louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05197660: Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study
Official title: Routine Surgical Procedures During COVID-19 Pandemic: a French Nationwide Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Cataract
Hip Arthroplasty
Knee Arthroplasty
Coronary Stent
Pacemaker
COVID-19 Pandemic
Lead sponsor: EPI-PHARE
Sponsor class: OTHER_GOV
First posted: 2022-01-19
Enrollment: 2000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All hospitalizations with at least one act of each surgery between January 1, 2019, and June 30, 2021 from the French National Health Data System (SNDS).

The National Health Data System (SNDS) is a set of strictly anonymous databases, comprising all mandatory national health insurance reimbursement data, particularly data derived from processing of health care claims (electronic or paper claims) and data from health care facilities (PMSI).

Brief summary: Determine the consequences of COVID-19 pandemic on routine targeted surgeries.

Five surgical procedures were considered : cataract surgery, hip and knee arthoplasties, coronary revascularisation by angioplasty and definitive cardiac stimulation.

The objective of the study is to quantify changes of these procedures in 2020 and in 2021 (up to June) compared to 2019 taking into account their annual evolution and according to the type of operation (primary or reoperation/revision) and emergency status, if applicable.


Eligibility criteria: Inclusion Criteria:

* hospitalizations with at least one act of cataract surgey hip arthroplasty knee arthroplasty coronary angioplasty definitive cardiac stimulation (pacemaker)
* between January 1, 2019, and June 30, 2021

Exclusion Criteria:

-hospitalizations for personal identifier problems in the database

Primary outcomes:
measure: observed and expected number
timeFrame: 2020 and first half of 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: E Dufour
state: Ile De France
Study officials:
affiliation: EPI-PHARE
name: Mahmoud Zureik
role: STUDY_DIRECTOR
References:
Clinical trial NCT02068560: The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion
Official title: The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gender Difference in V2 Receptor Function in Response to dDAVP Infusion
Nocturia
Nocturnal Enuresis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2014-02-21
Enrollment: 64
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: There is substantial evidence that women throughout life have significantly lower plasma levels of the antidiuretic hormone vasopressin (pAVP) compared to men. The importance of this is not yet fully elucidated, but in relation to the observations of lower pAVP levels, no significant difference in renal response parameters was found. This could be interpreted an increased renal sensitivity in females compared to males. The theory of increased renal sensitivity in females is supported by a few pharmacodynamic studies currently available on this topic. However none of the studies was designed with the purpose of investigate the gender difference.

The aim of this study is to investigate possible gender differences in the renal sensitivity to dDAVP and the effect of age on these differences. This will be done by low dose graded infusion of the synthetic AVP analog dDAVP.

Participants are 80 healthy volunteers equally distributed between four age groups, 8-10 years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Normal clinical examination
* Normal residual urine measurements
* Normal urine dip stick
* Informed consent by participant or legal guardian

Exclusion Criteria:

* Smoking, alcohol or drug abuse
* Conditions of importance to the results (endocrinological, renal or cardial)
* Current or previous history of incontinence, bedwetting or nocturia
* Drug use of importance (diuretics, hormone replacement therapy, birth control pills, desmopressin)
* Pregnancy
* Allergy towards dDAVP/desmopressin

Primary outcomes:
measure: Urine osmolality
timeFrame: Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day
measure: Urine Volume
timeFrame: Urine Volume is measured every half hour throughout the 9 hours study period
measure: Plasma dDAVP
timeFrame: Plasma concentrations of the synthetic hormone is measured every 90 minutes for the first 8 hours and every half hour, the last hour of the study period
Secondary outcomes:
measure: Plasma sodium
timeFrame: Plasma sodium is measured every 90 minutes throughout the first 8 hours and every half hour in the last hour of the study periode
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT04378660: Artificial Intelligence (AI) Validation Study for Polyp Detection
Official title: Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyp of Colon
Keywords: Colonic polyp
Artificial intelligence
Second observer
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Nuovo Regina Margherita Hospital, Rome, Italy
name: Universitäts Medizin, Mainz, Germany
First posted: 2020-05-07
Enrollment: 357
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy

Detailed description: This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR \> 20% and \< 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded.

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Diagnostic or screening colonoscopy
* Therapeutic colonoscopy

Exclusion Criteria:

* Inability to give informed consent by the patient or legal representative
* \< 18 years old
* Any contraindication for colonoscopy or biopsies of the colon
* Uncontrolled coagulopathy
* Confirmed diagnosis of inflammatory bowel disease
* Short bowel or ileostomy
* Pregnancy

Primary outcomes:
measure: Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard
timeFrame: 4 months
Secondary outcomes:
measure: Endoscopist's polyp miss rate as number of extra AI detections
timeFrame: 4 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Raf Bisschops
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00814060: Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)
Official title: A Single Dose Bioavailability Study of 2 New Tablet Formulations of Neratinib Compared With a Reference Capsule in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will examine the bioavailability (the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule formulation.


Eligibility criteria: Healthy male and female subjects, ages 18-50.

Primary outcomes:
measure: Blood will be collected to determine the pharmacokinetics of the various formulations of HKI-272
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References:
Clinical trial NCT00537160: Diet and Exercise in Overweight Children Postburn
Official title: The Impact of a Diet and Exercise Program in Overweight Pediatric Patients During Burn Rehabilitation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Obesity
Burns
Keywords: Pediatrics
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2007-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions.


Eligibility criteria: Inclusion Criteria:

* 10-18 years old
* BMI \> or = 95th percentile
* \> 1 year postburn and out of pressure garments
* Live within 100 minle radius of SHC
* Informed consent and HIPPA form signed
* Parent/guardia willing to make time commitment

Exclusion Criteria:

* Undergone major surgery in the 4 months prior to start of program or have any major surgery planned in 2 year time frame
* Physical/health condition that precludes regular exercise
* Significant mental health diagnosis
* Advised by MD not to exercise
* Thyroid disease, routine steroid use,pregnancy
* Unable to understand the instructions/content of program

Primary outcomes:
measure: BMI
timeFrame: 12 and 24 months following intervention
Secondary outcomes:
measure: fitness level
timeFrame: 12 and 24 months following intervention
Other outcomes:
Locations:
Study officials:
affiliation: Shriners Hospital for Children
name: Michele M Gottschlich, PhD, RD, CNSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00470860: Educational Technology to Enhance Diabetes Care - Retention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2007-05-08
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study mapped the time course of forgetting among resident physicians after they use an online learning exercise covering principles of diabetes care. Participants took a pre-test followed by an online tutorial covering aspects of diabetes care. They then completed a post-test on the same topics after a randomly-assigned time delay from 0 to 55 days. We hypothesized that post-test scores after these different time delays would decline following a curvilinear relationship with increasing time. This understanding of forgetting will inform our selection of a time for delivering reinforcement exercises in future educational studies among physicians.


Eligibility criteria: Inclusion Criteria:

* Family medicine residents (physicians in training)
* Internal medicine residents (physicians in training)

Primary outcomes:
measure: Knowledge related to blood pressure and lipid management for diabetes patients
timeFrame: Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Charles R. Drew University
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Douglas S Bell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05373160: Reference Values of Different Functional Tests With or Without Cognitive Dual-task in Young Adults
Official title: Determination of Age- and Gender-specific Reference Values of Different Functional Tests With or Without Cognitive Dual-task in Young Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dual-task
Functional Test
Keywords: dual-task
functional test
healthy young
reference value
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2022-05-13
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young people

Brief summary: In this study, reference values for the five basic functional tests that are commonly used, with and without the addition of dual-task activity, will be determined. It will be ensured that healthy normative data that researchers and clinicians can compare in determining the effects in different pathologies by using easy-to-perform evaluations. The aim of this study is to determine the reference values performed with and without dual-task of the five functional tests for young adults according to age and gender by considering the interaction between both mobility and cognitive tasks.


Eligibility criteria: Inclusion Criteria:

* 18-35 years
* Individuals who were not diagnosed with musculoskeletal disorder
* Volunteers

Exclusion Criteria:

* Using an assistive device for walking
* Having cognitive problems
* Individuals who had undergone lower extremity surgery due to musculoskeletal problems in the last six months
* Body mass index greater than 30 kg/m2

Primary outcomes:
measure: Timed Up and Go Test without dual task
timeFrame: Baseline
measure: 4 Meter Gait Speed Test without dual task
timeFrame: Baseline
measure: 10 Meter Walk Test without dual task
timeFrame: Baseline
measure: Timed 25-Foot Walk Test without dual task
timeFrame: Baseline
measure: 1 min-Sit-to-Stand Test without dual task
timeFrame: Baseline
measure: Timed Up and Go Test with dual task
timeFrame: Baseline
measure: 4 Meter Gait Speed Test with dual task
timeFrame: Baseline
measure: 10 Meter Walk Test with dual task
timeFrame: Baseline
measure: Timed 25-Foot Walk Test with dual task
timeFrame: Baseline
measure: 1 min-Sit-to-Stand Test with dual task
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Yildiz Analay Akbaba, PT, phD
role: STUDY_DIRECTOR
References:
citation: Ahman HB, Berglund L, Cedervall Y, Giedraitis V, McKee KJ, Rosendahl E, Aberg AC. Timed "Up & Go" Dual-Task Tests: Age- and Sex-Specific Reference Values and Test-Retest Reliability in Cognitively Healthy Controls. Phys Ther. 2021 Oct 1;101(10):pzab179. doi: 10.1093/ptj/pzab179.
Clinical trial NCT04382560: Coping Strategies and Responsiveness to a Brief Online Intervention During COVID-19 Pandemic
Official title: Resting Heart Rate Variability as a Predictor of Coping Strategies and Responsiveness to a Brief Online Intervention During Forced Quarantine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Social
Autonomic Imbalance
Lead sponsor: University of Parma
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
name: King's College London
First posted: 2020-05-11
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: wait-list control design
Primary purpose: OTHER

Brief summary: The present study investigates the efficacy of a brief and cost-effective video-intervention that combines bottom-up elements of deep breathing and third-wave cognitive behavioral therapy techniques (i.e., mindfulness and compassion) on coping strategies during the COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

* Being healthy
* Previous participation (maximum elapsed time: 2.0 years) in a study conducted by the same research group and incorporating cardiac autonomic assessment at rest

Exclusion Criteria:

* Self-reported development of cardiovascular disease since previous assessment
* Use of psychotropic medications or medications affecting the autonomic nervous system

Primary outcomes:
measure: Dispositional questionnaire 1
timeFrame: During waking hours for two consecutive days before the intervention/control condition
measure: Dispositional questionnaire 1
timeFrame: During waking hours for two consecutive days after the intervention/control condition
measure: Dispositional questionnaire 2
timeFrame: During waking hours for two consecutive days after the intervention/control condition
measure: Dispositional questionnaire 3
timeFrame: During waking hours for two consecutive days before the intervention/control condition
measure: Dispositional questionnaire 3
timeFrame: During waking hours for two consecutive days after the intervention/control condition
measure: Dispositional questionnaire 4
timeFrame: During waking hours for two consecutive days before the intervention/control condition
measure: Dispositional questionnaire 4
timeFrame: During waking hours for two consecutive days after the intervention/control condition
Secondary outcomes:
measure: Heart rate
timeFrame: During waking hours for two consecutive days before the intervention/control condition
measure: Heart rate
timeFrame: During waking hours for two consecutive days after the intervention/control condition
measure: Cardiac vagal modulation
timeFrame: During waking hours for two consecutive days before the intervention/control condition
measure: Cardiac vagal modulation
timeFrame: During waking hours for two consecutive days after the intervention/control condition
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome
Study officials:
References:
Clinical trial NCT01916031: Appropriate Care of URI (ACURI): Early Head Start
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Infection
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2013-08-05
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to comparatively assess the effectiveness of a tailored educational intervention to improve health literacy levels regarding upper respiratory infections (URIs) and to decrease pediatric emergency department (PED) visits, among Latino households in Early Head Start.


Eligibility criteria: Inclusion Criteria:

* Attending an infant or toddler EHS group at participating site

Exclusion Criteria:

* Participant in pilot study
* Participant in community intervention regarding URI

Primary outcomes:
measure: Number of pediatric emergency department visits
timeFrame: 5 months
Secondary outcomes:
measure: Use of over-the-counter medication
timeFrame: 5 months
measure: Use of incorrect measuring tool
timeFrame: 5 months
measure: Use of unprescribed antibiotic
timeFrame: 5 months
measure: Knowledge regarding URI
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Melissa Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stockwell MS, Catallozzi M, Larson E, Rodriguez C, Subramony A, Andres Martinez R, Martinez E, Barrett A, Meyer D. Effect of a URI-related educational intervention in early head start on ED visits. Pediatrics. 2014 May;133(5):e1233-40. doi: 10.1542/peds.2013-2350. Epub 2014 Apr 7.
Clinical trial NCT04997031: Tap Water Intake and Perceptions in US Latinx Adults
Official title: Tap Water Intake and Perceptions in US Latinx Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dehydration
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 492
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of Phoenix, Arizona

Brief summary: The purpose of this exploratory cross-sectional investigation is to evaluate associations between tap water perceptions, water consumption behaviors, and hydration status in Latinx adults (18 - 65 y). The objective is to identify perceptual determinants that explain the associations between tap water avoidance and plain water intake and hydration status in Latinx adults.

Aim 1: Characterize the degree to which individual- and community-level factors uniquely predict the perception that tap water is not safe in Latinx adults.

Aim 2: Evaluate household income, education level, and US nativity as potential moderators of the associations between predictors and perceptions of tap water safety.

Aim 3: Evaluate the influence of tap water safety perceptions on plain water intake and 24-h hydration status, after adjustment for predictors of tap water safety perceptions, in a sub-sample of Latinx adults.


Eligibility criteria: Inclusion Criteria:

* Self-identify as Hispanic or Latinx
* English- and/or Spanish-speaking
* Interested in participating in both study phases
* Live in Phoenix, Arizona

Exclusion Criteria:

* Currently pregnant or breastfeeding
* Currently use diuretics
* Do not have access to a desktop, laptop, tablet, or smartphone
* Do not have internet access

Primary outcomes:
measure: Perception of tap water safety
timeFrame: 1 day
measure: Plain water intake (mL)
timeFrame: 3-day average
measure: 24-h urine osmolality (mmol/kg)
timeFrame: 1 day
Secondary outcomes:
measure: 24-h urine volume (mL)
timeFrame: 1 day
measure: Total water intake (mL)
timeFrame: 3-day average
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Interdisciplinary Science and Technology Building 8
state: Arizona
Study officials:
References: