louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03409042: Caloric Compensation in Infants
Official title: Caloric Compensation in Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Self Regulation
Eating Behavior
Infant Behavior
Keywords: Caloric compensation
Lead sponsor: Centre des Sciences du Goût et de l'Alimentation
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 98
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment was conducted using leaflets distributed in health professionals' consulting rooms, an internal database (Chemosens Platform's PanelSens, CNIL n°1148039) and with the help of a recruitment agency.

Brief summary: The aim of this study is, first, to describe the evolution of the caloric compensation ability in infants from 3 to 15 months old and, secondly, to assess the links between changes in the caloric compensation ability and the individual characteristics (adiposity, age, gender, infant's eating behavior) and maternal feeding practices.

Three series of measurements of caloric compensation abitlity were conducted: at 3-4 months old, at 10.5 months old and at 14.5 months old in the laboratory.

In this study, a preload paradigm usually employed in children and adults to measure the caloric compensation ability was adapted to infants below 15 months old. The maternal eating behavior and their feeding practices were measured by questionnaires. The infants' height and weight were measured at the laboratory by trained experimenters.


Eligibility criteria: Inclusion Criteria:

* no chronic health problem or food allergies
* not having been fed with hydrolysate formula
* gestational age ≥ 37 weeks
* born weight ≥ 2.5kg
* without having being tube fed at any moment

Exclusion Criteria:

* infants from diabetic mothers
* infants from mothers having celiac disease
* infants from minor parents (\<18 years old) were excluded

Primary outcomes:
measure: COMPX score
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Birch, L.L. and M. Deysher, Conditioned and unconditioned caloric compensation: evidence for self regulation of food intake in young children. Learning and Motivation, 1985. 16: p. 341-355.
citation: Brugailleres P, Chabanet C, Issanchou S, Schwartz C. Caloric compensation ability around the age of 1 year: Interplay with the caregiver-infant mealtime interaction and infant appetitive traits. Appetite. 2019 Nov 1;142:104382. doi: 10.1016/j.appet.2019.104382. Epub 2019 Jul 23.
citation: Brugailleres P, Issanchou S, Nicklaus S, Chabanet C, Schwartz C. Caloric compensation in infants: developmental changes around the age of 1 year and associations with anthropometric measurements up to 2 years. Am J Clin Nutr. 2019 May 1;109(5):1344-1352. doi: 10.1093/ajcn/nqy357.
Clinical trial NCT05027542: Comparison of Distally Based Sural Artery and Supramalleolar Flap for Coverage of Dorsum of Foot and Ankle Defects
Official title: Comparison of Distally Based Sural Artery and Supramalleolar Flap for Coverage of Dorsum of Foot and Ankle Defects; A CROSS-SECTIONAL STUDY OF 53 PATIENTS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Wound of Lower Limb
Keywords: Soft Tissue Injuries, fasciocutaneous flaps, Survival Rate
Lead sponsor: Aga Khan University Hospital, Pakistan
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 53
Sex: ALL
Minimum age (years): 2
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data of all those patients was collected who underwent reconstruction of soft tissue defects of foot and ankle with Supramalleolar and sural artery flaps between 1996 and 2020. The data of these patients were collected from the Hospital inpatient management system and review of medical records through a structured proforma that included demographic variables, cause of soft tissue defects (secondary to open fractures, following debridement of chronic infected wounds, tumor excision and defects following release of scar contractures), side of defects, size and type of flap (supramalleolar or sural artery), complications and long-term outcome of the flap.

Brief summary: Our main aim for this study was to evaluate the long-term outcome comparisons between sural artery and Supramalleolar flap in the reconstruction of extensive defects of non-weight bearing regions of foot and ankle. The patients' information were collected through medical records and analyzed through SPSS

Detailed description: In this article we intend to present our experience comparing a series of the two types of flaps in terms of viability, coverage of defect, cosmetic appearance, and functions of foot and ankle based on self-designed Tool . This Tool contains 4 parameters i.e., Activity of daily living, coverage of defect, cosmetic appearance of Skin post flap, and Weight bearing status. A score was given to each parameter and on the basis of these scores, Long term outcome were analyzed of each patient

Eligibility criteria: Inclusion Criteria:

* Only defects of foot and ankle around dorsum and perimalleolar areas were included.

Exclusion Criteria:

* The defects reconstructed with other local flaps and free flaps were excluded from this review

Primary outcomes:
measure: self-designed assessment tool
timeFrame: 1996-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Agha Khan University Hospital
state: Sindh
Study officials:
affiliation: Agha Khan University Hospital
name: Pervaiz Hashmi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05213442: Liver Status in Psychiatric Inpatients
Official title: Liver Status in Psychiatric Inpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric Illness
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2022-01-28
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric, non randomized, non comparative cross-sectional study
Primary purpose: DIAGNOSTIC

Brief summary: Adults hospitalized in psychiatry have an increased frequency of somatic disorders, in particular various liver diseases (viral hepatitis, non-alcohol related liver steatosis, alcohol related liver disease).

The evaluation of these liver disorders in psychiatric inpatients remains very little explored in France, contributing to the poor overall medical status of psychiatric patients.

The LIVERSPIN study aims to estimate the prevalence rates of liver pathologies in psychiatric inpatients and to explore the factors associated with the existence of a liver pathology

Detailed description: The LIVERSPIN study aims to estimate the prevalence rates of liver disease in psychiatric inpatients and to explore factors associated with the existence of liver disease.

All hospitalized patients can potentially be recruited. They will benefit from the usual clinical and paraclinical examinations as part of their hospitalization diagnostic work-up. For the determination of biological analyses, a blood sample will be taken following inclusion as well as a Fibroscan examination.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years old
* Social insurance
* Current hospitalization in any psychiatric unit of the participating center
* Adult or legal representative who has given written and informed consent to participate in the study. By default, the oral consent of the adult will be obtained (as well as the written consent of the legal representative)
* Information given to the curator(for people under curatorship)

Exclusion Criteria:

* - Clinical state of the patient which do not allow the collection of study data (according to the investigator)

Primary outcomes:
measure: HCV diagnosis
timeFrame: At inclusion
Secondary outcomes:
measure: HBV diagnosis
timeFrame: At inclusion
measure: HIV diagnosis
timeFrame: At inclusion
measure: Suspicion of NAFLD
timeFrame: At inclusion
measure: Suspicion of alcoholic liver disease
timeFrame: At inclusion
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier Le Vinatier
state: Auvergne Rhone Alpes
Study officials:
affiliation: CH LE VINATIER
name: Benjamin ROLLAND, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02266342: GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry
Official title: Evaluation on the Treatment of Diseases of the Thoracic Aorta With the Thoracic Endoprosthesis GORE® TAG®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Thoracic
Descending Thoracic Aortic Dissection
Aortic Diseases
Aorta Thoracic; Traumatic Rupture
Penetrating Ulcer
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2014-10-17
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with a disease of the descending thoracic aorta, requiring treatment with a thoracic endoprosthesis.

Brief summary: This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.

Detailed description: Endovascular therapy to treat thoracic disease seems to provide a plausible benefit compared to surgery in terms of operative mortality and severe morbidity. The French National Health Authority (HAS) requires a 5-year follow-up as part of the renewal of reimbursement for these endoprostheses in order to collect long-term follow-up data under real-life conditions of use.

Eligibility criteria: Inclusion Criteria:

* Patient where a GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis is implanted (successfully or not) for the treatment of disease of the descending thoracic aorta.
* Patient who had previously consented to the collection and processing of personal medical data.
* Patient older than 18 years at the time of treatment.

Exclusion Criteria:

* Patients who have already received treatment with a thoracic endoprosthesis other than the GORE® TAG® or Conformable GORE® TAG® Thoracic Endoprosthesis and for whom 'revision' or reintervention is required.
* Patients whose clinical follow-up is not possible (i.e. patients who cannot return for control visits because they live abroad).

Primary outcomes:
measure: Number of Subjects With All-cause Mortality (Long-term)
timeFrame: 5 years
Secondary outcomes:
measure: Number of Subjects With Excluded Aneurysm, Penetrating Aortic Ulcer (PAU), False Lumen or Site of Rupture
timeFrame: 5 years
measure: Number of Subjects With Neurological Complications
timeFrame: 5 years
measure: Number of Subjects With Cardiac, Renal, and Pulmonary Complications
timeFrame: 5 years
measure: Number of Subjects With Device-related Complications
timeFrame: 5 years
measure: Number of Subjects With Surgical Conversion
timeFrame: 5 years
measure: Number of Subjects With Secondary Procedures
timeFrame: 5 years
measure: Number of Subjects With Disease Related Mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hopitaux Universitaire de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaire de Strasbourg
name: Nabil Chakfé, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01604642: Role of Activin A (ActA) in the Human Cancer Cachexia
Official title: Role of Activin A (ActA) in the Human Cancer Cachexia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lung Cancer
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2012-05-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the investigators study is to investigate the role of a hormone named Activin A (ActA) in the development of the skeletal muscle atrophy caused by cancer. According to the investigators hypothesis, ActA could be released by the tumor and activate a muscle atrophy gene program. To answer this question, the investigators plan first to compare circulating levels of ActA in cancer patients with and without cachexia. In a second step, the investigators would like to assess whether ActA circulating levels are predictive for the development of cachexia and short survival.


Eligibility criteria: Inclusion Criteria:

* 18-year-old or older
* Colorectal or lung cancer demonstrated by histology or cytology
* New diagnosis or new recurrence
* Expected survival more than 3 months
* No previous history of other cancer in the last 5 years
* No pregnancy or lactation
* Signed informed consent

Exclusion Criteria:

* Non-caucasian
* Major digestive malabsorption
* Major depression
* Artificial nutrition
* Height doses of steroids (\>1 mg/kg hydrocortisone equivalent)
* Hyperthyroidism
* Other causes of malnutrition
* Expected survival less than 3 months
* Severely impaired walking
* Anticoagulants or antiplatelet therapy
* Disability or medical condition which might prevent the compliance to the protocol
* Any conditions which may prevent the compliance to the protocol
* Performance status ECOG \> ou = 4
* Participation to other clinical studies

Primary outcomes:
measure: Circulating Activin A level
timeFrame: 2 years
Secondary outcomes:
measure: Dietary assessment measured by SNAQ score and 3-Day intake
timeFrame: 2 years
measure: Body mass index
timeFrame: 2 years
measure: Mid arm muscle circumference calculated by the triceps skinfold and the mid arm circumference
timeFrame: 2 years
measure: Body composition measured by bioimpedance
timeFrame: 2 years
measure: Muscle strength as measured by grip strength
timeFrame: 2 years
measure: Quality of life as assessed using the QLQ-C30
timeFrame: 2 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
References:
citation: Loumaye A, de Barsy M, Nachit M, Lause P, Frateur L, van Maanen A, Trefois P, Gruson D, Thissen JP. Role of Activin A and myostatin in human cancer cachexia. J Clin Endocrinol Metab. 2015 May;100(5):2030-8. doi: 10.1210/jc.2014-4318. Epub 2015 Mar 9.
Clinical trial NCT00564642: Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity
Official title: Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis
Tuberculosis
Lead sponsor: National Research Institute of Tuberculosis and Lung Disease, Iran
Sponsor class: OTHER_GOV
First posted: 2007-11-28
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Tuberculosis is one of the major health problems in developing countries. Isoniazid, rifampin and pyrazinamide, the first line drugs used for tuberculosis chemotherapy, are associated with hepatotoxicity. The rate of hepatotoxicity has been reported to be much higher in developing countries compared to that in advanced countries with a similar dose schedule. Oxidative stress has proposed as one of the mechanisms responsible for anti-tuberculosis drugs induced hepatic injury. The oxidative stress is closely associated with decrease of glutathione levels. In the present study N acetylcysteine, a precursor of glutathione, was investigated for hepatoprotective effect against anti-tuberculosis drugs induced liver injury.


Eligibility criteria: Inclusion Criteria:

* Two sputum specimens positives for tubercle bacilli on direct smear microscopy
* No previous anti-TB chemotherapy higher than two weeks
* Aged 60 years and over
* Agreement to participate in the study

Exclusion Criteria:

* Alcohol consumption
* Viral disease (Hepatitis,...)
* Abnormal pretreatment LFT level
* Chronic disease (liver and kidney disease, asthma,...)
* Additional hepatotoxic drug use
* HIV positive
* Liver TB
* Patient in a moribund state
* Hemoptysis

Primary outcomes:
measure: Hepatotoxicity
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Research Institute of Tuberculosis and Lung Disease (NRITLD)
Study officials:
affiliation: National Research Institute of Tuberculosis and Lung Disease (NRITLD)-Shaheed Beheshti University of Medical Sciences
name: Shadi Baniasadi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03780842: Effect of Changing Levels of Neurally Adjusted Ventilatory Assist (NAVA) in Newborns
Official title: Effect of Changing Levels of Neurally Adjusted Ventilatory Assist (NAVA) on Respiratory Parameters in Newborns Receiving NAVA Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Morbidity
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 21
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, interventional, exploratory study in a convenience sample
Primary purpose: SUPPORTIVE_CARE

Brief summary: To examine the effect of changing levels of support during NAVA-ventilation ("NAVA-level") on electrical diaphragm activity of the newborn on invasive or non-invasive NAVA ventilation.

The aim is to explore whether a so-called 'breakpoint', as defined in previous studies on NAVA ventilation in adults and children(1, 9), can be determined in newborn infants. Knowledge of this breakpoint will be used to optimise the settings of NAVA level at initiation of invasive or non-invasive NAVA ventilation.

This is an explorative study conducted in preparation of a randomized controlled trial that is planned in the near future to compare the effects of non-invasive NAVA with nasal continuous positive airway pressure (CPAP) in newborn infants.


Eligibility criteria: Inclusion Criteria:

* Newborns admitted to the NICU in need for respiratory support and put on invasive or non-invasive NAVA by the attending physician. Patients will be included when they are clinically stable and within 24h after starting NAVA or nivNAVA.

Exclusion Criteria:

* - Congenital malformations of the diaphragm or respiratory system, including congenital diaphragmatic hernia.
* Patients with abnormalities of the upper airway (e.g. vocal cord paralysis, post-extubation laryngeal edema, Pierre-Robin sequence...).
* More than 20% of time spent in back-up ventilationWhen a patient on NAVA ventilation is apneic for a certain period of time (apnea time), the ventilator switches tot backup-ventilation. Backup-ventilation is pressure controlled, the apnea time can variate between 2 and 10 seconds.
* Clinically unstable patients:
* hemodynamic instability as defined by need of inotropic support or
* rapid respiratory deterioration on NAVA ventilation.
* No informed consent.

Primary outcomes:
measure: Optimal NAVA level to unload the diaphragm
timeFrame: 24 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
References:
citation: Lefevere J, Van Delft B, Vervoort M, Cools W, Cools F. Non-invasive neurally adjusted ventilatory assist in preterm infants with RDS: effect of changing NAVA levels. Eur J Pediatr. 2022 Feb;181(2):701-707. doi: 10.1007/s00431-021-04244-3. Epub 2021 Sep 17.
Clinical trial NCT01475942: Probiotic Intervention With Elderly Subjects
Official title: Randomized Placebo Controlled Study to Assess the Effect of a Probiotic Supplement on the Subclinical Levels of Intestinal C. Difficile Among Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intestinal C. Difficile
Keywords: elderly
probiotic
bowel function
pathogen
constipation
diarrhoea
Subclinical levels
Lead sponsor: Danisco
Sponsor class: INDUSTRY
Collaborators: name: University of Turku
First posted: 2011-11-22
Enrollment: 104
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study objective is to evaluate the effect of probiotic on faecal Clostridium difficile levels of elderly subjects.

Detailed description: The study objective is to evaluate the effect of a probiotic Lactobacillus strain in lowering the levels of Clostridium difficile in the intestine of elderly subjects. In addition, the nutritional and general health status will be assessed using validated health related questionnaires. Bowel function and prevalence of infections will be followed throughout the intervention period. The study population consists of elderly home inhabitants. The study will be conducted as a double-blind placebo-controlled trial.

Eligibility criteria: Inclusion Criteria:

* elderly subjects
* no acute infection at recruitment

Exclusion Criteria:

* antibiotic treatment 1 month prior to beginning of study
* less than 6 month life expectancy

Primary outcomes:
measure: Change in level of faecal Clostridium difficile
timeFrame: 0 weeks, 8 weeks, 16 weeks
Secondary outcomes:
measure: Change in nutritional status
timeFrame: 0 weeks, 16 weeks
measure: Change in quality of life
timeFrame: 0 weeks, 16 weeks
measure: Change in levels of other intestinal pathogens than C. difficile
timeFrame: 0 weeks, 8 weeks, 16 weeks
measure: Change in bowel function
timeFrame: 0 weeks, 16 weeks
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Elderly Home Kerttuli
Study officials:
affiliation: Danisco
name: Sampo Lahtinen, PhD
role: STUDY_CHAIR
affiliation: Danisco
name: Anna Lyra, PhD
role: STUDY_DIRECTOR
affiliation: University of Turku
name: Matti Viitanen, MD
role: PRINCIPAL_INVESTIGATOR
References: