louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01776944: Resting Energy Expenditure Using a Handheld Calorimeter
Official title: Validating a Handheld Indirect Calorimeter in Overweight and Obese Pediatric Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Resting energy expenditure
Handheld calorimeter
Obese and overweight
Pediatrics
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 75
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese children aged 13-18y of both gender

Brief summary: High prevalence of obesity in children has increased associated complications such as type 2 diabetes, hypertension and fatty liver disease. Dietitians develop a meal plan that restricts caloric intake by estimating the resting and total daily energy expenditures.Estimation of energy needs is most commonly done using predictive equations. Reliable and valid energy requirements can be obtained using a traditional metabolic system, however this is an expensive option. Handheld indirect calorimeters may be a good alternative to measure energy needs. Several studies have been conducted to determine the validity and accuracy of handheld calorimeters in adults and health children, however, to the best of our knowledge, there are no such studies in the overweight and obese pediatric population.

The purpose of this study is to validate a handheld indirect calorimeter against a traditional metabolic system in overweight and obese children.

If handheld calorimeters can accurately measure resting energy expenditure in overweight and obese adolescents, dietitians will have an opportunity to tailor pediatric weight management interventions based on parameters that are unique to each individual.


Eligibility criteria: Inclusion Criteria:

* 13-18y of age
* BMI 85th percentile or more
* No severe illness, neurological and development issues
* not on insulin
* Able to fast overnight

Exclusion Criteria:

* not 13-18y of age
* BMI under 85th percentile
* ill or have neurological and development issues
* on insulin

Primary outcomes:
measure: Resting Energy Expenditure as measured by the traditional Indirect Calorimeter(metabolic cart) and the handheld indirect calorimeter in standardized conditions
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Child & Family Research Institute
state: British Columbia
Study officials:
affiliation: Child & Family Research Institute/University of British Columbia
name: Rajavel Elango, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woo P, Murthy G, Wong C, Hursh B, Chanoine JP, Elango R. Assessing resting energy expenditure in overweight and obese adolescents in a clinical setting: validity of a handheld indirect calorimeter. Pediatr Res. 2017 Jan;81(1-1):51-56. doi: 10.1038/pr.2016.182. Epub 2016 Sep 21.
Clinical trial NCT06423144: PD-1/PD-L1 Inhibitors and Anti-angiogenic Therapy Combined With/Without TACE/HAIC in Patients With BCLC B/C Hepatocellular Carcinoma Beyond Up-to-7
Official title: A Retrospective Study Comparing Interventional Therapy (TACE/HAIC) Combined With PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Versus PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Alone in the First-line Treatment of Intermediate and Advanced Hepatocellular Carcinoma Beyond up to Seven
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intermediate and advanced hepatocellular carcinoma beyond up to seven

Brief summary: This is a retrospective study that retrospectively included patients with intermediate and advanced HCC beyond up to seven who received first-line treatment with PD-1/PD-L1 inhibitors and anti-angiogenic agents combined with/without TACE/HAIC from January 01, 2019 to December 31, 2023 in the Department of Hepatic Oncology and Department of Liver Cancer Surgery, Zhongshan Hospital, Fudan University.


Eligibility criteria: Inclusion Criteria:

* Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or clinically.
* Patients with Barcelona (BCLC) stage B and C beyond up to seven;
* Have not received any prior systemic therapy for HCC (including: chemotherapy, molecular targeted therapy, immunotherapy);
* Receiving only post-marketing PD-1/PD-L1 inhibitors in combination with anti-angiogenic agents (including, but not limited to, drugs containing hepatocellular carcinoma indications);

  \*The interval between the first use of PD-1/PD-L 1 inhibitors and the use of anti-angiogenic drugs is ≤ 1 week
* TACE was performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment;
* TACE treatment followed by at least 1 cycle of combination therapy, including: cTACE and DEB-TACE;
* There is at least 1 measurable lesion in the liver according to RECIST v1.1 criteria

Exclusion Criteria:

* Cholangiocellular carcinoma, mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or hepatic fibrous laminar carcinoma that has been pathologically/histologically confirmed;
* Patients who do not meet the above definition of combination therapy;
* Patients had malignant tumors other than HCC within 5 years prior to enrollment (except cured limited tumors, including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ)

Primary outcomes:
measure: PFS
timeFrame: Up to 48 months
measure: ORR
timeFrame: Up to 48 months
Secondary outcomes:
measure: OS
timeFrame: Up to 48 months
measure: Safety
timeFrame: Up to 48 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03364244: Revatio Special Investigation for Long-term Use in Pediatric Patients
Official title: Revatio Special Investigation - Investigation for Long-Term Use of Revatio in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Keywords: Revatio
Pulmonary arterial hypertension
Pediatric patients
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-06
Enrollment: 1023
Sex: ALL
Minimum age (years): 0
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients aged 0 to under 15 years who were confirmed to have received Revatio after the approval date of dosage and administration of Revatio for pediatric patients

Brief summary: Secondary data collection study: safety and effectiveness of Revatio in pediatric patients under Japanese medical practice

Detailed description: The objective of this study is to obtain the information on dosage and administration, safety, and efficacy of Revatio when it is administered for a long period of time (1 year) under the actual use after the approval of the dosage and administration in pediatric patients (aged 1 year or older, weighed 8 kg or more) .

Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged 0 to under 15 years who were confirmed to have received Revatio after the approval date of dosage and administration of Revatio for pediatric patients.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Incidence of adverse drug reactions
timeFrame: 1 year (52 week) after observation start date
measure: Effictiveness rate for physician's evaluation of this product
timeFrame: 1 year (52 week) after observation start date
Secondary outcomes:
measure: the dosage and administration under the actual use (including patients under the age of 1 year, weighing below 8 kg)
timeFrame: 1 year (52 week) after observation start date
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Viatris Pharmaceuticals Japan Inc., 5-11-2; Toranomon, Minato-ku
Study officials:
affiliation: Viatris Inc.
name: Rajesh Nachankar
role: STUDY_DIRECTOR
References:
Clinical trial NCT04726644: Evaluation of Surgical Techniques in Cirrhotic Patients With Ventral Hernias
Official title: Ventral Hernias in Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernias in Cirrhotic Patients
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 148
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with liver cirrhosis present with ventral hernias

Brief summary: ventral hernias are defects of the anterior abdominal wall, which can be congenital or acquired including epigastric, umbilical and incisional hernia. Umbilical hernias represent a common surgical problem in cirrhotic patient with ascites with 20% incidence. This work was deigned to assess outcome of different techniques of closure of ventral hernias in cirrhotic patients.

Detailed description: Ventral hernias are defects of the anterior abdominal wall, which can be congenital or acquired including epigastric, umbilical and incisional hernia. Incisional ventral hernia is a frequent complication of laparotomy that occurs in up to 11 % of surgical abdominal wounds

Umbilical hernia represent a common surgical problem in cirrhotic patient with ascites with 20% incidence.Factors that play role in occurance of umbilical hernia in cirrhotic patient with ascites patients is chronic increased intra-abdominal pressure, recanalization of the left umbilical vein, muscle wasting and fascial weakening from nutritional deficiencies (3,4).

Most of interventions for umbilical herniorrhaphy in cirrhotic patients with ascites done in emergency setting due to the concept of high perioperative morbidity and mortality rates in those patients. However, this strategy leads to a high risk of life-threatening complications such as incarceration and skin rupture.

Eligibility criteria: Inclusion Criteria:

* all cirrhotic patients with ventral hernia

Exclusion Criteria:

* hepatic encephalopathy

Primary outcomes:
measure: ventral hernia repair
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01080144: Feasibility of Critical Flicker Frequency Procedure for the Diagnosis of Minimal Encephalopathy
Official title: A Pilot Study Aiming to Assess the Feasibility of Critical Flicker Frequency for the Diagnosis of Minimal Encephalopathy in Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Keywords: Cirrhosis
TIPS (Transjugular intrahepatic portosystemic shunt)
Encephalopathy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2010-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: All patients eligible for TIPS (Transjugular intrahepatic portosystemic shunt) procedure will be considered for inclusion. After written inform consent, psychometric tests in order to calculate the psychometric hepatic encephalopathy (PHES) score, the gold standard for the diagnosis of minimal encephalopathy and critical flicker frequency (CFF) will be performed before the TIPS procedure. After TIPS, patients will be followed during one year and the psychometric test and CFF will be performed every 3 months.

30 patients will be included.

The main endpoint is the success rate of CFF. The secondary end points are

* Correlation between CFF and PHES score
* Performance of CFF and PHES score to predict the occurrence of overt encephalopathy after TIPS procedure
* A sample collection during TIPS procedure is also performed for validation of biomarkers


Eligibility criteria: Inclusion Criteria:

* patients with cirrhosis in whom a TIPS is indicated
* patients have given their informed consent te be included

Exclusion Criteria:

* minor
* pregnant women
* patients who cannot see the red color
* refusal to participate

Primary outcomes:
measure: success rate of Critical Flicker Frequency (CFF) Procedure
timeFrame: before TIPS and every 3 months till one year
Secondary outcomes:
measure: occurrence of encephalopathy
timeFrame: every 3 months till one year after TIPS procedure
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Dr Christophe Bureau
state: Hôpital Rangueil
Study officials:
affiliation: University Hospital, Toulouse
name: Christophe Bureau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berlioux P, Robic MA, Poirson H, Metivier S, Otal P, Barret C, Lopez F, Peron JM, Vinel JP, Bureau C. Pre-transjugular intrahepatic portosystemic shunts (TIPS) prediction of post-TIPS overt hepatic encephalopathy: the critical flicker frequency is more accurate than psychometric tests. Hepatology. 2014 Feb;59(2):622-9. doi: 10.1002/hep.26684.
Clinical trial NCT04440644: Italian Validation of the Beaumont Behavioural Inventory (BBI)
Official title: Validazione Italiana Dello Strumento BBI (Beaumont Behavioural Inventory) Per la Valutazione Delle Alterazioni Comportamentali Nel Paziente Affetto da Malattia Del Motoneurone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS; frontotemporal degeneration; behavioural changes.
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: A.O.U. Città della Salute e della Scienza
First posted: 2020-06-19
Enrollment: 190
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject with amyotrophic lateral sclerosis

Brief summary: Up to 50% of patients affected with amyotrophic lateral sclerosis (ALS) can show behavioral dysfunctions within the spectrum of frontotemporal degenerations (FTD) - namely, apathy, disinhibition, loss of sympathy/empathy, perseverative and stereotyped behaviours, dietary changes \[Strong et al., 2017\].

The Beaumont Behavioural Inventory (BBI) \[Elamin et al., 2017\] is a questionnaire designed for detecting FTD-spectrum behavioural changes in ALS patients. The present study aims at both validating the BBI in an Italian ALS population and determining normative cut-off values of the instrument.


Eligibility criteria: Inclusion Criteria:

* possible, probable or definite ALS according to El Escorial revised criteria

Exclusion Criteria:

* Any other clinically significant cardiovascular, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results

Primary outcomes:
measure: Beaumont Behavioural Inventory
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ICS Maugeri
Study officials:
References:
citation: Iazzolino B, Pain D, Laura P, Aiello EN, Gallucci M, Radici A, Palumbo F, Canosa A, Moglia C, Calvo A, Mora G, Chio A. Italian adaptation of the Beaumont Behavioral Inventory (BBI): psychometric properties and clinical usability. Amyotroph Lateral Scler Frontotemporal Degener. 2022 Feb;23(1-2):81-86. doi: 10.1080/21678421.2021.1946085. Epub 2021 Jul 19.
Clinical trial NCT02871544: Predictive Value of Dynamic Combination of BNP and NGAL for the Prognosis of Patients With Sepsis
Official title: Predictive Value of Dynamic Combination of B-type Natriuretic Peptide and Neutrophil Gelatinase-associated Lipocalin for the Prognosis of Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 28-day Mortality
Sepsis
Keywords: BNP
NGAL
Sepsis
Mortality
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: Objective: to clarify the predictive value of brain natriuretic peptide (BNP) in combination with neutrophil gelatinase associated lipocalin (NGAL) for the prognosis of patients with sepsis.


Eligibility criteria: Inclusion Criteria:

* age ≥18 years and \<85 years;
* presence of severe sepsis according to Survival Sepsis Campaign 10;
* all patients voluntarily joined this study with informed consents.

Exclusion Criteria:

* participated in other trials within 30 days before the criteria for this trial were met;
* expected to die within 24 hours;
* pregnant;
* advanced malignancy with life expectancy \<6 months;
* history of congestive heart failure;
* chronic renal dysfunction (baseline creatinine \>176.8μmol/L); and
* relatives were unwilling to agree to the use of full life support.

Primary outcomes:
measure: patient-ventilator synchrony for 30mins
timeFrame: 30mins after the patients involved
Secondary outcomes:
measure: the numbers of days in the ICU between day 1 and day 28
timeFrame: the numbers of days in the ICU until day 28
measure: Mechanical ventilation duration between day 1 and day 28
timeFrame: days of mechanical ventilation between day 1 and day 28
measure: 28-day mortality
timeFrame: 28 days after the patients involved
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03905044: Clinical Characteristics in Congenital Cataract Eyes
Official title: Clinical Characteristics of Three Pathological Types of Posterior Capsule Abnormality in Congenital Cataract Eyes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Cataract
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 239
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with congenital cataracts

Brief summary: This study involved children with congenial cataract eyes, who underwent cataract surgeries at the Eye Hospital of Wenzhou Medical University (Hangzhou, China). All medical records were reviewed for primary diagnosis. All surgeries were performed by one experienced surgeon (Z.Y.E) and videos were collected for reviews in details. the clinical data after the surgery were also recorded for further analysis.


Eligibility criteria: Inclusion Criteria:

* children with congenital cataracts who underwent cataract surgeries at the Eye Hospital of Wenzhou Medical University (Hangzhou, China)

Exclusion Criteria:

* ocular trauma

Primary outcomes:
measure: complication rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ding X, Xiang L, Wang Q, Wang D, Chang P, Li Z, Zhao Y, Chu F, Ma C, Zhao YE. Clinical Characteristics and Surgical Safety in Congenital Cataract Eyes with Three Pathological Types of Posterior Capsule Abnormalities. J Ophthalmol. 2020 Mar 16;2020:6958051. doi: 10.1155/2020/6958051. eCollection 2020.
Clinical trial NCT04950244: Diagnostic Evaluation of Out-of-hospital High-sensitivity Troponin I in Patients Presenting Chest Pain
Official title: Diagnostic Evaluation of Out-of-hospital High-sensitivity Troponin I in Patients Presenting Chest Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Keywords: High-sensitivity cardiac Troponin I
Troponin I HS
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 800
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: overall population of callers to the emergency dispatch center

Brief summary: Conducting an analysis of the clinical performance of high-sensitivity cardiac troponin I, tested in the out-of-hospital setting, for ruling out cardiac origin in acute onset chest pain.

Acute onset chest pain is a complex symptom to narrow down in the out-of-hospital setting. This is due to the difficulty of obtaining pertinent information over the phone, and the absence of validated dispatch scores or criteria.

In France, the current standard of care relies on the rapid dispatch of Emergency Medical Response Teams along with a physician in patients presenting symptoms evocative of Coronary Artery Disease or Myocardial Infarction.

Typical anginal pain includes retrosternal pressure pain radiating to the jaw, neck, or left arm. Diagnostic work-up includes anamnesis, physical examination, routine blood work, and ECG.

In the absence of signification ST-segment modifications, the gold standard relies on trending serum Troponin T and I in the hospital setting .

This study aims to analyze the clinical performance of high-sensitivity cardiac Troponin I assays (hs-cTnI) in the out-of-hospital setting using a point-of-care device ; Atellica VTLi (Siemens Healthineers)


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Presenting with evocative acute onset chest pain

Exclusion Criteria:

* ECG modifications with ST segment elevations
* Patients for whom anginal origin was excluded in the out-of-hospital setting
* Medical evaluation in a delay inferior to 20 minutes
* Patients without medical insurance
* Pregnant or lactating women
* Patients under reinforced guardianship, minors, patients in hospice care

Primary outcomes:
measure: Clinical performance of hs-cTnI for rule-out of cardiac origin of chest pain in the out of hospital setting
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References:
Clinical trial NCT02391740: Therapeutic Patient Education and Cancer Pain
Official title: THERAPEUTIC PATIENT EDUCATION AND CANCER PAIN
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2015-03-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cancer and pain

Brief summary: Describe the expectations of therapeutic education for patients in management of cancer pain.


Eligibility criteria: Inclusion Criteria:

* Patient with cancer diagnosed for at least one month
* Patient with pain from the tumor or its treatment
* Patients with a life expectancy ≥ 6 months
* Health condition compatible with the requirements of the program (WHO performance scale \< or= 2)
* Age over 18 years
* Patient able to understand, speak and read French
* Absence of cognitive impairment

Exclusion Criteria:

* Primary cancer of the central nervous system or brain metastases
* Disorders of the documented higher functions
* Evolutionary psychiatric pathology
* Drug User
* Abusive alcohol consumption than the WHO recommendations (or 3 glasses of wine per day)
* Refusal to participate

Primary outcomes:
measure: describe the expectations of therapeutic education for patients in management of cancer pain
timeFrame: at inclusion
Secondary outcomes:
measure: Describe the expectations of close person in therapeutic education on management of cancer pain
timeFrame: at inclusion
measure: Estimate the intensity of the pain
timeFrame: at inclusion
measure: Estimate the echo of the pain on the daily activity of the patient
timeFrame: at inclusion
Other outcomes:
Locations:
city: Caen
country: France
facility: centre François Baclesse
Study officials:
References: