louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02081274: Influence of Tidal Volume During Mechanical Ventilation on Postoperative Clinical Outcome in Pediatric Patients Undergoing Congenital Heart Surgery
Official title: Influence of Tidal Volume During Mechanical Ventilation on Postoperative Clinical Outcome in Pediatric Patients Undergoing Congenital Heart Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Who Underwent Surgery for Congenital Heart Disease
Keywords: tidal volume
congenital heart disease
mortality
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 1000
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients who underwent surgery for congenital heart disease with cardiopulmonary bypass

Brief summary: High tidal volume during mechanical ventilation has been reported to increase mortality in patients with acute lung injury or acute respiratory distress syndrome. High tidal volume was also reported to be associated with increased mortality in adult patients without acute lung injury or acute respiratory distress syndrome. However, the influence of high tidal volume on clinical outcome in pediatric patients who underwent surgery for congenital heart disease has not been evaluated yet. The investigators attempted to evaluate the effect of tidal volume on clinical outcome in both cyanotic and non-cyanotic congenital heart disease.

Detailed description: High tidal volume during mechanical ventilation has been reported to increase mortality in patients with acute lung injury or acute respiratory distress syndrome. High tidal volume was also reported to be associated with increased mortality in adult patients without acute lung injury or acute respiratory distress syndrome. However, the influence of high tidal volume on clinical outcome in pediatric patients who underwent surgery for congenital heart disease has not been evaluated yet. The investigators attempted to evaluate the effect of tidal volume on clinical outcome in both cyanotic and non-cyanotic congenital heart disease.

Eligibility criteria: Inclusion Criteria:

* pediatric patients who underwent surgery for congenital heart disease with cardiopulmonary bypass between 2009 and 2013 in Samsung Medical Center

Exclusion Criteria:

* patients who lack data regarding mortality, creatinine, estimated glomerular filtration rate, or urine output.

Primary outcomes:
measure: Patient Mortality
timeFrame: six month after surgery
Secondary outcomes:
measure: Patient Mortality
timeFrame: in-hospital, one-month, and one-year after surgery
measure: acute kidney injury as defined by RIFLE criteria (for Risk, Injury, Failure, Loss, End-stage kidney disease)
timeFrame: during one week after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Ho Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06745674: Online Intervention for Cancer Patients
Official title: Effectiveness of Internet-based Acceptance and Commitment Therapy for Cancer Patients: A Pilot Randomized Controlled Trial Using Mixed Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Centrl China Normal University
First posted: 2024-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will focus on supporting cancer patients who often experience emotional challenges like anxiety and depression. It will test a two-week online program called Acceptance and Commitment Therapy (ACT), designed to help people manage difficult emotions and focus on what matters most in their lives.

The program will include short, easy-to-follow sessions covering helpful strategies like accepting distress and staying present in the moment. Participants will be randomly assigned to either join the ACT program or wait for the program while continuing their usual care. The study aims to determine whether the ACT program can reduce psychological distress, anxiety, and depression in cancer patients. The study will use a mixed-methods approach, combining both quantitative data (such as changes in distress, anxiety, and depression) and qualitative insights from participant interviews. This will help us gain a deeper understanding of how the ACT program may support the psychological distress of cancer patients.


Eligibility criteria: Inclusion Criteria:

* age 18 and above;
* diagnosed cancer with a clear disease course
* fluent in Chinese with the ability to read and understand questionnaires independently;
* ability to operate a smartphone independently;
* not participating in or intervening in other clinical studies.

Exclusion Criteria:

* younger than 18 years of age
* unable to use a smartphone
* have significant cognitive impairment or a serious systemic disease or psychiatric disorder
* concurrently participating in other clinical studies or undergoing other psychotherapy

Primary outcomes:
measure: Feasibility outcomes
timeFrame: Post-intervention (immediately after the 2-week intervention)
measure: Psychological Distress
timeFrame: Baseline, one week post-baseline, and post-intervention (immediately after the 2-week intervention)
measure: Anxiety and Depression
timeFrame: Baseline, one week post-baseline, and post-intervention (immediately after the 2-week intervention)
measure: Acceptability
timeFrame: Post-intervention (immediately after the 2-week intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT04477174: Validity and Reliability of the Turkish Translation of the Yale Pharyngeal Residue Severity Rating Scale
Official title: Validity and Reliability of the Turkish Translation of the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS-T)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Swallowing Disorder
Validation
Pharyngeal Dysphagia
Keywords: Pharyngeal
residue
swallow
scale
Yale
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health professionals

Brief summary: Purpose of the study is the validity and reliability of the Turkish version of the Yale Pharyngeal Residue Severity Rating Scale (YPRSRS-T), so that it would be used as an assessment tool for dysphagia patients.

Detailed description: The swallow function is a multidirectional process that depends on complex neuro-muscular network. The function can be evaluated using instrumental, such as fibreoptic endoscopic evaluation of swallowing (FEES), videofluoroscopy, or well structured scales. There are many questionnaire and scales for assessment of swallow but very few have been validated. The study will assess the construct validity and reliability of the Turkish version of Pharyngeal Residue Severity Rating Scale as known as Yale Pharyngeal Residue Severity Rating Scale.

Eligibility criteria: Inclusion Criteria:

* 18-70 years
* at least having undergraduate education on health profession
* agree to participant

Exclusion Criteria:

* out of age 18-70 years
* out of having undergraduate education
* mental disorder
* cognitive limitations
* visual limitations

Primary outcomes:
measure: Validation of Pharyngeal Residue Severity Rating Scale
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof Dr Cemil Tascioglu City Hospital
Study officials:
affiliation: University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital
name: Melis Ece Arkan Ararat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health Sciences, Prof Dr Cemil Tascioglu City Hospital
name: Ugur Uygan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06626074: Exploratory Study of MRI Biomarkers of NASH
Official title: Exploratory Study of MRI Biomarkers of NASH
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease NAFLD
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: University Angers
First posted: 2024-10-03
Enrollment: 60
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: Metabolic steatosis disease (NAFLD) is a rapidly growing disease in the world, particularly in industrialized countries.

NAFLD is defined by the presence of fatty liver disease. This is a reversible phenomenon that can be estimated by non-invasive means, such as ultrasound. Non-invasive quantification, on the other hand, requires MRI.

Nonalcoholic steatohepatitis (NASH) is the aggressive form of the disease that promotes the accumulation of fibrosis in the liver, which can progress to cirrhosis and its complications.

Currently there is no non-invasive biomarker of NASH and the diagnosis is based solely on liver biopsy.

There is therefore a need for non-invasive biomarkers of NASH in patients with steatosis to diagnose NASH without the use of liver biopsy.


Eligibility criteria: Inclusion Criteria:

* Patient included in the SNIFF cohort of the Angers hospital where there is a suspicion of NASH requiring a biopsy for which an MRI is requested by a hepatologist as part of the initial assessment of the disease.
* Adult patient
* Free, informed and express (oral) consent of the patient to participate in the study

Exclusion Criteria:

* Contraindication to MRI
* Time between the establishment of the Steatosis/NASH status and the MRI greater than 3 months
* Pregnant, parturient and breastfeeding woman
* Person deprived of liberty by judicial or administrative decision
* Person under compulsion to psychiatric care
* Person subject to a legal protection measure
* Person not affiliated or not covered by a social security scheme.

Primary outcomes:
measure: Evaluation of the diagnostic performance of new MRI biomarkers for NASH diagnosis
timeFrame: the outcome measurment is performed once during MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital, Angers
Study officials:
affiliation: University Hospital, Angers
name: Anita PAISANT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03808974: An Educational Video to Improve Patient Comprehension of Midurethral Sling
Official title: An Educational Video to Improve Patient Comprehension of Midurethral Sling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Knowledge, Attitudes, Practice
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
First posted: 2019-01-18
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research project is to test the effectiveness of a previsit educational video designed to help women understand the risks and benefits of a midurethral sling for treatment of stress urinary incontinence. A total of 38 participants will be recruited from both the Urogynecology pre-operative clinic of the university of California, Irvine Medical Center and the Urogynecology pre-operative clinic at Kaiser Permanente, Anaheim and Orange County. Participants will be randomized either to watch a 10 minute educational video (intervention group) or read a standard handout describing the midurethral sling (control group). Participants will then complete their pre-operative visit in the usual fashion. Participants will complete a pre- and post- intervention knowledge questionnaire to assess the primary outcome (change in knowledge before and after intervention). Participants will repeat the knowledge questionnaire and complete validated questionnaires for satisfaction with decision scale and decision regret at 2 and 6 weeks post-operative.


Eligibility criteria: Inclusion Criteria:

* Women scheduled for a mid-urethral sling for stress urinary incontinence with a urogynecology provider at a participating hospital

Exclusion Criteria:

* \< 18 years of age
* Non-English speaking or requiring interpreter assistance
* Presence of cognitive dysfunction
* Women receiving a repeat midurethral sling (not primary)
* Women with a history of pelvic mesh complication (erosion, pain, history of mesh excision)
* Pregnant women

Primary outcomes:
measure: Patient knowledge questionnaire (investigator-created)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Felicia Lane, MD
role: STUDY_DIRECTOR
References:
citation: Jeney SES, Whitcomb EL, Ihara J, Guaderrama N, Mukhtar F, Heliker BD. A Randomized Controlled Trial Evaluating the Effect of an Educational Video on Patient Understanding of Midurethral Sling. Female Pelvic Med Reconstr Surg. 2022 Mar 1;28(3):e73-e79. doi: 10.1097/SPV.0000000000001154.
Clinical trial NCT00969774: Facial Type Determination Through Cephalometry, Anthropometry and Facial Analysis
Official title: Facial Type Determination Through Ricketts Cephalometric Analysis, Anthropometric Measurements, Indices and Proportions and Facial Analysis Performed by Means of Photographs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Face
Cephalometry
Anthropometry
Photography
Diagnosis
Adult
Morphology
Comparative Study
Lead sponsor: Pontificia Universidade Catolica de Sao Paulo
Sponsor class: OTHER
First posted: 2009-09-01
Enrollment: 105
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: primary care orthodontic clinic

Brief summary: Introduction:

Human face with its bony and muscular structures has singular and peculiar characteristics. It may be classified in three types, associated with the variation of shape and craniofacial configuration, both in vertical and horizontal planes, directly affecting dental occlusion, face harmony, orofacial musculature and oral functions. Aim: to correlate cephalometric with anthropometric and facial analysis findings on determining the facial type.

Method:

105 leukoderm adults were involved, 34 male and 71 female aging between 20 and 40 years old. Data were collected in December 2006 in an orthodontic clinic located at Belo Horizonte- MG, Brazil. Cephalometric findings to determinate facial types were compared to seven anthropometric facial measurements, three anthropometric facial proportions and three anthropometric facial indices, in addition to facial type identification through clinical facial analysis of photographs.


Eligibility criteria: Inclusion Criteria:

* to have Ricketts cephalometric analysis

Exclusion Criteria:

* to have been submitted on orthognathic surgery
* black or asian people

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pontifícia Universidade Católica de São Paulo
name: Rossana R Ramires, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01649674: Comparison of Bowel Cleansing Regimens Prior to Colonoscopy
Official title: PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Patients Undergoing Elective Colonoscopy
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to to compare two bowel preparation regimens of patients who will undergo colonoscopy, in terms of quality of bowel preparation and in terms of patient satisfaction.


Eligibility criteria: Inclusion Criteria:

• Subjects who are candidate to undergo colonoscopy: Diagnosis Screening Follow-up after previous polypectomy

* Informed consent
* Age \> 18 years

Exclusion Criteria:

* Previous colonic resection
* Severe inflammatory bowel disease (IBD)

Primary outcomes:
measure: Boston Bowel Preparation Scale value
timeFrame: at time of colonscopy
measure: patient reported acceptability score
timeFrame: just prior to colonscopy
Secondary outcomes:
measure: percent of bowel cleansing regimen dose assumed as reported by patient
timeFrame: just prior to colonoscopy
Other outcomes:
Locations:
city: Marsicovetere
country: Italy
facility: Presidio Ospedaliero Villa d'Agri
city: Milano
country: Italy
facility: AO Fatebenefratelli ed Oftalmico
city: Napoli
country: Italy
facility: A.O.U. Seconda Universita di Napoli
city: Napoli
country: Italy
facility: Clinica Mediterranea
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: Presidio Ospedaliero Ascalesi
city: Torre del Greco
country: Italy
facility: Presidio Ospedaliero Maresca
Study officials:
affiliation: National Cancer Institute, Naples
name: Valentina D'Angelo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Mario de Bellis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06917274: The Banana Exercise Type 1 Diabetes Study
Official title: Effects of Pre-Exercise Banana Consumption on Glycemic Control in Individuals With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Keywords: nutrition
CGM
blood glucose
exercise
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2025-04-08
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Former and current KADET athletes participate in two controlled training sessions: one with a banana 20 minutes pre-exercise and one without. Tandem Data recorded includes sensor glucose, training details, insulin dosing, and meal intake. Continuous glucose monitoring (CGM) data is assessed. Endpoints include differences in glucose levels, hypoglycemia events (SG \<3.9 mmol/L), and Time in Range during training

Detailed description: Participants:

Former and current KADET athletes invited via a Facebook group. Previous participants in study projects who have expressed interest in being contacted for future studies.

Protocol:

Participants provide written consent for data collection and use.

Each participant completes two training sessions under controlled conditions, including:

Same training time Standardized pre-training meal timing and insulin corrections Similar intensity and environmental factors If pre-training hypoglycemia occurs, training is rescheduled or corrected with glucose tablets, which are documented.

Study Conditions:

Session 1: Participant eats a banana 20 minutes before training. Session 2: No pre-training food intake.

Tandem Control IQ users (insulin pump) take a microbolus (0.05 IE) before banana intake.

Recorded Data by participant:

Training start and end times Sensor glucose (SG) at start and end of training Training type and intensity (Borg scale, heart rate monitoring) Last insulin dose (meal and correction) Last meal details (content and timing) Banana documentation (photo, weight with peel, ripeness level)

CGM data are also assessed.

Endpoints:

Differences in GCG glucose level Time to hypoglycemia and number of hypoglycemia events (SG \<3.9 mmol/L) on banana vs. non-banana days.

Percentage of Time in Range during training. Additional data is reported as available.

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes

Exclusion Criteria:

* cardiovascular comorbidity
* neuropathy

Primary outcomes:
measure: CGM glucose
timeFrame: approximately 60 minute monitoring period during exercise
Secondary outcomes:
measure: Time to hypoglycemia
timeFrame: approximately 30 to 30 minutes
measure: Borg scale
timeFrame: Borg scale is assessed approximately 15 minutes after exercise
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00711074: Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers
Official title: An Open-Label, Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of [14C]AZD5672 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: pharmacokinetics
mass balance
radiolabel
AZD5672
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 4
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.


Eligibility criteria: Inclusion Criteria:

* Body Mass index (BMI) 18-30 kg/m2, inclusive.
* Clinically normal findings in physical examination, ECG, vital signs, clinical chemistry, haematology \& urinalysis, as judged by the investigator

Exclusion Criteria:

* Healthy volunteers who have been exposed to radiation levels above background (eg through X-ray examination) of \>5 mSv in the last year, \>10 mSv over the last 5 years or a cumulative total of \>1 mSv per year of life
* Clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator
* Use of prescribed medication (including St. John's Wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)

Primary outcomes:
measure: total radioactivity in plasma, whole blood, faeces and urine.
timeFrame: Pre-dose, post dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240h
measure: Additional metabolite identification
timeFrame: 0.5h, 3h, 6h, 12h, 24h
Secondary outcomes:
measure: general safety assessments: AE reporting, physical examination, ECG, safety haematology and clinical chemistry assessment, vital signs
timeFrame: Screening, pre-dose, Visit 2 (residential period) and visit 3 follow up
Other outcomes:
Locations:
city: Macclesfield
country: United Kingdom
facility: Research Site
state: Cheshire
Study officials:
affiliation: AstraZeneca
name: Mark Layton
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Raj Chetty
role: PRINCIPAL_INVESTIGATOR
References: