louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03359044: Bronchoscopy Anesthesia and Neuropsychological Assessment in Children (BANACH) Study
Official title: Bronchoscopy Anesthesia and Neuropsychological Assessment in Children (BANACH) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumonia
Atelectasis
Cough
Keywords: Fiberoptic bronchoscopy
Neuropsychological Development
general anesthesia
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 290
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (1)Age 4-10Years;(2)ASAⅠ～Ⅱ;(3)Plan to accept fiberoptic bronchoscopy treatment;(4) lives in the city where the research unit is located;(5)signed informed consent

Brief summary: Fiberoptic bronchoscopy plays a very important role in the diagnosis and treatment of respiratory diseases in children.In China,this procedure is mainly performed under two different anesthesia methods：sedation and general anesthesia(GA) . Which is better ? there are still a lot of controversies . Several early retrospective studies suggest that, in addition to the possible increase in costs, general anesthesia in intraoperative complications, postoperative recovery and other aspects did not bring significant improvement. But clinically we observed that children under sedation often can not cooperate, they often shows anxiety,restless,crying,and so on, under these situation, some restraint measures may be used, which may have an impact on the child's neuropsychological development. Therefore ,we design this study ,aiming to compare the influence between sedation and general anesthesia (GA) on children 's neuropsychological development.


Eligibility criteria: Inclusion Criteria:

* Age 4-10 years
* American society of anesthesiologists(ASA) gradeⅠ～Ⅱ
* Plan to accept fiberoptic bronchoscopy treatment
* lives in the city where the research unit is located
* signed informed consent

Exclusion Criteria:

* preterm infants less than 28 weeks of gestational age or preoperative screening found that development, cognitive or behavioral abnormalities
* known congenital malformations may have a potential impact on the development of children's neuropsychological function
* known to have central nervous system disorders or meet the diagnostic criteria of Diagnostic and Statistical Manual(DSM) mental illness
* children with contraindications to intravenous general anesthesia

Primary outcomes:
measure: The detection rate of abnormal behavior in both groups
timeFrame: Three years after operation
Secondary outcomes:
measure: Full Scale Intelligence Quotient (FSIQ) Score of the Wechsler Intelligence Scale for Children (WISC)-IV
timeFrame: Three years after operation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01230944: Conventional Nissen Fundoplication Versus Laparoscopic Nissen Fundoplication
Official title: Conventional Nissen Fundoplication vs. Laparoscopic Nissen Fundoplication: a Prospective Randomized Study, Long-term Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: GERD
Keywords: GERD
LNF
CNF
Laparoscopic Nissen fundoplication
Open Nissen fundoplication
Antireflux surgery
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2010-10-29
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a long-term follow-up of a prospective randomized trial comparing open and laparoscopic Nissen fundoplication.


Eligibility criteria: Inclusion Criteria:

* moderate / severe gastrointestinal reflux disease (GERD) requiring operative treatment

Primary outcomes:
measure: Subjective symptomatic outcome
timeFrame: 15 years
Secondary outcomes:
measure: Endoscopic evaluation of the fundoplication result
timeFrame: 15 years
measure: Reoperation rate
timeFrame: 15 years
measure: Postoperative proton pump inhibitor (PPI) use
timeFrame: 15 years
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Paulina Salminen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03035344: Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia (ALL)
Official title: Study of the Intermediate Metabolism in Children With Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Metabolism Disorder
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children diagnosed with acute lymphoblastic leukemia

Brief summary: Study of the intermediate metabolism in children diagnosed with ALL compared to healthy matched controls.

Detailed description: The primary cause of this study is to investigate the changes that ALL may cause to the metabolome of pediatric patients, in order to better understand its mechanism of action and target metabolic pathways for potential therapies.

Eligibility criteria: * Sex: all
* Minimum age: 1 year
* Maximum age: 16 years
* The study accepts healthy volunteers as matched controls for the patinets.
* Inclusion criteria: 1)Children diagnosed with ALL 2) Diagnosis confirmed with bone marrow biopsy 3) Sampling before the initiation of therapy 4) Informed consent signed
* Exclusion Criteria: 1) Children with a known chronic illness before ALL diagnosis 2) ALL remission 3) Not signed informed consent
* Population description: Patients are recruited from the Pediatric Hematology/Oncology Department of Aristotle University of Thessaloniki (AHEPA hospital) and from the Pediatric Hematology/ Oncology Department of Ippokration Hospital, that host all children diagnosed with ALL in nothern Greece. Matched controls are recruited from outpatient clinic of the 2nd and 4th Pediatric Department of Aristotle University of Thessaloniki.
* Sampling method: Non-probability sample

Primary outcomes:
measure: Difference in measurement of aminoacids and organic acids between ALL patients and healthy matched controls.
timeFrame: Up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Athanassios Evangeliou, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT01580644: Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers
Official title: Bioavailability Study of Two Formulations of the Isopropyl Malonate Prodrug of GLPG0187 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2012-04-19
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the amount of GLPG0187 present in the blood (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy subjects.

Two formulations of the GLPG0187 prodrug will be compared, as well as the effect of food and dose proportionality of the best formulation.

Furthermore, during the course of the study, safety and tolerability will be characterized.


Eligibility criteria: Inclusion Criteria:

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking

Primary outcomes:
measure: The amount of GLPG0187 in plasma over time after a single oral dose of either of 2 formulations of GLPG0187 prodrug
Secondary outcomes:
measure: The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug with food
measure: The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug at a higher dose (with or without food)
measure: Number of adverse events
measure: Changes in vital signs as measured by heart rate, blood pressure and body temperature
measure: Changes on 12-lead ECG measures
measure: Changes in physical exam measures
measure: Changes in blood and urine safety lab parameters
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Eva Vets, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05397444: Handgrip Strength (HGS) With HGS Asymmetry Are Associated With All-cause Mortality and Hospital Readmissions
Official title: Handgrip Strength (HGS) With HGS Asymmetry is Associated With All-cause Mortality and Hospital Readmissions Among Elderly Patients With Gastric Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 342
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly patients with gastric cancer

Brief summary: Adding the handgrip strength (HGS) asymmetry to the existing measurements of low HGS may improve the assessment of muscle function.

Detailed description: We sought to explore the associations between maximal HGS with HGS asymmetry and mortality, hospital readmissions, total complications, and prolonged length of stay (PLOS) among elderly patients with gastric cancer.

Eligibility criteria: Inclusion Criteria:

* with gastric cancer
* aged ≥60 years
* were scheduled to undergo radical surgery for the first time

Exclusion Criteria:

* received preoperative radiotherapy or chemotherapy
* combined with other types of malignant tumors

Primary outcomes:
measure: All-cause mortality
timeFrame: about 3 months
measure: Hospital readmissions
timeFrame: about 3 months
Secondary outcomes:
measure: Total complications
timeFrame: about 3 months
measure: prolonged length of stay
timeFrame: about 3 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing medical university
Study officials:
affiliation: Nanjing Medical University
name: xueyi miao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01208844: Study of Physical Health for Women With Posttraumatic Stress or Depression
Official title: Cardiovascular Risk in Relation to Posttraumatic Stress Disorder in Young Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Stress, Psychological
Depression
Posttraumatic Stress Disorders
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-09-24
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample, psychology clinics

Brief summary: The purpose of this study is to obtain a better understanding of how stress is related to health risks.

Detailed description: Participants complete up to two study visits of approximately 3-4 hours each. The first study visit involves an interview about life experiences and emotions. If the participant is eligible for the second assessment, the average length of time between visit 1 and visit 2 will be 1-7 days. The second visit included physical measurements such as cholesterol and blood pressure, performing math and speaking tasks, and surveys to help us learn about healthy behaviors and emotions. No further follow-up of participants is conducted beyond the two study visits.

Eligibility criteria: Inclusion Criteria:

* Pre-menopausal
* Must be able to speak and read English fluently

Exclusion Criteria:

* Specific medications and chronic diseases
* History of heart attack (myocardial infarction)
* Pregnant or given birth in last 3 months
* Peri-menopausal or post-menopausal

Primary outcomes:
measure: Number of Cardiovascular Risk Factors
timeFrame: Single assessment timepoint
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Center for Psychological Studies, Nova Southeastern University
state: Florida
Study officials:
affiliation: Nova Southeastern University
name: Jeffrey L Kibler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00224744: Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage
Official title: Prospective and Randomized Study to Evaluate Interest of Ultracision Use in Inguinal Lymph Nodes Curage.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vulvar Neoplasms
Skin Neoplasms
Keywords: Vulvar Neoplasms
Skin Neoplasms
Ultracision
Lymphadenectomy
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2005-09-23
Enrollment: 73
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 evaluate the decrease of post-operative morbidity in inguinal lymphadenectomies realised for vulvar tumors and inferior limb skin tumors by use of Ultracision with regard to classical operative techniques.


Eligibility criteria: Inclusion Criteria:

* Vulvar neoplasm, inferior limb's skin malignant tumours, with an inguinal curage indication.
* Age ≥ 18 years
* Hematological functions : leucocytes \> 1500/mm3, hemoglobin \> 8 g/dl, blood platelets \> 150000/mm3.
* Well informed written consent signed by the patient
* Negative pregnancy test for female patient of child-bearing potential.

Exclusion Criteria:

* Preliminary surgery of inguinal cavity (sentinel lymph node removal accepted)
* Massive lymph node invasion with femoro-vessels attack
* Inclusion in another study (excepted study turned to inguinal lymph node)
* Pregnant or nursing women
* Patient under guardianship or trusteeship

Primary outcomes:
measure: To evaluate the decrease of post-operative morbidity.
timeFrame: 2012
Secondary outcomes:
measure: To study differences between the two techniques according to : operative duration ; operative difficulties ; quantity of drainage ; hospitalization's duration ; necessity of local care ; number of consultations ; medical and economical assessment.
timeFrame: 2012
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Institut Claudius Regaud
name: Denis Querleu, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00629044: Genetic Polymorphysm of Cholesterol 24 S Hydroxylase in Patients With Glaucoma and AMD
Official title: Etude du Polymorphysme génétique de la cholestérol 24S Hydroxylase et Des Teneurs en 24S hydroxycholestérol Chez Des Patients Atteints de Glaucome ou de dégénérescence Maculaire liée à l'âge.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2008-03-05
Enrollment: 320
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study is to assess the implicitement of the cholesterol 24 S hydroxylase gene and the 24 S hydroxycholesterol in glaucoma and in age related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* Patient with Glaucoma
* Patient with AMD
* Healthy patient

Exclusion Criteria:

* All patients who use any treatment in order to maintain in normal value their blood cholesterol

Primary outcomes:
measure: To know if cholesterol 24 S hydroxylase and 24 hydroxycholesterol are involve in Glaucoma and AMD
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Ophthalmology Unit CHU Dijon
state: Burgundy
Study officials:
affiliation: CHU Dijon
name: Catherine Creuzot-Gracher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joffre C, Souchier M, Gregoire S, Viau S, Bretillon L, Acar N, Bron AM, Creuzot-Garcher C. Differences in meibomian fatty acid composition in patients with meibomian gland dysfunction and aqueous-deficient dry eye. Br J Ophthalmol. 2008 Jan;92(1):116-9. doi: 10.1136/bjo.2007.126144.
Clinical trial NCT00560144: A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors.
Official title: Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 34
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in children and adolescents with advanced solid tumors equivalent to the exposure achieved in adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion.An expanded cohort of patients will be enrolled at the optimal dose/MTD. The anticipated time on study treatment is until disease progression or dose limiting toxicity, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* pediatric patients aged 2-17 years of age;
* histologically confirmed solid tumors;
* cancer which has relapsed after, or failed to respond to, curative therapy, or no other potentially curative treatment options available.

Exclusion Criteria:

* treatment with corticosteroids within past 2 weeks;
* current or past use of anti-IGF-1R antibodies;
* current treatment with immunosuppressive agents;
* patients with diabetes mellitus;
* known HIV or hepatitis B or C;
* hypersensitivity to any of the components of R1507 or to monoclonal antibodies.

Primary outcomes:
measure: Serum drug exposure level equivalent to exposure in adults at adult recommended dose.
timeFrame: Throughout study
Secondary outcomes:
measure: MTD (AEs, laboratory parameters)
timeFrame: Throughout study
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Denver
country: United States
state: Colorado
city: Bethesda
country: United States
state: Maryland
city: New York
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01848444: Levels of Contaminants in Human Milk
Official title: Evaluation of Different Chemical Substances in the Milk of Breastfed Infant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lactating Women Who Give Their Milk to One of the 6 Milk Banks Participating in the Study
Keywords: Public Health
Epidemiology
Pharmacy Toxicology
Perinatal period
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 187
Sex: FEMALE
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: Lactating women given their milk to a milk bank

Brief summary: Recent international data have shown that the levels of chemical substances found in human milk could be at risk for breastfed infants. New data are necessary to assess this risk among French newborns.

Detailed description: The objective of this study is to assess levels of certain contaminants in breastmilk. Measurements will be made on breastmilk samples collected in Milk Bank but not suitable for infants due to bacteriological reasons. 6 Milk Banks well distributed on the French territory will be contacted to participate. 180 women will be included. Women who gave their milk and correspond to the inclusion criteria (in particular breastfeeding a child under 6 months at the time of the donation) will be contacted by the investigator by phone. They will be asked to fill in a written consent as well as a questionnaire on socio-demographic data, pregnancy related information and potential environmental exposures.

2 breastmilk samples of 50 mL will be sendsending to the lab for analysis and 2 samples of 50 mL will be collected.

Eligibility criteria: Inclusion Criteria:

For the samples:

* Not allowed to use for bacteriological reasons
* Breastmilk samples from lactating women between delivery and 6 months (+/- 1 month) of the infant

For the mothers:

* Age \> or = 18 years
* Lived on the French territory
* Well french writer and speaker
* Mother child couple in good health
* Non opposability

Primary outcomes:
measure: Presence of contaminants (PCB, dioxins, furans and brominated flame retardants)
timeFrame: at the moment of the milk's donation
Secondary outcomes:
measure: evaluate the concentration of other contaminants, perfluorinated compounds, organochlorine pesticides and inorganic compounds
timeFrame: at the moment of the milk's donation
measure: To estimate the exposure of breastfed infants and to assess the risk in this population
timeFrame: at the moment of the milk's donation
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Necker
Study officials:
affiliation: Assistance Publique
name: Virginie Rigourd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: