440,
25319,
1168,
9386,
6136,
1109,
2683,
1856,
2603,
1104,
13411,
27485,
1104,
2440,
25319,
113,
4442,
118,
2272,
1137,
1136,
114,
1209,
1129,
10056,
1166,
1159,
1107,
5174,
1425,
1367,
118,
1542,
1201,
24034,
16999,
1114,
1103,
24928,
11955,
2050,
4060,
19410,
1105,
120,
1137,
4501,
1219,
2025,
6251,
119,
13411,
27485,
1104,
2440,
25319,
1511,
1343,
2272,
1106,
131,
8974,
1107,
4487,
1665,
23851,
1348,
23123,
1766,
1197,
19911,
1207,
1167,
4267,
3202,
6647,
20752,
3322,
28117,
27804,
1785,
1168,
9386,
1159,
4207,
146,
8223,
9180,
1194,
123,
1201,
2112,
118,
24034,
9180,
1168,
9386,
4929,
138,
15475,
13851,
2781,
1112,
7140,
1118,
1103,
10429,
11442,
1130,
14850,
4649,
1168,
9386,
6136,
138,
15475,
13851,
2781,
113,
1118,
14940,
7432,
1121,
1103,
10429,
11442,
1130,
14850,
4649,
113,
139,
17243,
114,
117,
1719,
1103,
139,
17243,
118,
1563,
1137,
10429,
4866,
1130,
14850,
4649,
113,
139,
3663,
2240,
118,
1563,
114,
117,
5763,
1113,
1425,
1120,
1159,
1104,
1103,
3288,
12257,
5516,
114,
1209,
1129,
1758,
3073,
118,
24034,
9180,
117,
1112,
1218,
1112,
1111,
1103,
2112,
118,
24034,
9180,
1808,
124,
117,
127,
117,
130,
117,
1367,
1105,
1173,
1451,
1300,
1808,
119,
1168,
9386,
1159,
4207,
146,
8223,
9180,
1194,
123,
1201,
2112,
118,
24034,
9180,
1168,
9386,
4929,
151,
8816,
9706,
21155,
7542,
12641,
1112,
14758,
1118,
170,
4841,
118,
1383,
1104,
5715,
1107,
1103,
151,
2240,
3048,
6466,
1233,
8757,
3291,
25763,
11537,
1168,
9386,
6136,
151,
8816,
9706,
21155,
7542,
12641,
1112,
14758,
1118,
24928,
11955,
12685,
8401,
7810,
5193,
1114,
185,
24795,
9221,
2913,
117,
18013,
12989,
1905,
1106,
15187,
124,
13770,
1115,
1511,
2209,
117,
2962,
117,
1105,
18074,
113,
143,
27339,
1200,
1130,
23034,
4649,
6342,
1105,
1335,
5208,
2116,
5960,
117,
10041,
22087,
25113,
14500,
5960,
117,
1105,
10041,
159,
13335,
6639,
5552,
1183,
5960,
117,
3569,
114,
119,
1636,
12989,
1905,
1132,
1678,
1121,
1103,
151,
2240,
3048,
6466,
1233,
8757,
3291,
25763,
11537,
1105,
1209,
1129,
1758,
1118,
11124,
14940,
7432,
1111,
1103,
3073,
118,
24928,
11955,
2050,
4060,
19410,
24034,
9180,
1669,
117,
1112,
1218,
1112,
1111,
1103,
2683,
16323,
119,
1168,
9386,
1159,
4207,
146,
8223,
9180,
1194,
123,
1201,
2112,
118,
24034,
9180,
1168,
9386,
4929,
14286,
8298,
2553,
1849,
1107,
20752,
5625,
1168,
9386,
6136,
1109,
6556,
1849,
1107,
20752,
5625,
1209,
1129,
25172,
1105,
2103,
1118,
3151,
1116,
1105,
6297,
1200,
5600,
1111,
1296,
124,
118,
2370,
14235,
2150,
125,
1808,
2112,
118,
24034,
9180,
119,
1168,
9386,
1159,
4207,
146,
8223,
9180,
1194,
123,
1201,
2112,
118,
24034,
9180,
1168,
9386,
4929,
14801,
1104,
1297,
1112,
14758,
1118,
1103,
14801,
1104,
2583,
1107,
142,
24898,
12685,
1130,
14850,
4649,
113,
154,
13901,
17444,
114,
1168,
9386,
6136,
14801,
1104,
1297,
164,
1118,
14940,
7432,
1121,
1103,
154,
13901,
17444,
118,
5844,
118,
3615,
113,
9221,
2913,
1111,
6776,
1367,
118,
1542,
1201,
114,
1137,
154,
13901,
17444,
118,
1955,
118,
153,
113,
9221,
2913,
1111,
6776,
1407,
1105,
2214,
114,
117,
5763,
1113,
1425,
1120,
1159,
1104,
8670,
166,
1209,
1129,
1758,
3073,
118,
24928,
11955,
2050,
4060,
19410,
24034,
9180,
117,
1112,
1218,
1112,
1120,
13502,
1159,
1827,
119,
1168,
9386,
1159,
4207,
146,
8223,
9180,
1194,
123,
1201,
2112,
118,
24034,
9180,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
12859,
16811,
1144,
4267,
3202,
6647,
5968,
3014,
7597,
20752,
1116,
117,
2703,
7597,
20752,
1116,
117,
1105,
120,
1137,
1248,
18206,
22214,
20752,
1116,
119,
12120,
3202,
6647,
4431,
1106,
20752,
1116,
1115,
1132,
5199,
1536,
1106,
2612,
5917,
117,
1137,
5409,
24034,
8341,
8458,
2912,
1107,
13770,
1259,
6233,
117,
15604,
21155,
22354,
12562,
1972,
1105,
16178,
119,
12859,
16811,
1144,
20752,
1116,
1115,
1132,
4966,
117,
17000,
2340,
15328,
1958,
1115,
1169,
1129,
1231,
4567,
4999,
8566,
117,
1107,
1103,
4893,
1104,
1103,
17805,
117,
1118,
1103,
2548,
1137,
6486,
120,
1920,
5389,
4121,
119,
12859,
16811,
1125,
1126,
1903,
1104,
1210,
1137,
1167,
4267,
3202,
6647,
5968,
3014,
7597,
20752,
1116,
117,
2703,
7597,
20752,
1116,
1105,
120,
1137,
1248,
18206,
22214,
20752,
1116,
1166,
1103,
1160,
1211,
2793,
4776,
1476,
118,
1285,
6461,
117,
1114,
1185,
1476,
118,
1285,
1669,
1114,
1750,
1190,
1160,
20752,
1116,
1679,
2548,
1105,
120,
1137,
6486,
120,
1920,
5389,
4121,
2592,
119,
12859,
16811,
2604,
3252,
1114,
170,
5867,
1104,
1160,
2848,
118,
20752,
23897,
113,
1215,
1107,
5806,
24429,
114,
1114,
12373,
9437,
1104,
14037,
1105,
1103,
3154,
1104,
3252,
117,
1112,
3552,
1118,
1103,
17805,
119,
12859,
16811,
1144,
18369,
20346,
5193,
1112,
1226,
1104,
1117,
120,
1123,
2530,
1920,
1115,
1144,
3626,
1185,
1167,
1190,
1160,
174,
24898,
6451,
17960,
4001,
119,
12859,
16811,
1110,
2581,
1137,
170,
2130,
1104,
2027,
3962,
10832,
3209,
1606,
170,
10682,
3442,
1104,
14255,
4487,
19792,
113,
16358,
26654,
1348,
117,
9391,
3442,
117,
13467,
1137,
170,
4832,
5208,
2116,
114,
119,
12859,
16811,
1110,
1425,
1367,
1137,
2214,
1133,
1209,
1129,
1750,
1190,
1425,
1407,
113,
1144,
1136,
1680,
4186,
5913,
114,
1120,
1103,
1159,
1104,
24034,
9180,
1891,
1114,
1103,
155,
12412,
3910,
119,
12859,
16811,
1110,
1682,
1106,
4731,
1126,
4828,
12997,
2041,
1137,
1114,
1103,
5052,
1104,
170,
19555,
2510,
119,
12859,
16811,
1110,
1682,
1106,
4739,
12257,
16323,
1107,
10274,
1114,
1103,
2025,
6030,
119,
12859,
16811,
1105,
120,
1137,
6486,
120,
14436,
1538,
1129,
4988,
1105,
1682,
1106,
2194,
6189,
9635,
1105,
3919,
3452,
1165,
5806,
119,
12859,
16811,
1110,
1136,
1971,
24034,
16999,
1114,
1126,
155,
12412,
151,
8816,
15540,
4060,
19410,
1137,
151,
8816,
1186,
2101,
7954,
10440,
1116,
119,
1130,
1103,
17805,
112,
188,
4893,
117,
2548,
1110,
1682,
1106,
21073,
170,
24928,
11955,
6385,
10805,
4571,
7791,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
12859,
16811,
1144,
1151,
11534,
1114,
3120,
22214,
20752,
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119,
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16811,
5315,
8826,
1115,
1132,
14255,
4487,
24704,
4578,
1906,
1359,
1113,
1954,
155,
12412,
3910,
3107,
1158,
119,
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1103,
4893,
1104,
1103,
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117,
1103,
2548,
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170,
7300,
1193,
2418,
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2657,
3879,
113,
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3850,
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114,
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170,
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119,
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3910,
1907,
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113,
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119,
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119,
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114,
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8071,
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1398,
5867,
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3232,
1271,
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118,
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118,
3882,
1559,
1559,
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3232,
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full study rank 61718 study protocol section identification module n c t id NCT04832828 org study id info org study id PI-4321 organization org full name Universidad Autonoma de Madrid org class OTHER brief title Sensitivity and Specificity of the Roth Test in Patients With COVID-19 Positive official title Sensitivity and Specificity of the Roth Test in Patients With COVID-19 Positive status module status verified date April 2021 overall status Completed expanded access info has expanded access No start date struct start date June 1, 2020 start date type Actual primary completion date struct primary completion date November 28, 2020 primary completion date type Actual completion date struct completion date November 28, 2020 completion date type Actual study first submit date March 31, 2021 study first submit q c date April 3, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 3, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Raúl Ferrer-Peña responsible party investigator title Principal investigator responsible party investigator affiliation Universidad Autonoma de Madrid lead sponsor lead sponsor name Universidad Autonoma de Madrid lead sponsor class OTHER oversight module description module brief summary The presence of the described silent hypoxia in subjects diagnosed with COVID19 highlights the need for valid tools to assess respiratory capacity. The Roth test has been associated with acceptable sensitivity and specificity criteria in patients with previous respiratory pathology; however, its validity in this type of patient has not been proven. conditions module condition list condition Covid19 design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 114 enrollment type Actual arms interventions module arm group list arm group arm group label COVID+ Group arm group description Patients diagnosed with Covid19 positive in last 7 days arm group intervention list arm group intervention name Diagnostic Test: Roth´s Test intervention list intervention intervention type Diagnostic Test intervention name Roth´s Test intervention description Subjets must count from 1 to 30 in their languages, and health professional will count seconds that last in take breath during the count. intervention arm group label list intervention arm group label COVID+ Group outcomes module primary outcome list primary outcome primary outcome measure Oxygen Saturation primary outcome description The pulseoximeter percentage value primary outcome time frame 12 weeks secondary outcome list secondary outcome secondary outcome measure Roth´s test secondary outcome description The level described in the test secondary outcome time frame 12 weeks eligibility module eligibility criteria Inclusion Criteria:
having been diagnosed as COVID-19 positive and with symptoms compatible with Sars-Cov-2 infection in the last 7 days prior to assessment,
having an understanding of Spanish,
and having no history of respiratory pathology prior to the current infection. healthy volunteers No gender All minimum age 12 Years maximum age 99 Years std age list std age Child Adult Older Adult study population Subjects aged 18 to 90 years were recruited by non-probabilistic convenience sampling in Primary Health Care Centres of the Primary Health Care Management of SERMAS and the Intensive Care Unit of the University Hospital of Gran Canaria Doctor Negrín of the Canary Health Service sampling method Non-Probability Sample contacts locations module location list location location facility CS Entrevías location city Madrid location zip 28053 location country Spain i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000011024 condition ancestor term Pneumonia, Viral condition ancestor id D000011014 condition ancestor term Pneumonia condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M9170 condition browse leaf name Hypersensitivity condition browse leaf relevance low condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf relevance low condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC20 condition browse branch name Immune System Diseases condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology | NCT04832828 | [
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] |
full study rank 61555 study protocol section identification module n c t id NCT04834947 org study id info org study id 69HCL21_0063 organization org full name Hospices Civils de Lyon org class OTHER brief title Hemodynamic Effect of Prone Position in Non-intubated Patient With COVID 19 official title Hemodynamic Effect of Prone Positioning in Non-intubated Patient With COVID 19 Pneumonia: a Monocentric Prospective Cohort Study status module status verified date March 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date April 15, 2021 start date type Anticipated primary completion date struct primary completion date December 15, 2021 primary completion date type Anticipated completion date struct completion date December 15, 2021 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 6, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Hospices Civils de Lyon lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary Prone position in non-intubated patient has shown some respiratory physiological benefits. Prone positioning in patient intubated with ARDS has shown hemodynamic benefits. We aim to compare hemodynamic assessment before and after prone positioning in non-intubated patient with COVID 19 pneumonia. The study hypothesis is that prone positioning in non-intubated patient improve right ventricular preload, reduce afterload and increase Cardiac index compared to supine position. conditions module condition list condition Covid19 Pneumonia, Viral keyword list keyword COVID 19 prone position hemodynamic effect spontaneous ventilation design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 30 enrollment type Anticipated arms interventions module arm group list arm group arm group label Prone position in non-intubated COVID19 , before and after. arm group description Patients with non-intubated COVID19 pneumoniae for whom the clinician has decided to try prone positioning to increase the PaO2 in a context of hypoxemia with O2 requirement. arm group intervention list arm group intervention name Procedure: prone position intervention list intervention intervention type Procedure intervention name prone position intervention description Choice of prone positioning a patient is at the discretion of the anesthesia physician. intervention arm group label list intervention arm group label Prone position in non-intubated COVID19 , before and after. outcomes module primary outcome list primary outcome primary outcome measure Hemodynamic effect primary outcome description Cardiac index primary outcome time frame Cardiac index will be recorded before, just after prone position and after return to supine position. eligibility module eligibility criteria Inclusion Criteria:
Adult patient
COVID 19 pneumonias with Hypoxemia
for whom prone positioning has been decided by the attending physician.
Exclusion Criteria:
Mechanical ventilation
ECLS healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult study population Adult patients scheduled for cadiac surgery wih cardiopulmonary bypass sampling method Probability Sample contacts locations module central contact list central contact central contact name Matthias JACQUET LAGREZE, MD central contact role Contact central contact phone 0033472318933 central contact e mail matthias.jacquet-lagrèze@chu-lyon.fr central contact name Jean Luc FELLAHI, MD central contact role Contact central contact phone 0033472318933 central contact e mail jean-luc.fellahi@chu-lyon.fr location list location location facility Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, location city Bron location country France derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000086382 condition mesh term COVID-19 condition mesh id D000011014 condition mesh term Pneumonia condition mesh id D000011024 condition mesh term Pneumonia, Viral condition ancestor list condition ancestor condition ancestor id D000012141 condition ancestor term Respiratory Tract Infections condition ancestor id D000007239 condition ancestor term Infections condition ancestor id D000014777 condition ancestor term Virus Diseases condition ancestor id D000018352 condition ancestor term Coronavirus Infections condition ancestor id D000003333 condition ancestor term Coronaviridae Infections condition ancestor id D000030341 condition ancestor term Nidovirales Infections condition ancestor id D000012327 condition ancestor term RNA Virus Infections condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M2562 condition browse leaf name COVID-19 condition browse leaf as found COVID-19 condition browse leaf relevance high condition browse leaf id M13056 condition browse leaf name Pneumonia condition browse leaf as found Pneumonia condition browse leaf relevance high condition browse leaf id M13066 condition browse leaf name Pneumonia, Viral condition browse leaf as found Pneumonia, Viral condition browse leaf relevance high condition browse leaf id M9435 condition browse leaf name Infections condition browse leaf relevance low condition browse leaf id M5520 condition browse leaf name Communicable Diseases condition browse leaf relevance low condition browse leaf id M14130 condition browse leaf name Respiratory Tract Infections condition browse leaf relevance low condition browse leaf id M16674 condition browse leaf name Virus Diseases condition browse leaf relevance low condition browse leaf id M19643 condition browse leaf name Coronavirus Infections condition browse leaf relevance low condition browse leaf id M5707 condition browse leaf name Coronaviridae Infections condition browse leaf relevance low condition browse leaf id M22838 condition browse leaf name Nidovirales Infections condition browse leaf relevance low condition browse leaf id M14301 condition browse leaf name RNA Virus Infections condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC01 condition browse branch name Infections condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M3259 intervention browse leaf name Anesthetics intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04834947 | [
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full study rank 61905 study protocol section identification module n c t id NCT04830384 org study id info org study id PLA1020 organization org full name Freedom Laser, Inc. org class INDUSTRY brief title Evaluation of LLLT/Music for Smoking Cessation official title Evaluation Into the Efficacy of Low Level Laser/Light and Music as a Combined Therapy Device for Smoking Cessation Treatment status module status verified date March 2021 overall status Completed expanded access info has expanded access No start date struct start date July 1, 2020 start date type Actual primary completion date struct primary completion date November 1, 2020 primary completion date type Actual completion date struct completion date December 31, 2020 completion date type Actual study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date March 31, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Freedom Laser, Inc. lead sponsor class INDUSTRY collaborator list collaborator collaborator name NST Consultants, Inc. collaborator class UNKNOWN oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device Yes is unapproved device Yes is u s export No description module brief summary The purpose of this research is to study the preliminary effectiveness of a light therapy and music device for at-home use to aid the seasoned cigarette smoker in his/her attempt to stop smoking. This device, called the FQS system, is a type of cold, or non-heat producing laser and tranquil music system that will emit light and music onto the ear surface, through commonly found music earphones, available in most electronic stores. The theory behind this treatment technique is that the light and music will stimulate the part of the brain responsible for producing chemicals that satisfy the desire for nicotine. If this is correct, then the user will replace the need for nicotine with the pleasant treatment experience of light and music therapy. detailed description This study aims to define the safety and physiologic effects that occur when low level light and music, configured in a wearable binaural head set are employed by seasoned smokers of cigarettes, with the end result of reducing the desire to smoke. This device use does not require any complementary or adjunctive drug use. A review of unregulated products that are marketed for smoking cessation, have as common mechanism of action, the administration and withdrawal of nicotine in a controlled dosing format. The proposed study device does not consider the use of the culprit drug, the best pathway to achieve rapid and long-lasting cessation results. The theoretical principle at work is the competition for absorption by nicotinic cholinergic receptors located in the brain by nicotine or by the LLLT and music therapy. If this competition for absorption by two competing elements (cigarettes and the proposed device) can result in the device "winning the race", then the neurotransmitters will respond to the LLLT and music stimulus instead of the serum nicotine and yield a reduced desire to consume nicotine. As with any new technology, it is essential to learn the variance between true efficacy and the placebo level of efficacy. This study seeks to define that variance. conditions module condition list condition Nicotine Dependence, Cigarettes design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Factorial Assignment design intervention model description Not all participants in this study will receive the actual, fully functioning device. One-quarter of the subjects will receive a fully functioning device with laser and music; one-quarter will receive laser only; one-quarter will receive music only; one quarter will receive a placebo or inactive device. design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 28 enrollment type Actual arms interventions module arm group list arm group arm group label Fully Active arm group type Experimental arm group description LLLT & Music Therapy arm group intervention list arm group intervention name Device: Fully Active arm group label LLLT Only arm group type Active Comparator arm group description LLLT Therapy arm group intervention list arm group intervention name Device: LLLT Only arm group label Music Only arm group type Placebo Comparator arm group description Music Therapy arm group intervention list arm group intervention name Device: Music Only arm group label Placebo arm group type Sham Comparator arm group description No Therapy arm group intervention list arm group intervention name Device: Placebo intervention list intervention intervention type Device intervention name Fully Active intervention description 7 subjects will be dispensed active treatment devices with light and music fully functional intervention arm group label list intervention arm group label Fully Active intervention type Device intervention name LLLT Only intervention description 7 subjects will be dispensed active treatment devices with only light functional intervention arm group label list intervention arm group label LLLT Only intervention type Device intervention name Music Only intervention description 7 subjects will be dispensed placebo comparator devices with only music functional intervention arm group label list intervention arm group label Music Only intervention type Device intervention name Placebo intervention description 7 subjects will be dispensed placebo or sham devices with no light or music functional intervention arm group label list intervention arm group label Placebo outcomes module primary outcome list primary outcome primary outcome measure Nicotine Consumption primary outcome description Number of Cigarettes Smoked Daily primary outcome time frame 6 weeks eligibility module eligibility criteria Inclusion Criteria:
Male and female subjects who have been smoking cigarettes for at least 5 years without any intervention therapy within the past 12 months.
Apparent good health.
Must admit to possessing the desire to stop smoking.
Willing to use the proposed device at home, every day, for 15 minutes, for up to 6 weeks.
Willing to participate in weekly monitoring program conducted through brief phone survey not to exceed 5 minutes per week.
Exclusion Criteria:
Previous involvement in other smoking cessation studies.
Use of any product, drug or device, designated as smoking cessation or reduction aid during the trial period or within the preceding last 12 months.
Active and chronic consumption of any psychotropic or illicit drugs
Evidence of any current viral, fungal or bacterial infection.
Diagnosed mental disorders or habits that indicate self-destructive behavior, such as nail biting, morbid obesity, compulsive gambling or alcoholism.
History of having been arrested for a criminal act or repeated non-criminal violations related to motor vehicle use. healthy volunteers Accepts Healthy Volunteers gender All minimum age 21 Years maximum age 65 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Raymond Blanche overall official affiliation NST Consultants, Inc. overall official role Study Director overall official name Adam Bodian, MD overall official affiliation The Bodian Dermatology Group overall official role Principal Investigator overall official name Rebecca Settar, RN overall official affiliation NST Consultants, Inc. overall official role Study Director location list location location facility NST Consultants, Inc. location city Mendham location state New Jersey location zip 07945 location country United States i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000014029 condition mesh term Tobacco Use Disorder condition ancestor list condition ancestor condition ancestor id D000019966 condition ancestor term Substance-Related Disorders condition ancestor id D000064419 condition ancestor term Chemically-Induced Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M15937 condition browse leaf name Tobacco Use Disorder condition browse leaf as found Nicotine Dependence condition browse leaf relevance high condition browse leaf id M20990 condition browse leaf name Substance-Related Disorders condition browse leaf relevance low condition browse leaf id M29455 condition browse leaf name Chemically-Induced Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC25 condition browse branch name Substance Related Disorders condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions | NCT04830384 | [
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] |
full study rank 61760 study protocol section identification module n c t id NCT04832282 org study id info org study id 20-01436 organization org full name NYU Langone Health org class OTHER brief title Napoleon Measurement of Gastrojejunal Anastomosis official title Feasibility of a New Method Named Napoleon to Measure Gastrojejunal Anastomosis in Gastric Bypass Patients With Weight Regain status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date June 14, 2021 start date type Actual primary completion date struct primary completion date June 1, 2023 primary completion date type Anticipated completion date struct completion date July 1, 2023 completion date type Anticipated study first submit date April 1, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date May 9, 2022 last update post date struct last update post date May 13, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name NYU Langone Health lead sponsor class OTHER collaborator list collaborator collaborator name Brigham and Women's Hospital collaborator class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device Yes description module brief summary This is a clinical trial assessing the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital. investigators aim for a sample size of up to 100 cases. For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. Then, they will measure the GJA with Napoleon. Investigators will compare the GJA measurements performed using visual estimation and Napoleon. A survey will be given to all endoscopists to assess the level of ease using Napoleon. conditions module condition list condition Gastric Bypass Weight Regain design module study type Interventional phase list phase Early Phase 1 design info design allocation N/A design intervention model Single Group Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Roux-en-Y gastric bypass patients with weight regain arm group type Other arm group description The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital. arm group intervention list arm group intervention name Device: Napoleon Other: Visual estimation intervention list intervention intervention type Device intervention name Napoleon intervention description The Micro-Tech Endoscopic Measurement Device named Napoleon is a small catheter with a 30mm ruler calibrated at 1mm intervals with 5mm demarcations. It is classified as a Class 1, 510(k) exempt device by the FDA. The device was originally intended to measure polyps. However, it is used off-label in this study and is considered investigational. intervention arm group label list intervention arm group label Roux-en-Y gastric bypass patients with weight regain intervention type Other intervention name Visual estimation intervention description For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. intervention arm group label list intervention arm group label Roux-en-Y gastric bypass patients with weight regain outcomes module primary outcome list primary outcome primary outcome measure Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation primary outcome time frame 8 months secondary outcome list secondary outcome secondary outcome measure Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device secondary outcome time frame 8 months secondary outcome measure Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition secondary outcome time frame 8 months secondary outcome measure Additional procedure time needed to incorporate use of Napoleon secondary outcome time frame 8 months secondary outcome measure Proportion of cases with adverse events or unanticipated problems related to use of Napoleon secondary outcome time frame 8 months eligibility module eligibility criteria Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
RYGB patient with weight regain age 18-90
Scheduled for an endoscopy
Willingness and ability to provide informed consent
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. History of prior endoscopies with complications healthy volunteers No gender All minimum age 18 Years maximum age 90 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Violeta Popov, MD central contact role Contact central contact phone 212-686-7500 central contact phone ext 3905 central contact e mail Violeta.Popov@nyulangone.org central contact name Sandy Ng, MD central contact role Contact central contact e mail Sandy.Ng@nyulangone.org location list location location facility Brigham and Women's Hospital location status Recruiting location city Boston location state Massachusetts location zip 02115 location country United States location contact list location contact location contact name Christopher Thompson, MD location contact role Contact location facility Bellevue Hospital Center location status Recruiting location city New York location state New York location zip 10016 location country United States location contact list location contact location contact name Violeta Popov, MD location contact role Contact i p d sharing statement module i p d sharing Yes i p d sharing description The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Violeta.Popov@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research. i p d sharing info type list i p d sharing info type Study Protocol Statistical Analysis Plan (SAP) i p d sharing time frame beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements i p d sharing access criteria Requests may be directed to: Violeta.Popov@nyulangone.org. derived section misc info module version holder December 02, 2022 condition browse module condition browse leaf list condition browse leaf condition browse leaf id M4266 condition browse leaf name Body Weight condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions | NCT04832282 | [
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full study rank 61190 study protocol section identification module n c t id NCT04839692 org study id info org study id 2021P000010 organization org full name Massachusetts General Hospital org class OTHER brief title Assessment and Augmentation of Lip Appearance in Specific Study Populations official title Assessment and Augmentation of Lip Appearance in Specific Study Populations status module status verified date August 2022 overall status Active, not recruiting expanded access info has expanded access No start date struct start date July 7, 2021 start date type Actual primary completion date struct primary completion date September 2022 primary completion date type Anticipated completion date struct completion date February 2023 completion date type Anticipated study first submit date February 25, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date August 30, 2022 last update post date struct last update post date September 1, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor-Investigator responsible party investigator full name Dieter Manstein, MD responsible party investigator title Principal Investigator responsible party investigator affiliation Massachusetts General Hospital lead sponsor lead sponsor name Dieter Manstein, MD lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary This study aims to learn more about the effects of aging and lip filler treatment on lips and the surrounding skin by comparing, among two different age groups of people, changes in the blood vessels and nerves, volume, color and texture change before and after lip filler treatment and pain tolerance from lip filler treatment. detailed description This study will investigate aging of the cutaneous changes of human skin anatomy in the lips and perioral area to better understand and quantify the aging process in this, including the effect of age on lip redness. Additionally, the investigators aim to test the effects of a common lip augmentation procedure, hyaluronic-acid based fillers, on the appearance (volume, texture and color) of aging lips, in addition to the tolerability of this procedure. It is hypothesized that dermal lip fillers may decrease the redness of the lips.
Besides, the investigators want to evaluate oxytocin level changes and relate it to subjects' satisfaction after the lip filler procedure. conditions module condition list condition Lip Aging Lip Augmentation Lip design module study type Interventional phase list phase Phase 4 design info design allocation Non-Randomized design intervention model Parallel Assignment design intervention model description Investigators will enroll 40 subjects; 20 subjects who are 21-30 years old and 20 subjects who are post-menopausal women. Both groups will receive identical treatments. design primary purpose Treatment design masking info design masking Single design masking description Standard photographs will be blindly reviewed by a physician. design who masked list design who masked Investigator enrollment info enrollment count 40 enrollment type Anticipated arms interventions module arm group list arm group arm group label Young females (21-30 years old) arm group type Other arm group description young healthy females (21-30 years old) from all phototypes who have thin or moderately thick lips arm group intervention list arm group intervention name Drug: Hyaluronic acid filler arm group label post menopausal females arm group type Other arm group description post menopausal females from all phototypes who have thin or moderately thick lips arm group intervention list arm group intervention name Drug: Hyaluronic acid filler intervention list intervention intervention type Drug intervention name Hyaluronic acid filler intervention description Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation. intervention arm group label list intervention arm group label Young females (21-30 years old) post menopausal females outcomes module primary outcome list primary outcome primary outcome measure Change in Global Aesthetic Improvement Scale (GAIS) primary outcome description Compare Global Aesthetic Improvement Scale scores pre and post treatment to assess effectiveness of aesthetic procedure. The GAIS is a five-point scale ranging from 1= exceptional improvement, 2 = very improved patient, 3 = improved patient, 4 = unaltered patient, 5 = worsened patient. primary outcome time frame Day 1 and day 14 primary outcome measure Change in Lip Fullness Grading Scale (LFGS) primary outcome description Compare Lip Fullness Grading Scale scores pre and post treatment to assess the lip volume change. This photonumeric rating scale ranges from 0 = very thin; 1 = thin; 2 = moderately thick; 3 = thick; and 4 = full. Improvement of lip volume is defined as ≥1 increase at post-treatment compared to pretreatment. primary outcome time frame Day 1 and day 14 secondary outcome list secondary outcome secondary outcome measure Wong-Baker FACES Pain Rating Scale secondary outcome description This scale will be used to record subject pain from the first insertion of dermal filler and the overall pain from the procedure. There are 6 faces ranging from 0 no hurt to 10 hurts the worst. secondary outcome time frame Day 1 other outcome list other outcome other outcome measure Change in Lip color other outcome description All non-invasive imaging (OCT, digital and Cherry Imaging) will be compared pre and post treatment for possible effects on lip color.
The Cherry Imaging analysis software contains distinct algorithms that process the generated three-dimensional images to calculate volume in cubic centimeters, precise color using saturation and hue, roughness detecting local variations in height/depth, and a ruler function that measures the distance between two distinct points. other outcome time frame Day 1 and Day 14 other outcome measure Change in Lip texture other outcome description All non-invasive imaging (OCT, digital and Cherry Imaging) will be compared pre and post treatment for possible effects on lip texture.
The Cherry Imaging analysis software contains distinct algorithms that process the generated three-dimensional images to calculate volume in cubic centimeters, precise color using saturation and hue, roughness detecting local variations in height/depth, and a ruler function that measures the distance between two distinct points. other outcome time frame Day 1 and Day 14 other outcome measure Change in Lip volume other outcome description All non-invasive imaging (OCT, digital and Cherry Imaging) will be compared pre and post treatment for possible effects on lip volume.
The Cherry Imaging analysis software contains distinct algorithms that process the generated three-dimensional images to calculate volume in cubic centimeters, precise color using saturation and hue, roughness detecting local variations in height/depth, and a ruler function that measures the distance between two distinct points. other outcome time frame Day 1 and Day 14 eligibility module eligibility criteria Inclusion Criteria:
Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
In good general health, based on answers provided during the screening visit;
Subjects must be able to read and understand English;
Caucasian female;
Aged 21-30 years and post-menopausal;
Skin Types (all Fitzpatrick Skin Phototypes );
Smoking history is self-report.
Have very thin to moderately thick lips (Lip Fullness Grading Scale [LFGS] scores 0-2).
Exclusion Criteria:
Participation in another investigational drug or device clinical trial in the past 30 days;
Are pregnant or lactating;
Intake of hormone replacement therapy (HRT) in the past 6 months;
Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day [e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks];
Presence of eczema, psoriasis, or any other skin disease on the lips or perioral skin;
Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skin area of interest;
Use of any anti-aging skin care products containing retinoic acid, retinol, or other retinoids (e.g. tazarotene, adapalene) or estrogen on the skin area of interest in the past 6 months;
Use of any prescription topical medication, such as corticosteroids or hydroquinone on the skin area of interest in the past 6 months;
Have a history of photodynamic therapy treatment or any skin rejuvenation procedure on the skin area of interest;
History of blood-clotting abnormality;
History of keloid formation or hypertrophic scarring;
Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study;
Exhibits any clinical conditions or takes any medication which in the opinion of the investigator may interfere with the study or pose a risk to subject safety during the study;
Is not able to follow study protocol;
Have permanent lip implant, and lip enhancement or laser therapy performed within the preceding 12 months;
Known history of allergy or sensitivity to glycerol, Tegaderm, lidocaine, hyaluronic acid dermal fillers or materials with gram-positive bacterial proteins. healthy volunteers Accepts Healthy Volunteers gender Female minimum age 21 Years std age list std age Adult Older Adult contacts locations module overall official list overall official overall official name Dieter Manstein, MD, PhD overall official affiliation Massachusetts General Hospital overall official role Principal Investigator overall official name Neera Nathan, MD, MSHS overall official affiliation Massachusetts General Hospital overall official role Principal Investigator location list location location facility MGH Clinical Unit for Research Trials & Outcomes Research location city Boston location state Massachusetts location zip 02114 location country United States references module reference list reference reference p m i d 9358147 reference type background reference citation Uitto J. Understanding premature skin aging. N Engl J Med. 1997 Nov 13;337(20):1463-5. doi: 10.1056/NEJM199711133372011. No abstract available. reference p m i d 12955259 reference type background reference citation Zouboulis ChC. [Intrinsic skin aging. A critical appraisal of the role of hormones]. Hautarzt. 2003 Sep;54(9):825-32. German. reference p m i d 12452869 reference type background reference citation Leung WC, Harvey I. Is skin ageing in the elderly caused by sun exposure or smoking? Br J Dermatol. 2002 Dec;147(6):1187-91. reference p m i d 27104752 reference type background reference citation Argyropoulos AJ, Robichaud P, Balimunkwe RM, Fisher GJ, Hammerberg C, Yan Y, Quan T. Alterations of Dermal Connective Tissue Collagen in Diabetes: Molecular Basis of Aged-Appearing Skin. PLoS One. 2016 Apr 22;11(4):e0153806. doi: 10.1371/journal.pone.0153806. eCollection 2016. reference p m i d 28632785 reference type background reference citation van Waateringe RP, Mook-Kanamori MJ, Slagter SN, van der Klauw MM, van Vliet-Ostaptchouk JV, Graaff R, Lutgers HL, Suhre K, El-Din Selim MM, Mook-Kanamori DO, Wolffenbuttel BHR. The association between various smoking behaviors, cotinine biomarkers and skin autofluorescence, a marker for advanced glycation end product accumulation. PLoS One. 2017 Jun 20;12(6):e0179330. doi: 10.1371/journal.pone.0179330. eCollection 2017. reference p m i d 6886112 reference type background reference citation Gilchrest BA, Soter NA, Hawk JL, Barr RM, Black AK, Hensby CN, Mallet AI, Greaves MW, Parrish JA. Histologic changes associated with ultraviolet A--induced erythema in normal human skin. J Am Acad Dermatol. 1983 Aug;9(2):213-9. reference p m i d 2186787 reference type background reference citation Rogers GS, Gilchrest BA. The senile epidermis: environmental influences on skin ageing and cutaneous carcinogenesis. Br J Dermatol. 1990 Apr;122 Suppl 35:55-60. Review. reference p m i d 25917013 reference type background reference citation Bentov I, Reed MJ. The effect of aging on the cutaneous microvasculature. Microvasc Res. 2015 Jul;100:25-31. doi: 10.1016/j.mvr.2015.04.004. Epub 2015 Apr 24. Review. reference p m i d 29405429 reference type background reference citation Tamura E, Ishikawa J, Sugata K, Tsukahara K, Yasumori H, Yamamoto T. Age-related differences in the functional properties of lips compared with skin. Skin Res Technol. 2018 Aug;24(3):472-478. doi: 10.1111/srt.12456. Epub 2018 Feb 6. reference p m i d 29059146 reference type background reference citation Hilton S, Sattler G, Berg AK, Samuelson U, Wong C. Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement. Dermatol Surg. 2018 Feb;44(2):261-269. doi: 10.1097/DSS.0000000000001282. reference p m i d 30636365 reference type background reference citation Stojanovic L, Majdic N. Effectiveness and safety of hyaluronic acid fillers used to enhance overall lip fullness: A systematic review of clinical studies. J Cosmet Dermatol. 2019 Apr;18(2):436-443. doi: 10.1111/jocd.12861. Epub 2019 Jan 12. reference p m i d 24436079 reference type background reference citation Savoia A, Accardo C, Vannini F, Di Pasquale B, Baldi A. Outcomes in thread lift for facial rejuvenation: a study performed with happy lift™ revitalizing. Dermatol Ther (Heidelb). 2014 Jun;4(1):103-14. doi: 10.1007/s13555-014-0041-6. Epub 2014 Jan 17. reference p m i d 19021674 reference type background reference citation Carruthers A, Carruthers J, Hardas B, Kaur M, Goertelmeyer R, Jones D, Rzany B, Cohen J, Kerscher M, Flynn TC, Maas C, Sattler G, Gebauer A, Pooth R, McClure K, Simone-Korbel U, Buchner L. A validated lip fullness grading scale. Dermatol Surg. 2008 Nov;34 Suppl 2:S161-6. doi: 10.1111/j.1524-4725.2008.34365.x. see also link list see also link see also link label Restylane Kysse Patient Brochure see also link u r l https://www.galderma.com/us/sites/g/files/jcdfhc341/files/2020-04/Restylane_Kysse-Patient_Brochure.pdf?_ga=2.59052845.1698235642.1604334264-853585669.1604334264&_gac=1.157524424.1604378565.CjwKCAiA-f78BRBbEiwATKRRBPyH8_64L0BLjGEHNISljih9I6tz-fSQohCtDMdwKAe7hz57dYQAihoCieQQAvD_BwE i p d sharing statement module i p d sharing No i p d sharing description There is no plan to make individual participant data (IPD) available to other researchers. derived section misc info module version holder December 02, 2022 intervention browse module intervention mesh list intervention mesh intervention mesh id D000006820 intervention mesh term Hyaluronic Acid intervention ancestor list intervention ancestor intervention ancestor id D000000276 intervention ancestor term Adjuvants, Immunologic intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000055675 intervention ancestor term Viscosupplements intervention ancestor id D000020011 intervention ancestor term Protective Agents intervention browse leaf list intervention browse leaf intervention browse leaf id M9030 intervention browse leaf name Hyaluronic Acid intervention browse leaf as found Compression intervention browse leaf relevance high intervention browse leaf id M2780 intervention browse leaf name Adjuvants, Immunologic intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse leaf id M27448 intervention browse leaf name Viscosupplements intervention browse leaf relevance low intervention browse leaf id M21022 intervention browse leaf name Protective Agents intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04839692 | [
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] |
full study rank 61586 study protocol section identification module n c t id NCT04834544 org study id info org study id IOV12 organization org full name Peking University Third Hospital org class OTHER brief title A Study of Maintenance DCVAC/OvCa After First-line Chemotherapy Added Standard of Care official title A Randomized, Double-blind, Placebo-controlled, Preliminary Verifying Study About Safety and Efficacy of Maintenance DCVAC/OvCa After First-line Chemotherapy Added to Standard of Care in Patients With Newly Diagnosed FIGO III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma. status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 19, 2021 start date type Actual primary completion date struct primary completion date October 20, 2024 primary completion date type Anticipated completion date struct completion date April 20, 2027 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 6, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 30, 2021 last update post date struct last update post date May 3, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Peking University Third Hospital lead sponsor class OTHER collaborator list collaborator collaborator name SOTIO a.s. collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary This is a randomized, double-blind, placebo-controlled,parallel-group preliminary verifying study about safety and efficacy of maintenance DCVAC/OvCa after first-line chemotherapy added to standard of care in patients with newly diagnosed FIGO III-IV ovarian, fallopian tube, or primary peritoneal carcinoma. conditions module condition list condition Epithelial Ovarian Carcinoma Fallopian Tube Carcinoma Primary Peritoneal Carcinoma design module study type Interventional phase list phase Phase 2 design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 75 enrollment type Anticipated arms interventions module arm group list arm group arm group label DCVAC/OvCa arm arm group type Experimental arm group intervention list arm group intervention name Combination Product: DCVAC/OvCa arm group label Placebo arm arm group type Placebo Comparator arm group intervention list arm group intervention name Combination Product: Placebo intervention list intervention intervention type Combination Product intervention name DCVAC/OvCa intervention description An active cellular immunotherapy product containing autologous dendritic cells that are generated ex vivo from patient's monocytes and apoptotic tumor cells prepared from tumor cell lines intervention arm group label list intervention arm group label DCVAC/OvCa arm intervention type Combination Product intervention name Placebo intervention description Placebo intervention arm group label list intervention arm group label Placebo arm outcomes module primary outcome list primary outcome primary outcome measure Progress Free Survival primary outcome description PFS defined as the time from randomization to the earlier date of assessment of objective progression or death by any cause in the absence of progression; progression will be assessed by the investigator per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 primary outcome time frame From randomization to the earlier date of assessment of objective progression or death by any cause in the absence of progression, the follow up period is about 2 years. eligibility module eligibility criteria Inclusion Criteria:
Eighteen years of age or older at the time written informed consent is obtained
Newly diagnosed, histologically confirmed FIGO stage III or IV EOC (high-grade serous or high-grade endometrioid)
After primary debulking surgery or after interval debulking surgery; residual disease after surgery with optimal resection as R0 or R1 (R0 is defined as no macroscopic residual disease, R1 is defined as macroscopic residual disease with a maximal diameter of <1 cm)
Known BRCA status; if BRCA mutation status not known, results of BRCA testing must be available before randomization
Laboratory criteria:
5.1. White blood cells >4000/mm3 (4.0×109/L) 5.2. Neutrophil count >1500/mm3 (1.5×109/L) 5.3. Hemoglobin ≥8 g/dL (80 g/L) 5.4. Platelet count ≥100,000/mm3 (100×109/L) 5.5. Total bilirubin <2× upper limit of normal (ULN) (benign hereditary hyperbilirubinemias, e.g., Gilbert's syndrome, are permitted) 5.6. Serum alanine aminotransferase, aspartate aminotransferase, and creatinine <2×ULN 5.7. Blood urea nitrogen <2×ULN
Adequate coagulation parameters:
6.1. Activated partial thromboplastin time ≤1.5×ULN 6.2. International normalized ratio ≤1.5
ECOG performance status 0-2
Patients of child-bearing potential and their partners who are sexually active must agree to the use of 2 highly effective forms of contraception from the patient's signing of the ICF until 6 months after the last/final dose of first-line Pt-based adjuvant chemotherapy or IMP, whichever occurs later:
a. Condom with spermicide and one of the following:
Oral contraceptive or hormonal therapy (e.g., hormone implants)
Placement of an intra-uterine device (IUD)
Acceptable non-hormonal birth control methods include:
Total sexual abstinence from the patient's signing of the ICF until 6 months after the last/final dose of first-line Pt-based adjuvant chemotherapy or IMP, whichever occurs later
Vasectomized sexual partner plus male condom with spermicide and participant assurance that partner received post-vasectomy confirmation of azoospermia
Tubal occlusion plus male condom with spermicide
IUD plus male condom with spermicide. Provided coils are copper-banded.
Acceptable hormonal methods include:
Etonogestrel implants (e.g., Implanon, Norplan) plus male condom with spermicide
Normal and low dose combined oral pills plus male condom with spermicide
Norelgestromin/ethinyl estradiol transdermal system plus male condom with spermicide
Intravaginal device plus male condom with spermicide (e.g., ethinyl estradiol and etonogestrel)
Cerazette (desogestrel) plus male condom with spermicide. Cerazette is currently the only highly efficacious progesterone-based pill.
Signed informed consent and ability to comprehend its content
Exclusion Criteria:
Non-epithelial ovarian carcinoma or mixed epithelial histology
Borderline tumors (tumors of low malignant potential)
First-line Pt-based adjuvant chemotherapy already started after surgery
Intention to treat with intraperitoneal chemotherapy
Previous or concurrent radiotherapy to the abdomen and pelvis
Major surgery (with the exception of debulking surgery) within 3 weeks before informed consent signature or patient has not recovered from any effects of any major surgery
Malignancy other than EOC, except malignancy that has been in complete remission for a minimum of 3 years and except carcinoma in situ of the cervix or non-melanoma skin carcinomas that have been definitively treated
Use of any immunotherapy in the past (e.g., anti-PD-1/PD-L1 or other immune checkpoint inhibitors, therapeutic vaccines, adoptive cell therapy, cytokines); in case of uncertainty, discuss with the medical monitor
Symptomatic uncontrolled brain or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required. Patients with spinal cord compression may be considered if they have received definitive treatment for this and evidence of clinically stable disease for 28 days.
Co-morbidities:
10.1. HIV positive 10.2. Active hepatitis B (HBV) and/or C (HCV), active syphilis 10.3. Evidence of active bacterial, viral, or fungal infection requiring systemic treatment 10.4. Clinically significant cardiovascular disease including: 10.4.1. Symptomatic congestive heart failure 10.4.2. Unstable angina pectoris 10.4.3. Severe cardiac arrhythmia requiring medication 10.4.4. Uncontrolled hypertension 10.4.5. Myocardial infarction or ventricular arrhythmia or stroke within a 6-month period before inclusion, ejection fraction <40% or serious cardiac conduction system disorders, if a pacemaker is not present 10.5. Pericardial effusion of any CTCAE grade 10.6. Severe chronic obstructive pulmonary disease defined as grade C and D according to Global Initiative for Obstructive Lung Disease 10.7. Patients considered a poor medical risk due to other serious, uncontrolled medical disorders, non-malignant systemic diseases or active, uncontrolled infections 10.8. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study treatment, or is not in the best interest of the patient to participate 10.9. Active autoimmune disease requiring treatment 10.10. History of severe forms of primary immune deficiencies 10.11. History of anaphylaxis or other severe reactions following vaccination 10.12. Psychiatric or social conditions which, in the investigator's opinion, would prevent participation in the study
Known hypersensitivity to any constituent of IMP
Systemic immunosuppressive therapy for any reason (except inhaled / intranasal steroids and short-term systemic steroids <30 days duration and ≤10 mg prednisone-equivalent per day are allowed)
Participation in a clinical trial using experimental therapy within the last 4 weeks before informed consent signature
Pregnant or breast feeding, or expecting to conceive children within the projected duration of the study treatment
Refusal to sign informed consent healthy volunteers No gender Female minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Yuan LI, Master central contact role Contact central contact phone +86 18610689868 central contact e mail yuanli@bjmu.edu.cn location list location location facility Peking University Third Hospital location status Recruiting location city Beijing location state Beijing location zip 100191 location country China location contact list location contact location contact name Yuan LI location contact role Contact location contact phone +86 18610689868 location contact e mail yuanli@bjmu.edu.cn derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002277 condition mesh term Carcinoma condition mesh id D000077216 condition mesh term Carcinoma, Ovarian Epithelial condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000010051 condition ancestor term Ovarian Neoplasms condition ancestor id D000004701 condition ancestor term Endocrine Gland Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000010049 condition ancestor term Ovarian Diseases condition ancestor id D000000291 condition ancestor term Adnexal Diseases condition ancestor id D000005833 condition ancestor term Genital Neoplasms, Female condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000004700 condition ancestor term Endocrine System Diseases condition ancestor id D000006058 condition ancestor term Gonadal Disorders condition browse leaf list condition browse leaf condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf as found Carcinoma condition browse leaf relevance high condition browse leaf id M12126 condition browse leaf name Ovarian Neoplasms condition browse leaf relevance low condition browse leaf id M1704 condition browse leaf name Carcinoma, Ovarian Epithelial condition browse leaf as found Epithelial Ovarian Carcinoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse leaf id M7015 condition browse leaf name Endocrine Gland Neoplasms condition browse leaf relevance low condition browse leaf id M12124 condition browse leaf name Ovarian Diseases condition browse leaf relevance low condition browse leaf id M2795 condition browse leaf name Adnexal Diseases condition browse leaf relevance low condition browse leaf id M8097 condition browse leaf name Genital Neoplasms, Female condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M7014 condition browse leaf name Endocrine System Diseases condition browse leaf relevance low condition browse leaf id M8315 condition browse leaf name Gonadal Disorders condition browse leaf relevance low condition browse leaf id T4352 condition browse leaf name Ovarian Cancer condition browse leaf as found Epithelial Ovarian Carcinoma condition browse leaf relevance high condition browse leaf id T4354 condition browse leaf name Ovarian Epithelial Cancer condition browse leaf as found Epithelial Ovarian Carcinoma condition browse leaf relevance high condition browse leaf id T2189 condition browse leaf name Fallopian Tube Cancer condition browse leaf as found Fallopian Tube Carcinoma condition browse leaf relevance high condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev BC19 condition browse branch name Gland and Hormone Related Diseases condition browse branch abbrev Rare condition browse branch name Rare Diseases | NCT04834544 | [
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full study rank 61440 study protocol section identification module n c t id NCT04836442 org study id info org study id STUDY2021001-AP-PFI organization org full name University of Houston org class OTHER brief title PFI Hazardous Drinkers With Subclinical PTSD official title An Integrated Personalized Feedback Intervention for Hazardous Drinkers With Subclinical PTSD status module status verified date July 2022 overall status Not yet recruiting expanded access info has expanded access No start date struct start date July 2022 start date type Anticipated primary completion date struct primary completion date December 2022 primary completion date type Anticipated completion date struct completion date July 2023 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date July 20, 2022 last update post date struct last update post date July 25, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Michael J. Zvolensky, Ph.D. responsible party investigator title Hugh Roy and Lillie Cranz Cullen Distinguished University Professor responsible party investigator affiliation University of Houston lead sponsor lead sponsor name University of Houston lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary The objective of the present study is to assist on a randomized controlled trial (RCT), aimed at developing and testing the efficacy of a novel computer based PFI among hazardous drinkers with at least subclinical posttraumatic stress disorder (PTSD) (i.e., endorsing at least two symptoms in each PTSD symptom cluster) and elevated anxiety sensitivity (AS). The objective of this trial is to examine the feasibility, acceptability, and efficacy of this novel PFI on (1) primary outcomes including drinking motivational factors and alcohol-related behaviors and (2) secondary outcomes including changes in AS and PTSD, and (3) exploring theoretically relevant mediators/moderators. Follow-up assessments will occur at post-test, one-week, and one-month post-intervention. Hazardous drinkers with at least subclinical PTSD and elevated AS (N=100) recruited from the community will be randomly assigned to receive Alcohol-PTSD-PFI (AP-PFI) or an active comparison condition (C-PFI). detailed description Hazardous drinking (i.e., a pattern of alcohol use that increases risk for adverse health consequences) and posttraumatic stress disorder (PTSD) are highly prevalent and commonly co-occurring conditions that are associated with greater disability, mortality, and poor health outcomes as compared to either condition alone. More than 25% of U.S. adults endorse hazardous drinking, which is one of the leading causes of preventable death in the U.S. and globally. Among individuals who engage in hazardous drinking, the prevalence of PTSD is 27% (reflecting 5.81 million people) and individuals who experience PTSD symptoms are roughly three times more likely to endorse hazardous drinking compared to those without PTSD symptomatology. Hazardous drinking-PTSD comorbidity evince bidirectional and transactional effects between PTSD and the maintenance and/or exacerbation of alcohol use. Yet, no empirically supported "gold standard" treatments are available and the most promising interventions are marked by substantive attrition and small effect sizes. Therefore, it is important to consider malleable factors that underlie hazardous drinking-PTSD relations to inform personalized evidence-based interventions among this underserved population.
A transdiagnostic factor for hazardous drinking and PTSD is anxiety sensitivity (AS). AS, defined as the fear of anxiety-related sensations and cognitions, has been positively related to hazardous drinking and coping-oriented drinking motives. Elevated AS has also been implicated in the development and maintenance of PTSD. AS may underlie (i.e., help explain) hazardous drinking-PTSD comorbidity by amplifying PTSD symptomatology and motivating drinking to down regulate such affect. Despite the efficacy of AS interventions for reducing hazardous drinking and PTSD symptoms, an integrated intervention to specifically target AS in the context of hazardous drinking and PTSD symptoms has not been developed or tested. Personalized feedback interventions (PFI) may help to address this gap as they have demonstrated efficacy in reducing hazardous drinking and alcohol-related consequences across various populations. PFI's target misperceptions regarding an individual's behaviors and actual normative behaviors, highlight consequences of these behaviors, and offer strategies for modifying them. Thus, PFIs are brief, cost-effective, easily disseminable, and clinically relevant given low treatment-seeking rates found among hazardous drinkers with PTSD.
Concordant with NIAAA's 2017-2021 Strategic Plan, the objective of the present study is to assist on a randomized controlled trial (RCT) aimed at developing and testing the efficacy of a novel computer based PFI among hazardous drinkers with at least subclinical PTSD (i.e., endorsing at least two symptoms in each PTSD symptom cluster) and elevated AS. The objective of this proposal is to examine the feasibility, acceptability, and efficacy of this novel PFI on (1) primary outcomes including drinking motivational factors and alcohol-related behaviors and (2) secondary outcomes including changes in AS and PTSD, and (3) exploring theoretically relevant mediators/moderators. Follow-up assessments will occur at post-test, one-week, and one-month post-intervention. Hazardous drinkers with at least subclinical PTSD and elevated AS (N=100) recruited from the community will be randomly assigned to receive Alcohol-PTSD-PFI (AP-PFI) or an active comparison condition (C-PFI).
The AP-PFI will focus on feedback about alcohol behavior in the context of PTSD symptoms, AS, and coping-oriented alcohol use, to address the following aims:
Aim 1. Assist on evaluating the feasibility and acceptability of AP-PFI vs. C-PFI.
Evaluate initial metrics of feasibility and efficacy focused on the following:
Recruitment/retention rates throughout the duration of the study.
Treatment acceptability at post-test, treatment utilization at one-week and one-month follow-up.
Initial efficacy at post-test, one-week, and one-month follow-up.
Aim 2. Assist on conducting a RCT to examine the efficacy of AP-PFI vs. C-PFI.
At post-test, participants randomized to AP-PFI (vs. C-PFI) will report:
H1A: Greater motivation/intention to reduce (i.e., from hazardous to non-hazardous) drinking.
H1B: Lower levels of AS.
At one-week and one-month follow-up, participants randomized to AP-PFI (vs. C-PFI) will evince:
H2A: Greater change in rates from hazardous to non-hazardous drinking. H2B: Lower frequency and quantity of alcohol consumption and reduced negative consequences of drinking.
H2C: Lower PTSD symptom severity.
Exploratory Aim 3. Explore mediators and moderators. H3: Effects of AP-PFI (vs. C-PFI) on follow-up outcomes (H2A; H2B; H2C) will be mediated by: (1) motivation/intention to reduce drinking (H1A) and (2) lower levels of AS (H1B).
H4: The effects of AP-PFI (vs. C-PFI) on post-test and one-week and one-month follow-up outcomes will be larger among female (relative to male) participants.
H5: Associations between PTSD and alcohol-related outcomes (e.g., urges, cravings, motivation to reduce drinking, hazardous drinking levels) will be moderated by family history of AUD. conditions module condition list condition Hazardous Drinking Posttraumatic Stress Disorder design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 100 enrollment type Anticipated arms interventions module arm group list arm group arm group label Alcohol-PTSD-PFI (AP-PFI) arm group type Experimental arm group description Hazardous drinkers with at least subclinical PTSD and elevated AS (N=100) recruited from the community will be randomly assigned to receive Alcohol-PTSD-PFI (AP-PFI) or an active comparison control condition (C-PFI). arm group intervention list arm group intervention name Other: Alcohol-PTSD-PFI (AP-PFI) arm group label Active Comparison Condition (C-PFI) arm group type Other arm group description Participants in the time-matched comparison condition will receive personalized feedback on alcohol use but will not receive PTSD or AS-related personalized feedback. C-PFI will include alcohol-focused components identical to those provided in AP-PFI (e.g., alcohol profiles, normative feedback). Therefore, it will be possible to isolate the impact of personalized PTSD and AS feedback versus personalized alcohol feedback. arm group intervention list arm group intervention name Other: Active Comparison Condition (C-PFI) intervention list intervention intervention type Other intervention name Alcohol-PTSD-PFI (AP-PFI) intervention description Integrated computer-based personalized feedback intervention to specifically target anxiety sensitivity in the context of hazardous drinking and PTSD symptoms. The AP-PFI will focus on feedback about alcohol behavior in the context of PTSD symptoms, AS, and coping-oriented alcohol use. intervention arm group label list intervention arm group label Alcohol-PTSD-PFI (AP-PFI) intervention type Other intervention name Active Comparison Condition (C-PFI) intervention description Participants in the time-matched comparison condition will receive personalized feedback on alcohol use but will not receive PTSD or AS-related personalized feedback. C-PFI will include alcohol-focused components identical to those provided in AP-PFI (e.g., alcohol profiles, normative feedback). Therefore, it will be possible to isolate the impact of personalized PTSD and AS feedback versus personalized alcohol feedback. intervention arm group label list intervention arm group label Active Comparison Condition (C-PFI) outcomes module primary outcome list primary outcome primary outcome measure Changes in anxiety sensitivity levels: Short Scale Anxiety Sensitivity Index (SSASI) primary outcome description The Short Scale Anxiety Sensitivity Index utilizes a 5-item Likert scale to measure anxiety sensitivity. The minimum value is "very little" and the maximum value is "Very much". Higher score indicate higher levels of anxiety sensitivity. This index will be used to assess changes in levels of anxiety sensitivity throughout the study. Hypothesis 1b: At post-test, participants randomized to AP-PFI (vs. C-PFI) will report lower levels of anxiety sensitivity. primary outcome time frame administered at one-week and one-month follow-ups primary outcome measure Changes in motivation/intention to reduce drinking: The Alcohol Ladder primary outcome description The Alcohol Ladder is a one-item, reliable measure that assesses an individual's motivation to change their alcohol use. The ladder includes 10 rungs and asks participants to rate readiness to change their drinking habits by asking "Each rung of this ladder shows where a person might be in thinking about changing their drinking. Select the number that best matches where you are now.". The higher participants rate themselves on the ladder, the higher their readiness to change their drinking. This measure will be used to assess changes in motivation to reduce drinking throughout the study. Hypothesis 1a: At post-test, participants randomized to AP-PFI (vs. C-PFI) will report greater motivation/intention to reduce (i.e., from hazardous to non-hazardous) drinking. primary outcome time frame administered at one-week and one-month follow-ups primary outcome measure Changes in hazardous drinking patterns: Alcohol Use Disorders Identification Test primary outcome description The alcohol use disorder identification test assesses drinking patterns and related consequences, and is valid, reliable, and demonstrates excellent sensitivity to detect potentially hazardous drinkers. Although all participants will be screened with the full measure, the first three items will be administered at follow-ups to evaluate hazardous alcohol use over time. Hypothesis 2a: At one-week and one-month follow-up, participants randomized to AP-PFI (vs. C-PFI) will evince greater change in rates from hazardous to non-hazardous drinking. primary outcome time frame administered at baseline, one-week and one-month follow-ups primary outcome measure Changes in frequency and quantity of alcohol consumption: Timeline Follow-Back primary outcome description The Timeline Follow-Back (TLFB) is a calendar-based questionnaire that collects information regarding alcohol consumption over the past 30 days and is a reliable measure. It will be used to assess the changes in frequency and quantity of alcohol consumption throughout the study. Hypothesis 2b: at one-week and one-month follow-up, participants randomized to AP-PFI (vs. C-PFI) will evince lower frequency and quantity of alcohol consumption and reduced negative consequences of drinking. primary outcome time frame administered at baseline, one-week and one-month follow-ups primary outcome measure Changes in PTSD symptom severity: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) primary outcome description The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) measures PTSD symptom severity as it relates to the "worst" traumatic event endorsed throughout the participant's lifespan. The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items, whereas higher scores represent higher symptom severity. It will be administered to participant throughout the study in order to assess changes in posttraumatic stress disorder symptom severity. Hypothesis 2c: At one-week and one-month follow-up, participants randomized to AP-PFI (vs. C-PFI) will evince lower PTSD symptom severity primary outcome time frame administered at baseline, one-week and one-month follow-ups secondary outcome list secondary outcome secondary outcome measure Evaluate the feasibility and acceptability of AP-PFI vs. C-PFI: Treatment Credibility/Expectancy Questionnaire secondary outcome description The acceptability of the intervention (i.e., AP-PFI) will be assessed via the Treatment Credibility/Expectancy Questionnaire (TCEQ). This measure is a reliable index that will be used to assess perceptions of treatment credibility/expectancies about treatment, including satisfaction, acceptability of AP-PFI relative to control. Additionally, it will assess how participants think the intervention will be successful in terms of reducing alcohol use, PTSD symptoms, and anxiety sensitivity, while also assessing anticipated reductions in alcohol use, PTSD symptoms, and anxiety sensitivity (0-100%). secondary outcome time frame administered at one-month follow-up secondary outcome measure Evaluate the moderating role of family history of AUD on PTSD and alcohol-related outcomes secondary outcome description Will be assessed via the Alcohol History Measure (AHM), a 11-item questionnaire that collects information on a participant's history of alcohol use, including familial history, consequences associated with use, and age of first use. secondary outcome time frame Administered at baseline eligibility module eligibility criteria Inclusion Criteria:
≥ 21 years of age
Current hazardous drinking pattern (AUDIT scores ≥ 8 for males and ≥ 7 for females; this approach does not exclude persons with alcohol use disorder)
Lifetime exposure to a DSM-5 Criterion A traumatic event and endorsing at least two symptoms in each DSM-5 PTSD symptom cluster.
Elevated AS score (1 SD above normative mean)
Fluent in English
Exclusion Criteria:
Concurrent alcohol or other substance use treatment
Current/past bipolar or psychotic disorder
Current imminent risk of suicidality (i.e., past month ideation with intent or plan)
Current stable use of prescription opioids/ benzodiazepines/positive urine drug screen
Current pregnancy
Inability to provide verbal or written consent
Breath analysis (Alco-Sensor FST) estimating blood alcohol concentration (BAC) above 0 healthy volunteers Accepts Healthy Volunteers gender All minimum age 21 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Antoine Lebeaut, M.A. central contact role Contact central contact phone 713-743-8056 central contact e mail amlebeaut@uh.edu central contact name Andre Bizier, B.S. central contact role Contact central contact phone 713-743-0946 central contact e mail abizier@central.uh.edu location list location location facility Anxiety and Health Research Lab- Substance Use Treatment Clinic location city Houston location state Texas location zip 77204 location country United States location contact list location contact location contact name Antoine Lebeaut, M.A. location contact role Contact location contact phone 713-743-8056 location contact e mail amlebeaut@uh.edu location contact name Pam Nizio, B.S. location contact role Contact location contact phone 713-743-8056 location contact e mail niziopam@gmail.com location contact name Michael Zvolensky, Ph.D location contact role Principal Investigator location contact name Anka Vujanovic, Ph.D location contact role Principal Investigator derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000013313 condition mesh term Stress Disorders, Post-Traumatic condition ancestor list condition ancestor condition ancestor id D000040921 condition ancestor term Stress Disorders, Traumatic condition ancestor id D000068099 condition ancestor term Trauma and Stressor Related Disorders condition ancestor id D000001523 condition ancestor term Mental Disorders condition browse leaf list condition browse leaf condition browse leaf id M15255 condition browse leaf name Stress Disorders, Post-Traumatic condition browse leaf as found Posttraumatic Stress Disorder condition browse leaf relevance high condition browse leaf id M24069 condition browse leaf name Stress Disorders, Traumatic condition browse leaf relevance low condition browse leaf id M16837 condition browse leaf name Wounds and Injuries condition browse leaf relevance low condition browse leaf id M222 condition browse leaf name Trauma and Stressor Related Disorders condition browse leaf relevance low condition browse leaf id M3967 condition browse leaf name Mental Disorders condition browse leaf relevance low condition browse leaf id M13625 condition browse leaf name Psychotic Disorders condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BXM condition browse branch name Behaviors and Mental Disorders condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev BC26 condition browse branch name Wounds and Injuries intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M2929 intervention browse leaf name Ethanol intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infe intervention browse branch name Anti-Infective Agents intervention browse branch abbrev CNSDep intervention browse branch name Central Nervous System Depressants intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04836442 | [
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23406,
5600,
2032,
1103,
9355,
1104,
1103,
2025,
119,
19165,
4392,
6328,
1120,
2112,
118,
2774,
117,
3252,
190,
19621,
2734,
1120,
1141,
118,
1989,
1105,
1141,
118,
2370,
2812,
118,
1146,
119,
20242,
23891,
1120,
2112,
118,
2774,
117,
1141,
118,
1989,
117,
1105,
1141,
118,
2370,
2812,
118,
1146,
119,
19294,
1306,
123,
119,
1249,
22398,
1113,
9239,
170,
25157,
1942,
1106,
11755,
1103,
23891,
1104,
10997,
118,
153,
17675,
5016,
119,
140,
118,
153,
17675,
119,
1335,
2112,
118,
2774,
117,
6635,
7091,
2200,
1106,
10997,
118,
153,
17675,
113,
5016,
119,
140,
118,
153,
17675,
114,
1209,
2592,
131,
145,
1475,
1592,
131,
6752,
15710,
120,
6247,
1106,
4851,
113,
178,
119,
174,
119,
117,
1121,
20981,
1106,
1664,
118,
20981,
114,
5464,
119,
145,
1475,
2064,
131,
5738,
3001,
1104,
15278,
119,
1335,
1141,
118,
1989,
1105,
1141,
118,
2370,
2812,
118,
1146,
117,
6635,
7091,
2200,
1106,
10997,
118,
153,
17675,
113,
5016,
119,
140,
118,
153,
17675,
114,
1209,
174,
6871,
2093,
131,
145,
1477,
1592,
131,
6752,
1849,
1107,
5600,
1121,
20981,
1106,
1664,
118,
20981,
5464,
119,
145,
1477,
2064,
131,
5738,
5625,
1105,
11978,
1104,
6272,
8160,
1105,
3549,
4366,
8421,
1104,
5464,
119,
145,
1477,
1658,
131,
5738,
22216,
15203,
188,
17162,
6451,
4165,
20997,
119,
16409,
1643,
24171,
6207,
19294,
1306,
124,
119,
16409,
1643,
21425,
2394,
5067,
1105,
5418,
19527,
119,
145,
1495,
131,
23009,
1104,
10997,
118,
153,
17675,
113,
5016,
119,
140,
118,
153,
17675,
114,
1113,
2812,
118,
1146,
13950,
113,
145,
1477,
1592,
132,
145,
1477,
2064,
132,
145,
1477,
1658,
114,
1209,
1129,
22060,
1118,
131,
113,
122,
114,
15710,
120,
6247,
1106,
4851,
5464,
113,
145,
1475,
1592,
114,
1105,
113,
123,
114,
2211,
3001,
1104,
15278,
113,
145,
1475,
2064,
114,
119,
145,
1527,
131,
1109,
3154,
1104,
10997,
118,
153,
17675,
113,
5016,
119,
140,
118,
153,
17675,
114,
1113,
2112,
118,
2774,
1105,
1141,
118,
1989,
1105,
1141,
118,
2370,
2812,
118,
1146,
13950,
1209,
1129,
2610,
1621,
2130,
113,
5236,
1106,
2581,
114,
6635,
119,
145,
1571,
131,
1791,
1116,
1206,
22216,
15203,
1105,
6272,
118,
2272,
13950,
113,
174,
119,
176,
119,
117,
27169,
117,
172,
1611,
3970,
1116,
117,
15710,
1106,
4851,
5464,
117,
20981,
5464,
3001,
114,
1209,
1129,
8828,
1181,
1118,
1266,
1607,
1104,
21646,
2137,
119,
2975,
13196,
3879,
2190,
3879,
11679,
18551,
2285,
1987,
10223,
1158,
3799,
4487,
25930,
1457,
7370,
12120,
21484,
2692,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
19165,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
7330,
113,
3353,
20943,
114,
10803,
23992,
10803,
5099,
1620,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
2586,
2528,
14084,
118,
22216,
15203,
118,
153,
17675,
113,
10997,
118,
153,
17675,
114,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
11679,
18551,
2285,
3668,
1468,
1114,
1120,
1655,
4841,
1665,
21472,
7867,
22216,
15203,
1105,
8208,
15278,
113,
151,
134,
1620,
114,
8443,
1121,
1103,
1661,
1209,
1129,
19729,
3346,
1106,
3531,
2586,
2528,
14084,
118,
22216,
15203,
118,
153,
17675,
113,
10997,
118,
153,
17675,
114,
1137,
1126,
2327,
7577,
1654,
3879,
113,
140,
118,
153,
17675,
114,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
2586,
2528,
14084,
118,
22216,
15203,
118,
153,
17675,
113,
10997,
118,
153,
17675,
114,
1981,
1372,
3107,
17244,
3291,
8223,
26464,
1320,
16752,
14669,
113,
140,
118,
153,
17675,
114,
1981,
1372,
2076,
2189,
1981,
1372,
6136,
4539,
27989,
21868,
1107,
1103,
1159,
118,
10260,
7577,
3879,
1209,
3531,
2357,
2200,
13032,
1113,
6272,
1329,
1133,
1209,
1136,
3531,
22216,
15203,
1137,
15278,
118,
2272,
2357,
2200,
13032,
119,
140,
118,
153,
17675,
1209,
1511,
6272,
118,
3378,
5644,
6742,
1106,
1343,
2136,
1107,
10997,
118,
153,
17675,
113,
174,
119,
176,
119,
117,
6272,
21138,
117,
18570,
5838,
13032,
114,
119,
6589,
117,
1122,
1209,
1129,
1936,
1106,
1110,
14995,
1103,
3772,
1104,
2357,
2200,
22216,
15203,
1105,
15278,
13032,
6055,
2357,
2200,
6272,
13032,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
17244,
3291,
8223,
26464,
1320,
16752,
14669,
113,
140,
118,
153,
17675,
114,
9108,
2190,
9108,
9108,
2076,
2189,
9108,
1271,
2586,
2528,
14084,
118,
22216,
15203,
118,
153,
17675,
113,
10997,
118,
153,
17675,
114,
9108,
6136,
18926,
2775,
118,
1359,
2357,
2200,
13032,
9108,
1106,
4418,
4010,
10507,
15750,
1107,
1103,
5618,
1104,
20981,
5464,
1105,
22216,
15203,
8006,
119,
1109,
10997,
118,
153,
17675,
1209,
2817,
1113,
13032,
1164,
6272,
4658,
1107,
1103,
5618,
1104,
22216,
15203,
8006,
117,
15278,
117,
1105,
9947,
1158,
118,
7779,
6272,
1329,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
2586,
2528,
14084,
118,
22216,
15203,
118,
153,
17675,
113,
10997,
118,
153,
17675,
114,
9108,
2076,
2189,
9108,
1271,
17244,
3291,
8223,
26464,
1320,
16752,
14669,
113,
140,
118,
153,
17675,
114,
9108,
6136,
4539,
27989,
21868,
1107,
1103,
1159,
118,
10260,
7577,
3879,
1209,
3531,
2357,
2200,
13032,
1113,
6272,
1329,
1133,
1209,
1136,
3531,
22216,
15203,
1137,
15278,
118,
2272,
2357,
2200,
13032,
119,
140,
118,
153,
17675,
1209,
1511,
6272,
118,
3378,
5644,
6742,
1106,
1343,
2136,
1107,
10997,
118,
153,
17675,
113,
174,
119,
176,
119,
117,
6272,
21138,
117,
18570,
5838,
13032,
114,
119,
6589,
117,
1122,
1209,
1129,
1936,
1106,
1110,
14995,
1103,
3772,
1104,
2357,
2200,
22216,
15203,
1105,
15278,
13032,
6055,
2357,
2200,
6272,
13032,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
17244,
3291,
8223,
26464,
1320,
16752,
14669,
113,
140,
118,
153,
17675,
114,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
21395,
1107,
10507,
15750,
3001,
131,
6373,
20334,
1760,
8745,
20656,
14895,
5053,
3121,
14499,
10146,
113,
6663,
10719,
2240,
114,
2425,
9386,
6136,
1109,
6373,
20334,
1760,
8745,
20656,
14895,
5053,
3121,
14499,
10146,
24242,
170,
126,
118,
8926,
2409,
3740,
3418,
1106,
4929,
10507,
15750,
119,
1109,
5867,
2860,
1110,
107,
1304,
1376,
107,
1105,
1103,
4177,
2860,
1110,
107,
6424,
1277,
107,
119,
7715,
2794,
5057,
2299,
3001,
1104,
10507,
15750,
119,
1188,
7448,
1209,
1129,
1215,
1106,
15187,
2607,
1107,
3001,
1104,
10507,
15750,
2032,
1103,
2025,
119,
145,
1183,
11439,
22063,
122,
1830,
131,
1335,
2112,
118,
2774,
117,
6635,
7091,
2200,
1106,
10997,
118,
153,
17675,
113,
5016,
119,
140,
118,
153,
17675,
114,
1209,
2592,
2211,
3001,
1104,
10507,
15750,
119,
2425,
9386,
1159,
4207,
8318,
1120,
1141,
118,
1989,
1105,
1141,
118,
2370,
2812,
118,
12534,
2425,
9386,
4929,
21395,
1107,
15710,
120,
6247,
1106,
4851,
5464,
131,
1109,
2586,
2528,
14084,
2001,
19541,
2425,
9386,
6136,
1109,
2586,
2528,
14084,
2001,
19541,
1110,
170,
1141,
118,
8926,
117,
10682,
4929,
1115,
15187,
1279,
1126,
2510,
112,
188,
15710,
1106,
1849,
1147,
6272,
1329,
119,
1109,
11413,
2075,
1275,
1576,
5700,
1105,
4390,
6635,
1106,
2603,
25922,
1106,
1849,
1147,
5464,
15640,
1118,
4107,
107,
2994,
1576,
1403,
1104,
1142,
11413,
2196,
1187,
170,
1825,
1547,
1129,
1107,
2422,
1164,
4787,
1147,
5464,
119,
18193,
1103,
1295,
1115,
1436,
2697,
1187,
1128,
1132,
1208,
119,
107,
119,
1109,
2299,
6635,
2603,
2310,
1113,
1103,
11413,
117,
1103,
2299,
1147,
25922,
1106,
1849,
1147,
5464,
119,
1188,
4929,
1209,
1129,
1215,
1106,
15187,
2607,
1107,
15710,
1106,
4851,
5464,
2032,
1103,
2025,
119,
145,
1183,
11439,
22063,
122,
1161,
131,
1335,
2112,
118,
2774,
117,
6635,
7091,
2200,
1106,
10997,
118,
153,
17675,
113,
5016,
119,
140,
118,
153,
17675,
114,
1209,
2592,
3407,
15710,
120,
6247,
1106,
4851,
113,
178,
119,
174,
119,
117,
1121,
20981,
1106,
1664,
118,
20981,
114,
5464,
119,
2425,
9386,
1159,
4207,
8318,
1120,
1141,
118,
1989,
1105,
1141,
118,
2370,
2812,
118,
12534,
2425,
9386,
4929,
21395,
1107,
20981,
5464,
6692,
131,
2586,
2528,
14084,
11696,
12120,
21484,
10097,
146,
11951,
5783,
5960,
2425,
9386,
6136,
1109,
6272,
1329,
8936,
9117,
2774,
15187,
1279,
5464,
6692,
1105,
2272,
8421,
117,
1105,
1110,
9221,
117,
10682,
117,
1105,
17798,
6548,
15750,
1106,
11552,
9046,
20981,
3668,
1468,
119,
1966,
1155,
6635,
1209,
1129,
12468,
1114,
1103,
1554,
4929,
117,
1103,
1148,
1210,
4454,
1209,
1129,
8318,
1120,
2812,
118,
12534,
1106,
17459,
20981,
6272,
1329,
1166,
1159,
119,
145,
1183,
11439,
22063,
123,
1161,
131,
1335,
1141,
118,
1989,
1105,
1141,
118,
2370,
2812,
118,
1146,
117,
6635,
7091,
2200,
1106,
10997,
118,
153,
17675,
113,
5016,
119,
140,
118,
153,
17675,
114,
1209,
174,
6871,
2093,
3407,
1849,
1107,
5600,
1121,
20981,
1106,
1664,
118,
20981,
5464,
119,
2425,
9386,
1159,
4207,
8318,
1120,
2259,
2568,
117,
1141,
118,
1989,
1105,
1141,
118,
2370,
2812,
118,
12534,
2425,
9386,
4929,
21395,
1107,
5625,
1105,
11978,
1104,
6272,
8160,
131,
2614,
2568,
19253,
118,
4388,
2425,
9386,
6136,
1109,
2614,
2568,
19253,
118,
4388,
113,
157,
25470,
2064,
114,
1110,
170,
8729,
118,
1359,
2304,
24730,
1115,
19213,
1869,
4423,
6272,
8160,
1166,
1103,
1763,
1476,
1552,
1105,
1110,
170,
10682,
4929,
119,
1135,
1209,
1129,
1215,
1106,
15187,
1103,
2607,
1107,
5625,
1105,
11978,
1104,
6272,
8160,
2032,
1103,
2025,
119,
145,
1183,
11439,
22063,
123,
1830,
131,
1120,
1141,
118,
1989,
1105,
1141,
118,
2370,
2812,
118,
1146,
117,
6635,
7091,
2200,
1106,
10997,
118,
153,
17675,
113,
5016,
119,
140,
118,
153,
17675,
114,
1209,
174,
6871,
2093,
2211,
5625,
1105,
11978,
1104,
6272,
8160,
1105,
3549,
4366,
8421,
1104,
5464,
119,
2425,
9386,
1159,
4207,
8318,
1120,
2259,
2568,
117,
1141,
118,
1989,
1105,
1141,
118,
2370,
2812,
118,
12534,
2425,
9386,
4929,
21395,
1107,
22216,
15203,
188,
17162,
6451,
4165,
20997,
131,
1109,
3799,
4487,
25930,
1457,
7370,
12120,
21484,
2692,
23114,
7276,
1111,
18448,
2107,
118,
126,
113,
7054,
2162,
118,
126,
114,
2425,
9386,
6136,
1109,
3799,
4487,
25930,
1457,
7370,
12120,
21484,
2692,
23114,
7276,
1111,
18448,
2107,
118,
126,
113,
7054,
2162,
118,
126,
114,
5252,
22216,
15203,
188,
17162,
6451,
4165,
20997,
1112,
1122,
15286,
1106,
1103,
107,
4997,
107,
23057,
1856,
11889,
2032,
1103,
14031,
112,
188,
1297,
27894,
119,
1109,
7054,
2162,
118,
126,
1110,
170,
1406,
118,
8926,
2191,
118,
2592,
4929,
1115,
15187,
1279,
1103,
1406,
18448,
2107,
118,
126,
8006,
1104,
22216,
15203,
119,
138,
1703,
188,
17162,
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full study rank 61426 study protocol section identification module n c t id NCT04836624 org study id info org study id RIO 008-21 organization org full name Swansea University org class OTHER brief title Co-designing Personalised Assistive Technology official title Co-designing Personalised Aids of Daily Living With Users With Chronic Conditions: a Feasibility Study status module status verified date May 2022 overall status Recruiting expanded access info has expanded access No start date struct start date May 10, 2021 start date type Actual primary completion date struct primary completion date June 30, 2022 primary completion date type Actual completion date struct completion date December 2022 completion date type Anticipated study first submit date March 29, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date October 26, 2022 last update post date struct last update post date October 27, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Swansea University lead sponsor class OTHER collaborator list collaborator collaborator name Swansea Bay University Health Board collaborator class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Assistive technology is an important tool in helping people maintain independence, allowing them to actively participate in education, work, and society. If maximised to its full potential there would be significant health and wellbeing benefits for individuals, reduced reliance on formal health and social care services and reduced healthcare costs. However, current equipment is often unsuitable in meeting an individual's needs. Previous review work by the research team highlighted issues with the design, function, and service provision of assistive technology as barriers to its use. Two specific barriers, a lack of equipment customisation and a lack of end-user involvement in the provision process, are the focus of this work.
This research aims to assess a new method that provides personalised assistive technology to individuals. The method will actively engage participants to input into the design of their own assistive device(s) to help them overcome their challenges of daily living. This method will help enable the device to be customized to their needs, a process known as co-design. Participants will be recruited from Swansea Bay University Health Board with a range of long-term physical health conditions whose current needs are unable to be met by current standard and off-the-shelf assistive technology solutions. Participants must be aged 18+ and currently living within the community.
Participants will be involved in up to 6 interactive sessions spread over 3 months with the researcher. In the initial session the researcher will work with the participants to identify challenges in daily living for the device to overcome. In subsequent sessions, the researcher will design different solutions for the participant to try and feedback on, enabling the design to be adapted to the participants needs. Finally, the participants will evaluate the device provided through questionnaires and individual semi-structured interviews. This feedback will help assess the effectiveness of co-design and its feasibility to be incorporated into future NHS services. detailed description PROCEDURE:
Referral: Potential participants will be identified by a healthcare professional from their current care team and asked whether they would like to participate in the study. Potential participants will be provided with the participant information sheet and asked to consent if they would like their details to be referred onto the principal investigator.
1.1 Arrange appointment: The principal investigator will telephone the potential participant to arrange an appointment to discuss their involvement in the research and gain consent. The consent form will be sent out to the participant (email or posted, depending on preference of participant).
Consent and eligibility [Virtual appointment]: The principal investigator will go through the participant information sheet with the participant and answer any questions they have about the study. The researcher will check they are eligible to take part in the study. If the participant is happy to be involved, they will be asked to sign the consent form and return it back to the researcher (either by email or posting back).
Initial assessment [Virtual appointment]: Through discussion with the participant, the researcher will gather relevant information to help identify their assistive technology needs. This will include information about their medical history and social context, likes and dislikes, current and any previous solutions used and challenges they faces in daily living. For each challenge identified, participants will be asked to score 1-5 about how important the challenge is to them and how difficult it is. This is for the Individually Prioritised Problem Assessment (IPPA) base-line measure. The researcher will complete the Client Service Receipt Inventory base-line measure with the participant to capture demographic information, information on heathcare services accessed in the previous 3 months and medication being taken.
Follow-up appointments, approximately 3-5 [Predominantly virtually, with face-to-face only if required]: In subsequent appointments the participant will meet with the researcher to discuss design ideas, provide feedback and agree on design changes for the devices(s) provided by the researcher to the participant. The participant will be asked to describe what they like/dislike about the current design and what changes they would make. The researcher may show design prototypes over video call to demonstrate how a device will work and to help facilitate gathering feedback.
Following the appointment, the researcher will make design alterations, manufacture designs and post prototypes out for the participant to try. Appointments will be 2-3 weeks apart.
Device issue: Once the design has been refined to a level the participant and researcher are happy with, a final solution will be manufactured. The device will be sent out to the participant and the researcher will meet virtually with the participant to provide any necessary training and instructions for safe usage of the device.
Outcome measures [Virtually, same appointment as above]: The researcher will explain and go through the three different questionnaires being used as outcome measures for the study. The participant will be asked to score 1-5 the difficulty they now find the previously identified challenges (from initial assessment). For the two other measures, QUEST and PIADS [explained below], the researcher will either email or post out the questionnaires to the participant, preference of participant. Participants will be asked to complete and send back (email/post) once completed. Participants will be invited to complete the first of the semi-structured interviews with the researcher to obtain feedback on the co-design process and the device provided. Prior to beginning the interview, participants will be reminded it will be audio-recorded. If required, an additional appointment can be arranged to help the participant complete the questionnaires.
Three month follow-up feedback [Virtual appointment]: Participants will be invited to again complete and return the two questionnaires, QUEST and PIADS, to the researcher. Participants will complete the follow-up CSRI with the researcher. Participants will also be invited to undertake the second semi-structured interview to obtain feedback on the long-term use of device provided. Prior to beginning the interview, participants will be reminded it will be audio recorded Upon completion of the interview the participants involvement in the study will finish. Participants will be advised to contact the Rehabilitation Engineering Unit with any issues with their devices or further queriers about the research.
SETTING:
Due to COVID-19 pandemic, where possible the majority of appointments with occur virtually using a video consultation programme called Attend Anywhere. This will include assessing eligibility and gaining consent, initial assessment, follow-up appointments and the semi-structured interviews. Information on how to access an appointment through this will be provided to participants when they are invited to their first appointment.
Between appointments, the researcher will contact participants using telephone or email to arrange subsequent appointments. During the study, any devices for the participant to trial will be posted out to them. Training and/or instructions will be provided on how to use the device prior to it being sent out. conditions module condition list condition Disability or Chronic Disease Leading to Disablement keyword list keyword Co-design Assistive technology Assisitve Device design module study type Interventional phase list phase Not Applicable design info design allocation N/A design intervention model Single Group Assignment design primary purpose Other design masking info design masking None (Open Label) enrollment info enrollment count 15 enrollment type Anticipated arms interventions module arm group list arm group arm group label Co-designing personalised aids of daily living arm group type Experimental arm group description Participants will be involved in up to 6 interactive sessions spread over 3 months with the researcher. Participants will work with the researcher to help develop their own assistive device to overcome challenges of daily living they experience. arm group intervention list arm group intervention name Device: Co-designing of personalised aids of daily living intervention list intervention intervention type Device intervention name Co-designing of personalised aids of daily living intervention description In the initial session the researcher will work with the participants to identify challenges in daily living for the device to overcome.
In between sessions the researcher will design and manufacture different solutions which will then be sent out for the participant to trial. The participant will then meet with the researcher to and feedback on the device provided. Feedback from the user is used to alter and improve the design of the device; new device(s) are then , enabling the design to be adapted to the participants needs. The process of design changes and feedback forms an iterative loop. This is expected to continue for 4-5 appointments over a period of serveral months until a final design is agreed upon.
After the device is issue, both qualitative and quantitative outcome measures are provided to participants to complete, including questionnaires and semi-structured interviews. . intervention arm group label list intervention arm group label Co-designing personalised aids of daily living outcomes module primary outcome list primary outcome primary outcome measure Qualitative Feedback - Semi-structured interviews primary outcome description Semi-structured questions will be used in individual interviews to facilitate an understanding of:
Any change the device(s) provided have had on the participants life
Identify components of the co-design methodology that participants like and dislike and changes to it in the future.
If co-design has changed any of the barriers to accessing and using assistive technology primary outcome time frame At initial device issue and at 3-months post device issue secondary outcome list secondary outcome secondary outcome measure Quebec User Evaluation of Satisfaction with Technical Aids (QUEST 2.0) secondary outcome description A 12-item outcome measure that assesses the user's satisfaction with both the device and service provided in supplying the device. For each item of the questionnaire, a 5-point scale is used, 1 being not satisfied at all and 5 being very satisfied. secondary outcome time frame At initial device issue and repeated at 3-months post device issue secondary outcome measure Psychosocial Impact of Assistive Devices Scale (PIADS) secondary outcome description A 26-item self-reported questionnaire to assess the effects of an assistive device on three sub-scales: competence, adaptability and self-esteem. For each item of the questionnaire, a 7-point scale is used, ranging from -3 (maximum negative impact) to 3 (maximum positive impact) secondary outcome time frame At initial device issue and repeated at 3-months post device issue secondary outcome measure Individually Prioritised Problem Assessment (IPPA) secondary outcome description An instrument to assess the effectiveness of assistive technology provision in relation to activities the individual considers most relevant. The participant can select up to 7 problems they experience in everyday life. For each problem the participant assigns two scores, one for the importance of the activity and the second for the difficulty. Both scores are assigned using a 5 point scale: 1 not important to 5 most important and 1 not difficult to 5 too difficult to perform. secondary outcome time frame At initial appointment and repeated at initial device issue secondary outcome measure Client Service Receipt Inventory (CSRI) secondary outcome description A tool used to capture and record information on health and social care services and resources used by study participants to help estimate the costs of services received. It will be used to calculate the economic cost changes associated with participation in the study.
The inventory asks participants to idenfify the healthcare services they have accessed in the previous 3 months and any medication they are taking relevant to the health condition and challenges of daily living identified. It will also capture demographic information about the participants. The CRSI will measure any changes to services accessed, medication taken and demographic information as a result of participating in this study. secondary outcome time frame Completed at the initial assessment and again at the 3-month follow-up assessment other outcome list other outcome other outcome measure Resources used other outcome description For each participant an estimate of the resources used and costs involved will be calculated. Costs will be calculated based on the number of person-hours required to engage participant and produce device, manufacturing time and material cost of all components required to produce the final device. This will include time for each appointment with the participant, time spent developing and changing the design, and time to create documentation required to comply with quality management system. other outcome time frame Through study completion, an average of 8 months. eligibility module eligibility criteria Inclusion Criteria:
Confirmed diagnosis of a long-term chronic condition
Living in the community
Age eighteen years or older
Ability to actively engage in a co-design process, as determined by the referring clinician, including:
Sufficient comprehension of language to engage in meaningful verbal dialogue with the researcher.
Sufficient insight into their condition such that they understand their needs.
Sufficient ability to communicate their needs.
Sufficient ability to retain information between sessions
Currently under the care of healthcare services within Swansea Bay University Health Board
At least three-month post injury/diagnosis at the point of recruitment allowing time for spontaneous recovery and for the person to become aware of their difficulties and the implications of this on their lives
Exclusion Criteria:
Receptive or expressive language difficulties, or extremely low memory function that may preclude people from engaging meaningfully
Medically unstable, severe mental health or cognitive difficulties which may preclude meaningful engagement in the study.
Not able to provide informed consent.
Have insufficient access to the internet to engage virtually with the researcher through video conferencing software. healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Jonathan Howard, PhD student central contact role Contact central contact phone 01792703609 central contact e mail 997063@swansea.ac.uk central contact name Jeremy Tree, Professor central contact role Contact central contact phone 1792 602908 central contact e mail j.tree@swansea.ac.uk overall official list overall official overall official name Jonathan Howard, PhD Student overall official affiliation Swansea University overall official role Principal Investigator location list location location facility Swansea Bay University Health Board location status Recruiting location city Swansea location zip SA6 6NL location country United Kingdom location contact list location contact location contact name Jonathan Howard location contact role Contact location contact phone 01792703609 location contact e mail Jonathan.Howard2@wales.nhs.uk location contact name Lorna Tasker location contact role Contact location contact phone 01792703609 location contact e mail SBU.REU@wales.nhs.uk location contact name Jonathan Howard location contact role Principal Investigator i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002908 condition mesh term Chronic Disease condition ancestor list condition ancestor condition ancestor id D000020969 condition ancestor term Disease Attributes condition ancestor id D000010335 condition ancestor term Pathologic Processes condition browse leaf list condition browse leaf condition browse leaf id M5299 condition browse leaf name Chronic Disease condition browse leaf as found Chronic Disease condition browse leaf relevance high condition browse leaf id M21853 condition browse leaf name Disease Attributes condition browse leaf relevance low condition browse leaf id T1303 condition browse leaf name Chronic Graft Versus Host Disease condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC23 condition browse branch name Symptoms and General Pathology condition browse branch abbrev All condition browse branch name All Conditions condition browse branch abbrev Rare condition browse branch name Rare Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M21013 intervention browse leaf name Pharmaceutical Solutions intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev PhSol intervention browse branch name Pharmaceutical Solutions intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04836624 | [
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full study rank 61465 study protocol section identification module n c t id NCT04836117 org study id info org study id 1051629 organization org full name Intermountain Health Care, Inc. org class OTHER brief title Evaluating the Impact of SomaSignal Tests on Medical Management and Change in Risk in Patients at Higher Risk of Cardiovascular Disease: A Feasibility and an Adaptive Implementation Study official title Evaluating the Impact of SomaSignal Tests on Medical Management and Change in Risk in Patients at Higher Risk of Cardiovascular Disease: A Feasibility and an Adaptive Implementation Study (SomaSignal Study) acronym SomaSignal status module status verified date November 2022 overall status Recruiting expanded access info has expanded access No start date struct start date August 12, 2021 start date type Actual primary completion date struct primary completion date August 12, 2024 primary completion date type Anticipated completion date struct completion date August 12, 2024 completion date type Anticipated study first submit date April 5, 2021 study first submit q c date April 5, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date November 16, 2022 last update post date struct last update post date November 17, 2022 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Intermountain Health Care, Inc. lead sponsor class OTHER collaborator list collaborator collaborator name SomaLogic, Inc. collaborator class INDUSTRY oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Feasibility Study Informed consent will be obtained using an IRB-approved form. The first 12 consenting patients will be placed in the planned assessment group for feasibility and will not be randomized. These participants will undergo visits and blood draw collection at 3 months. They will be informed of their SomaSignal Test results at baseline and 3 months.
Recommendations for any medical management changes will be made based on an understanding of those results.
Randomized Study The succeeding 200 participants will be randomized using permuted mixed block randomization, in a 2:1 ratio, i.e., 2 participants to Group 1 (informed of their test results) and 1 participant to Group 2 (uninformed of their test results). At enrollment, and for 6 months thereafter, clinical information will be obtained from each participant's medical records, and/or directly from the participant during procedures, treatments, study-specific visits, and/or follow-up visits. Data collected for the study will have data linkage at SomaLogic, Inc., where data analysis will be done.
At baseline and 6-months (+30 days) post-enrollment, patients will undergo a patient visit and blood collection. Blood will be collected as a stand-alone sample collection, or when other ordered lab work is done, or from access lines inserted during a usual or specialized care. Samples will be sent to the Intermountain Central laboratory for clinical testing. A sample will also be processed and shipped to SomaLogic, Inc. for analysis at baseline and 6 months.
For the informed arm, the SomaSignal Test reports will be provided at the time they are available (2 to 4 weeks after the blood draw). Any recommended changes in medical management will be recorded in the case report forms and will be verified by the Principal Investigator.
For the uninformed arm, the SomaSignal Test results will not be provided to the study team until after the 6-month post-test visit. Adjustments, if any, would be made to the participant's management at that time. conditions module condition list condition Health Behavior design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Health Services Research design masking info design masking None (Open Label) design masking description All participants will know what group they are placed in. For Group 1 (Informed), clinicians and participants will receive their test results immediately. Those in Group 2 (Uninformed) will not receive their test results until study conclusion. enrollment info enrollment count 200 enrollment type Anticipated arms interventions module arm group list arm group arm group label Informed arm group type Experimental arm group description Blood draw for SomaSignal Test and laboratory assessments at baseline, and 6 months (±30 days); SomaSignal Test results to be sent to investigators as available. Review and discussion of results with the participant from baseline and 6 months within 30 days (2-4 weeks to get SomaSignal results) after blood draw. Initiation of changes in medical management as soon as test results are known and discussed with patient.
Patients will have a blood draw performed at baseline and 6 months for lipid panel, hemoglobin A1C, CBC, and BMP. arm group intervention list arm group intervention name Other: SomaSignal Test Results arm group label Uninformed arm group type No Intervention arm group description Blood draw for SomaSignal Test at baseline and 6 months (+30 days). However, results will not be provided to clinician and participant until study conclusion. Patients contacted within 30 days (2-4 weeks) after baseline and 6-month visits to discuss treatment strategy (nothing, add/ remove medication, etc.) made at visit. Patients will have a blood draw performed at baseline and for lipid panel, hemoglobin A1C, CBC, and BMP
SomaSignal Test results to be sent to investigators AFTER study conclusion. Patients will be provided with SomaSignal Test results after the 6 month post-test timepoint. intervention list intervention intervention type Other intervention name SomaSignal Test Results intervention description SomaLogic, Inc. translates patterns from 5000 protein measurements made in thousands of participants in clinical trials into validated models (SomaSignal Tests) that predict important health outcomes or correlate with established health measures. SomaLogic, Inc. has developed these protein-based tests for the detection, subtyping and prognosis of heart disease and related medical, physiological and behavioral conditions. These tests are demonstrated in large retrospective studies to provide information superior to best available alternatives. intervention arm group label list intervention arm group label Informed outcomes module primary outcome list primary outcome primary outcome measure Porportion of participants that undergo a change in their treatment plan after receipt of the SomaSignal test. primary outcome description Lifestyle changes are defined as referrals for
A structured dietary or weight loss program (ie., Intermountain's Weigh to Health)
Physical therapy for cardiovascular fitness
Cardiac rehabilitation Medications
Antianginals
Antiarrhythmics
Antilipidemics
Coagulation modifiers
Heart failure medications
Hypertension medications
Antidiabetic
Antiplatelets
Patients will receive a point for each change made. Documentation will be made on whether the change was made because of the SomaSignal results, a side-effect or a request by the patient, or a non-SomaSignal test related reason. The total number of changes at baseline and 6-months will be computed for each patient and will be compared between the arms. primary outcome time frame Baseline, 6 months eligibility module eligibility criteria Inclusion Criteria:
Male or female 40 - 80 years of age
Receiving care at Intermountain Medical Center
At higher than typical risk for cardiovascular events, as assessed by the Principal Investigator or his/her delegate (further defined in the protocol)
Currently not pregnant
Ability to understand and sign a written informed consent form which must be obtained prior to initiation of any study procedures
Willing and able to comply with any virtual or in-person follow-up visits, tests, and schedule of evaluations
Willing and able to undergo a blood draw for SomaSignal Tests
Willing and able to provide access to their electronic health records
Exclusion Criteria:
Presence of Systemic Lupus Erythematosus
Inability to communicate appropriately
Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
Other conditions that in the opinion of the Principal Investigator and/or Co-Principal Investigators may increase risk to the participants and/or compromise the quality of the clinical trial
The Principal Investigator and/or Co-Principal Investigator determine(s) that the participant is not eligible for participation in this research study. healthy volunteers No gender All minimum age 40 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Darija Rujaic Ward central contact role Contact central contact phone 8015074701 central contact e mail Darija.RujaicWard@imail.org location list location location facility Intermountain Medical Center location status Recruiting location city Salt Lake City location state Utah location zip 84107 location country United States location contact list location contact location contact name Jeffrey L Anderson, MD location contact role Contact references module reference list reference reference p m i d 28974520 reference type background reference citation Williams SA, Murthy AC, DeLisle RK, Hyde C, Malarstig A, Ostroff R, Weiss SJ, Segal MR, Ganz P. Improving Assessment of Drug Safety Through Proteomics: Early Detection and Mechanistic Characterization of the Unforeseen Harmful Effects of Torcetrapib. Circulation. 2018 Mar 6;137(10):999-1010. doi: 10.1161/CIRCULATIONAHA.117.028213. Epub 2017 Oct 3. reference p m i d 27327800 reference type background reference citation Ganz P, Heidecker B, Hveem K, Jonasson C, Kato S, Segal MR, Sterling DG, Williams SA. Development and Validation of a Protein-Based Risk Score for Cardiovascular Outcomes Among Patients With Stable Coronary Heart Disease. JAMA. 2016 Jun 21;315(23):2532-41. doi: 10.1001/jama.2016.5951. reference p m i d 31792462 reference type background reference citation Williams SA, Kivimaki M, Langenberg C, Hingorani AD, Casas JP, Bouchard C, Jonasson C, Sarzynski MA, Shipley MJ, Alexander L, Ash J, Bauer T, Chadwick J, Datta G, DeLisle RK, Hagar Y, Hinterberg M, Ostroff R, Weiss S, Ganz P, Wareham NJ. Plasma protein patterns as comprehensive indicators of health. Nat Med. 2019 Dec;25(12):1851-1857. doi: 10.1038/s41591-019-0665-2. Epub 2019 Dec 2. i p d sharing statement module i p d sharing Undecided derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002318 condition mesh term Cardiovascular Diseases intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id M207490 intervention browse leaf name Chrysarobin intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev ARhu intervention browse branch name Antirheumatic Agents intervention browse branch abbrev Analg intervention browse branch name Analgesics intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04836117 | [
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8087,
1111,
7300,
5193,
119,
138,
6876,
1209,
1145,
1129,
14659,
1105,
12212,
1106,
1573,
1918,
2162,
8032,
1596,
117,
3561,
119,
1111,
3622,
1120,
2259,
2568,
1105,
127,
1808,
119,
1370,
1103,
6189,
1981,
117,
1103,
1573,
1918,
1708,
11368,
1348,
5960,
3756,
1209,
1129,
2136,
1120,
1103,
1159,
1152,
1132,
1907,
113,
123,
1106,
125,
2277,
1170,
1103,
1892,
3282,
114,
119,
6291,
6315,
2607,
1107,
2657,
2635,
1209,
1129,
1802,
1107,
1103,
1692,
2592,
2769,
1105,
1209,
1129,
22480,
1118,
1103,
8013,
1130,
5710,
3121,
25524,
1766,
119,
1370,
1103,
8362,
1394,
17747,
1981,
117,
1103,
1573,
1918,
1708,
11368,
1348,
5960,
2686,
1209,
1136,
1129,
2136,
1106,
1103,
2025,
1264,
1235,
1170,
1103,
127,
118,
2370,
2112,
118,
2774,
3143,
119,
24930,
9380,
2050,
4385,
117,
1191,
1251,
117,
1156,
1129,
1189,
1106,
1103,
14031,
112,
188,
2635,
1120,
1115,
1159,
119,
2975,
13196,
3879,
2190,
3879,
3225,
4108,
2328,
17564,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
3225,
4326,
2713,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
7330,
113,
3353,
20943,
114,
1902,
7739,
1158,
6136,
1398,
6635,
1209,
1221,
1184,
1372,
1152,
1132,
1973,
1107,
119,
1370,
1990,
122,
113,
1130,
17747,
114,
117,
12257,
5895,
1105,
6635,
1209,
3531,
1147,
2774,
2686,
2411,
119,
4435,
1107,
1990,
123,
113,
12118,
1394,
17747,
114,
1209,
1136,
3531,
1147,
2774,
2686,
1235,
2025,
6593,
119,
10803,
23992,
10803,
5099,
2363,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
1130,
17747,
1981,
1372,
2076,
17635,
1981,
1372,
6136,
5657,
3282,
1111,
1573,
1918,
1708,
11368,
1348,
5960,
1105,
8087,
25451,
1120,
2259,
2568,
117,
1105,
127,
1808,
113,
212,
13144,
1552,
114,
132,
1573,
1918,
1708,
11368,
1348,
5960,
2686,
1106,
1129,
1850,
1106,
17718,
1112,
1907,
119,
4960,
1105,
6145,
1104,
2686,
1114,
1103,
14031,
1121,
2259,
2568,
1105,
127,
1808,
1439,
1476,
1552,
113,
123,
118,
125,
2277,
1106,
1243,
1573,
1918,
1708,
11368,
1348,
2686,
114,
1170,
1892,
3282,
119,
1130,
17030,
1891,
1104,
2607,
1107,
2657,
2635,
1112,
1770,
1112,
2774,
2686,
1132,
1227,
1105,
6352,
1114,
5351,
119,
7195,
24767,
1209,
1138,
170,
1892,
3282,
1982,
1120,
2259,
2568,
1105,
127,
1808,
1111,
4764,
2386,
5962,
117,
23123,
8032,
2858,
7939,
18967,
1658,
117,
13979,
117,
1105,
139,
12347,
119,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
2189,
131,
1573,
1918,
1708,
11368,
1348,
5960,
16005,
1981,
1372,
3107,
12118,
1394,
17747,
1981,
1372,
2076,
1302,
11300,
21987,
1981,
1372,
6136,
5657,
3282,
1111,
1573,
1918,
1708,
11368,
1348,
5960,
1120,
2259,
2568,
1105,
127,
1808,
113,
116,
1476,
1552,
114,
119,
1438,
117,
2686,
1209,
1136,
1129,
2136,
1106,
12257,
1811,
1105,
14031,
1235,
2025,
6593,
119,
7195,
24767,
12017,
1439,
1476,
1552,
113,
123,
118,
125,
2277,
114,
1170,
2259,
2568,
1105,
127,
118,
2370,
7508,
1106,
6265,
3252,
5564,
113,
1720,
117,
5194,
120,
5782,
15683,
117,
3576,
119,
114,
1189,
1120,
3143,
119,
7195,
24767,
1209,
1138,
170,
1892,
3282,
1982,
1120,
2259,
2568,
1105,
1111,
4764,
2386,
5962,
117,
23123,
8032,
2858,
7939,
18967,
1658,
117,
13979,
117,
1105,
139,
12347,
1573,
1918,
1708,
11368,
1348,
5960,
2686,
1106,
1129,
1850,
1106,
17718,
138,
26321,
9637,
2025,
6593,
119,
7195,
24767,
1209,
1129,
2136,
1114,
1573,
1918,
1708,
11368,
1348,
5960,
2686,
1170,
1103,
127,
2370,
2112,
118,
2774,
1159,
7587,
119,
9108,
2190,
9108,
9108,
2076,
2189,
9108,
1271,
1573,
1918,
1708,
11368,
1348,
5960,
16005,
9108,
6136,
1573,
1918,
2162,
8032,
1596,
117,
3561,
119,
17391,
6692,
1121,
13837,
4592,
12307,
1189,
1107,
4674,
1104,
6635,
1107,
7300,
7356,
1154,
9221,
2913,
3584,
113,
1573,
1918,
1708,
11368,
1348,
21189,
114,
1115,
17163,
1696,
2332,
13950,
1137,
1884,
18337,
2193,
1114,
1628,
2332,
5252,
119,
1573,
1918,
2162,
8032,
1596,
117,
3561,
119,
1144,
1872,
1292,
4592,
118,
1359,
5715,
1111,
1103,
11432,
117,
4841,
2340,
2624,
1105,
5250,
25566,
4863,
1104,
1762,
3653,
1105,
2272,
2657,
117,
23292,
1105,
18560,
2975,
119,
1636,
5715,
1132,
7160,
1107,
1415,
18675,
2527,
1106,
2194,
1869,
7298,
1106,
1436,
1907,
18815,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
1130,
17747,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
18959,
15615,
12148,
1988,
1104,
6635,
1115,
13971,
170,
1849,
1107,
1147,
3252,
2197,
1170,
1231,
27333,
1104,
1103,
1573,
1918,
1708,
11368,
1348,
2774,
119,
2425,
9386,
6136,
2583,
19994,
2607,
1132,
3393,
1112,
5991,
16179,
1111,
138,
15695,
10211,
3113,
1137,
2841,
2445,
1788,
113,
178,
1162,
119,
117,
11300,
15364,
8104,
112,
188,
12068,
5084,
1106,
3225,
114,
10618,
7606,
1111,
3621,
25575,
12691,
10103,
12571,
14178,
2508,
13923,
1116,
8329,
4993,
14196,
1116,
8329,
1813,
1197,
7889,
1582,
7257,
1116,
8329,
10913,
3269,
7257,
1116,
3291,
28026,
6840,
182,
5412,
17792,
1116,
4641,
4290,
23897,
145,
24312,
23826,
1988,
23897,
8329,
7168,
16632,
1596,
8329,
16671,
9585,
7195,
24767,
1209,
3531,
170,
1553,
1111,
1296,
1849,
1189,
119,
11387,
15447,
24832,
1209,
1129,
1189,
1113,
2480,
1103,
1849,
1108,
1189,
1272,
1104,
1103,
1573,
1918,
1708,
11368,
1348,
2686,
117,
170,
1334,
118,
2629,
1137,
170,
4566,
1118,
1103,
5351,
117,
1137,
170,
1664,
118,
1573,
1918,
1708,
11368,
1348,
2774,
2272,
2255,
119,
1109,
1703,
1295,
1104,
2607,
1120,
2259,
2568,
1105,
127,
118,
1808,
1209,
1129,
3254,
18505,
1111,
1296,
5351,
1105,
1209,
1129,
3402,
1206,
1103,
1739,
119,
2425,
9386,
1159,
4207,
14562,
2042,
117,
127,
1808,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
10882,
1137,
2130,
1969,
118,
2908,
1201,
1104,
1425,
11336,
24271,
1920,
1120,
11300,
15364,
8104,
3875,
1945,
1335,
2299,
1190,
4701,
3187,
1111,
3621,
25575,
1958,
117,
1112,
14758,
1118,
1103,
8013,
1130,
5710,
3121,
25524,
1766,
1137,
1117,
120,
1123,
13715,
113,
1748,
3393,
1107,
1103,
11309,
114,
7199,
1136,
6391,
138,
5474,
1106,
2437,
1105,
2951,
170,
1637,
6189,
9635,
1532,
1134,
1538,
1129,
3836,
2988,
1106,
21252,
1104,
1251,
2025,
8826,
3100,
1158,
1105,
1682,
1106,
14616,
1114,
1251,
8496,
1137,
1107,
118,
1825,
2812,
118,
1146,
7508,
117,
5715,
117,
1105,
6030,
1104,
10540,
1116,
3100,
1158,
1105,
1682,
1106,
13971,
170,
1892,
3282,
1111,
1573,
1918,
1708,
11368,
1348,
21189,
3100,
1158,
1105,
1682,
1106,
2194,
2469,
1106,
1147,
4828,
2332,
3002,
16409,
1665,
17855,
140,
10587,
3464,
131,
11689,
3792,
2093,
1104,
3910,
1596,
14557,
10306,
142,
1616,
25962,
10024,
14410,
1130,
6328,
1106,
10621,
26620,
4539,
27989,
22578,
1107,
1251,
1168,
7300,
7356,
5336,
4449,
1348,
1137,
11777,
2982,
1439,
1476,
1552,
2988,
1106,
3990,
1107,
1103,
2025,
2189,
2975,
1115,
1107,
1103,
4893,
1104,
1103,
8013,
1130,
5710,
3121,
25524,
1766,
1105,
120,
1137,
3291,
118,
8013,
1130,
5710,
3121,
25524,
3864,
1336,
2773,
3187,
1106,
1103,
6635,
1105,
120,
1137,
13018,
1103,
3068,
1104,
1103,
7300,
3443,
1109,
8013,
1130,
5710,
3121,
25524,
1766,
1105,
120,
1137,
3291,
118,
8013,
1130,
5710,
3121,
25524,
1766,
4959,
113,
188,
114,
1115,
1103,
14031,
1110,
1136,
7408,
1111,
6251,
1107,
1142,
1844,
2025,
119,
8071,
8118,
1302,
5772,
1398,
5867,
1425,
1969,
5848,
4177,
1425,
2908,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2129,
3232,
2190,
2129,
3232,
2129,
3232,
1271,
23612,
18158,
155,
1358,
3174,
1596,
5661,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
2908,
16337,
1568,
1559,
24766,
24400,
2129,
3232,
174,
6346,
23612,
18158,
119,
155,
1358,
3174,
1596,
2924,
2881,
137,
13280,
11922,
119,
8916,
2450,
2190,
2450,
2450,
3695,
11300,
15364,
8104,
3875,
1945,
2450,
2781,
11336,
1665,
27975,
1158,
2450,
1331,
8881,
2161,
1392,
2450,
1352,
6041,
2450,
195,
9717,
5731,
10424,
1559,
2450,
1583,
1244,
1311,
2450,
3232,
2190,
2450,
3232,
2450,
3232,
1271,
10708,
149,
4347,
117,
9292,
2450,
3232,
1648,
24367,
7732,
13196,
3835,
2190,
3835,
3835,
185,
182,
178,
173,
1743,
1580,
1559,
21336,
10973,
3835,
2076,
3582,
3835,
19548,
2902,
13411,
117,
19569,
11687,
1183,
9690,
117,
3177,
2162,
1548,
1513,
155,
2428,
117,
11878,
140,
117,
18880,
7666,
3121,
1403,
138,
117,
152,
21216,
3101,
155,
117,
19375,
156,
4538,
117,
17979,
1233,
25827,
117,
144,
1389,
1584,
153,
119,
146,
8223,
20620,
19721,
1104,
13982,
9218,
4737,
5096,
1566,
18882,
6063,
131,
4503,
27524,
10294,
2116,
1105,
2508,
18546,
5562,
23543,
2734,
1104,
1103,
12118,
14467,
4894,
9561,
11679,
9019,
2365,
23009,
1104,
19928,
2093,
4487,
8508,
1830,
119,
140,
3161,
21608,
2116,
119,
1857,
9751,
127,
132,
15679,
113,
1275,
114,
131,
4850,
1580,
118,
7393,
1568,
119,
9465,
131,
1275,
119,
13096,
1475,
120,
140,
18172,
23520,
10783,
21669,
11414,
1592,
11612,
119,
12737,
119,
5507,
1604,
18202,
1495,
119,
142,
16091,
1830,
1504,
14125,
124,
119,
3835,
185,
182,
178,
173,
1765,
17101,
1559,
18910,
1568,
3835,
2076,
3582,
3835,
19548,
144,
1389,
1584,
153,
117,
1124,
3269,
8638,
139,
117,
145,
2707,
5521,
148,
117,
10693,
2142,
140,
117,
10785,
1186,
156,
117,
17979,
1233,
25827,
117,
12319,
141,
2349,
117,
2902,
13411,
119,
3273,
1105,
12226,
6859,
2116,
1104,
170,
5096,
7242,
118,
7457,
19547,
18417,
1111,
10103,
25575,
3929,
19191,
1116,
3841,
7195,
24767,
1556,
1457,
1895,
3291,
15789,
1616,
4641,
20012,
119,
147,
10964,
1592,
119,
1446,
12865,
1626,
132,
25495,
113,
1695,
114,
131,
25894,
1477,
118,
3746,
119,
9465,
131,
1275,
119,
1620,
1475,
120,
17462,
1161,
119,
1446,
119,
4589,
24050,
119,
3835,
185,
182,
178,
173,
1955,
1559,
1580,
19598,
1545,
1477,
3835,
2076,
3582,
3835,
19548,
2902,
13411,
117,
14477,
5086,
1918,
2293,
150,
117,
24192,
8904,
140,
117,
8790,
18255,
23851,
5844,
117,
17154,
1116,
18283,
117,
9326,
9827,
2881,
140,
117,
10693,
2142,
140,
117,
17784,
11819,
5730,
5437,
9960,
117,
12863,
1926,
150,
4538,
117,
2792,
149,
117,
8603,
147,
117,
19211,
157,
117,
9578,
6196,
147,
117,
10136,
5100,
144,
117,
3177,
2162,
1548,
1513,
155,
2428,
117,
11679,
5526,
162,
117,
8790,
22456,
2953,
150,
117,
152,
21216,
3101,
155,
117,
19375,
156,
117,
144,
1389,
1584,
153,
117,
22846,
2522,
21166,
119,
153,
7580,
1918,
4592,
6692,
1112,
8232,
24091,
1104,
2332,
119,
15857,
2508,
1181,
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full study rank 61627 study protocol section identification module n c t id NCT04834011 org study id info org study id RACOMERC 01/2021 organization org full name University of Palermo org class OTHER brief title Radiologic Assessment in Complete Mesocolic Excision for Right Colon Cancer (RACOMERC) official title Complete Mesocolic Excision (CME) and Central Vascular Ligation (CVL) in Right-sided Colon Cancer: Surgical and Radiological Assessment. A Prospective Observational Study (RACOMERC) acronym RACOMERC status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date January 1, 2013 start date type Actual primary completion date struct primary completion date December 31, 2020 primary completion date type Actual completion date struct completion date December 31, 2023 completion date type Anticipated study first submit date March 22, 2021 study first submit q c date April 2, 2021 study first post date struct study first post date April 6, 2021 study first post date type Actual last update submit date April 2, 2021 last update post date struct last update post date April 6, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Prof. Antonino Agrusa responsible party investigator title Associate professor responsible party investigator affiliation University of Palermo lead sponsor lead sponsor name University of Palermo lead sponsor class OTHER oversight module description module brief summary Colorectal surgery has made progressive advances in recent years related on one hand to the implementation of diagnostic methods that allow an early diagnosis of tumors and on the other hand to the development of therapeutic options based on laparoscopic surgery. In particular, multicenter clinical trials have shown that the laparoscopic approach to colorectal cancer had a comparable or even better outcomes in terms of perioperative complications and functional recovery of patients than traditional surgery. Complete Mesocolic Excision (CME) in right colonic resections is a surgical approach, of greater technical complexity, that appears to improve the oncological outcomes of these patients at the cost of an increased rate of complications. The highest rate of complications reported in the literature in patients undergoing CME was related to intraoperative bleeding due to the central vascular dissection that is performed. CT technological advances have made possible to perform CT angiography with multiplanar and three-dimensional reconstructions with the possibility of obtaining a detailed preoperative map of the vascular anatomy of these patients. CT scan was acquired immediately before contrast material injection and during arterial and venous phase. Arterial phase was obtained using the bolus tracking technique with an automated scan-triggering software. Image analysis was performed using multiplanar reformations (MPR), maximum intensity projection (MIP) and 3D volume rendering (VR) technique. The purpose of the CT was to identify three different parameters necessary for proper performance of CME and CVL and to compare preoperative observations with intraoperative evidence. All surgeries were performed by teams experienced in laparoscopic colorectal surgery. The investigators evaluated:- Fascia of Fredet; vascular structures; lymph nodes. detailed description x conditions module condition list condition Right-sided Colon Cancer keyword list keyword Right colon cancer complete mesocolic excision CT abdominal scan design module study type Observational patient registry No design info design observational model list design observational model Case-Only design time perspective list design time perspective Prospective enrollment info enrollment count 100 enrollment type Anticipated arms interventions module intervention list intervention intervention type Procedure intervention name Laparoscopic right colonic resection with Complete Mesocolic Excision (CME) intervention type Radiation intervention name 3D CT angiography outcomes module primary outcome list primary outcome primary outcome measure Preoperative radiologic assessment of patients with diagnosis of right-sided colon cancer. The investigators evaluated: fascia of Fredet; vascular structures (ileocolic vessels; right colic artery, middle colic artery, trunk of Henle); lymph nodes. primary outcome description Evaluation of preoperative CT scan features during enrollment of patients. primary outcome time frame Evaluation of preoperative CT scan features during enrollment of patients. secondary outcome list secondary outcome secondary outcome measure Perioperative outcomes: intraoperative complications secondary outcome description complication occurred during surgery secondary outcome time frame intraoperative time secondary outcome measure Perioperative outcomes: postoperative complications secondary outcome description complication occurred in postoperative period secondary outcome time frame up to 30 days postoperative secondary outcome measure Perioperative outcomes: mean operative time secondary outcome description operative time secondary outcome time frame intraoperative time secondary outcome measure perioperative outcomes: rate of conversion secondary outcome description rate of conversion from laparoscopy to open surgery secondary outcome time frame intraoperative time eligibility module eligibility criteria Inclusion Criteria:
patients with diagnosis of right-sided colon cancer
patients underwent to CT angiography
laparoscopic right hemicolectomy with CME and CVL.
Exclusion Criteria:
metastatic disease
palliative treatment
impossibility to perform CT angiography
patients underwent to a traditional colonic resection with D2 lymphadenectomy. healthy volunteers No gender All minimum age 18 Years maximum age 85 Years std age list std age Adult Older Adult study population Patients with endoscopic diagnosis of right-sided colon cancer sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name Antonino Agrusa, Professor central contact role Contact central contact phone +390916552612 central contact e mail antonino.agrusa@unipa.it overall official list overall official overall official name Antonino Agrusa, Professor overall official affiliation University of Palermo - Italy overall official role Principal Investigator location list location location facility Azienda Ospedaliera Universitaria Policlinico "P. Giaccone" Palermo - University of Palermo location status Recruiting location city Palermo location state Italy - Sicily location zip 90127 location country Italy location contact list location contact location contact name Antonino Agrusa, Professor location contact role Contact location contact phone +390916552612 location contact e mail antonino.agrusa@unipa.it references module reference list reference reference p m i d 24515451 reference type background reference citation Mike M, Kano N. Laparoscopic surgery for colon cancer: a review of the fascial composition of the abdominal cavity. Surg Today. 2015 Feb;45(2):129-39. doi: 10.1007/s00595-014-0857-9. Epub 2014 Feb 11. Review. reference p m i d 23292563 reference type background reference citation Mari FS, Nigri G, Pancaldi A, De Cecco CN, Gasparrini M, Dall'Oglio A, Pindozzi F, Laghi A, Brescia A. Role of CT angiography with three-dimensional reconstruction of mesenteric vessels in laparoscopic colorectal resections: a randomized controlled trial. Surg Endosc. 2013 Jun;27(6):2058-67. doi: 10.1007/s00464-012-2710-9. Epub 2013 Jan 5. reference p m i d 25203372 reference type background reference citation Açar Hİ, Cömert A, Avşar A, Çelik S, Kuzu MA. Dynamic article: surgical anatomical planes for complete mesocolic excision and applied vascular anatomy of the right colon. Dis Colon Rectum. 2014 Oct;57(10):1169-75. doi: 10.1097/DCR.0000000000000128. reference p m i d 27461539 reference type background reference citation Murono K, Kawai K, Ishihara S, Otani K, Yasuda K, Nishikawa T, Tanaka T, Kiyomatsu T, Hata K, Nozawa H, Yamaguchi H, Watanabe T. Evaluation of the vascular anatomy of the right-sided colon using three-dimensional computed tomography angiography: a single-center study of 536 patients and a review of the literature. Int J Colorectal Dis. 2016 Sep;31(9):1633-8. doi: 10.1007/s00384-016-2627-1. Epub 2016 Jul 27. Review. reference p m i d 25565654 reference type background reference citation Miyazawa M, Kawai M, Hirono S, Okada K, Shimizu A, Kitahata Y, Yamaue H. Preoperative evaluation of the confluent drainage veins to the gastrocolic trunk of Henle: understanding the surgical vascular anatomy during pancreaticoduodenectomy. J Hepatobiliary Pancreat Sci. 2015 May;22(5):386-91. doi: 10.1002/jhbp.205. Epub 2015 Jan 7. derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000003110 condition mesh term Colonic Neoplasms condition ancestor list condition ancestor condition ancestor id D000015179 condition ancestor term Colorectal Neoplasms condition ancestor id D000007414 condition ancestor term Intestinal Neoplasms condition ancestor id D000005770 condition ancestor term Gastrointestinal Neoplasms condition ancestor id D000004067 condition ancestor term Digestive System Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000004066 condition ancestor term Digestive System Diseases condition ancestor id D000005767 condition ancestor term Gastrointestinal Diseases condition ancestor id D000003108 condition ancestor term Colonic Diseases condition ancestor id D000007410 condition ancestor term Intestinal Diseases condition browse leaf list condition browse leaf condition browse leaf id M5490 condition browse leaf name Colonic Neoplasms condition browse leaf as found Colon Cancer condition browse leaf relevance high condition browse leaf id M17042 condition browse leaf name Colorectal Neoplasms condition browse leaf relevance low condition browse leaf id M9600 condition browse leaf name Intestinal Neoplasms condition browse leaf relevance low condition browse leaf id M8038 condition browse leaf name Gastrointestinal Neoplasms condition browse leaf relevance low condition browse leaf id M6408 condition browse leaf name Digestive System Neoplasms condition browse leaf relevance low condition browse leaf id M8035 condition browse leaf name Gastrointestinal Diseases condition browse leaf relevance low condition browse leaf id M6407 condition browse leaf name Digestive System Diseases condition browse leaf relevance low condition browse leaf id M5488 condition browse leaf name Colonic Diseases condition browse leaf relevance low condition browse leaf id M9596 condition browse leaf name Intestinal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC06 condition browse branch name Digestive System Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention browse leaf list intervention browse leaf intervention browse leaf id T120 intervention browse leaf name Cola intervention browse leaf as found 325 mg intervention browse leaf relevance high intervention browse branch list intervention browse branch intervention browse branch abbrev HB intervention browse branch name Herbal and Botanical intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04834011 | [
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14424,
10036,
5187,
120,
17881,
1475,
2369,
8916,
1554,
1271,
1239,
1104,
20250,
8916,
1705,
152,
24162,
9637,
4094,
1641,
2664,
13791,
1596,
19721,
1107,
12735,
2508,
7301,
2528,
8031,
16409,
16073,
1111,
4114,
9518,
1320,
11558,
113,
26547,
15678,
14424,
10036,
114,
2078,
1641,
12735,
2508,
7301,
2528,
8031,
16409,
16073,
113,
140,
14424,
114,
1105,
1970,
159,
2225,
11702,
7837,
2116,
113,
140,
2559,
2162,
114,
1107,
4114,
118,
11641,
9518,
1320,
11558,
131,
17078,
20851,
1105,
2664,
7810,
19721,
119,
138,
24667,
2109,
152,
4832,
1200,
11583,
1348,
8690,
113,
26547,
15678,
14424,
10036,
114,
22478,
26547,
15678,
14424,
10036,
2781,
13196,
2781,
22480,
2236,
1364,
17881,
1475,
2905,
2781,
11336,
1665,
27975,
1158,
3631,
2469,
23992,
1144,
3631,
2469,
1302,
1838,
2236,
188,
23055,
1838,
2236,
1356,
122,
117,
1381,
1838,
2236,
2076,
2173,
4746,
2425,
6026,
2236,
188,
23055,
2425,
6026,
2236,
1382,
1955,
117,
12795,
2425,
6026,
2236,
2076,
2173,
4746,
6026,
2236,
188,
23055,
6026,
2236,
1382,
1955,
117,
17881,
1495,
6026,
2236,
2076,
8329,
6617,
16963,
1181,
2025,
1148,
12295,
2236,
1345,
1659,
117,
17881,
1475,
2025,
1148,
12295,
186,
172,
2236,
1364,
123,
117,
17881,
1475,
2025,
1148,
2112,
2236,
188,
23055,
2025,
1148,
2112,
2236,
1364,
127,
117,
17881,
1475,
2025,
1148,
2112,
2236,
2076,
2173,
4746,
1314,
11984,
12295,
2236,
1364,
123,
117,
17881,
1475,
1314,
11984,
2112,
2236,
188,
23055,
1314,
11984,
2112,
2236,
1364,
127,
117,
17881,
1475,
1314,
11984,
2112,
2236,
2076,
2173,
4746,
10767,
24146,
13196,
2784,
1710,
2784,
1710,
2076,
8013,
1130,
5710,
3121,
25524,
1766,
2784,
1710,
17805,
1554,
1271,
11644,
119,
9809,
4559,
138,
1403,
6208,
1161,
2784,
1710,
17805,
1641,
9666,
3083,
2784,
1710,
17805,
13494,
1239,
1104,
20250,
1730,
10767,
1730,
10767,
1271,
1239,
1104,
20250,
1730,
10767,
1705,
152,
24162,
9637,
20051,
13196,
6136,
13196,
4094,
14940,
13066,
10294,
6163,
6059,
1144,
1189,
8706,
11823,
1107,
2793,
1201,
2272,
1113,
1141,
1289,
1106,
1103,
7249,
1104,
20346,
4069,
1115,
2621,
1126,
1346,
12645,
1104,
24309,
1105,
1113,
1103,
1168,
1289,
1106,
1103,
1718,
1104,
20340,
6665,
1359,
1113,
4443,
14452,
21442,
6059,
119,
1130,
2440,
117,
4321,
8298,
1200,
7300,
7356,
1138,
2602,
1115,
1103,
4443,
14452,
21442,
3136,
1106,
2942,
10294,
6163,
4182,
1125,
170,
12763,
1137,
1256,
1618,
13950,
1107,
2538,
1104,
1679,
2660,
3365,
5838,
13522,
1105,
8458,
7593,
1104,
4420,
1190,
2361,
6059,
119,
12735,
2508,
7301,
2528,
8031,
16409,
16073,
113,
140,
14424,
114,
1107,
1268,
1884,
4934,
1596,
1231,
25461,
1116,
1110,
170,
13467,
3136,
117,
1104,
3407,
4301,
12133,
117,
1115,
2691,
1106,
4607,
1103,
1113,
23388,
13950,
1104,
1292,
4420,
1120,
1103,
2616,
1104,
1126,
2569,
2603,
1104,
13522,
119,
1109,
2439,
2603,
1104,
13522,
2103,
1107,
1103,
3783,
1107,
4420,
15819,
140,
14424,
1108,
2272,
1106,
1107,
4487,
19807,
5838,
9793,
1496,
1106,
1103,
2129,
26557,
4267,
11553,
5796,
1115,
1110,
1982,
119,
16899,
12675,
11823,
1138,
1189,
1936,
1106,
3870,
16899,
1126,
10712,
8944,
1114,
4321,
1643,
20592,
1197,
1105,
1210,
118,
8611,
10442,
1116,
1114,
1103,
5417,
1104,
11621,
170,
6448,
3073,
19807,
5838,
4520,
1104,
1103,
26557,
19768,
1104,
1292,
4420,
119,
16899,
14884,
1108,
2888,
2411,
1196,
5014,
2578,
14546,
1105,
1219,
1893,
19860,
1105,
1396,
23901,
4065,
119,
20654,
13119,
4065,
1108,
3836,
1606,
1103,
171,
4063,
1361,
10066,
5531,
1114,
1126,
14717,
14884,
118,
9887,
1158,
3594,
119,
15065,
3622,
1108,
1982,
1606,
4321,
1643,
20592,
1197,
5851,
6006,
113,
5478,
2069,
114,
117,
4177,
7657,
15178,
113,
26574,
2101,
114,
1105,
7860,
3884,
15171,
113,
159,
2069,
114,
5531,
119,
1109,
3007,
1104,
1103,
16899,
1108,
1106,
6183,
1210,
1472,
11934,
3238,
1111,
4778,
2099,
1104,
140,
14424,
1105,
140,
2559,
2162,
1105,
1106,
14133,
3073,
19807,
5838,
9959,
1114,
1107,
4487,
19807,
5838,
2554,
119,
1398,
12814,
3377,
1127,
1982,
1118,
1929,
4531,
1107,
4443,
14452,
21442,
2942,
10294,
6163,
6059,
119,
1109,
17718,
17428,
131,
118,
143,
2225,
6052,
1104,
5291,
2105,
132,
26557,
4413,
132,
181,
25698,
15029,
119,
6448,
6136,
193,
2975,
13196,
3879,
2190,
3879,
4114,
118,
11641,
9518,
1320,
11558,
2501,
12565,
2190,
2501,
12565,
4114,
1884,
4934,
4182,
2335,
1143,
7301,
2528,
8031,
4252,
16073,
16899,
24716,
14884,
1902,
13196,
2025,
2076,
152,
4832,
1200,
11583,
1348,
5351,
25097,
1302,
1902,
23992,
1902,
8310,
1348,
2235,
2190,
1902,
8310,
1348,
2235,
9060,
118,
2809,
1902,
1159,
7281,
2190,
1902,
1159,
7281,
24667,
2109,
10803,
23992,
10803,
5099,
1620,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
9108,
2190,
9108,
9108,
2076,
5096,
9650,
3313,
9108,
1271,
2001,
17482,
2155,
22258,
1268,
1884,
4934,
1596,
1231,
25461,
1114,
12735,
2508,
7301,
2528,
8031,
16409,
16073,
113,
140,
14424,
114,
9108,
2076,
16890,
25971,
9108,
1271,
7860,
16899,
1126,
10712,
8944,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
11689,
19807,
5838,
2070,
13791,
1596,
8670,
1104,
4420,
1114,
12645,
1104,
1268,
118,
11641,
1884,
4934,
4182,
119,
1109,
17718,
17428,
131,
175,
2225,
6052,
1104,
5291,
2105,
132,
26557,
4413,
113,
14596,
8209,
2528,
8031,
5956,
132,
1268,
1884,
8031,
18593,
117,
2243,
1884,
8031,
18593,
117,
8716,
1104,
1124,
1179,
1513,
114,
132,
181,
25698,
15029,
119,
2425,
9386,
6136,
27845,
1104,
3073,
19807,
5838,
16899,
14884,
1956,
1219,
10803,
1104,
4420,
119,
2425,
9386,
1159,
4207,
27845,
1104,
3073,
19807,
5838,
16899,
14884,
1956,
1219,
10803,
1104,
4420,
119,
3718,
9386,
2190,
3718,
9386,
3718,
9386,
4929,
14286,
2660,
3365,
5838,
13950,
131,
1107,
4487,
19807,
5838,
13522,
3718,
9386,
6136,
3254,
15534,
3296,
1219,
6059,
3718,
9386,
1159,
4207,
1107,
4487,
19807,
5838,
1159,
3718,
9386,
4929,
14286,
2660,
3365,
5838,
13950,
131,
2112,
19807,
5838,
13522,
3718,
9386,
6136,
3254,
15534,
3296,
1107,
2112,
19807,
5838,
1669,
3718,
9386,
1159,
4207,
1146,
1106,
1476,
1552,
2112,
19807,
5838,
3718,
9386,
4929,
14286,
2660,
3365,
5838,
13950,
131,
1928,
13035,
1159,
3718,
9386,
6136,
13035,
1159,
3718,
9386,
1159,
4207,
1107,
4487,
19807,
5838,
1159,
3718,
9386,
4929,
1679,
2660,
3365,
5838,
13950,
131,
2603,
1104,
7497,
3718,
9386,
6136,
2603,
1104,
7497,
1121,
4443,
14452,
11428,
5005,
1106,
1501,
6059,
3718,
9386,
1159,
4207,
1107,
4487,
19807,
5838,
1159,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
4420,
1114,
12645,
1104,
1268,
118,
11641,
1884,
4934,
4182,
4420,
9315,
1106,
16899,
1126,
10712,
8944,
4443,
14452,
21442,
1268,
23123,
10658,
18465,
18574,
1114,
140,
14424,
1105,
140,
2559,
2162,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
27154,
27372,
3653,
185,
5727,
1465,
3946,
3252,
24034,
13159,
7706,
1106,
3870,
16899,
1126,
10712,
8944,
4420,
9315,
1106,
170,
2361,
1884,
4934,
1596,
1231,
25461,
1114,
141,
1477,
181,
25698,
6397,
21032,
18574,
119,
8071,
8118,
1302,
5772,
1398,
5867,
1425,
1407,
5848,
4177,
1425,
4859,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
2025,
1416,
7195,
24767,
1114,
1322,
2155,
22258,
12645,
1104,
1268,
118,
11641,
1884,
4934,
4182,
18200,
3442,
7922,
118,
5096,
2822,
5474,
2687,
7136,
10492,
4541,
13196,
2129,
3232,
2190,
2129,
3232,
2129,
3232,
1271,
9809,
4559,
138,
1403,
6208,
1161,
117,
2986,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
116,
21830,
1580,
16229,
25491,
25129,
11964,
2129,
3232,
174,
6346,
22904,
11153,
2728,
119,
170,
1403,
6208,
1161,
137,
8362,
9717,
1161,
119,
1122,
2905,
2078,
2190,
2905,
2078,
2905,
2078,
1271,
9809,
4559,
138,
1403,
6208,
1161,
117,
2986,
2905,
2078,
13494,
1239,
1104,
20250,
118,
2413,
2905,
2078,
1648,
8013,
1130,
5710,
3121,
25524,
1766,
2450,
2190,
2450,
2450,
3695,
138,
15039,
7807,
152,
20080,
14604,
9888,
1161,
12118,
25105,
5168,
3464,
17129,
1596,
21472,
2528,
107,
153,
119,
144,
12571,
7235,
1162,
107,
20250,
118,
1239,
1104,
20250,
2450,
2781,
11336,
1665,
27975,
1158,
2450,
1331,
20250,
2450,
1352,
2413,
118,
12180,
2450,
195,
9717,
3078,
11964,
1559,
2450,
1583,
2413,
2450,
3232,
2190,
2450,
3232,
2450,
3232,
1271,
9809,
4559,
138,
1403,
6208,
1161,
117,
2986,
2450,
3232,
1648,
24367,
2450,
3232,
2179,
116,
21830,
1580,
16229,
25491,
25129,
11964,
2450,
3232,
174,
6346,
22904,
11153,
2728,
119,
170,
1403,
6208,
1161,
137,
8362,
9717,
1161,
119,
1122,
7732,
13196,
3835,
2190,
3835,
3835,
185,
182,
178,
173,
23067,
16337,
21336,
1475,
3835,
2076,
3582,
3835,
19548,
2639,
150,
117,
14812,
2728,
151,
119,
2001,
17482,
2155,
22258,
6059,
1111,
1884,
4934,
4182,
131,
170,
3189,
1104,
1103,
175,
2225,
12562,
5239,
1104,
1103,
24716,
19421,
119,
17078,
1403,
3570,
119,
1410,
13650,
132,
2532,
113,
123,
114,
131,
14949,
118,
3614,
119,
9465,
131,
1275,
119,
1620,
1559,
120,
188,
7629,
1571,
1580,
1571,
118,
5187,
1527,
118,
4775,
1571,
1559,
118,
130,
119,
142,
16091,
1830,
1387,
13650,
1429,
119,
4960,
119,
3835,
185,
182,
178,
173,
22637,
1580,
17600,
1545,
1495,
3835,
2076,
3582,
3835,
19548,
17978,
143,
1708,
117,
27453,
1403,
2047,
144,
117,
6991,
7867,
3309,
138,
117,
3177,
24664,
14566,
140,
2249,
117,
12384,
17482,
19764,
150,
117,
25938,
1233,
112,
152,
23655,
1186,
138,
117,
21902,
13645,
15284,
143,
117,
2001,
5084,
1182,
138,
117,
139,
4894,
6052,
138,
119,
17094,
1104,
16899,
1126,
10712,
8944,
1114,
1210,
118,
8611,
10442,
1104,
1143,
27408,
26237,
5956,
1107,
4443,
14452,
21442,
2942,
10294,
6163,
1231,
25461,
1116,
131,
170,
7091,
2200,
4013,
3443,
119,
17078,
1403,
5135,
2155,
1665,
119,
1381,
12865,
132,
1765,
113,
127,
114,
131,
17342,
1604,
118,
5486,
119,
9465,
131,
1275,
119,
1620,
1559,
120,
188,
7629,
23435,
1527,
118,
5187,
1477,
118,
1765,
10424,
118,
130,
119,
142,
16091,
1830,
1381,
4945,
126,
119,
3835,
185,
182,
178,
173,
25479,
1568,
23493,
1559,
1477,
3835,
2076,
3582,
3835,
19548,
138,
15331,
1197,
145,
28229,
117,
140,
19593,
4027,
1204,
138,
117,
138,
1964,
18272,
1813,
138,
117,
232,
21091,
1377,
156,
117,
23209,
10337,
9960,
119,
141,
27500,
3342,
131,
13467,
1126,
10024,
7257,
1348,
10025,
1111,
2335,
1143,
7301,
2528,
8031,
4252,
16073,
1105,
3666,
26557,
19768,
1104,
1103,
1268,
1884,
4934,
119,
12120,
1116,
9518,
1320,
11336,
5822,
1818,
119,
1387,
14125,
132,
4667,
113,
1275,
114,
131,
13096,
1580,
118,
3453,
119,
9465,
131,
1275,
119,
11523,
1559,
120,
5227,
2069,
119,
1288,
7629,
7629,
7629,
7629,
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full study rank 61872 study protocol section identification module n c t id NCT04830826 org study id info org study id D7913C00727 organization org full name The First Affiliated Hospital of Guangzhou Medical University org class OTHER brief title A Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China official title A Prospective, National, Multi-center, Non-intervention Real-world Study of Adjuvant Therapy in Early Stage NSCLC With EGFR Mutation-Positive in China status module status verified date March 2021 overall status Recruiting expanded access info has expanded access No start date struct start date June 10, 2020 start date type Actual primary completion date struct primary completion date January 2024 primary completion date type Anticipated completion date struct completion date July 2024 completion date type Anticipated study first submit date March 24, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date March 31, 2021 last update post date struct last update post date April 5, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Jianxing He responsible party investigator title Clinical Professor responsible party investigator affiliation The First Affiliated Hospital of Guangzhou Medical University lead sponsor lead sponsor name The First Affiliated Hospital of Guangzhou Medical University lead sponsor class OTHER oversight module is f d a regulated drug No is f d a regulated device No description module brief summary This study is a prospective, national, multi-center, non-interventional study. The main purpose is to explore the initial adjuvant treatment pattern after radical resection for early-stage NSCLC patients with EGFR Mutation-Positive in the real world. The secondary purpose was to observe the postoperative follow-up treatment pattern and its subgroups (based on different EGFR mutation status and different clinical stages). detailed description About 2,000 eNSCLC patients who received radical resection from about 50 research centers across the country will be included in this study, and will be followed up to 2 years after enrollment according to the actual clinical situation. The analysis method of this study is mainly based on descriptive statistics. The information about the human genetic resources of the subjects to be collected includes: demography, physical examination, WHO fitness status, medical history, smoking history, disease characteristics, surgical information, initial and follow-up adjuvant treatment pattern, laboratory tests, survival status, and adverse events related to gefitinib/osimertinib, serious adverse events/non-severe ADR, measures taken for adverse events, outcome of adverse events. conditions module condition list condition NSCLC, Stage I NSCLC, Stage II NSCLC, Stage III keyword list keyword EGFR Mutation NSCLC Adjuvant Therapy design module study type Observational patient registry No design info design observational model list design observational model Cohort design time perspective list design time perspective Prospective enrollment info enrollment count 2000 enrollment type Anticipated arms interventions module intervention list intervention intervention type Procedure intervention name Surgeries intervention description Surgeries outcomes module primary outcome list primary outcome primary outcome measure The distribution of participants with initial adjuvant treatment pattern after radical resection surgery for early-stage NSCLC patients primary outcome description Descriptive summary statistics ( total number of cases, number of missing cases, frequency, and percentage of each category) were used to describe the distribution of participants with initial adjuvant treatment patterns, including chemical, targeted, combined, or other therapy.
Set subgroup analysis for different initial adjuvant treatment pattern, including different clinical stages (according to phase I/ Phase II/ stage III) and different EGFR mutation status (19del or 21 L858R); primary outcome time frame 2 years primary outcome measure Time on initial adjuvant treatment primary outcome description Calculate the time from the start date to the end of initial adjuvant treatment. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description. primary outcome time frame 2 years primary outcome measure The interval from the date of operation to the start date of initial adjuvant therapy with EGFR-TKI. primary outcome description Calculate the interval of operation to the adjuvant therapy with EGFR-TKI, which is classified into single-drug therapy and combined therapy. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description. primary outcome time frame 2 years primary outcome measure Numbers of therapy cycles of initial adjuvant treatment primary outcome description The patients with chemotherapy were mainly calculated, divided into chemotherapy and targeted combination chemotherapy. The total number of chemotherapy cycles, the number of missing cases, the mean, standard deviation, the median, the 25th and 75th percentiles, the minimum and the maximum were statistically described primary outcome time frame 2 years secondary outcome list secondary outcome secondary outcome measure The distribution of participants with follow-up treatment pattern after initial adjuvant treatment. secondary outcome description Descriptive summary statistics ( total number of cases, number of missing cases, frequency, and percentage of each category) were used to describe the distribution of participants with follow-up treatment patterns after advanced events evaluated by an investigator, including chemical, targeted, combined, or other therapy.
Set subgroup analysis for different follow-up treatment pattern including different clinical stages (according to phase I/ Phase II/ stage III) and different EGFR mutation status (19del or 21 L858R); secondary outcome time frame 2 years secondary outcome measure Time on follow-up treatment secondary outcome description Calculate the time from the start date to the end of follow-up treatment. The results are shown in months, to one decimal place. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description. secondary outcome time frame 2 years secondary outcome measure The interval from the date of operation to the start date of the follow-up treatment with EGFR-TKI. secondary outcome description Calculate the interval of operation to the follow-up treatment with EGFR-TKI, which is classified into single-drug therapy and combined therapy. The results are shown in months, to one decimal place. The total number of cases, number of missing cases, mean, standard deviation, median, 25th and 75th percentiles, minimum and maximum were used for statistical description. secondary outcome time frame 2 years secondary outcome measure Numbers of therapy cycles of follow-up treatment secondary outcome description The patients with chemotherapy of follow-up treatment were mainly calculated, divided into chemotherapy and targeted combination chemotherapy. The total number of chemotherapy cycles, the number of missing cases, the mean, standard deviation, the median, the 25th and 75th percentiles, the minimum and the maximum were statistically described secondary outcome time frame 2 years eligibility module eligibility criteria Inclusion Criteria:
Informed consent signed;
Newly confirmed EGFR Mutation-Positive NSCLC confirmed by histopathology except for cytology;
Receiving or not receiving neoadjuvant treatment before surgery;
Patients with stage I-III NSCLC undergo confirmed radical R0 resection;
Exclusion Criteria:
Patients who currently or have previously participated in any other anti-tumor clinical studies;
Patients with NSCLC who have received any systemic anti-cancer therapy as the main treatment in the past. Cytotoxic therapy, targeted therapy (tyrosine kinase inhibitors or monoclonal antibodies) and immunotherapy included except for the use of neoadjuvant therapy;
Patients who have received adjuvant therapy before enrollment.
Patients with stage I-III NSCLC whose surgical resection cannot be confirmed.
Patients assessed by the investigator as unfit for enrollment, such as neurological disorders or metabolic disorders, physical examination or laboratory examination suspected that the patient has a possible disease, or has contraindications to the use of study drugs, or has treatment-related complications High risk etc. healthy volunteers No gender All std age list std age Child Adult Older Adult study population Continuously enroll all patients with early-stage (stage I-III), histopathologically confirmed, and EGFR mutation-positive NSCLC after R0 resection sampling method Non-Probability Sample contacts locations module central contact list central contact central contact name jianxing He, President central contact role Contact central contact phone 13802777270 central contact e mail hejx@vip.163.com central contact name wenhua Liang, Director central contact role Contact central contact phone 13710249454 central contact e mail 550627660@qq.com overall official list overall official overall official name jianxing He, President overall official affiliation The First Affiliated Hospital of Guangzhou Medical University overall official role Principal Investigator location list location location facility Beijing Cancer Hospital location status Not yet recruiting location city Peking location state Beijing location zip 100000 location country China location contact list location contact location contact name Chao Lv, Deputy Director location contact role Contact location contact e mail bmu28@sina.com location facility Beijing Chest Hospital，Capital Medical university location status Not yet recruiting location city Peking location state Beijing location zip 100000 location country China location contact list location contact location contact name Zitong Wang, Director location contact role Contact location contact e mail wztdoctor@163.com location facility Peking Union Medical College Hospital location status Not yet recruiting location city Peking location state Beijing location zip 100000 location country China location contact list location contact location contact name Naixin Liang, Deputy Director location contact role Contact location contact e mail pumchnelson@163.com location facility Peking University People'S Hospital location status Not yet recruiting location city Peking location state Beijing location zip 100000 location country China location contact list location contact location contact name Fan Yang location contact role Contact location facility Peking University Third Hospital location status Not yet recruiting location city Peking location state Beijing location zip 100000 location country China location contact list location contact location contact name Shaohua Ma, Director location contact role Contact location contact e mail doctormsh@163.com location facility Xuanwu Hospital Capital Medical University location status Not yet recruiting location city Peking location state Beijing location zip 100000 location country China location contact list location contact location contact name Yi Zhang, Director location contact role Contact location contact e mail steven9130@sina.com location facility Chongqing Cancer Hospital location status Not yet recruiting location city Chongqing location state Chongqing location zip 400000 location country China location contact list location contact location contact name Zhiqiang Wang location contact role Contact location facility Fujian Provincial Hospital location status Not yet recruiting location city Fuzhou location state Fujian location zip 350000 location country China location contact list location contact location contact name Xiaojie Pan, Deputy Director location contact role Contact location contact e mail pxj1028@hotmail.com location facility Cancer Center of Guangzhou Medical university location status Not yet recruiting location city Guangzhou location state Guangdong location zip 510000 location country China location contact list location contact location contact name Jian Zhao, Director location contact role Contact location contact e mail zj_hjh@163.com location facility Guangdong Provincial People's Hospital location status Not yet recruiting location city Guangzhou location state Guangdong location zip 510000 location country China location contact list location contact location contact name Guibin Qiao, Director location contact role Contact location contact e mail guibinqiao@126.com location facility The First Affiliated Hospital of Guangzhou Medical University location status Recruiting location city Guangzhou location state Guangdong location zip 510000 location country China location contact list location contact location contact name Jianxing He, President location contact role Contact location contact e mail hejx@vip.163.com location facility The First Affiliated Hospital,Sun Yat-sen University location status Not yet recruiting location city Guangzhou location state Guangdong location zip 510000 location country China location contact list location contact location contact name Jianjun Lu, Director location contact role Contact location contact e mail 470695353@qq.com location facility Shenzhen People's Hospital location status Not yet recruiting location city Shenzhen location state Guangdong location zip 518000 location country China location contact list location contact location contact name Lin Yang, Deputy Director location contact role Contact location contact e mail 13798314779@163.com location facility Affiliated Hospital of Guangdong Medical University location status Not yet recruiting location city Zhanjiang location state Guangdong location zip 524000 location country China location contact list location contact location contact name Jie Chen, Deputy Director location contact role Contact location contact e mail chen.jie13579@163.com location facility The second affiliated hospital of guangxi medical university location status Not yet recruiting location city Nanning location state Guangxi location zip 530000 location country China location contact list location contact location contact name Lei Xian, Director location contact role Contact location contact e mail xianlei59@163.com location facility Cangzhou Central Hospital location status Not yet recruiting location city Cangzhou location state Hebei location zip 061000 location country China location contact list location contact location contact name Fanyi Kong location contact role Contact location facility The Fourth Hospital of Hebei Medical University location status Not yet recruiting location city Shijiazhuang location state Hebei location zip 50000 location country China location contact list location contact location contact name Junfeng Liu, Director location contact role Contact location contact e mail 13931152296@163.com location facility Anyang Tumour Hospital location status Not yet recruiting location city Anyang location state Henan location zip 455000 location country China location contact list location contact location contact name Mingfei Geng, Director location contact role Contact location contact e mail gengmingf@sina.cn location facility Henan Provincial People's Hospital location status Not yet recruiting location city Zhengzhou location state Henan location zip 450000 location country China location contact list location contact location contact name Li Wei, Director location contact role Contact location contact e mail wlixxt@sina.com location facility Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology location status Not yet recruiting location city Wuhan location state Hubei location zip 430000 location country China location contact list location contact location contact name Yongde Liao location contact role Contact location facility Xiangya Hospital Central South University location status Not yet recruiting location city Changsha location state Hunan location zip 410000 location country China location contact list location contact location contact name Chunfang Zhang, Director location contact role Contact location contact e mail zhcf3801@csu.edu.cn location facility Jiangsu Province Hospital location status Not yet recruiting location city Nanjing location state Jiangsu location zip 210000 location country China location contact list location contact location contact name Liang Chen, Director location contact role Contact location contact e mail 2434794740@qq.com location facility Suzhou Municipal Hospital location status Not yet recruiting location city Suzhou location state Jiangsu location zip 215000 location country China location contact list location contact location contact name Xiaoqiang Liu, Deputy Director location contact role Contact location contact e mail 1959005821@qq.com location facility The First Affiliated Hospital of Soochow University location status Not yet recruiting location city Suzhou location state Jiangsu location zip 215000 location country China location contact list location contact location contact name Haitao Ma, Director location contact role Contact location contact e mail mht7403@163.com location facility The First Affiliated Hospital of Nanchang University location status Not yet recruiting location city Nanchang location state Jiangxi location zip 330000 location country China location contact list location contact location contact name Bentong Yu, Director location contact role Contact location contact e mail yubengton@126.com location facility The Second Affiliated Hospital Of Nanchang University location status Not yet recruiting location city Nanchang location state Jiangxi location zip 330000 location country China location contact list location contact location contact name Dongliang Yu, Director location contact role Contact location contact e mail 13576133363@126.com location facility Bethune first hospital of jilin university location status Not yet recruiting location city Changchun location state Jilin location zip 130000 location country China location contact list location contact location contact name Wei Liu, Director location contact role Contact location contact e mail davidliuw@hotmail.com location facility China-Japan Union Hospital of JiLin University location status Not yet recruiting location city Changchun location state Jilin location zip 130000 location country China location contact list location contact location contact name Hua Xin, Director location contact role Contact location contact e mail 13596118509@163.com location facility The Second Hospital of Dalian Medical University location status Not yet recruiting location city Dalian location state Liaoning location zip 116000 location country China location contact list location contact location contact name Changhong Liu location contact role Contact location facility Shengjing Hospital of China Medical University location status Not yet recruiting location city Shenyang location state Liaoning location zip 110000 location country China location contact list location contact location contact name Suning Zhang, Director location contact role Contact location contact e mail zhangsn@sj-hospital.org location facility The First Hospital of China Medical University location status Not yet recruiting location city Shenyang location state Liaoning location zip 110000 location country China location contact list location contact location contact name Shun Xu, Director location contact role Contact location contact e mail xushun2005@sina.com location facility Affiliated Hospital of Chifeng University location status Not yet recruiting location city Chifeng location state Neimenggu location zip 24000 location country China location contact list location contact location contact name Zhiyong Su, Director location contact role Contact location contact e mail suzhiyong1967@126.com location facility The Affliated of Inner Mongolia Medical University location status Not yet recruiting location city Hohhot location state Neimenggu location zip 010000 location country China location contact list location contact location contact name Zhanlin Guo, Director location contact role Contact location contact e mail nmggzl@163.com location facility Qilu Hospital of Shandong Yniversity location status Not yet recruiting location city Jinan location state Shandong location zip 250000 location country China location contact list location contact location contact name Hui Tian location contact role Contact location facility Shandong Cancer Hospital location status Not yet recruiting location city Jinan location state Shandong location zip 250000 location country China location contact list location contact location contact name Baijiang Zhang, Director location contact role Contact location contact e mail zhbaijiang@sina.com location facility PKUCare Luzhong Hospital location status Not yet recruiting location city Zibo location state Shangdong location zip 255000 location country China location contact list location contact location contact name Zeshu Li, Director location contact role Contact location contact e mail 329409166@qq.com location facility Shanghai Jiaotong University Medical College Affiliated Ruijin hospital location status Not yet recruiting location city Shanghai location state Shanghai location zip 200000 location country China location contact list location contact location contact name Hecheng Li, Director location contact role Contact location contact e mail lihecheng2000@hotmail.com location facility Shanghai Jiaotong University School of Medicine location status Not yet recruiting location city Shanghai location state Shanghai location zip 200000 location country China location contact list location contact location contact name Xiaoqing Zhao location contact role Contact location facility ZhongShan Hospital location status Not yet recruiting location city Shanghai location state Shanghai location zip 200000 location country China location contact list location contact location contact name Songtao Xu, Deputy Director location contact role Contact location contact e mail 13501671739@139.com location facility Shanxi Provincial Cancer Hospital location status Not yet recruiting location city Taiyuan location state Shanxi location zip 030000 location country China location contact list location contact location contact name Hongguang Zhang location contact role Contact location facility West China Hospital of Sichuan University location status Not yet recruiting location city Chengdu location state Sichuang location zip 610000 location country China location contact list location contact location contact name Lunxu Liu, Vice President location contact role Contact location contact e mail lunxu_liu@aliyun.com location facility The Affliated of Southwest Medical University location status Not yet recruiting location city Luzhou location state Sichuang location zip 646000 location country China location contact list location contact location contact name Tianyang Dai location contact role Contact location facility Tianjin Chest Hospital location status Not yet recruiting location city Tianjin location state Tianjin location zip 300000 location country China location contact list location contact location contact name Xun Zhang location contact role Contact location facility Tianjin Medical University General Hospital location status Not yet recruiting location city Tianjin location state Tianjin location zip 300000 location country China location contact list location contact location contact name Jun Chen, Director location contact role Contact location contact e mail Huntercj2004@yahoo.com location facility Sir Run Shaw Hospital Zhejiang University School of Medicine location status Not yet recruiting location city Hangzhou location state Zhejiang location zip 310000 location country China location contact list location contact location contact name Zhengfu He location contact role Contact location facility The first affiliated hospital zhejiang university location status Not yet recruiting location city Hangzhou location state Zhejiang location zip 310000 location country China location contact list location contact location contact name Jian Hu, Director location contact role Contact location contact e mail dczjhj@163.com location facility The Second Affiliated hospital of Zhejiang University Achool of Medical location status Not yet recruiting location city Hangzhou location state Zhejiang location zip 310000 location country China location contact list location contact location contact name Ying Chai, Director location contact role Contact location contact e mail Chaiy@126.com location facility Zhejiang cancer hospital location status Not yet recruiting location city Hangzhou location state Zhejiang location zip 310000 location country China location contact list location contact location contact name Qixun Chen, Director location contact role Contact location contact e mail chenqixun@64sina.com location facility Ningbo Medical Center Lihuili Hospital location status Not yet recruiting location city Ningbo location state Zhejiang location zip 315000 location country China location contact list location contact location contact name Weiyu Shen, Director location contact role Contact location contact e mail nblhlswy@163.com location facility Shaoxing People's Hospital location status Not yet recruiting location city Shaoxing location state Zhejiang location zip 312000 location country China location contact list location contact location contact name Guangmao Yu location contact role Contact location facility Taizhou Hospita of Zhejiang Province location status Not yet recruiting location city Taizhou location state Zhejiang location zip 318000 location country China location contact list location contact location contact name Baofu Chen location contact role Contact derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002289 condition mesh term Carcinoma, Non-Small-Cell Lung condition ancestor list condition ancestor condition ancestor id D000002283 condition ancestor term Carcinoma, Bronchogenic condition ancestor id D000001984 condition ancestor term Bronchial Neoplasms condition ancestor id D000008175 condition ancestor term Lung Neoplasms condition ancestor id D000012142 condition ancestor term Respiratory Tract Neoplasms condition ancestor id D000013899 condition ancestor term Thoracic Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000008171 condition ancestor term Lung Diseases condition ancestor id D000012140 condition ancestor term Respiratory Tract Diseases condition browse leaf list condition browse leaf condition browse leaf id M4698 condition browse leaf name Carcinoma, Non-Small-Cell Lung condition browse leaf as found NSCLC condition browse leaf relevance high condition browse leaf id M4686 condition browse leaf name Carcinoma condition browse leaf relevance low condition browse leaf id M4692 condition browse leaf name Carcinoma, Bronchogenic condition browse leaf relevance low condition browse leaf id M4412 condition browse leaf name Bronchial Neoplasms condition browse leaf relevance low condition browse leaf id M10324 condition browse leaf name Lung Neoplasms condition browse leaf relevance low condition browse leaf id M14131 condition browse leaf name Respiratory Tract Neoplasms condition browse leaf relevance low condition browse leaf id M15810 condition browse leaf name Thoracic Neoplasms condition browse leaf relevance low condition browse leaf id M10320 condition browse leaf name Lung Diseases condition browse leaf relevance low condition browse leaf id M14129 condition browse leaf name Respiratory Tract Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BC08 condition browse branch name Respiratory Tract (Lung and Bronchial) Diseases condition browse branch abbrev All condition browse branch name All Conditions | NCT04830826 | [
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1104,
20272,
3875,
1239,
1730,
10767,
1730,
10767,
1271,
1109,
1752,
138,
3101,
21896,
3355,
1104,
20272,
3875,
1239,
1730,
10767,
1705,
152,
24162,
9637,
20051,
13196,
1110,
175,
173,
170,
12521,
3850,
1302,
1110,
175,
173,
170,
12521,
4442,
1302,
6136,
13196,
4094,
14940,
1188,
2025,
1110,
170,
19916,
117,
1569,
117,
4321,
118,
2057,
117,
1664,
118,
9108,
1348,
2025,
119,
1109,
1514,
3007,
1110,
1106,
8664,
1103,
3288,
8050,
9380,
14194,
3252,
4844,
1170,
8276,
1231,
25461,
1111,
1346,
118,
2016,
151,
10844,
12674,
4420,
1114,
142,
2349,
2271,
2069,
19569,
7984,
118,
18959,
22472,
1107,
1103,
1842,
1362,
119,
1109,
3718,
3007,
1108,
1106,
12326,
1103,
2112,
19807,
5838,
2812,
118,
1146,
3252,
4844,
1105,
1157,
23470,
1116,
113,
1359,
1113,
1472,
142,
2349,
2271,
2069,
17895,
2781,
1105,
1472,
7300,
5251,
114,
119,
6448,
6136,
3517,
123,
117,
1288,
174,
12412,
26351,
1658,
4420,
1150,
1460,
8276,
1231,
25461,
1121,
1164,
1851,
1844,
6425,
1506,
1103,
1583,
1209,
1129,
1529,
1107,
1142,
2025,
117,
1105,
1209,
1129,
1723,
1146,
1106,
123,
1201,
1170,
10803,
2452,
1106,
1103,
4315,
7300,
2820,
119,
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1104,
1142,
2025,
1110,
2871,
1359,
1113,
27938,
9161,
119,
1109,
1869,
1164,
1103,
1769,
7434,
3979,
1104,
1103,
5174,
1106,
1129,
4465,
2075,
131,
11238,
8944,
117,
2952,
8179,
117,
23750,
12691,
2781,
117,
2657,
1607,
117,
9987,
1607,
117,
3653,
5924,
117,
13467,
1869,
117,
3288,
1105,
2812,
118,
1146,
8050,
9380,
14194,
3252,
4844,
117,
8087,
5715,
117,
8115,
2781,
117,
1105,
16798,
1958,
2272,
1106,
176,
11470,
17030,
2605,
1830,
120,
184,
5053,
4027,
6105,
13292,
117,
3021,
16798,
1958,
120,
1664,
118,
5199,
5844,
2069,
117,
5252,
1678,
1111,
16798,
1958,
117,
9386,
1104,
16798,
1958,
119,
2975,
13196,
3879,
2190,
3879,
151,
10844,
12674,
117,
6160,
146,
151,
10844,
12674,
117,
6160,
1563,
151,
10844,
12674,
117,
6160,
2684,
2501,
12565,
2190,
2501,
12565,
142,
2349,
2271,
2069,
19569,
7984,
151,
10844,
12674,
24930,
9380,
14194,
23789,
1902,
13196,
2025,
2076,
152,
4832,
1200,
11583,
1348,
5351,
25097,
1302,
1902,
23992,
1902,
8310,
1348,
2235,
2190,
1902,
8310,
1348,
2235,
3291,
13252,
1204,
1902,
1159,
7281,
2190,
1902,
1159,
7281,
24667,
2109,
10803,
23992,
10803,
5099,
1539,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
9108,
2190,
9108,
9108,
2076,
5096,
9650,
3313,
9108,
1271,
17078,
2895,
1905,
9108,
6136,
17078,
2895,
1905,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
1109,
3735,
1104,
6635,
1114,
3288,
8050,
9380,
14194,
3252,
4844,
1170,
8276,
1231,
25461,
6059,
1111,
1346,
118,
2016,
151,
10844,
12674,
4420,
2425,
9386,
6136,
14177,
13590,
2109,
14940,
9161,
113,
1703,
1295,
1104,
2740,
117,
1295,
1104,
3764,
2740,
117,
5625,
117,
1105,
6556,
1104,
1296,
4370,
114,
1127,
1215,
1106,
5594,
1103,
3735,
1104,
6635,
1114,
3288,
8050,
9380,
14194,
3252,
6692,
117,
1259,
5297,
117,
9271,
117,
3490,
117,
1137,
1168,
7606,
119,
9617,
23470,
3622,
1111,
1472,
3288,
8050,
9380,
14194,
3252,
4844,
117,
1259,
1472,
7300,
5251,
113,
2452,
1106,
4065,
146,
120,
12278,
1563,
120,
2016,
2684,
114,
1105,
1472,
142,
2349,
2271,
2069,
17895,
2781,
113,
1627,
6738,
1137,
1626,
149,
1604,
1571,
1604,
2069,
114,
132,
2425,
9386,
1159,
4207,
123,
1201,
2425,
9386,
4929,
2614,
1113,
3288,
8050,
9380,
14194,
3252,
2425,
9386,
6136,
11917,
24029,
1103,
1159,
1121,
1103,
1838,
2236,
1106,
1103,
1322,
1104,
3288,
8050,
9380,
14194,
3252,
119,
1109,
1703,
1295,
1104,
2740,
117,
1295,
1104,
3764,
2740,
117,
1928,
117,
2530,
1260,
27444,
117,
3151,
117,
10938,
1105,
3453,
1582,
3029,
12846,
117,
5867,
1105,
4177,
1127,
1215,
1111,
11435,
6136,
119,
2425,
9386,
1159,
4207,
123,
1201,
2425,
9386,
4929,
1109,
14235,
1121,
1103,
2236,
1104,
2805,
1106,
1103,
1838,
2236,
1104,
3288,
8050,
9380,
14194,
7606,
1114,
142,
2349,
2271,
2069,
118,
157,
2428,
2240,
119,
2425,
9386,
6136,
11917,
24029,
1103,
14235,
1104,
2805,
1106,
1103,
8050,
9380,
14194,
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1114,
142,
2349,
2271,
2069,
118,
157,
2428,
2240,
117,
1134,
1110,
5667,
1154,
1423,
118,
3850,
7606,
1105,
3490,
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119,
1109,
1703,
1295,
1104,
2740,
117,
1295,
1104,
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117,
1928,
117,
2530,
1260,
27444,
117,
3151,
117,
10938,
1105,
3453,
1582,
3029,
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117,
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4177,
1127,
1215,
1111,
11435,
6136,
119,
2425,
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1159,
4207,
123,
1201,
2425,
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4929,
19661,
1104,
7606,
13874,
1104,
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8050,
9380,
14194,
3252,
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1127,
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10056,
117,
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119,
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117,
1103,
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117,
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117,
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117,
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117,
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1105,
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117,
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1103,
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1127,
11435,
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1758,
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1159,
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123,
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2190,
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9386,
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1109,
3735,
1104,
6635,
1114,
2812,
118,
1146,
3252,
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1170,
3288,
8050,
9380,
14194,
3252,
119,
3718,
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6136,
14177,
13590,
2109,
14940,
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113,
1703,
1295,
1104,
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117,
1295,
1104,
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2740,
117,
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117,
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6556,
1104,
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4370,
114,
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5594,
1103,
3735,
1104,
6635,
1114,
2812,
118,
1146,
3252,
6692,
1170,
3682,
1958,
17428,
1118,
1126,
17805,
117,
1259,
5297,
117,
9271,
117,
3490,
117,
1137,
1168,
7606,
119,
9617,
23470,
3622,
1111,
1472,
2812,
118,
1146,
3252,
4844,
1259,
1472,
7300,
5251,
113,
2452,
1106,
4065,
146,
120,
12278,
1563,
120,
2016,
2684,
114,
1105,
1472,
142,
2349,
2271,
2069,
17895,
2781,
113,
1627,
6738,
1137,
1626,
149,
1604,
1571,
1604,
2069,
114,
132,
3718,
9386,
1159,
4207,
123,
1201,
3718,
9386,
4929,
2614,
1113,
2812,
118,
1146,
3252,
3718,
9386,
6136,
11917,
24029,
1103,
1159,
1121,
1103,
1838,
2236,
1106,
1103,
1322,
1104,
2812,
118,
1146,
3252,
119,
1109,
2686,
1132,
2602,
1107,
1808,
117,
1106,
1141,
1260,
27924,
1282,
119,
1109,
1703,
1295,
1104,
2740,
117,
1295,
1104,
3764,
2740,
117,
1928,
117,
2530,
1260,
27444,
117,
3151,
117,
10938,
1105,
3453,
1582,
3029,
12846,
117,
5867,
1105,
4177,
1127,
1215,
1111,
11435,
6136,
119,
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1159,
4207,
123,
1201,
3718,
9386,
4929,
1109,
14235,
1121,
1103,
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1104,
2805,
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1103,
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1103,
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118,
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142,
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118,
157,
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157,
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117,
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118,
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119,
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117,
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119,
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117,
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117,
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117,
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117,
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117,
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117,
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119,
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118,
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118,
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119,
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13874,
117,
1103,
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117,
1103,
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117,
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117,
1103,
3151,
117,
1103,
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1105,
3453,
1582,
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117,
1103,
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1103,
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1758,
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1159,
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123,
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13196,
11768,
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3561,
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140,
10587,
3464,
131,
1130,
17747,
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132,
1203,
1193,
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142,
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19569,
7984,
118,
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22472,
151,
10844,
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1111,
172,
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132,
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3556,
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14194,
3252,
1196,
6059,
132,
7195,
24767,
1114,
2016,
146,
118,
2684,
151,
10844,
12674,
13971,
3659,
8276,
155,
1568,
1231,
25461,
132,
16409,
1665,
17855,
140,
10587,
3464,
131,
7195,
24767,
1150,
1971,
1137,
1138,
2331,
3360,
1107,
1251,
1168,
2848,
118,
14601,
7300,
2527,
132,
7195,
24767,
1114,
151,
10844,
12674,
1150,
1138,
1460,
1251,
27410,
2848,
118,
4182,
7606,
1112,
1103,
1514,
3252,
1107,
1103,
1763,
119,
27688,
2430,
2430,
8745,
1665,
7606,
117,
9271,
7606,
113,
189,
12577,
2155,
2042,
24779,
27558,
1116,
1137,
19863,
13335,
4934,
1348,
26491,
114,
1105,
13280,
13601,
12512,
4679,
11478,
1183,
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1111,
1103,
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132,
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1150,
1138,
1460,
8050,
9380,
14194,
7606,
1196,
10803,
119,
7195,
24767,
1114,
2016,
146,
118,
2684,
151,
10844,
12674,
2133,
13467,
1231,
25461,
2834,
1129,
3659,
119,
7195,
24767,
14758,
1118,
1103,
17805,
1112,
8362,
14067,
1111,
10803,
117,
1216,
1112,
24928,
11955,
7810,
11759,
1137,
25158,
11759,
117,
2952,
8179,
1137,
8087,
8179,
6321,
1115,
1103,
5351,
1144,
170,
1936,
3653,
117,
1137,
1144,
14255,
4487,
24704,
4578,
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1106,
1103,
1329,
1104,
2025,
5557,
117,
1137,
1144,
3252,
118,
2272,
13522,
1693,
3187,
3576,
119,
8071,
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1302,
5772,
1398,
188,
1204,
1181,
1425,
2190,
188,
1204,
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11635,
26694,
11635,
2025,
1416,
16752,
6105,
8163,
1193,
4035,
10747,
1155,
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1114,
1346,
118,
2016,
113,
2016,
146,
118,
2684,
114,
117,
1117,
9870,
9779,
7542,
1193,
3659,
117,
1105,
142,
2349,
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17895,
118,
3112,
151,
10844,
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155,
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1231,
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18200,
3442,
7922,
118,
5096,
2822,
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13196,
2129,
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23220,
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1124,
117,
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2129,
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174,
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1119,
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1775,
137,
191,
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119,
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119,
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117,
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10424,
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174,
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137,
186,
4426,
119,
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117,
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138,
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21896,
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153,
25819,
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195,
9717,
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] |
full study rank 61401 study protocol section identification module n c t id NCT04836949 org study id info org study id 1-2020-0072 organization org full name Yonsei University org class OTHER brief title Verification of Shear Wave Elastography for DEtection of Prostate Cancer official title Verification of Shear Wave Elastography for DEtection of Prostate Cancer status module status verified date April 2021 overall status Not yet recruiting expanded access info has expanded access No start date struct start date May 3, 2021 start date type Anticipated primary completion date struct primary completion date December 8, 2023 primary completion date type Anticipated completion date struct completion date February 1, 2024 completion date type Anticipated study first submit date April 6, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 8, 2021 study first post date type Actual last update submit date April 7, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Sponsor lead sponsor lead sponsor name Yonsei University lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug No is f d a regulated device No description module brief summary Objective To provide evidence that adding shear wave elastography during sono-guided prostate biopsy can increase prostate cancer detection rate and to demonstrate that shear wave elastography of the prostate can discriminate malignant lesions to reduce the number of unnecessary prostate biopsies.
Overview Patients who are indicated for prostate biopsy in suspicion of prostate cancer will be assigned to a control group and an intervention group under double blinded randomization.
Control group : Patients will undergo prostate biopsy guided by conventional ultrasonography (B mode, gray scale).
Experimental group : Patients will undergo prostate biopsy guided by shear wave elastography in addition to conventional ultrasonography.
A comparative statistical analysis of the two groups will be performed.
The study is planned to be conducted for 3 years, with 2 years for patient enrollment and 1 year of follow-up. Three hospitals will participate in the study to enroll 85 patients for each group and a total of 170 patients.
3. Inclusion and Exclusion criteria
Male patients with suspected prostate cancer must meet at least one of the following three criteria.
PSA level over 4ng/dl
Suspicious hard prostatic nodule on digital rectal examination.
Hypoechoic lesion on ultrasound of the prostate suspicious for cancer.
Patients who (1) are less than 20 years old, (2) have a history of surgery on the prostate such as HoLEP, (3) have moderate cognitive impairment, or (4) have medical conditions precluding transrectal procedures such as rectal cancer are excluded from the study.
4. Research method
Patients who wish to participate in this study and meet the inclusion/exclusion criteria are randomly assigned to the 2 groups as described above.
The biopsy results are checked one week after the procedure.
Patients confirmed to have prostate cancer are provided proper treatment according to generally accepted treatment methods.
Patients with negative biopsy results are followed according to general follow-up protocol for suspected prostate cancer patients. After 6 months from the biopsy the patients are re-evaluated and if cancer is still suspected based on PSA level or other clinical symptoms, prostate MRI or additional biopsy is be performed.
Patients are followed again after 12 months since the initial biopsy with identical methods from the 6 months follow-up protocol. conditions module condition list condition Prostatic Neoplasms design module study type Interventional phase list phase Not Applicable design info design allocation Non-Randomized design intervention model Parallel Assignment design primary purpose Diagnostic design masking info design masking Quadruple design who masked list design who masked Participant Care Provider Investigator Outcomes Assessor enrollment info enrollment count 170 enrollment type Anticipated arms interventions module arm group list arm group arm group label Shear Wave Elastography Group arm group type Experimental arm group intervention list arm group intervention name Device: Shear Wave Elastography of prostate arm group label Conventional ultrasonography Group arm group type Active Comparator arm group intervention list arm group intervention name Device: Conventional Prostate Ultrasound intervention list intervention intervention type Device intervention name Shear Wave Elastography of prostate intervention description A 12-core template biopsy is planned as during a conventional prostate biopsy. The prostate is divided in to 1) Rt apex, 2) Rt mid, 3) Rt base, 4) Rt apex lateral, 5) Rt mid lateral, 6) Rt base lateral, 7) Lt apex, 8) Lt mid, 9) Lt base, 10) Lt apex lateral, 11) Lt mid lateral, and 12) Lt base lateral areas. The elasticity of each area is evaluated and region with the maximum Young's modulus value is selected and targeted for biopsy. Additional biopsy for suspicious lesions can be performed at the discretion of the practitioner. intervention arm group label list intervention arm group label Shear Wave Elastography Group intervention type Device intervention name Conventional Prostate Ultrasound intervention description A conventional 12-core template biopsy is planned. The prostate is divided in to 1) Rt apex, 2) Rt mid, 3) Rt base, 4) Rt apex lateral, 5) Rt mid lateral, 6) Rt base lateral, 7) Lt apex, 8) Lt mid, 9) Lt base, 10) Lt apex lateral, 11) Lt mid lateral, and 12) Lt base lateral areas. Random biopsy of each area is performed. Additional biopsy of suspicious hypoechoic nodular lesions can be performed at the discretion of the practitioner. intervention arm group label list intervention arm group label Conventional ultrasonography Group outcomes module primary outcome list primary outcome primary outcome measure Detection rate of prostate cancer primary outcome description The number of subjects diagnosed with prostate cancer and the rate of detection by each group. primary outcome time frame The presence of prostate cancer on pathologic results is checked one to two weeks after the biopsy. eligibility module eligibility criteria Inclusion Criteria:
PSA level over 4ng/dl
Suspicious hard prostatic nodule on digital rectal examination.
Hypoechoic lesion on ultrasound of the prostate suspicious for cancer.
Exclusion Criteria:
Less than 20 years old
History of surgery on the prostate such as HoLEP
More than moderate cognitive impairment which limits understanding of the study
Medical conditions precluding transrectal procedures such as rectal cancer healthy volunteers No gender Male gender based Yes gender description Male patients minimum age 21 Years maximum age 90 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Woong Kyu Han central contact role Contact central contact phone 82-2-2228-2310 central contact e mail hanwk@yuhs.ac overall official list overall official overall official name Woong Kyu Han overall official affiliation Severance Hospital overall official role Principal Investigator location list location location facility Yonsei University Health System, Severance Hospital location city Seoul location country Korea, Republic of i p d sharing statement module i p d sharing No derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000011471 condition mesh term Prostatic Neoplasms condition ancestor list condition ancestor condition ancestor id D000005834 condition ancestor term Genital Neoplasms, Male condition ancestor id D000014565 condition ancestor term Urogenital Neoplasms condition ancestor id D000009371 condition ancestor term Neoplasms by Site condition ancestor id D000009369 condition ancestor term Neoplasms condition ancestor id D000011469 condition ancestor term Prostatic Diseases condition browse leaf list condition browse leaf condition browse leaf id M13487 condition browse leaf name Prostatic Neoplasms condition browse leaf as found Prostatic Neoplasms condition browse leaf relevance high condition browse leaf id M8098 condition browse leaf name Genital Neoplasms, Male condition browse leaf relevance low condition browse leaf id M16467 condition browse leaf name Urogenital Neoplasms condition browse leaf relevance low condition browse leaf id M13485 condition browse leaf name Prostatic Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev BXS condition browse branch name Urinary Tract, Sexual Organs, and Pregnancy Conditions condition browse branch abbrev All condition browse branch name All Conditions | NCT04836949 | [
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2554,
1115,
5321,
21660,
4003,
8468,
12788,
9543,
1219,
1488,
1186,
118,
8610,
5250,
19596,
25128,
12685,
1169,
2773,
5250,
19596,
4182,
11432,
2603,
1105,
1106,
10541,
1115,
21660,
4003,
8468,
12788,
9543,
1104,
1103,
5250,
19596,
1169,
6187,
10205,
14248,
12477,
2646,
15454,
26052,
1106,
4851,
1103,
1295,
1104,
14924,
5250,
19596,
25128,
3491,
1905,
119,
3278,
7334,
7195,
24767,
1150,
1132,
4668,
1111,
5250,
19596,
25128,
12685,
1107,
11340,
1104,
5250,
19596,
4182,
1209,
1129,
3346,
1106,
170,
1654,
1372,
1105,
1126,
9108,
1372,
1223,
2702,
24255,
7091,
2734,
119,
6342,
1372,
131,
7195,
24767,
1209,
13971,
5250,
19596,
25128,
12685,
8610,
1118,
7228,
18737,
2142,
9543,
113,
139,
5418,
117,
5021,
3418,
114,
119,
17635,
1372,
131,
7195,
24767,
1209,
13971,
5250,
19596,
25128,
12685,
8610,
1118,
21660,
4003,
8468,
12788,
9543,
1107,
1901,
1106,
7228,
18737,
2142,
9543,
119,
138,
18008,
11435,
3622,
1104,
1103,
1160,
2114,
1209,
1129,
1982,
119,
1109,
2025,
1110,
2919,
1106,
1129,
3303,
1111,
124,
1201,
117,
1114,
123,
1201,
1111,
5351,
10803,
1105,
122,
1214,
1104,
2812,
118,
1146,
119,
2677,
8894,
1209,
4868,
1107,
1103,
2025,
1106,
4035,
10747,
4859,
4420,
1111,
1296,
1372,
1105,
170,
1703,
1104,
10837,
4420,
119,
124,
119,
3561,
17855,
1105,
16409,
1665,
17855,
9173,
10882,
4420,
1114,
6321,
5250,
19596,
4182,
1538,
2283,
1120,
1655,
1141,
1104,
1103,
1378,
1210,
9173,
119,
12727,
1592,
1634,
1166,
125,
2118,
120,
173,
1233,
15463,
20080,
25430,
1662,
5250,
27372,
6873,
8722,
1113,
3539,
1231,
5822,
1348,
8179,
119,
145,
1183,
5674,
11252,
8136,
1665,
8241,
1988,
1113,
18737,
22909,
1104,
1103,
5250,
19596,
10108,
1111,
4182,
119,
7195,
24767,
1150,
113,
122,
114,
1132,
1750,
1190,
1406,
1201,
1385,
117,
113,
123,
114,
1138,
170,
1607,
1104,
6059,
1113,
1103,
5250,
19596,
1216,
1112,
9800,
17516,
2101,
117,
113,
124,
114,
1138,
8828,
12176,
24034,
8341,
1880,
117,
1137,
113,
125,
114,
1138,
2657,
2975,
3073,
1665,
7535,
3408,
14715,
1874,
5822,
1348,
8826,
1216,
1112,
1231,
5822,
1348,
4182,
1132,
12728,
1121,
1103,
2025,
119,
125,
119,
2713,
3442,
7195,
24767,
1150,
3683,
1106,
4868,
1107,
1142,
2025,
1105,
2283,
1103,
10838,
120,
18434,
9173,
1132,
19729,
3346,
1106,
1103,
123,
2114,
1112,
1758,
1807,
119,
1109,
25128,
12685,
2686,
1132,
6488,
1141,
1989,
1170,
1103,
7791,
119,
7195,
24767,
3659,
1106,
1138,
5250,
19596,
4182,
1132,
2136,
4778,
3252,
2452,
1106,
2412,
3134,
3252,
4069,
119,
7195,
24767,
1114,
4366,
25128,
12685,
2686,
1132,
1723,
2452,
1106,
1704,
2812,
118,
1146,
11309,
1111,
6321,
5250,
19596,
4182,
4420,
119,
1258,
127,
1808,
1121,
1103,
25128,
12685,
1103,
4420,
1132,
1231,
118,
17428,
1105,
1191,
4182,
1110,
1253,
6321,
1359,
1113,
12727,
1592,
1634,
1137,
1168,
7300,
8006,
117,
5250,
19596,
25827,
2240,
1137,
2509,
25128,
12685,
1110,
1129,
1982,
119,
7195,
24767,
1132,
1723,
1254,
1170,
1367,
1808,
1290,
1103,
3288,
25128,
12685,
1114,
6742,
4069,
1121,
1103,
127,
1808,
2812,
118,
1146,
11309,
119,
2975,
13196,
3879,
2190,
3879,
5096,
27372,
14521,
1643,
7580,
4206,
1902,
13196,
2025,
2076,
11300,
21987,
1348,
4065,
2190,
4065,
1753,
138,
8661,
9538,
2165,
1902,
23992,
1902,
18205,
7922,
118,
19441,
2200,
1902,
9108,
2235,
23994,
4838,
1233,
1249,
19638,
1880,
1902,
2425,
3007,
12120,
8517,
14226,
2941,
1902,
7739,
1158,
23992,
1902,
7739,
1158,
154,
18413,
20910,
1513,
1902,
1150,
19970,
2190,
1902,
1150,
19970,
4539,
27989,
10224,
1204,
8396,
5096,
22650,
1197,
1130,
5710,
3121,
25524,
1766,
3929,
19191,
1116,
1249,
8830,
21484,
10803,
23992,
10803,
5099,
10837,
10803,
2076,
8329,
6617,
16963,
1181,
1739,
22496,
13196,
1981,
1372,
2190,
1981,
1372,
1981,
1372,
3107,
18352,
1197,
13531,
2896,
12788,
9543,
1990,
1981,
1372,
2076,
17635,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
15545,
2093,
131,
18352,
1197,
13531,
2896,
12788,
9543,
1104,
5250,
19596,
1981,
1372,
3107,
5818,
1348,
18737,
2142,
9543,
1990,
1981,
1372,
2076,
17244,
3291,
8223,
4626,
2772,
1981,
1372,
9108,
2190,
1981,
1372,
9108,
1271,
15545,
2093,
131,
5818,
1348,
5096,
19596,
17781,
22909,
9108,
2190,
9108,
9108,
2076,
15545,
2093,
9108,
1271,
18352,
1197,
13531,
2896,
12788,
9543,
1104,
5250,
19596,
9108,
6136,
138,
1367,
118,
4160,
27821,
25128,
12685,
1110,
2919,
1112,
1219,
170,
7228,
5250,
19596,
25128,
12685,
119,
1109,
5250,
19596,
1110,
3233,
1107,
1106,
122,
114,
155,
1204,
15764,
117,
123,
114,
155,
1204,
2286,
117,
124,
114,
155,
1204,
2259,
117,
125,
114,
155,
1204,
15764,
11937,
117,
126,
114,
155,
1204,
2286,
11937,
117,
127,
114,
155,
1204,
2259,
11937,
117,
128,
114,
8403,
15764,
117,
129,
114,
8403,
2286,
117,
130,
114,
8403,
2259,
117,
1275,
114,
8403,
15764,
11937,
117,
1429,
114,
8403,
2286,
11937,
117,
1105,
1367,
114,
8403,
2259,
11937,
1877,
119,
1109,
25460,
1785,
1104,
1296,
1298,
1110,
17428,
1105,
1805,
1114,
1103,
4177,
2701,
112,
188,
182,
5412,
11430,
2860,
1110,
2700,
1105,
9271,
1111,
25128,
12685,
119,
8154,
25128,
12685,
1111,
10108,
26052,
1169,
1129,
1982,
1120,
1103,
21435,
1104,
1103,
22351,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
18352,
1197,
13531,
2896,
12788,
9543,
1990,
9108,
2076,
15545,
2093,
9108,
1271,
5818,
1348,
5096,
19596,
17781,
22909,
9108,
6136,
138,
7228,
1367,
118,
4160,
27821,
25128,
12685,
1110,
2919,
119,
1109,
5250,
19596,
1110,
3233,
1107,
1106,
122,
114,
155,
1204,
15764,
117,
123,
114,
155,
1204,
2286,
117,
124,
114,
155,
1204,
2259,
117,
125,
114,
155,
1204,
15764,
11937,
117,
126,
114,
155,
1204,
2286,
11937,
117,
127,
114,
155,
1204,
2259,
11937,
117,
128,
114,
8403,
15764,
117,
129,
114,
8403,
2286,
117,
130,
114,
8403,
2259,
117,
1275,
114,
8403,
15764,
11937,
117,
1429,
114,
8403,
2286,
11937,
117,
1105,
1367,
114,
8403,
2259,
11937,
1877,
119,
19441,
25128,
12685,
1104,
1296,
1298,
1110,
1982,
119,
8154,
25128,
12685,
1104,
10108,
177,
1183,
5674,
11252,
8136,
1665,
6873,
5552,
26052,
1169,
1129,
1982,
1120,
1103,
21435,
1104,
1103,
22351,
119,
9108,
1981,
1372,
3107,
2190,
9108,
1981,
1372,
3107,
5818,
1348,
18737,
2142,
9543,
1990,
13950,
13196,
2425,
9386,
2190,
2425,
9386,
2425,
9386,
4929,
27524,
10294,
2116,
2603,
1104,
5250,
19596,
4182,
2425,
9386,
6136,
1109,
1295,
1104,
5174,
11534,
1114,
5250,
19596,
4182,
1105,
1103,
2603,
1104,
11432,
1118,
1296,
1372,
119,
2425,
9386,
1159,
4207,
1109,
2915,
1104,
5250,
19596,
4182,
1113,
3507,
12805,
11007,
2686,
1110,
6488,
1141,
1106,
1160,
2277,
1170,
1103,
25128,
12685,
119,
11768,
13196,
11768,
9173,
3561,
17855,
140,
10587,
3464,
131,
12727,
1592,
1634,
1166,
125,
2118,
120,
173,
1233,
15463,
20080,
25430,
1662,
5250,
27372,
6873,
8722,
1113,
3539,
1231,
5822,
1348,
8179,
119,
145,
1183,
5674,
11252,
8136,
1665,
8241,
1988,
1113,
18737,
22909,
1104,
1103,
5250,
19596,
10108,
1111,
4182,
119,
16409,
1665,
17855,
140,
10587,
3464,
131,
13568,
1190,
1406,
1201,
1385,
2892,
1104,
6059,
1113,
1103,
5250,
19596,
1216,
1112,
9800,
17516,
2101,
3046,
1190,
8828,
12176,
24034,
8341,
1880,
1134,
6263,
4287,
1104,
1103,
2025,
3875,
2975,
3073,
1665,
7535,
3408,
14715,
1874,
5822,
1348,
8826,
1216,
1112,
1231,
5822,
1348,
4182,
8071,
8118,
1302,
5772,
10882,
5772,
1359,
2160,
5772,
6136,
10882,
4420,
5867,
1425,
1626,
5848,
4177,
1425,
3078,
5848,
188,
1204,
1181,
1425,
2190,
188,
1204,
1181,
1425,
11635,
26694,
11635,
10492,
4541,
13196,
2129,
3232,
2190,
2129,
3232,
2129,
3232,
1271,
160,
6931,
1403,
148,
9379,
7699,
2129,
3232,
1648,
24367,
2129,
3232,
2179,
5787,
118,
123,
118,
20640,
1604,
118,
22154,
1568,
2129,
3232,
174,
6346,
5871,
1179,
2246,
1377,
137,
194,
23698,
1116,
119,
170,
1665,
2905,
2078,
2190,
2905,
2078,
2905,
2078,
1271,
160,
6931,
1403,
148,
9379,
7699,
2905,
2078,
13494,
22087,
24374,
3355,
2905,
2078,
1648,
8013,
1130,
5710,
3121,
25524,
1766,
2450,
2190,
2450,
2450,
3695,
14941,
19054,
1182,
1239,
3225,
3910,
117,
22087,
24374,
3355,
2450,
1331,
10853,
2450,
1583,
3577,
117,
2250,
1104,
178,
185,
173,
6303,
4195,
13196,
178,
185,
173,
6303,
1302,
4408,
2237,
1940,
1116,
1665,
23992,
13196,
1683,
10266,
1382,
5507,
117,
17881,
1477,
3879,
11424,
1162,
13196,
3879,
24000,
2190,
3879,
24000,
3879,
24000,
25021,
141,
7629,
7629,
14541,
24766,
1475,
3879,
24000,
1858,
5096,
27372,
14521,
1643,
7580,
4206,
3879,
13596,
2190,
3879,
13596,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1571,
1604,
23124,
3879,
13596,
1858,
9198,
19058,
14521,
1643,
7580,
4206,
117,
10882,
3879,
13596,
25021,
141,
7629,
7629,
17175,
1571,
27677,
3879,
13596,
1858,
158,
26767,
19058,
14521,
1643,
7580,
4206,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1580,
26303,
1475,
3879,
13596,
1858,
14521,
1643,
7580,
4206,
1118,
9338,
3879,
13596,
25021,
141,
7629,
7629,
1568,
1580,
22997,
1580,
3879,
13596,
1858,
14521,
1643,
7580,
4206,
3879,
13596,
25021,
141,
7629,
7629,
14541,
23435,
1580,
3879,
13596,
1858,
5096,
27372,
20012,
1116,
3879,
11424,
1162,
7404,
2190,
3879,
11424,
1162,
7404,
3879,
11424,
1162,
7404,
25021,
26528,
23124,
1604,
1559,
3879,
11424,
1162,
7404,
1271,
5096,
27372,
14521,
1643,
7580,
4206,
3879,
11424,
1162,
7404,
1112,
1276,
5096,
27372,
14521,
1643,
7580,
4206,
3879,
11424,
1162,
7404,
25319,
1344,
3879,
11424,
1162,
7404,
25021,
150,
18910,
1580,
1604,
3879,
11424,
1162,
7404,
1271,
9198,
19058,
14521,
1643,
7580,
4206,
117,
10882,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
7404,
25021,
26528,
22433,
1545,
1559,
3879,
11424,
1162,
7404,
1271,
158,
26767,
19058,
14521,
1643,
7580,
4206,
3879,
11424,
1162,
7404,
25319,
1822,
3879,
11424,
1162,
7404,
25021,
26528,
23124,
1604,
1571,
3879,
11424,
1162,
7404,
1271,
5096,
27372,
20012,
1116,
3879,
11424,
1162,
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25319,
1822,
3879,
11424,
1162,
3392,
2190,
3879,
11424,
1162,
3392,
3879,
11424,
1162,
3392,
170,
13834,
1874,
1964,
3823,
1568,
1527,
3879,
11424,
1162,
3392,
1271,
14521,
1643,
7580,
4206,
3879,
11424,
1162,
3392,
170,
13834,
1874,
1964,
139,
3190,
1708,
3879,
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158,
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157,
19366,
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21843,
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1105,
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7232,
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16718,
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170,
13834,
1874,
1964,
1398,
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full study rank 61247 study protocol section identification module n c t id NCT04838951 org study id info org study id 2021.141 organization org full name Chinese University of Hong Kong org class OTHER brief title Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training official title Effect of Real-time Computer-aided System (ENDO-AID) on Adenoma Detection in Endoscopist-in-training: a Single-blind Randomized Study acronym ENDOAID-TRAIN status module status verified date July 2021 overall status Recruiting expanded access info has expanded access No start date struct start date April 19, 2021 start date type Actual primary completion date struct primary completion date June 30, 2022 primary completion date type Anticipated completion date struct completion date December 31, 2022 completion date type Anticipated study first submit date March 23, 2021 study first submit q c date April 7, 2021 study first post date struct study first post date April 9, 2021 study first post date type Actual last update submit date July 28, 2021 last update post date struct last update post date August 3, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Louis Ho Shing Lau responsible party investigator title Resident Specialist responsible party investigator affiliation Chinese University of Hong Kong lead sponsor lead sponsor name Chinese University of Hong Kong lead sponsor class OTHER oversight module oversight has d m c Yes is f d a regulated drug No is f d a regulated device No description module brief summary The investigator's hypothesis is that a CADe system (ENDO-AID) would improve the adenoma detection rate in junior endoscopists. detailed description Colorectal cancer (CRC) is the most common and second most lethal cancer in Hong Kong with more than 5,600 new cases and 2,300 deaths annually. Colonoscopy with polypectomy has shown to reduce CRC-related mortality by 53%. However, high polyp miss rates were reported to be up to 26% for adenomas and 9% for advanced adenomas in standard colonoscopies. Risk factors included proximal location, serrate or flat lesions, poor bowel preparation and short withdrawal time (<6 minutes). Insufficient trainee experience was also associated with a higher adenoma miss rate. A significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy leading to adverse patient outcomes.
As a result, various techniques were developed to improve adenoma detection rate (ADR) during colonoscopies. Techniques including water exchange method, second examination of the right colon (retroflexion or second forward view)and cap/cuff-assisted colonoscopies were proven to increase ADR effectively. However, these techniques were operator-dependent requiring certain level of expertise.
Recently, artificial intelligence and computer-aided polyp detection (CADe) systems have developed rapidly around the globe. These systems can provide real-time CADe by flagging the suspected lesions to endoscopists, with the adoption of deep learning or convoluted neural networks. A number of prospective randomized clinical trials reported a significant increase in ADR in CADe group. The number of adenoma detected per colonoscopy was consistently higher among different polyp sizes, location and morphology. The ADR increment was particularly higher for diminutive adenomas smaller than 5mm.
Nevertheless, most of the aforementioned studies only involved senior endoscopists for the procedures. Theoretically, the senior endoscopists were more skillful to expose colonic mucosa and more experienced to distinguish the false positive computer signals, leading to an enhanced performance of CADe in real-time colonoscopies. The effect of CADe on inexperienced junior endoscopists performing colonoscopies remains largely unknown.
In this single-blind randomized study, the investigators aim to evaluate the effect of a new CADe system (ENDO-AID) on adenoma detection and quality improvement in junior endoscopists. conditions module condition list condition Screening Colonoscopy design module study type Interventional phase list phase Not Applicable design info design allocation Randomized design intervention model Parallel Assignment design primary purpose Treatment design masking info design masking Double design masking description Endoscopist wil not be blinded to treatment. Treatment arm allocation will be concealed to patients, data collector and data analysts. design who masked list design who masked Participant Outcomes Assessor enrollment info enrollment count 856 enrollment type Anticipated arms interventions module arm group list arm group arm group label Intervention arm arm group type Experimental arm group description CADe system will be used during withdrawal phase of colonoscopy. arm group intervention list arm group intervention name Device: ENDO-AID CADe arm group label Control arm arm group type No Intervention arm group description Colonoscopy will be performed according to hospital protocol. intervention list intervention intervention type Device intervention name ENDO-AID CADe intervention description ENDO-AID CADe will be used during the withdrawal process of the colonoscopy. intervention arm group label list intervention arm group label Intervention arm outcomes module primary outcome list primary outcome primary outcome measure ADR primary outcome description adenoma detection rate primary outcome time frame During the colonoscopy secondary outcome list secondary outcome secondary outcome measure ADR for adenomas of different sizes secondary outcome description <5mm, 5-10mm, >10mm secondary outcome time frame During the colonoscopy secondary outcome measure ADR for adenomas of different colonic segments secondary outcome description caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum secondary outcome time frame During the colonoscopy secondary outcome measure Mean number of adenomas per colonoscopy secondary outcome description Mean number of adenomas per colonoscopy secondary outcome time frame During the colonoscopy secondary outcome measure Advanced adenoma detection rate secondary outcome description Advanced adenoma detection rate secondary outcome time frame During the colonoscopy secondary outcome measure Sessile serrate lesion (SSL) detection rate secondary outcome description Sessile serrate lesion (SSL) detection rate secondary outcome time frame During the colonoscopy secondary outcome measure Polyp detection rate secondary outcome description Polyp detection rate secondary outcome time frame During the colonoscopy secondary outcome measure Non-neoplastic resection rate secondary outcome description defined as absence of adenoma or SSL within resected specimen secondary outcome time frame During the colonoscopy secondary outcome measure Missed polyp rate secondary outcome description defined as a polyp which the junior endoscopist fails to recognize and withdraws the endoscope to next colonic segment, but detected by the supervisor secondary outcome time frame During the colonoscopy secondary outcome measure False positive rate secondary outcome description defined as computer artifacts due to colonic mucosal wall or bowel content lasting for >2 seconds secondary outcome time frame During the colonoscopy secondary outcome measure Cecal intubation time secondary outcome description Cecal intubation time secondary outcome time frame During the colonoscopy secondary outcome measure Withdrawal time secondary outcome description excluding interventions secondary outcome time frame During the colonoscopy secondary outcome measure Total procedural time secondary outcome description Total procedural time secondary outcome time frame During the colonoscopy secondary outcome measure Percentage of change in ADR in relation to the personal experience in colonoscopy secondary outcome description Percentage of change in ADR in relation to the personal experience in colonoscopy based on number of procedures performed <200 vs 200-500 secondary outcome time frame During the colonoscopy eligibility module eligibility criteria Inclusion Criteria:
Aged 18 years old or above;
They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or gastrointestinal bleeding;
Written informed consent obtained.
Exclusion Criteria:
Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, significant bleeding tendency, uninterrupted anticoagulation or dual antiplatelets)
Scheduled staged procedure for polypectomy or biopsy
Previous colonic resection
Personal history of colorectal cancer
Personal history of polyposis syndrome
Personal history of inflammatory bowel disease
Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
Pregnancy
Unable to obtain informed consent healthy volunteers No gender All minimum age 18 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Felix Sia central contact role Contact central contact phone +85226370428 central contact e mail felix.sia@cuhk.edu.hk central contact name Thomas Lam central contact role Contact central contact phone +85226370428 central contact e mail thomas.lam@cuhk.edu.hk location list location location facility Prince of Wales Hospital location status Recruiting location city Shatin location state New Territories location country Hong Kong i p d sharing statement module i p d sharing No i p d sharing description There is no plan to share individual participant data to other researchers derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000000236 condition mesh term Adenoma condition ancestor list condition ancestor condition ancestor id D000009375 condition ancestor term Neoplasms, Glandular and Epithelial condition ancestor id D000009370 condition ancestor term Neoplasms by Histologic Type condition ancestor id D000009369 condition ancestor term Neoplasms condition browse leaf list condition browse leaf condition browse leaf id M2743 condition browse leaf name Adenoma condition browse leaf as found Adenoma condition browse leaf relevance high condition browse leaf id M11472 condition browse leaf name Neoplasms, Glandular and Epithelial condition browse leaf relevance low condition browse leaf id M11467 condition browse leaf name Neoplasms by Histologic Type condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC04 condition browse branch name Neoplasms condition browse branch abbrev All condition browse branch name All Conditions | NCT04838951 | [
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full study rank 61839 study protocol section identification module n c t id NCT04831255 org study id info org study id 21584 organization org full name University of Virginia org class OTHER brief title ZILRETTA™ for Treatment of Idiopathic Adhesive Capsulitis official title A Stratified Investigation of a Single Injection of ZILRETTA™ (Triamcinolone Acetonide Extended-release Injectable Suspension) for Symptomatic Relief in Patients With Idiopathic Adhesive Capsulitis of the Shoulder status module status verified date April 2021 overall status Recruiting expanded access info has expanded access No start date struct start date June 21, 2019 start date type Actual primary completion date struct primary completion date July 31, 2023 primary completion date type Anticipated completion date struct completion date December 31, 2023 completion date type Anticipated study first submit date March 31, 2021 study first submit q c date March 31, 2021 study first post date struct study first post date April 5, 2021 study first post date type Actual last update submit date April 5, 2021 last update post date struct last update post date April 8, 2021 last update post date type Actual sponsor collaborators module responsible party responsible party type Principal Investigator responsible party investigator full name Brian Werner, MD responsible party investigator title Assistant Professor, Department of Orthopaedic Surgery responsible party investigator affiliation University of Virginia lead sponsor lead sponsor name University of Virginia lead sponsor class OTHER oversight module oversight has d m c No is f d a regulated drug Yes is f d a regulated device No is u s export Yes description module brief summary Adhesive capsulitis is a fairly common orthopedic condition that causes pain and loss of range of motion. There are a variety of ways to treat adhesive capsulitis, one of them being an intra-articular steroid injection. This is done to help decrease the inflammatory response caused by adhesive capsulitis. In this study, all participants will receive an intra-articular glenohumeral injection of ZILRETTA and will be followed up with at four time points over 1 year to observe pain, function and range of motion following the injection. detailed description Adhesive capsulitis is a painful shoulder condition characterized by a gradual loss of both passive and active range of motion due to inflammatory changes and eventual fibrosis and contracture of the shoulder joint capsule. It occurs in about 2% to 5% of the population, and a majority of patients are female. The true cause of the condition remains unclear, however, it has been proposed that the initial synovitis stimulates the development of a fibrotic cascade. The development of adhesive capsulitis has been associated with diabetes mellitus, thyroid dysfunction, Dupuytrens contractures, autoimmune diseases and treatments for certain cancers. Adhesive capsulitis progresses through four predictable phases, defined by symptoms, physical examination, arthroscopic appearance and biopsies.
Regardless of stage, the mainstay of treatment for adhesive capsulitis of the shoulder is conservative, focused mainly on physical therapy combined with a home exercise program, regardless of stage. Pharmacologic agents are often used as adjuncts to physical therapy, and include nonsteroidal anti-inflammatory medications (NSAIDs), oral corticosteroids and intra-articular injections of corticosteroids. Although a large percentage of patients in the early stages of disease respond well to conservative treatments, those who fail therapy and injections may require surgical intervention, including arthroscopy with lysis of adhesions and/or manipulation under anesthesia.
Numerous studies have investigated the effect and success of injections combined with standard physical therapy for adhesive capsulitis of the shoulder. In general, intra-articular injection of corticosteroids has been found to be superior to administration of oral cortisone and at least equivalent to manipulation under anesthesia alone. Injections have been shown to reduce pain quicker and result in earlier return of range of motion. Low doses of steroid appear equally as effective as higher doses. Image-guided injections, whether ultrasound or fluoroscopic guided injections, have also been shown to be more effective than blinded injections.
Failure of an injection and therapy to provide relief either results in a repeat image-guided injection or surgical intervention, both of which have significant associated cost and potential morbidity. Thus, there would be significant potential value to a long-acting, sustained release intra-articular steroid injection for the treatment of adhesive capsulitis of the shoulder. Zilretta®, triamcinolone acetonide extended release suspension 32 mg, is a microsphere formulation of injectable steroid which is FDA-approved for and has shown significant promise for the treatment of knee osteoarthritis. This long-acting steroid could have several important advantages in the treatment of shoulder adhesive capsulitis. It may potentiate and prolong the anti-inflammatory effect of the steroid, and potentially avoid the need for costly additional image-guided injections or expensive and potentially morbid surgery. An additional potential benefit is less elevation of peripheral blood glucose in diabetics, a known complication of traditional steroid injections that has been demonstrated to be mitigated using a sustained release formulation.
Out primary aim in this study is to assess patient reported pain and outcomes in patients with idiopathic adhesive capsulitis of the shoulder at 3, 6 and 12 months following single, image guided ZILRETTA injection. conditions module condition list condition Adhesive Capsulitis Frozen Shoulder Adhesive Capsulitis of Shoulder design module study type Interventional phase list phase Phase 1 design info design allocation N/A design intervention model Single Group Assignment design intervention model description All subjects receive the ZILRETTA injection design primary purpose Treatment design masking info design masking None (Open Label) enrollment info enrollment count 50 enrollment type Anticipated arms interventions module arm group list arm group arm group label ZILRETTA arm group type Experimental arm group description Single injection of triamcinolone acetonide extended-release injectable suspension, injected in the glenohumeral joint under ultrasound guidance. arm group intervention list arm group intervention name Drug: triamcinolone acetonide extended-release injectable suspension intervention list intervention intervention type Drug intervention name triamcinolone acetonide extended-release injectable suspension intervention description ZILRETTA (triamcinolone acetonide extended-release injectable suspension) injection in the glenohumeral joint administered under ultrasound guidance. intervention arm group label list intervention arm group label ZILRETTA intervention other name list intervention other name ZILRETTA outcomes module primary outcome list primary outcome primary outcome measure Visual Analog Scale Score primary outcome description Pain rating on a scale of 0-10, higher numbers indicating a worse outcome primary outcome time frame 6 months after injection secondary outcome list secondary outcome secondary outcome measure American Shoulder and Elbow Society Score secondary outcome description Pain and function patient reported outcome for the shoulder. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. secondary outcome time frame 6 months after injection secondary outcome measure American Shoulder and Elbow Society Score secondary outcome description Pain and function patient reported outcome for the shoulder. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. secondary outcome time frame 12 months after injection secondary outcome measure PROMIS Physical Function Score secondary outcome description Patient reported outcome measuring physical function level measured by T scores and standard deviations. The average is 50, so a T score lower than 50 indicates a worse outcome. secondary outcome time frame 6 months after injection secondary outcome measure PROMIS Physical Function Score secondary outcome description Patient reported outcome measuring physical function level measured by T scores and standard deviations. The average is 50, so a T score lower than 50 indicates a worse outcome. secondary outcome time frame 12 months after injection secondary outcome measure Triplanar Range of Motion secondary outcome description Shoulder range of motion secondary outcome time frame 1 month after injection secondary outcome measure Triplanar Range of Motion secondary outcome description Shoulder range of motion secondary outcome time frame 3 months after injection secondary outcome measure Triplanar Range of Motion secondary outcome description Shoulder range of motion secondary outcome time frame 6 months after injection secondary outcome measure Triplanar Range of Motion secondary outcome description Shoulder range of motion secondary outcome time frame 12 months after injection secondary outcome measure Need for another injection secondary outcome description Yes or no answer if the patient needed another corticosteroid injection during their time enrolled in the study secondary outcome time frame 12 months after injection secondary outcome measure Time to second injection (if applicable) secondary outcome description how long after the ZILRETTA injection the patient needed another corticosteroid injection secondary outcome time frame 12 months after injection eligibility module eligibility criteria Inclusion Criteria:
Diagnosis of idiopathic adhesive capsulitis (onset <6 months prior)
Pain rating of 5 or greater out of 10 on 0-10 scale at time of enrollment
Willing to come on site for follow up evaluations at 1 month, 3 months, 6 months, and 12 months after the injection
Exclusion Criteria:
Active workers compensation case
Known psychiatric disorders under active treatment
Uncontrolled diabetes (defined as diabetic ketoacidosis, severe peripheral neuropathy, ophthalmologic or renal manifestations)
Diagnosed osteoarthritis of the ipsilateral or contralateral shoulder
Painful joint condition in another part of the body affecting perceived pain healthy volunteers No gender All minimum age 18 Years maximum age 80 Years std age list std age Adult Older Adult contacts locations module central contact list central contact central contact name Kaitlyn Shank, MEd, ATC central contact role Contact central contact phone 434-243-5653 central contact e mail kshank@virginia.edu central contact name Lizzie Leitch, MEd, ATC central contact role Contact central contact phone 434-243-0256 central contact e mail ebl7nu@hscmail.mcc.virginia.edu overall official list overall official overall official name Brian Werner, MD overall official affiliation University of Virginia overall official role Principal Investigator location list location location facility University of Virginia location status Recruiting location city Charlottesville location state Virginia location zip 22908 location country United States location contact list location contact location contact name Kaitlyn Shank, MEd, ATC location contact role Contact location contact phone 434-243-5653 location contact e mail kshank@virginia.edu location contact name Lizzie Leitch, MEd, ATC location contact role Contact location contact phone 434-243-0256 location contact e mail ebl7nu@hscmail.mcc.virginia.edu location contact name Brian Werner, MD location contact role Principal Investigator i p d sharing statement module i p d sharing No document section large document module large doc list large doc large doc type abbrev ICF large doc has protocol No large doc has s a p No large doc has i c f Yes large doc label Informed Consent Form large doc date June 21, 2019 large doc upload date 03/19/2021 08:54 large doc filename ICF_000.pdf derived section misc info module version holder December 02, 2022 condition browse module condition mesh list condition mesh condition mesh id D000002062 condition mesh term Bursitis condition ancestor list condition ancestor condition ancestor id D000007592 condition ancestor term Joint Diseases condition ancestor id D000009140 condition ancestor term Musculoskeletal Diseases condition browse leaf list condition browse leaf condition browse leaf id M4484 condition browse leaf name Bursitis condition browse leaf as found Adhesive Capsulitis condition browse leaf relevance high condition browse leaf id M9773 condition browse leaf name Joint Diseases condition browse leaf relevance low condition browse leaf id M11249 condition browse leaf name Musculoskeletal Diseases condition browse leaf relevance low condition browse branch list condition browse branch condition browse branch abbrev BC05 condition browse branch name Musculoskeletal Diseases condition browse branch abbrev All condition browse branch name All Conditions intervention browse module intervention mesh list intervention mesh intervention mesh id D000014221 intervention mesh term Triamcinolone intervention mesh id D000014222 intervention mesh term Triamcinolone Acetonide intervention mesh id C000005900 intervention mesh term Triamcinolone hexacetonide intervention mesh id C000030262 intervention mesh term Triamcinolone diacetate intervention ancestor list intervention ancestor intervention ancestor id D000000893 intervention ancestor term Anti-Inflammatory Agents intervention ancestor id D000005938 intervention ancestor term Glucocorticoids intervention ancestor id D000006728 intervention ancestor term Hormones intervention ancestor id D000006730 intervention ancestor term Hormones, Hormone Substitutes, and Hormone Antagonists intervention ancestor id D000045505 intervention ancestor term Physiological Effects of Drugs intervention ancestor id D000007166 intervention ancestor term Immunosuppressive Agents intervention ancestor id D000007155 intervention ancestor term Immunologic Factors intervention ancestor id D000004791 intervention ancestor term Enzyme Inhibitors intervention ancestor id D000045504 intervention ancestor term Molecular Mechanisms of Pharmacological Action intervention browse leaf list intervention browse leaf intervention browse leaf id M16126 intervention browse leaf name Triamcinolone intervention browse leaf as found Manual intervention browse leaf relevance high intervention browse leaf id M16127 intervention browse leaf name Triamcinolone Acetonide intervention browse leaf as found Correlative studies intervention browse leaf relevance high intervention browse leaf id M237968 intervention browse leaf name Triamcinolone hexacetonide intervention browse leaf as found Correlative studies intervention browse leaf relevance high intervention browse leaf id M209570 intervention browse leaf name Triamcinolone diacetate intervention browse leaf as found Correlative studies intervention browse leaf relevance high intervention browse leaf id M3369 intervention browse leaf name Anti-Inflammatory Agents intervention browse leaf relevance low intervention browse leaf id M8199 intervention browse leaf name Glucocorticoids intervention browse leaf relevance low intervention browse leaf id M8941 intervention browse leaf name Hormones intervention browse leaf relevance low intervention browse leaf id M8940 intervention browse leaf name Hormone Antagonists intervention browse leaf relevance low intervention browse leaf id M9364 intervention browse leaf name Immunosuppressive Agents intervention browse leaf relevance low intervention browse leaf id M9353 intervention browse leaf name Immunologic Factors intervention browse leaf relevance low intervention browse branch list intervention browse branch intervention browse branch abbrev Infl intervention browse branch name Anti-Inflammatory Agents intervention browse branch abbrev All intervention browse branch name All Drugs and Chemicals | NCT04831255 | [
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122,
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1981,
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119,
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1981,
1372,
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163,
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140,
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180,
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117,
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117,
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117,
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117,
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