louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02354820: Child Health Improvement Through Computer Automation of Constipation Management in Primary Care
Official title: Child Health Improvement Through Computer Automation of Constipation Management in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Encopresis
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-02-03
Enrollment: 16264
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project seeks to expand an existing computerized decision support system used in pediatric primary care. The expanded system will add a module that helps clinicians recognize constipated children and then provides evidence-based reminders for constipation management, as well as automates patient educational materials. The current system is deployed across multiple sites, and the constipation module will be randomized to deployment in different sites. The difference in constipation management and patient outcomes will then be compared between sites receiving the intervention and sites not receiving the intervention over a 12 month period.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to one of 5 primary care clinics in the Eskenazi Health system in Indianapolis, IN.
* Patients given a pre-screener form as part of the existing CHICA decision support system.
* Age between 2 years and 12 years, inclusive.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Number of Patients With Persistent Constipation Within 6 Months
timeFrame: All visits within 6 months of initial constipation complaint.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02180620: Pre-dinner vs. Post-dinner Exercise on Glycemic Control
Official title: Exercise Timing and Postprandial Glycemia in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: GIP
GLP-1
exercise timing
resistance exercise
glucose concentrations
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2014-07-02
Enrollment: 13
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: With many medications we prescribe them relative to time of day or a meal. This study established if pre dinner vs post dinner exercise was more effective at altering post dinner glucose and triglyceride levels vs no exercise at all.

Detailed description: All participants completed three trials in a random order in which they consumed a standardized dinner meal with 1) no RE (NoRE), 2) pre-dinner RE (RE→M), and 3) post-dinner RE beginning 45 min after dinner (M→RE). Diet was standardized during the day of testing. Participants reported to the lab for testing sometime between 3 - 5:30 p.m. and upon arrival a venous catheter was inserted into a forearm vein. Frequent blood sampling, indirect calorimetry measurements, and subjective well-being measurements ensued for \~5.75 h while the participants were in the lab.

Eligibility criteria: Inclusion Criteria:

* Obese ( body mass index 30-45 kg/m2)
* Physician diagnosed with type 2 diabetes receiving standard medical care
* Non-smokers
* Pregnancy
* Lactating mothers

Exclusion Criteria:

* Insulin
* Surgical weight loss
* Orthopedic limitations to exercise
* Weight loss in the previous 3 months

Primary outcomes:
measure: glucose concentrations
timeFrame: Blood samples were taken every 5-10 min during the first 3.7 h of testing and every 30 min during the last 2 h
Secondary outcomes:
measure: triglyceride concentrations
timeFrame: Blood samples were taken every 5-10 min during the first 3.7 h of testing and every 30 min during the last 2 h
Other outcomes:
measure: GLP-1 concentrations
timeFrame: Blood samples were taken every 5-10 min during the first 3.7 h of testing and every 30 min during the last 2 h
Locations:
Study officials:
References:
citation: Heden TD, Liu Y, Kanaley JA. A comparison of adipose tissue interstitial glucose and venous blood glucose during postprandial resistance exercise in patients with type 2 diabetes. J Appl Physiol (1985). 2018 Apr 1;124(4):1054-1061. doi: 10.1152/japplphysiol.00475.2017. Epub 2017 Sep 28.
Clinical trial NCT04722120: Low Contrast Agent and Radiation Dose Protocol for Liver CT in Patients With HCC
Official title: Low Contrast Agent and Radiation Dose Protocol Liver CT With Deep-learning-based Contrast Boosting Model in Patients at High Risk for HCC: Prospective, Randomized, Single Blinded - Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: CT
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the image quality and clinical feasibility of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.

Detailed description: The purpose of this study is to investigate the image quality (CNR, subjective inage quality, vessel and lesion conspicuity) and clinical feasibility (rate of lesion detection) of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis
* Tumor marker (aFP, PIVKA) elevation
* Nodular lesion on USG
* Received RFA for HCC

Exclusion Criteria:

* hypersensitivity at iodine
* GFR under 30
* BMI over 30
* Nursing or pregnant women
* enrolled the other study

Primary outcomes:
measure: Detection rate of solid focal lesion in liver
timeFrame: 12 months after last patient's image work up
measure: Quantitative image quality analysis
timeFrame: Immediate after study enrollement
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04589520: The Effects of the App HeartBot on the Stress and Emotional Well-Being Over a 21-day Challenge
Official title: The Effects of the App HeartBot on the Stress and Emotional Well-Being Over a 21-day Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Mental Health Wellness 1
Lead sponsor: Heartfulness Institute
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 88
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness. The study is conducted to examine the effect of the app on stress and emotional wellness in participants 14 years and older.

Research Question: Does HeartBot affect the stress levels and emotional wellness in participants 14 years and older?

Hypothesis: Participants who use HeartBot for 21 days will see a significant decrease in their stress levels and an improvement in emotional wellness.


Eligibility criteria: Inclusion Criteria:

* Participants 14 years of age and older willing to participate in the study; parental/guardian consent in case of the student below 18 years of age.

Exclusion Criteria:

* Individuals less than 14 years of age. As the app is available on iOS only, you need to have an iOS device to participate.

Primary outcomes:
measure: Change in Stress Levels
timeFrame: 21 days for 30 minutes every day based on a 21-day calendar
Secondary outcomes:
measure: Change in Emotional Wellbeing
timeFrame: 21 days for 30 minutes every day based on a 21-day calendar
Other outcomes:
Locations:
city: Novi
country: United States
facility: Ranjani B Iyer
state: Michigan
Study officials:
affiliation: Heartfulness Institute
name: Ranjani B Iyer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iyer L, Iyer RB, Kumar V. A Relaxation App (HeartBot) for Stress and Emotional Well-Being Over a 21-Day Challenge: Randomized Survey Study. JMIR Form Res. 2021 Jan 29;5(1):e22041. doi: 10.2196/22041.
Clinical trial NCT00390520: Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes
Official title: A Single-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Effect of Vildagliptin on Glucagon Counterregulatory Response During Hypoglycemia in Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
glucagon
hypoglycemia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This mechanistic study is designed to investigate the effect of vildagliptin on the sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2 diabetes (T2DM).


Eligibility criteria: Inclusion Criteria:

* Patients with T2DM, diagnosed at least 6 weeks prior to visit 1, who have had no treatment with oral antidiabetic agents for at least 12 weeks prior to study entry (visit 1) and no treatment with oral antidiabetic agents at any time in the past for \> 3 consecutive months
* \>/= 18 years
* Body mass index in the range of 22-35 kg/m2
* HbA1c \</=7.5%

Exclusion Criteria:

* Type 1 diabetes
* Acute metabolic diabetic complications
* Evidence of significant diabetic complications
* Insulin treatment within the past 6 months

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment
Secondary outcomes:
measure: Glucagon counterregulatory response to hypoglycemia assessed as glucagon Cmax of the 2.5 mM hypoglycemic clamp step after 4 weeks treatment
measure: The 'insulin secretion rate relative to glucose' at the hypoglycemic clamp step after 4 weeks treatment
measure: Change from baseline on hemoglobinA1c (HbA1c)and fasting plasma glucose
measure: Safety based primarily on frequency of adverse events, number of notable abnormal laboratory values, and frequency and severity of hypoglycemic events
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Ahren B, Schweizer A, Dejager S, Dunning BE, Nilsson PM, Persson M, Foley JE. Vildagliptin enhances islet responsiveness to both hyper- and hypoglycemia in patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 Apr;94(4):1236-43. doi: 10.1210/jc.2008-2152. Epub 2009 Jan 27.
Clinical trial NCT06908720: Defining the Role of Optical Super-high Magnification Dermoscopy in the Diagnosis of Skin Tumors
Official title: A Prospective Observational Study for Defining the Role of Optical Super-high Magnification Dermoscopy in the Diagnosis of Skin Tumors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Skin Cancers
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who will come to our attention for skin cancer screening with dermoscopy, willing to partecipate to the study

Brief summary: This is a prospective study aimed at evaluating the diagnostic accuracy (compared to histopathological diagnosis) and clinical utility of optical super-high magnification dermoscopy (OSHMD) in detecting and differentiating skin tumors, including both benign and malignant lesions, particularly in nevi/melanoma and basal cell carcinoma, in patients with suspicious lesions at a magnification of 20x. Additionally, the characteristics of skin lesions will be analyzed using OSHMD, and their distribution in skin tumors will be assessed. The agreement between the examiners' evaluations and the concordance between dermoscopic diagnoses at 20x and 400x compared to histopathological diagnosis will also be examined. The hypothesis is that OSHMD could assist in identifying malignancy features, thus improving the diagnostic accuracy of skin tumors and potentially leading to earlier and more precise detection of neoplasms


Eligibility criteria: Inclusion Criteria:

* patients who will come to our attention for skin cancer screening with dermoscopy, willing to partecipate to the study

Exclusion Criteria:

* patients aged under 18 year old
* patients unable to understand and signed the onformed consent

Primary outcomes:
measure: Evaluate the diagnostic accuracy and clinical utility of super-high magnification dermoscopy in the detection and differentiation of skin tumors
timeFrame: from the enrollment to the reaching of 1000 patients or up to 156 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02669420: Misoprostol for Second Trimester Pregnancy Termination
Official title: Intra Uterine Extra Amniotic (200 μg ) Versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intra Uterine Fetal Death
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 180
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The majority of second-trimester pregnancy termination performed in the United States are performed surgically by dilation and evacuation. The frequency of induction of abortion increases as gestational age advances. In the late second trimester and early third trimester, induction is the primary method of termination in cases of fetal abnormalities. In many other countries, however, induction is the primary method of abortion throughout the second trimester


Eligibility criteria: Inclusion Criteria:

* Pregnancy 13-24 weeks.
* Women with indication for termination of the pregnancy due to intra uterine fetal death

Exclusion Criteria:-Pregnancy before 13 weeks.

* Pregnancy beyond 24 weeks.
* Women with scared uterus.
* Known hypersensitivity for misoprostol.
* Refusal of the woman to participate.

Primary outcomes:
measure: mean duration from the initial misoprostol dose until complete fetal expulsion
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
Clinical trial NCT03753620: Development of a Software Correlating Simultaneously fMRI, EEG and Peripheral Physiological Activity
Official title: Development of a Software Correlating Simultaneously fMRI, EEG and Peripheral Physiological Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music Listening
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study aim to improve the quality of EEG recordings during simultaneous fMRI acquisitions. The second aim is to validate the correspondence between cerebral areas activated in fMRI and cortical areas identified with high density EEG during the listening of emotional musical pieces.


Eligibility criteria: Inclusion Criteria:

* Right handed healthy people
* Sensitive to "music chill" (Barcelona Reward music Questionnaire\>50)
* Having given their participation agreement
* Individual with health insurance coverage.

Exclusion Criteria:

* Pregnant women
* Individuals in "exclusion period" of another study
* No inclusion criteria of fMRI acquisition
* Subjects with auditory deficits.

Primary outcomes:
measure: Correlation between synchronous cerebral hemodynamics and electric patterns recorded with both EEG and fMRI simultaneously during the production of musical emotions.
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT04264520: Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
Official title: Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Perinatal Problems
Post Traumatic Stress Disorder
Post Partum Depression
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: MUSC Specialized Center of Research Excellence
First posted: 2020-02-11
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label Pilot Trial (no control group)
Primary purpose: TREATMENT

Brief summary: The current study aims to test a brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms. In this open trial pilot feasibility study, 20 pregnant women in their first trimester will be invited to participate in the study if they endorse elevated PTSD symptoms. Oxytocin and cortisol will be measured at baseline, one month post-intervention, three months post-intervention, and post-delivery to inform the relationship between these hormones, PTSD symptoms, and peripartum/postpartum outcomes. In addition to receiving the psychoeducation + skills intervention during their first trimester, women will be offered a "booster session" intervention following delivery to enhance utilization of skills during a critical period for maternal mental and physical health outcomes.


Eligibility criteria: Inclusion Criteria:

* 18-40 years old
* Fluent in English

Exclusion Criteria:

* Active and severe domestic violence
* Evidence of a significant mental illness or current substance use disorder that would impede the completion of the intervention
* Suicidal individuals deemed at immediate danger or risk (i.e., requiring immediate hospitalization or treatment)
* Women who smoke
* Women who have a metabolic or endocrine disorder.

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5) Total Scores
timeFrame: Baseline to follow-up (follow-up will occur at one-month following the baby's birth)
measure: Baby's Weight at Birth in Pounds/Ounces
timeFrame: Baseline to birth of baby.
measure: Total Gestation Length in Weeks
timeFrame: Baseline to birth of baby.
measure: Baby's APGAR Score at Birth
timeFrame: Baseline to birth of baby.
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina Institute of Psychiatry
state: South Carolina
Study officials:
References:
Clinical trial NCT04159220: Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care
Official title: Randomized Controlled Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Complication
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-11-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intra hospital transport of ICU patients is still at high risk of respiratory complications.We propose to determine if endotracheal tube clamping prior to disconnect ventilator allows to avoid oxygenation decrease.

Detailed description: Changing respiratory support and multiples endotracheal tube disconnections may induce a loss of PEEP and finally lead to alveolar derecruitment. This study is an evaluation of a care procedure to limit the incidence of alveolar derecruitment in ventilated intubated ICU patients during transport for CT scan.

Intra hospital transport of ICU patients are performed by anesthesiologist nurses, the physician entrusts them this activity.

This is a randomized controlled study, the procedure is to clamp endotracheal tube before each disconnection from ventilator.

Eligibility criteria: Inclusion Criteria:

* intensive care patient
* intubated, sedated, controlled assisted ventilation
* Intra hospital transport for CT scan
* arterial catheter
* the patient or his trusted person consent to the study

Exclusion Criteria:

* Patient Covid tests positive or Covid test results not received
* extubated, unsedated,
* reinforced tube
* tracheotomy
* pregnancy
* guardianship

Primary outcomes:
measure: Measure of the pa02/Fi02
timeFrame: 1 hour after the end of the transport
Secondary outcomes:
measure: Assessment of the pa02
timeFrame: 1 hour after the end of the HIT
measure: Assessment of the pa02
timeFrame: immediately after the end of the HIT
measure: Assessment of the pa02
timeFrame: 6 hours after the end of of the HIT
measure: length of stay
timeFrame: up to 28 days
measure: duration of invasive ventilation
timeFrame: up to 28 days
measure: occurrence of adverse events during the HIT
timeFrame: immediately after the end of the HIT
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Departement d'anesthésie et réanimation Gui de Chauliac (DAR C)
Study officials:
References: