louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03572673: Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy
Official title: Randomized Controlled Multicenter Study to Evaluate the Performance of a New 2-piece Ostomy Appliance vs. Flexima® 3S in Patients With Enterostomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enterostomy
Lead sponsor: BBraun Medical SAS
Sponsor class: INDUSTRY
First posted: 2018-06-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the performance of the comparator Flexima 3S appliance to a new 2-piece appliance in patients with enterostomy.


Eligibility criteria: Inclusion Criteria:

* patient having a colostomy or an ileostomy for at least 1 month
* patient currently using a flat appliance
* patient wearing his appliance, on average, at least 5 days
* patient with a stoma's diameter less than 65 mm
* patient who agrees to participate in the evaluation and who have signed the inform consent
* patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)

Exclusion Criteria:

* Patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
* Patient receiving or having received, within the last month, chemotherapy or corticotherapy
* Patient already participating in another clinical study or who have previously participated in this investigation
* Pregnant or breast-feeding woman

Primary outcomes:
measure: Change from baseline in base plate wear time, on average every 5 days, up to 21 (±3) days, for each study period
timeFrame: On average every 5 days, up to 21 (±3) days for each period
Secondary outcomes:
measure: Assessment of the condition of peristomal skin
timeFrame: After base plate removal at protocol visit 1 (day 0) and visit 2 (at 21 (±3) days)
measure: Assessment of the main reason of base plate removal
timeFrame: From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period
measure: Assessment of acceptability
timeFrame: At the end of each study period (21 (±3) days), at visit 2 (21 (±3) days) and at visit 3 (42 (±6) days)
measure: Assessment of use of accessories
timeFrame: From date of randomization, on average every 5 days, after each base plate removal, up to 21 (±3) days for each study period
measure: Preference between Flexima® 3S and the new 2-piece ostomy appliance
timeFrame: At the end of the study, at 42 (±6) days
measure: Safety: Adverse(s) Event(s)
timeFrame: From date of randomization until the date of first adverse event, assessed up to 42 (±6) days
Other outcomes:
Locations:
city: Batu Caves
country: Malaysia
facility: Hospital Selayang
city: Kuala Lumpur
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz
Study officials:
References:
Clinical trial NCT03346473: The Double Burden of Malnutrition Among Adolescents in Low-income and Middle-income Countries
Official title: The Double Burden of Malnutrition Among Adolescents: Analysis of Data From the Global School-Based Student Health and Health Behaviour in School-Aged Children Surveys in 57 Low-income and Middle-income Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stunting
Thinness
Obese
Lead sponsor: University of Warwick
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 129276
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adolescents aged 12-15 years from the Global School-Based Student Health Surveys (GSHS) and Health Behaviour in School-Aged Children (HSBC) surveys.

Brief summary: Individual-participant data analysis of the Global School-Based Student Health Survey and Health Behaviour in School-Aged Children surveys in 57 LMICs between 2003-2013.

Detailed description: We used the most recent Global School-Based Student Health Surveys (GSHS) and Health Behaviour in School-Aged Children (HSBC) surveys, with data available on height and weight. The GSHS is a World Health Organisation (WHO) initiative, designed to assess health behaviours of adolescents through cross-sectional school-based surveys, across several countries using similar standardised procedures. The HSBC study are WHO sponsored cross-sectional school-based surveys that uses similar standardised procedures to the GSHS to examine the physical and mental health of adolescents in the WHO European Region and North America.

Eligibility criteria: Inclusion Criteria:

* Low-income or middle-income countries with completed Global School-Based Student Health Survey or Health Behaviour in School-Aged Children surveys.
* Adolescents aged 12-15 years
* Recorded sex, height and weight

Exclusion Criteria:

- High-income countries

Primary outcomes:
measure: Prevalence of stunting
timeFrame: 2003-2013
measure: Prevalence of thinness
timeFrame: 2003-2013
measure: Prevalence of overweight and obesity
timeFrame: 2003-2013
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Warwick Medical School, Warwick University
name: Rishi Caleyachetty, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caleyachetty R, Thomas GN, Kengne AP, Echouffo-Tcheugui JB, Schilsky S, Khodabocus J, Uauy R. The double burden of malnutrition among adolescents: analysis of data from the Global School-Based Student Health and Health Behavior in School-Aged Children surveys in 57 low- and middle-income countries. Am J Clin Nutr. 2018 Aug 1;108(2):414-424. doi: 10.1093/ajcn/nqy105.
Clinical trial NCT04513873: The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy
Official title: The Effect Of Diverting The Children's Attention To A Different Point During Phlebotomy On Pain And Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain and Anxiety of Children During Phlebotomy
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 256
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to investigate the effect of diverting the children's attention to a different point during phlebotomy which is an invasive procedure with acute pain. This is a randomized controlled experimental study. The study was conducted with two groups: the intervention group (n=127) and the control group (n=129). The control group was applied to standard phlebotomy procedures. In contrast, the intervention group had a piece of equipment that looks like a blood tube in front of them during the phlebotomy process to divert their attention from the phlebotomy process to the equipment.

Detailed description: The equipment used for the intervention group was designed and developed by the researchers with the project support of TÜBİTAK BİDEB 2209A in 2016. It is an equipment that looks like a blood tube with a fixed arm on the right and a moving arm on the left with a total height of 80 cm. It has some answers to common questions of parents as well as the key concerns of the children " Will it hurt me?"

Eligibility criteria: Inclusion Criteria:

* making a request for the phlebotomy
* being in the 7-12 age group
* having the consent of the parent
* willing to participate in the research
* with the history of invasive procedure
* not using any medication with analgesic effect in the last 12 hours
* without any communication barriers of either child or the parent
* with a normal level of consciousness during the process
* without the history of passing out during the phlebotomy

Exclusion Criteria:

* not being in the 7-12 age group
* not having the consent of the parent
* not willing to participate in the research
* without the history of invasive procedure
* had medication with analgesic effect in the last 12 hours
* with communication barriers of either child or the parent
* with an abnormal level of consciousness during the process
* with the history of passing out during the phlebotomy

Primary outcomes:
measure: Assessment of Children's Anxiety Level Change
timeFrame: Twice ( Immediately after the procedure and 14 days after the procedure)
Secondary outcomes:
measure: Revised Face Pain Scale (FPS-R)
timeFrame: Twice ( During the procedure and 5-10 minutes after the procedure)
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Manavgat State Hospital
state: Manavgat
Study officials:
References:
Clinical trial NCT03909373: Validation of PSFS in Carpal Tunnel Syndrome
Official title: Validation of the Patient-Specific Functional Survey in Patients With Carpal Tunnel
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 0
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: Patients of the Principal Investigator who meet inclusion criteria

Brief summary: Validation of the Patient Specific Functional Scale in patients with carpal tunnel syndrome


Eligibility criteria: Inclusion Criteria:

* diagnosis of carpal tunnel syndrome

Exclusion Criteria:

-

Primary outcomes:
measure: Patient Specific Functional Scale Scores
timeFrame: 2 weeks after initial completion
measure: Patient Specific Functional Scale Scores
timeFrame: 6 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Health Care
state: California
Study officials:
References:
Clinical trial NCT04127773: Correct Gastric Tube Placement in Very Low Birth Weight Neonates
Official title: Correct Gastric Tube Placement in Very Low Birth Weight Neonates: Comparison of NEX and NEMU Methods
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Tube Placement
Keywords: VLBW - Very Low Birth Weight Infant
Gastric tube
Enteral nutrition
Prematurity
Nursing
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 220
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: VLBW infants

Brief summary: Gastric tube (GT) placement is a recurrent procedure in VLBW infants due to feeding impairment correlated with low birth weight.

Correct GT depth is mandatory to ensure an appropriate and safe enteral feeding: X-ray is the gold standard in order to check GT position, but this cannot be routinely performed due to x-ray exposure risk. Feeding a neonate through a misplaced GT is potentially harmful and may increase morbidity, mortality and hospitalization length.

Nurses estimate GT depth through external measurements. This study aims to identify the most appropriate insertion length predictor for orogastric tube placement in VLBW infants by comparing two different methods.

Detailed description: Several methods have been suggested to estimate orogastric tube insertion length, but none of them has been validated in VLBW infants. The most commonly used methods are NEX (Nose-Ear-Xyphoid) and NEMU (Nose-Ear-Mid-Umbilicus) as predictors of nasogastric tube insertion. For the purpose of the present study NEX and NEMU methods were adjusted for orogastric tube placement.

Hence, primary aim of this study is:

To identify the most appropriate insertion length predictor for orogastric tube placement in VLBW infants by comparing NEX and NEMU methods.

Secondary aim is:

- To develop a new mathematical formula, based on the neonate's weight or length, to predict the insertion length of orogastric tube in VLBW infants

Eligibility criteria: Inclusion Criteria:

* Birth Weight ≤1500 grams (Very Low Birth Weight Infants)
* Need for both umbilical catheter and gastric tube positioning at birth

Exclusion Criteria:

* Birth Weight \>1500 grams
* Congenital respiratory or gastrointestinal tract malformations (from oral cavity to stomach included)
* Critically unstable preterm infants will be excluded according to nurse or physician evaluation

Primary outcomes:
measure: Gastric tube position
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Mangiagalli Regina Elena
Study officials:
affiliation: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Mangiagalli Regina Elena, Milano (ITALY)
name: Chiara Baracetti, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01419873: Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
Official title: Pilot Study of a Model-based Approach to Blood Glucose Control in Very-low-birthweight Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperglycaemia
Keywords: Hyperglycaemia
Very low birthweight infants
Insulin
Lead sponsor: Christchurch Women's Hospital
Sponsor class: OTHER
First posted: 2011-08-18
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Very low birthweight neonates commonly develop high blood sugar levels. There is an association between high blood sugar levels and poorer short term outcomes but it is not known whether the high sugar level itself actually causes the problems.

There are a range of ways to manage high sugar levels but there are no consensus guidelines to follow. One option is to manage the high sugar levels with an infusion of insulin. Studies looking at insulin infusions have often used fixed protocols to guide the amount of insulin to be given and are often complicated by hypoglycaemia.

This study investigated whether using a model-based approach to individualise insulin administration to neonates with high sugar levels would provide a safe and effective management option for controlling blood sugar levels and avoid the complication of low blood sugar levels.


Eligibility criteria: Inclusion Criteria:

* Birthweight \<1500g
* Blood sugar \>/= 10mmol/L
* Clinician decision to start an insulin infusion

Exclusion Criteria:

* Infants who were moribund and not expected to survive

Primary outcomes:
measure: Hypoglycaemia whilst receiving insulin
timeFrame: Length of hospital stay in NICU which will be from birth to 5 months of age
Secondary outcomes:
Other outcomes:
Locations:
city: Christchurch
country: New Zealand
facility: Christchurch Womens Hospital, Canterbury District Health Board
Study officials:
affiliation: Canterbury District Helath Board
name: Adrienne M Lynn, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Compte AJ, Lynn AM, Lin J, Pretty CG, Shaw GM, Chase JG. Pilot study of a model-based approach to blood glucose control in very-low-birthweight neonates. BMC Pediatr. 2012 Aug 7;12:117. doi: 10.1186/1471-2431-12-117.
Clinical trial NCT00526773: Enhancing Heart Failure Self-Care
Official title: Enhancing Heart Failure Self-Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: motivational therapy
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the effectiveness of a motivational intervention compared with standard patient education in improving economic and clinical outcomes in patients enrolled in an existing heart failure (HF) disease management program.


Eligibility criteria: Inclusion Criteria:

* Chronic heart failure, hospitalized for heart failure or hospitalized for heart failure within the past 30 days, speak and read English

Exclusion Criteria:

* Severe renal failure requiring dialysis, HIV-AIDS, psychosis, uncorrected hearing loss

Primary outcomes:
measure: To test the effectiveness of a motivational intervention compared with standard patient education in improving economic and clinical outcomes in patients enrolled in HF disease management.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
Study officials:
affiliation: University of Pennsylvania
name: Barbara Reigel, DNSc, RN, CS, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02973373: MRI of the Chest Under High Frequency Ventilation
Official title: MRI of the Chest Under High Frequency Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-invasive Ventilation
High-frequency Ventilation
Healthy Volunteer
Keywords: MRI
Chest
Apnea
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to evaluate the benefit on image quality of MRI of the chest performed under high frequency non-invasive ventilation. This technique indeed allows to generate an apnea duration of several minutes with acquisitions performed at full inspiration. This study will be applied on healthy subjects.

Detailed description: High frequency ventilation (HF-V) has been applied by using a non-invasive interface allowing to obtain a prolonged apnea in awaken subjects. Such an application should be of interest for MRI taking into account its susceptibility to motion of the chest and the imperfect techniques of respiratory gating that are usually performed at end expiration. The purpose of this study is to assess the benefit on image quality of different sequences performed with and without the device in healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy subjets : normal respiratory function and no known lung disease
* Age \>=18y

Exclusion Criteria:

• Pregnancy

Primary outcomes:
measure: Image quality assessment (soapbubble, maximum of first derivative, signal to noise, contrast to noise)
timeFrame: within 2 weeks after MRI acquisition
Secondary outcomes:
measure: Heart and coronary arteries evaluation (soapbubble, signal to noise, contrast to noise)
timeFrame: within 2 weeks after MRI acquisition
measure: Synchronization of the acquisition
timeFrame: during the MRI examination
measure: Subjective tolerance (questionnaire)
timeFrame: at the end of the MRI examination
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospitals
Study officials:
affiliation: University Hospitals Lausanne Switzerland
name: Catherine I Beigelman-Aubry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delacoste J, Dournes G, Dunet V, Ogna A, Noirez L, Simons J, Long O, Berchier G, Stuber M, Lovis A, Beigelman-Aubry C. Ultrashort echo time imaging of the lungs under high-frequency noninvasive ventilation: A new approach to lung imaging. J Magn Reson Imaging. 2019 Dec;50(6):1789-1797. doi: 10.1002/jmri.26808. Epub 2019 May 28.
Clinical trial NCT05062473: Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem
Official title: Hypertension Control in the Age of COVID-19: Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
First posted: 2021-09-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the feasibility of creating a health education telemedicine curriculum that can be delivered by Weill Cornell Medicine faculty and medical students and NY-Presbyterian Hospital resident physicians to community dwelling adults in an under-resourced local community.


Eligibility criteria: Inclusion Criteria:

* Male or female greater than or equal to 18 years of age.
* Self-report of a hypertension diagnosis.

Exclusion Criteria:

* Pregnant or breastfeeding.
* End-stage renal disease on hemodialysis.

Primary outcomes:
measure: Participant's Satisfaction with the Curriculum at 12 Weeks
timeFrame: Week 12
measure: Change in Number of Participants Virtually Attending the Health Education Seminars
timeFrame: Baseline to 12 weeks.
measure: Change in Participant's Rate of Completion of Weekly Blood Pressure Recordings
timeFrame: Baseline to 12 weeks.
measure: Change in Participant's Rate of Completion of Weekly Steps Recordings
timeFrame: Baseline to 12 weeks.
Secondary outcomes:
measure: Mean Change in Systolic Blood Pressure Measurement.
timeFrame: Baseline to week 12
measure: Mean Change in Diastolic Blood Pressure Measurement.
timeFrame: Baseline to week 12
measure: Mean Change in Number of Daily Steps Measured by Pedometer.
timeFrame: Baseline to week 12
measure: Change in Self-Reported Health Attitudes and Behaviors As Assessed by Survey.
timeFrame: Baseline, week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Cornell Medicine/NY Presbyterian Hospital
name: Tracy K Paul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Artinian NT, Washington OG, Templin TN. Effects of home telemonitoring and community-based monitoring on blood pressure control in urban African Americans: a pilot study. Heart Lung. 2001 May-Jun;30(3):191-9. doi: 10.1067/mhl.2001.112684.
citation: Liu S, Brooks D, Thomas SG, Eysenbach G, Nolan RP. Effectiveness of User- and Expert-Driven Web-based Hypertension Programs: an RCT. Am J Prev Med. 2018 Apr;54(4):576-583. doi: 10.1016/j.amepre.2018.01.009. Epub 2018 Feb 16.
citation: Bove AA, Homko CJ, Santamore WP, Kashem M, Kerper M, Elliott DJ. Managing hypertension in urban underserved subjects using telemedicine--a clinical trial. Am Heart J. 2013 Apr;165(4):615-21. doi: 10.1016/j.ahj.2013.01.004. Epub 2013 Mar 6.