AIM-Harvard/TrialPanorama-filtered huggingface dataset:
Study NCT06132425 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Exposure
Description: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Study NCT06132425 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exposure
Description: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Study NCT06132425 — intervention group
Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Rehearsal
Description: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
Study NCT06132425 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Rehearsal
Description: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: The Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F)
Description: The Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F; Robins, Fein, \& Barton, 2009) is a 2-stage parent-report screening tool to assess risk for Autism Spectrum Disorder (ASD). It is valid for children 16-30 months old.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: The Autism Spectrum Quotient-Children's Version (AQ-Child)
Description: The Autism Spectrum Quotient-Children's Version (AQ-Child; Auyeung, Baron-Cohen, Wheelwright \& Allison, 2008) is a parent-report questionnaire that aims to quantify autistic traits in children 4-11 years old. It contains 50 likert-type items with responses ranging from definitely agree to definitely disagree.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: The Autism-Spectrum Quotient (AQ)-Adolescent Version (AQ-Adolescent)
Description: The Autism Spectrum Quotient-Children's Version (AQ-Child; Auyeung, Baron-Cohen, Wheelwright \& Allison, 2008) is a parent-report questionnaire that aims to quantify autistic traits in children 12-15 years old. It contains 50 likert-type items with responses ranging from definitely agree to definitely disagree.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: The Viking's Speech Scale
Description: The Viking Speech Scale (Pennington, Virella, Mjøen, da Graça Andrada, Murray, Colver, ... \& Andersen, 2013) is used to classify children's speech production, specifically the ease at which children can make themselves understood using different methods of communication. The scale has four levels and is ordinal. The four levels include: (1) speech is not affected by motor disorder (2) speech is imprecise but usually understandable to unfamiliar listeners (3) speech is unclear and not usually understandable to unfamiliar listeners out of context (3) no understandable speech. It is intended for children above the age of 4 years.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: The Functional Communication Classification System (FCCS)
Description: The Functional Communication Classification System (Barty, Caynes \& Johnston, 2016) was designed to classify how children with cerebral palsy communicate on a daily basis. The tool focuses on how children typically communicate with familiar and unfamiliar communication partners. There are five classifications a child can be categorized in: (1) effective communicator in most situations (2) effective communicator in most situations, but does need some help (3) an effective communicator in most situations and can communicate small ranges of messages and topics to most familiar people (4) assistance is required in most situations, especially with unfamiliar people and environments. Communicates daily needs and wants to familiar people (5) communicates using undirected movement, vocalisation and/or behaviour, for interpretation by familiar people. The FCCS is valid for use in children up to 13 years.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Brief Infant Sleeping Questionnaire (BISQ)
Description: The Brief Infant Sleep Questionnaire (BISQ; Sadeh, 2004) is used to assess sleep patterns, parent perception, and sleep-related behaviors in young children (0-36 months). The BISQ has been validated against actigraphy, daily logs, and has high sensitivity in documenting expected developmental trends in sleep.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Pediatric Sleep Questionnaire (PSQ)
Description: Pediatric Sleep Questionnaire (PSQ; Chervin, Hedger, Dillon, Pituch, 2000) has been designed to screen for sleep problems in children. The scale consists of 22 parent-reported items examining snoring and breathing problems, daytime sleepiness, inattention, hyperactivity, and other signs and symptoms of apnea including obesity and nocturnal enuresis. Those questions specifically relate to sleep-disordered breathing (SDB) in children. PSQ has been validated for children 2-18 years old.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: The Eating and Drinking Ability Classification System (EDACS)
Description: The Eating and Drinking Ability Classification System (EDACS; Sellers, Mandy, Pennington, Hankins, Morris, 2013) has been developed for people with cerebral palsy to describe five distinct levels of ability using the key features of safety and efficiency. The patient can be categorized in: (1) eats and drinks safely and efficiently, (2) eats and drinks safely but with some limitations to efficiency, (3) eats and drinks with some limitations to safety; maybe limitations to efficiency, (4) eats and drinks with significant limitations to safety or (5) unable to eat or drink safely - tube feeding may be considered to provide nutrition. The EDACS is valid for use in children above the age of 36 months.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Mini Manual Ability Classification System (Mini-MACS)
Description: The Mini Manual Ability Classification System (Mini-MACS; Eliasson, Krumlinde-Sundholm, 2013) describes how children with cerebral palsy use their hands to handle objects in daily activities. MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. It has been validated for children 1-4 years of age.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Manual Ability Classification System (MACS)
Description: The Manual Ability Classification System (MACS; Eliasson, Krumlinde Sundholm, Rösblad, Beckung, Arner, Öhrvall, Rosenbaum, 2006) describes how children with cerebral palsy use their hands to handle objects in daily activities. MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. It has been validated for children 4-18 years.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: The Gross Motor Function Classification System - Expanded and Revised (GMFCS - E&R)
Description: The Gross Motor Function Classification System - Expanded \& Revised (GMFCS - E\&R; Palisano, Rosenbaum, Bartlett, Livingston, 2007) is a 5-level classification system that describes the gross motor function of children and youth with cerebral palsy on the basis of their self-initiated movement with particular emphasis on sitting, walking, and wheeled mobility. Distinctions between levels are based on functional abilities, the need for assistive technology, including hand-held mobility devices (walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement. The questionnaire is available for four age groups of children and youth: 2 to \< 4 years, 4 to \< 6 years, 6 to \< 12 years, and 12 to 18 years.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: The Visual Function Classification System (VFCS)
Description: The Visual Function Classification System (Baranello et al, 2019) is a valid and reliable 5-level classification system of visual functioning for children with Cerebral Palsy. It describes the use of visual abilities in daily life, focusing on activity and participation.
Study NCT05842044 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Oxycodone
Description: Standardized regimen of Oxycodone administered orally (PO) on demand for moderate pain during post-surgery (inpatient) period.~At discharge 5mg Oxycodone will be administered to participants on demand if pain score is greater than 7, or if participant required greater than 25mg Oxycodone during the hospitalization.
Study NCT05842044 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Hydromorphone
Description: Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: The Early Childhood Oral Health Impact Scale (ECOHIS)
Description: The ECOHIS measures the impact of oral problems and/or experience of dental treatment on the quality of life in children under 5 years old and their parents or other family members. It has 13 questions divided into two domains: one related to impact on the child (9 questions), and another to impact on the family (4 questions), measured using the Likert scale. In children with cerebral palsy and/or the ECOHIS has been validated for ages up to 6,5 years, in children with intellectual disability for ages up to 5 years and in children with special need for ages up to 9 years.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: The Family Impact Scale (FIS)
Description: The FIS evaluates the impact of a child's oral condition on family life. It consists of 14 items divided into three subscales: parental/family activity (PA), parental emotions (PE), and family conflict (FC). The financial burden subscale (FB) is the only one that is evaluated separately, since it comprises a single item and addresses economic rather than psychosocial or behavioural impact. It has been validated for children above the age of 12 years.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: The Achenbach System of Empirically Based Assessment (ASEBA)
Description: The Achenbach System of Empirically Based Assessment (ASEBA; Achenbach) is a collection of questionnaires used to assess adaptive and maladaptive behavior and overall functioning in individuals. The system includes report forms for multiple informants - the Child Behavior Checklist (CBCL) is used for caregivers to fill out ratings of their child's behavior, the Youth Self Report Form (YSR) is used for children to rate their own behavior, and the Teacher Report Form (TRF) is used for teachers to rate their pupil's behavior. The ASEBA seeks to capture consistencies or variations in behavior across different situations and with different interaction partners. The ASEBA exists for multiple age groups, including preschool-aged children, school-aged children, adults, and older adults. Scores for individuals in each age group are norm-referenced.
Study NCT04812119 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: Adaptive Behavior Assessment System Third Edition (ABAS-3)
Description: The ABAS-3 (Harrison, Oakland, 2015) is a rating scale useful for assessing skills of daily living in individuals with developmental delays, autism spectrum disorder, intellectual disability, learning disabilities, neuropsychological disorders, and sensory or physical impairments. Rating forms are filled out by the parent and a teacher. The ABAS-3 covers three broad domains: conceptual, social, and practical, using 11 skill areas within these domains. Tasks focus on everyday activities required to function, meet environmental demands, care for oneself, and interact with others effectively and independently. On a 4-point response scale, raters indicate whether, and how frequently, the individual performs each activity.
Study NCT05058573 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Control group (n=22)
Description: Control group will be received only medical treatment
Study NCT05594121 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Extended Release Subcutaneous Buprenorphine
Description: Monthly subcutaneous injections of long-acting buprenorphine
Study NCT05594121 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Immediate Release Sublingual Buprenorphine
Description: Daily sublingual fast-acting buprenorphine
Study NCT05842044 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Hydromorphone
Description: Standardized regimen of Hydromorphone administered intravenously (IV) on demand for severe pain during post-surgery (inpatient) period.
Study NCT05842044 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ibuprofen
Description: 400mg Ibuprofen tablets administered orally (PO) every eight (8) hours for 5 days.
Study NCT04667754 — intervention group
Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Internet-delivered Cognitive Behavioural Therapy
Description: ICBT provides online structured self-help modules over several months based on the principles of CBT in combination with weekly guidance through emails and telephone calls. The course comprises 6 online lessons that provide psychoeducation about: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure/pacing; 5) memory and attention; and 6) relapse prevention. Participants will also have the opportunity to ask any questions regarding the content of the program materials and will receive a response from their Guide within 48-72 hours. Guide will spend \~15 mins. per week/per participant. All Guides have completed a university program (psychology or social work) and are registered clinicians or students working under supervision of a registered clinician.
Study NCT04640493 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dapagliflozin
Description: If patients have been diagnosed with SDB using the WatchPat device, they will start dapagliflozin. Repeat WatchPat SDB assessment will be performed after 3 and 6 months of continuous dapagliflozin therapy.
Study NCT04640493 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: WatchPat
Description: HF patients undergo SDB testing with the WatchPat device. (non-experimental)
Study NCT06248632 — intervention group
Intervention type: OTHER
Intervention: Expression of inflammatory markers (Il6, Il8, Il1β, CXCL1, CCL2, CXCR3, Il1R, Il6R)
Description: Expression of inflammatory markers obtained from circulating monocytic cells of XLH
Study NCT04782050 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Ultrasound liver assessment
Description: The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.
Study NCT06441071 — intervention group
Intervention type: PROCEDURE
Group type: OTHER
Intervention: position
Description: Patients undergoing Video-assisted Thoracoscopic Surgery were selected for the study, and nerve block was performed before surgery, followed by holding different positions for 30 min, after which the effect of the block was measured.
Study NCT06441071 — intervention group
Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: position
Description: Patients undergoing Video-assisted Thoracoscopic Surgery were selected for the study, and nerve block was performed before surgery, followed by holding different positions for 30 min, after which the effect of the block was measured.
Study NCT06163300 — intervention group
Intervention type: DIAGNOSTIC_TEST
Intervention: MRI advanced techniques
Description: Participants will be submitted to MRI studies at diagnosis, during disease evolution and after treatment. Data collected will be analysed by two different neuroradiologists using advanced techniques.
Study NCT05407272 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Health Education Manual
Description: A health education manual based on a shared model
Study NCT05407272 — intervention group
Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: manual
Description: routine care
Study NCT05710757 — intervention group
Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: myofascial release
Description: Myofascial release (MFR) is a technique that involves applying gentle sustained pressure into the myofascial connective tissue restrictions to eliminate pain and restore motion.
Study NCT05710757 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: blood flow restriction
Description: Blood flow restricted (BFR) exercise is the brief and non-continuous blockage of venous blood flow using a device that restricts the flow of blood while exercising. This technique is used to produce hypertrophy (muscle growth) and strength responses while exercising at a lighter load than traditionally required to produce a similar response.
Study NCT05710757 — intervention group
Intervention type: DEVICE
Group type: SHAM_COMPARATOR
Intervention: blood flow restriction
Description: Blood flow restricted (BFR) exercise is the brief and non-continuous blockage of venous blood flow using a device that restricts the flow of blood while exercising. This technique is used to produce hypertrophy (muscle growth) and strength responses while exercising at a lighter load than traditionally required to produce a similar response.
Study NCT05710757 — intervention group
Intervention type: OTHER
Group type: SHAM_COMPARATOR
Intervention: myofascial release
Description: Sham MFR.
Study NCT04553016 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Vaccine
Description: IM vaccination with ChAdOx1.tHIVconsv1, MVA.tHIVconsv3 and MVA.tHIVconsv4
Study NCT04553016 — intervention group
Intervention type: BIOLOGICAL
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: IM administration of 0.9% sterile sodium chloride solution
Study NCT05926349 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Andexanet alfa
Description: Andexanet is a recombinant version of human FXa
Study NCT05926349 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Usual Care
Description: As per the label of the chosen usual care product(s) and/or usual care standards.
Study NCT05082051 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Part A
Description: Randomized, double-blind, placebo-controlled dose escalation part to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after single oral dose administration in healthy adult subjects.~Single-dose administration of CDX-7108 at the following anticipated dose levels. 10 000, 50 000, 150 000, 250 000, and 500 000 lipase units will be evaluated in 5 sequential cohorts of 6 subjects each.
Study NCT05082051 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Part A
Description: Randomized, double-blind, placebo-controlled dose escalation part to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after single oral dose administration in healthy adult subjects.~Single-dose administration of CDX-7108 at the following anticipated dose levels. 10 000, 50 000, 150 000, 250 000, and 500 000 lipase units will be evaluated in 5 sequential cohorts of 6 subjects each.
Study NCT05082051 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Part B
Description: Randomized, double-blind, placebo-controlled dose escalation parts to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after multiple oral dose administration in healthy adult subjects.~It will evaluate multiple dose administration of CDX-7108 at an appropriate low (50 000 lipase units), mid (150 000 lipase units), and high dose (250 000 lipase units) 4 times a day (QID) for 6 consecutive days in 3 sequential cohorts of 6 subjects each.
Study NCT05082051 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Part B
Description: Randomized, double-blind, placebo-controlled dose escalation parts to investigate the safety, tolerability, immunogenicity, and PK of CDX-7108 after multiple oral dose administration in healthy adult subjects.~It will evaluate multiple dose administration of CDX-7108 at an appropriate low (50 000 lipase units), mid (150 000 lipase units), and high dose (250 000 lipase units) 4 times a day (QID) for 6 consecutive days in 3 sequential cohorts of 6 subjects each.
Study NCT05082051 — intervention group
Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Part C
Description: Randomized, double-blind, placebo-controlled, single-dose, 2-way crossover part to assess POC of CDX-7108 in terms of PD as well as its safety, tolerability, and immunogenicity in subjects with EPI.~Approximately 10 subjects with severe EPI from partial/total pancreatectomy or chronic pancreatitis will be enrolled. It is anticipated that Part C (POC study) will commence after completion of the third single-dose cohort from Part A (SAD study) and following SRC review of the data from this cohort.
Study NCT05082051 — intervention group
Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Part C
Description: Randomized, double-blind, placebo-controlled, single-dose, 2-way crossover part to assess POC of CDX-7108 in terms of PD as well as its safety, tolerability, and immunogenicity in subjects with EPI.~Approximately 10 subjects with severe EPI from partial/total pancreatectomy or chronic pancreatitis will be enrolled. It is anticipated that Part C (POC study) will commence after completion of the third single-dose cohort from Part A (SAD study) and following SRC review of the data from this cohort.
Study NCT05007496 — intervention group
Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: AV-COVID-19
Description: DCL previously loaded with varying quantity of S-protein
Study NCT04173260 — intervention group
Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Deutetrabenazine 6 MG
Description: Increasing doses of Deutetrabenazine
Study NCT04762043 — intervention group
Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Experimental System: MyoVoice
Description: Person-centric augmentative and alternative communication (AAC) system comprising a user-specific set of wearable sensors for capturing articulatory muscle activity and mobile software that provides real-time audible speech outputs.