louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06226519: Integrated PET/MRI and Germline Variants to Differentiate Brain Tumopr Recurrence From Iatrogenicchanges in Children
Official title: Integrated PET/MRI and Germline Variants to Differentiate Brain Tumopr Recurrence From Iatrogenicchanges in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Brain Tumor
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 60
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 children and/or adolescents (≤18 years) with a diagnosis of brain tumor (medulloblastoma, other embryonal tumors or high-grade gliomas), who have followed the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy and completed radiotherapy for at at least 6 months will undergo a brain MET-PET/MRI.

Brief summary: Nuclear magnetic resonance imaging (NMR) is used in pediatric brain tumors for purposes of diagnosis, evaluation of response to treatments, and monitoring of patients in follow-up. Through conventional imaging techniques it remains difficult to differentiate tumor recurrence from pseudo-progression or other iatrogenic changes after radiotherapy or chemotherapy, but it remains a relevant and essential clinical need for patient management.


Eligibility criteria: Inclusion Criteria:

* children and/or adolescents (≤18 years) diagnosed with brain tumor.
* children who underwent the contemporary adjuvant therapy protocol of post-surgical chemo and radiotherapy.

Exclusion Criteria:

* patients \>18 years

Primary outcomes:
measure: MET-PET/brain MRI in children with brain tumor for diagnosis of brain tumor recurrence compared to therapy-induced changes.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs San Raffaele
Study officials:
References:
Clinical trial NCT02838719: Analgesic Efficacy of Dexamethasone in Different Routes of Administration in Transverse Abdominis Plane Block
Official title: Effect of Perineural Versus Intravenous Dexamethasone On Analgesic Efficacy of Transverse Abdominis Plane Block With Levobupivacaine In Laparoscopic Gynaecological Procedures: A Randomized, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: INFERTILITY
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2016-07-20
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Transverse abdominis plane (TAP) block is a regional anaesthesia technique that provides analgesia to the parietal peritoneum as well as skin and muscles of the anterior abdominal wall. In the past, a number of adjuvants have been added to the local anaesthetics in peripheral and neuraxial blocks resulting in an effective and long lasting analgesia.In recent times, dexamethasone has been increasingly used as an adjuvant to local anaesthetics in peripheral nerve blocks. Dexamethasone has a long and efficient glucocorticoid structure and also has anti-inflammatory property. It also blocks the C- fibers of pain pathway. When added to local anaesthetics as an adjuvant in peripheral nerve blocks, it has shown to prolong the analgesia time. A number of previous studies have also shown an opioid sparing effect of steroids, when used intravenously perioperatively. Though previous studies have shown that addition of dexamethasone to local anaesthetics in transverse abdominis plane block prolongs the duration of block, however it is not known whether this effect of dexamethasone is due to its peripheral action or because of its systemic absorption. Thus, in this study planned to compare the effectiveness of dexamethasone on quality and duration of analgesia when used as an adjuvant with local anaesthetics in transverse abdominis plane block versus when given systemically by intravenous route along with transverse abdominis plane block using local anaesthetics only, in patients undergoing gynaecological laparoscopic procedures under general anaesthesia.


Eligibility criteria: Inclusion Criteria:

1. Women aged between 18 to 70 years undergoing gynaecological laparoscopic surgeries under general anaesthesia
2. ASA physical status1 or 2

Exclusion Criteria:

1. Local infection
2. Morbid obesity (body mass index \>35kg/m2)
3. Allergy to local anaesthetics
4. Patient refusal
5. Severe respiratory or cardiac disorders
6. Pre-existing neurological deficits
7. Liver or renal insufficiency
8. Preexisting diabetics
9. Patient on steroid treatment for any reason.
10. Peri Operative use of steroids

Primary outcomes:
measure: Time to first rescue analgesic
timeFrame: first 24 hours
Secondary outcomes:
measure: Total amount of rescue analgesic required in 1st 24 hours postoperatively
timeFrame: 0, 0.25, 0.50, 0.75, 1 , 2, 4, 6, 8,12, 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01304719: A Computer-based Intervention to Augment Home Visitation Services: The E-Parenting Project
Official title: A Computer-based Intervention to Augment Home Visitation Services: The E-Parenting Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Maltreatment
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2011-02-25
Enrollment: 413
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current protocol aims to examine the effects of a computer-based intervention used in conjunction with existing Healthy Families America (HFA) home visitation programs on the challenges related to participant enrollment, retention, and motivation as well as parent and child outcomes.

Detailed description: The present study aims to determine whether a computer-based intervention can provide augmentation of home visiting services to decrease the risk of child maltreatment. The computer-based software includes modules on motivation, Cognitive Retraining, and elements of the ecobehavioral SafeCare approach. A total of 420 mother-infant dyads from four Healthy Families America (HFA) sites will be randomly assigned to either treatment as usual, software-supplemented home visitation, or community control conditions. For families in the software-supplemented condition, home visitors will present the software to parents via a Tablet PC during regular home visits. All parents will be followed-up at 6, 12, and 18 months by independent and blinded research assistants. Parents are evaluated for maltreatment and maltreatment risks as measured by self-report, home visitor report, blinded independent observers, and statewide CPS data. If validated, the proposed intervention can provide augmentation of home visiting services with unprecedented ease of dissemination, at negligible additional cost, and with limitless potential for further development.

Eligibility criteria: Inclusion Criteria:

Pregnant or post-partum mothers who are eligible (i.e., score 25 or greater on the Kempe Family Stress Checklist and are not involved in CPS open case investigation at the time of HFA participation) and willing to participate in the HFA program are eligible to participate in the current study, with the following restrictions:

1. Mothers must be 18 years or older and able to complete the baseline assessment within 4 weeks of delivery.
2. Mothers have not completed any prior post-partum treatment plan.
3. Participants must have functional cognitive abilities.
4. Premature infants have to be released from hospital care within 6 weeks of birth.
5. Participants must be able to communicate in English.

Primary outcomes:
measure: Child maltreatment reports
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Wayne State University
name: Steven Ondersma, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02126319: Facilitating Participation in a Prostate Cancer Risk Assessment Program
Official title: Facilitating Participation in a Prostate Cancer Family Risk Assessment Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Cognitive-affective preparation
prostate cancer counseling
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 128
Sex: MALE
Minimum age (years): 34
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to examine whether a cognitive-affective preparation was more beneficial, in general, and more specifically for certain subgroups, such as African-American men and individuals with high monitoring style.

Detailed description: High risk men enrolling in a state of the science Prostate Cancer Risk Assessment Program (N = 128) underwent a Pca counseling visit immediately followed by either a cognitive-affective preparation (CAP) session designed to help men process the information they received or a general health education session to control for time and attention (comparison group). All men chose to participate in Pca screening.

Eligibility criteria: Inclusion Criteria:

* Caucasian men, 34 and 69 years of age, at least one first or second degree relative with prostate cancer

OR

* African American men, 35 and 69 years of age

Exclusion Criteria:

* cancer diagnosis
* difficulty communicating in English
* impaired competency to give informed consent.

Primary outcomes:
measure: Pca Risk-related Knowledge
timeFrame: three weeks
measure: Pca Perceived Risk
timeFrame: three weeks
measure: Pca-related Positive Expectations
timeFrame: three weeks
measure: Negative Expectations Regarding Pca Risk
timeFrame: three weeks
measure: Pca Related Intrusive Ideation
timeFrame: three weeks
measure: Pca Risk-related Knowledge
timeFrame: six months
measure: Pca Perceived Risk
timeFrame: six months
measure: Pca-related Positive Expectations
timeFrame: six months
measure: Negative Expectations Regarding Pca Risk
timeFrame: Six months
measure: Pca Related Intrusive Ideation
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Suzanne M Miller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03681119: The Hospice Advanced Dementia Symptom Management and Quality of Life Trial
Official title: The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2018-09-21
Enrollment: 83
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Alzheimer's Disease and Related Disorders (dementia) are a group of serious life limiting illness that cause significant challenges to our public health system, with significant illness burden for both the person with dementia and the caregiver. At the end of life, over 230,000 persons with dementia annually are cared for in hospice, yet hospice agencies are ill prepared to care for this population and often resort to inappropriate pharmacologic measures such as antipsychotics that reduce quality of life rather than improve it. This study will therefore through its two phases refine and then implement, using a pragmatic stepped wedge trial design, the Dementia Symptom Management at Home Program Hospice Edition, with the goal improving quality of care for the person with dementia and their caregiver, reducing antipsychotic use, and increasing bereaved caregiver satisfaction in the hospice setting.


Eligibility criteria: Inclusion Criteria:

* Must have dementia as primary diagnosis for admission to hospice
* Must be newly admitted to a participating hospice
* Must be 50 years or older

Clinicians:

* Must be a skilled clinician or home health aide who provides care through an eligible home health agency
* Must be 18 years or older

Exclusion Criteria:

Persons with Dementia:

* None

Clinicians:

* None

Primary outcomes:
measure: Percentage of Hospice IDT Members Who Complete Required Education and Training
timeFrame: 2 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Abraham Brody, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin SY, Schneider CE, Bristol AA, Clancy M, Sprague SA, Aldridge M, Cortes T, Goldfeld KS, Kutner JS, Mitchell SL, Shega JW, Wu B, Zhu CW, Brody AA. Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial. Gerontologist. 2022 Feb 9;62(2):304-314. doi: 10.1093/geront/gnaa220.
citation: Schneider CE, Bristol A, Ford A, Lin SY, Palmieri J, Meier MR, Brody AA; HAS-QOL Trial Investigators. The Impact of Aliviado Dementia Care-Hospice Edition Training Program on Hospice Staff's Dementia Symptom Knowledge. J Pain Symptom Manage. 2020 Aug;60(2):e7-e13. doi: 10.1016/j.jpainsymman.2020.05.010. Epub 2020 May 15.
Clinical trial NCT05924919: The Effects of Passive Heat Therapy in Patients With Chronic Kidney Disease
Official title: The Effects of Passive Heat Therapy in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Insufficiency, Chronic
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this proposal is to investigate the acute effects of whole-body passive heat therapy using far-infrared technology on vascular function, exercise capacity, and renal function in CKD patients. The central hypothesis is that an acute bout of whole-body passive heat therapy will be well-tolerated and lead to acute improvements in large blood vessel (macrovascular) function, small blood vessel (microvascular) function, and exercise capacity without significantly altering markers of acute kidney injury.


Eligibility criteria: Inclusion Criteria for participants with CKD:

* Age \> 18 years old
* Stage 2-4 CKD

Exclusion Criteria for participants with CKD:

* Unstable medical conditions characterized by frequent or unpredictable biological, chemical, or psychological changes
* Uncontrolled hypertension
* Current fluid restrictions
* End stage kidney disease or currently on dialysis treatment
* Body weight \< 40kg
* Exhibits any contraindications to exercise as per ACSM guidelines
* Regular tobacco and/or nicotine use
* History of heat-related illness
* Participates in regular exercise and/or sauna use
* Current hormone replacement therapy
* Pacemaker or electro-medical implant
* Persons with or at risk of intestinal disorders including gastroporesis
* History of diverticula
* Persons who have undergone surgical procedures in the GI tract
* Swallowing disorders
* Chron's disease
* Current pregnancy
* Inability to provide informed consent

Primary outcomes:
measure: Renal Safety of Heat Therapy
timeFrame: Change from baseline to 90 minutes after intervention
measure: Tolerability of Heat Therapy as Assessed using Validated Questionnaires of Thermal Perception
timeFrame: During 25 minute intervention
Secondary outcomes:
measure: Conduit artery endothelial function
timeFrame: 90 minutes after intervention
measure: Lower Limb Microvascular Function
timeFrame: 90 minutes after intervention
measure: Exercise Capacity
timeFrame: 90 minutes after intervention
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Danielle Kirkman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02661919: Assessment of the Emfit Mattress Sensor for Detection and Alarm of Night-time Generalized Tonic-clonic Seizures.
Official title: Assessment of the Emfit Mattress Sensor (L-4060SLC) and Monitor (DVM-GPRS-V2) and Their Acoustic and Cloud Interface Notification Capabilities as a Nocturnal Detection System for Movements Associated With Generalized Tonic-clonic Seizures.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Seizures
Keywords: Epilepsy
Seizure
Seizures
Mattress monitor
Bed monitor
Bed alarm
Generalized tonic-clonic seizure
GTC
Lead sponsor: Emfit, Corp.
Sponsor class: INDUSTRY
First posted: 2016-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Sudden unexpected death in epilepsy (SUDEP) is the most important epilepsy-related mode of death. The exact mechanism of SUDEP is not known. It is thought that cardiac and respiratory factors are involved. Several ways of preventing SUDEP have been identified. These include seizure control, stress reduction, physical activity, family's ability to perform CPR, and night supervision.

A mattress alarm system that monitors nocturnal seizures can alert family members of night time seizure activity. Thus, a family member could provide aid and therefore potentially avoid SUDEP. The Emfit monitor is intended to perform these tasks.

Investigators tested the Emfit mattress monitor DVM-GPRS-V2 in combination with the Emfit bed sensor L-4060SL in the epilepsy monitoring unit and were able to demonstrate that the device has a high predictive value for detection of generalized convulsions and that it can notify caregivers in the early stages of convulsive activity.

This study will further investigate the upgraded (connected to a cloud server via an integrated cellular GPRS module) Emfit mattress monitor DVM-GPRS-V2 and the upgraded Emfit mattress sensor L-4060SLC in combination with an acoustic and new cloud-based notification system.


Eligibility criteria: Inclusion Criteria:

* Overnight Epilepsy Monitoring Unit admission

Exclusion Criteria:

* 12 hours or shorter Epilepsy Monitoring Unit admission

Primary outcomes:
measure: Alarm effectiveness
timeFrame: 22 months
Secondary outcomes:
measure: Seizure type distinction
timeFrame: 10 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Stephan U. Schuele, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Narechania AP, Garic II, Sen-Gupta I, Macken MP, Gerard EE, Schuele SU. Assessment of a quasi-piezoelectric mattress monitor as a detection system for generalized convulsions. Epilepsy Behav. 2013 Aug;28(2):172-6. doi: 10.1016/j.yebeh.2013.04.017. Epub 2013 Jun 7.
Clinical trial NCT06841419: Reliability and Versatility of Pedicled Anterolateral Thigh Flap in Reconstruction of Soft Tissue Defects
Official title: Reliability and Versatility of Pedicled Anterolateral Thigh Flap in Reconstruction of Soft Tissue Defects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Soft Tissue Defects That Could be Reached by Pedicled Anterolateral Thigh Flap
Post Tumor Excision Soft Tissue Defects
Post Debridement Soft Tissue Defects
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: a prospective case series study for evaluation of the reliability and versatility of pedicled anterolateral thigh flap in the reconstruction of soft tissue defects as regards flap survival and complications, donor site morbidity and aesthetic outcome.


Eligibility criteria: Inclusion Criteria:

* All patients with clean hip, thighs or lower abdomen defects either traumatic or non_traumatic that cannot be closed primarily.

Exclusion Criteria:

* Patients with possible compromise of vascular pedicle due to previous trauma or surgery.
* Patient refusal

Primary outcomes:
measure: Flap Survival Rate
timeFrame: "From enrollment to the end of treatment at 8 weeks"
Secondary outcomes:
measure: Range of Motion in Reconstructed Area
timeFrame: "From enrollment to the end of treatment at 8 weeks"
measure: Strength in Reconstructed Area
timeFrame: "From enrollment to the end of treatment at 8 weeks"
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospitals
Study officials:
References:
Clinical trial NCT03600519: Retinal Imaging Using NOTAL-OCT V2.5
Official title: Retinal Imaging Using NOTAL-OCT V2.5
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AMD
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: MAD patients

Brief summary: Primary objectives:

To compare between retinal measurements, done by the NOTAL-OCT V2.5 device and a commercial OCT.

Secondary objectives:

1. To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula.
2. To evaluate the repeatability of the NOTAL-OCT V2.5

Detailed description: Study population:

1. AMD population - intermediate and advanced AMD (with active and nonactive CNV)
2. DR population. Patient with and without DME

Eligibility criteria: 1. Inclusion Criteria:

   a- Ability and agreement to give informed consent (IC) b -Diagnosis of AMD or DR in SE by OCT c- Ability to undergo OCT scans d- VA of 20/400 (6/120) or better in SE
2. Exclusion Criteria:

   1. AMD and DR in the same SE
   2. Evidence of macular disease other than AMD or DME in SE
   3. Patient with dilated eye(s)

Primary outcomes:
measure: The level of agreement between NOTAL-OCT V2.5 and commercial OCT in detecting fluid
timeFrame: less than an hour
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnei Zion
Study officials:
References: