louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03286894: AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood
Official title: AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 1264
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of 1264 healthy schoolchildren, both males and females, aged 8 to 14 years, recruited in 7 primary and secondary schools of the city of Palermo.

Brief summary: The AQUA© questionnaire developed in 2008 is a validated tools for the screening of allergic diseases in adult athletes. The objective of the present study is to develop and validate a modified version of the AQUA© questionnaire to be used in childhood. In this phase, the validation is intended to assess the reliability of the information collected through the AQUA© modified version: question difficulty and response patterns with respect to children characteristics (in particular age, sex and physical activity). In particular, the focus will be on the "core questions", i.e. the indicators of allergic disorders. This is a cross-sectional study on 1264 healthy schoolchildren aged 8 to 14 years.


Eligibility criteria: Inclusion Criteria:

* Aforementioned sex and age criteria.

Exclusion Criteria:

* Respiratory infections in the previous 3 weeks;
* Immunological or metabolic systemic disease;
* Major malformations of the upper airways;
* Active smoker.

Primary outcomes:
measure: Question difficulty
timeFrame: Study end (4 months)
Secondary outcomes:
measure: Patterns of missing response
timeFrame: Study end (4 months)
measure: Patterns of non-missing responses
timeFrame: Study end (4 months)
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council
state: Sicily
Study officials:
References:
Clinical trial NCT01903694: Randomized Trial Sorafenib-Pravastatin Versus Sorafenib Alone for the Palliative Treatment of Child-Pugh A Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Child-Pugh A Hepatocellular Carcinoma
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 474
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: Principal objective: to evaluate the effect of the combination pravastatin - sorafenib versus sorafenib alone on overall survival in patients with hepatocellular carcinoma developing on Child-Pugh A cirrhosis who are unsuitable for curative treatment.

Secondary objectives: evaluate the effect of this treatment on progression-free survival, the time to progression, the time to treatment failure and quality of life (QLQ-C30 et FACT HEP)


Eligibility criteria: Inclusion Criteria:

* Hepatocellular carcinoma diagnosed by:
* either a histological examination
* or if histological evidence cannot be obtained (ascites, coagulation disorders) the diagnosis can be made in cases of cirrhosis according to EASL/AASLD 2005 criteria, by revealing a hepatic focal lesion of more than 10 mm
* on two dynamic imaging techniques (helical CT-scan, MRI, contrast-enhanced ultrasound) for tumours measuring less than 2 cm. The lesion must be characterised by hyperdensity during the arterial phase and wash-out during the delayed portal phase Patients who are not suitable for treatment with a curative intent (transplantation, resection, percutaneous destruction) or by chemo-embolisation or with progressive hepatocellular carcinoma after the failure of specific treatment Prognostic CLIP score 0 to 4 Child-Pugh Class A Transaminases ≤ 5 N and Creatininemia ≤ 1.5 N WHO: 0, 1 or 2 Age more than 18 years Foreseeable survival \> 12 weeks Possibility of regular follow-up Written informed consent

Exclusion Criteria:

* Extra-hepatic disease that could be life-threatening in the short or medium term Another progressive cancer with the exception of in situ cervical cancer, a superficial bladder tumour and treated basocellular carcinoma.

Any other cancer treated with a curative intent in the previous 3 years can be included in the study Heart failure (≥New York Heart Association class 2), uncontrolled AHT or arrhythmia, myocardial infarction in the previous 6 months Digestive haemorrhage in the previous month Patients who are receiving or have already received treatment with statins or sorafenib Pregnancy and breast-feeding. Women of child-bearing age must use an effective method of contraception throughout the trial and for 3 months after the end of the treatment.

Primary outcomes:
measure: determination of the tumor according to the evaluation criteria of Response Evaluation Criteria in Solid Tumors
timeFrame: To be done within the month preceding baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
References:
Clinical trial NCT05060094: Comparison of Outcomes Between TransPRK and Off-flap Epi-LASIK
Official title: Comparison of Outcomes Between Single-step Transepithelial Photorefractive Keratectomy and Off-flap Epipolis Laser in Situ Keratomileusis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Surgery
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people accepted refractive surgery

Brief summary: To compare the quantitative and qualitative optical outcomes between single-step transepithelial photorefractive keratectomy (TransPRK) and off-flap epipolis laser in situ keratomileusis (Epi-LASIK) in moderate to high myopia.we included patients with moderate to high myopia who were randomized to have TransPRK in one eye and Epi-LASIK in the other eye. All patients underwent comprehensive ophthalmological examinations, including uncorrected (UDVA) and corrected distance visual acuities (CDVA), manifest refraction, intraocular pressure, anterior and posterior segment examination, corneal topography measured by Scheimpflug scanning-slit topographer (Pentacam, Oculus Optikgerate GmbH), contrast sensitivity (CS) under photopic and mesopic conditions (CSV-1000E, Vector Vision Inc., Greenville, OH, USA) with correction by spectacles, ocular wavefront aberrometry (OPD-Scan II, Nidek Co. Ltd). At each follow-up, CS and aberration measures were repeated 3 times and the average value was analyzed. Optical parameters were repeated 1, 3, 6, and 12 months after surgery.Statistical analysis was performed using SPSS software (version 22.0, SPSS, Chicago, Inc.). Kolmogorov-Smirnov test was used to check the normal distribution of variables. Student t-test or Wilcoxon rank sum test was used based on the normality of data. A P value less than 0.05 was considered statistically significant.


Eligibility criteria: Inclusion Criteria:

* age over 18 years
* corrected distance visual acuity (CDVA) in logarithm of minimal angle of resolution (LogMAR) of 0.10 or better
* refractive error stabilized for at least 1 year
* discontinued contact lens use for at least 2 weeks

Exclusion Criteria:

* presence of corneal scars
* keratoconus
* glaucoma
* retinal diseases
* a history of corneal or intraocular surgery

Primary outcomes:
measure: aberrations
timeFrame: 2016.03.01-2018.06.05
Secondary outcomes:
measure: contrast sensitivity
timeFrame: 2016.03.01-2018.06.05
measure: haze
timeFrame: 2016.03.01-2018.06.05
measure: postoperative pain
timeFrame: 2016.03.01-2018.06.05
Other outcomes:
Locations:
Study officials:
References:
citation: Zhang Y, Li T, Li Z, Dai M, Wang Q, Xu C. Clinical outcomes of single-step transepithelial photorefractive keratectomy and off-flap epipolis-laser in situ keratomileusis in moderate to high myopia: 12-month follow-up. BMC Ophthalmol. 2022 May 23;22(1):234. doi: 10.1186/s12886-022-02443-6.
Clinical trial NCT06869694: Energy CT in Imaging and Diagnosis of Gastric Cancer
Official title: Diagnostic and Predictive Performance of Dual-/ Muti- Energy CT and MRI in the Treatment Response and Survival Prognosis of Gastric Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
CT
Keywords: CT
Gastric cancer
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 300
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: For patients undergoing radical resection, abdominal exploration or palliative tumor resection, CT scanning and dynamic contrast-enhanced magnetic resonance DCE-MRI scanning shall be completed in GSI mode before operation; for patients undergoing neoadjuvant chemotherapy, CT scanning and dynamic contrast-enhanced magnetic resonance DCE-MRI scanning shall be completed in GSI mode before neoadjuvant chemotherapy at least, and if the above scanning mode can still be used during chemotherapy, it is the best choice.

Signed informed consent form. Patients who were diagnosed with gastric cancer at various medical centers were included in this study

Brief summary: Accurate preoperative prediction of risk stratification, treatment response, and survival prognosis in gastric cancer is important for improving clinical treatment decisions, prolonging patient survival, and improving patient quality of life. The purpose of this study is to investigate the performance of the multi-parametric magnetic resonance imaging (mpMRI) and Dual-/Muti-energy CT and photon-counting Detector CT(PCD-CT) in the diagnosis and management of gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Pathological biopsy confirmed gastric cancer;
2. Surgery: patients undergoing radical gastrectomy. Patients undergoing exploratory abdominal surgery or palliative tumor resection were still included in the study when peritoneal metastasis or adjacent organ invasion was identified intraoperatively and radical surgical resection was not possible.

Exclusion Criteria:

1. Refusal or inability to sign informed consent;
2. CT or MRI images are poor or the focus is small and CT images are not clear;
3. Patients with other tumors complicated with patients with important organ dysfunction.

Primary outcomes:
measure: Diagnostic and Predictive performance of Dual-/ Muti- energy CT and MRI in the treatment response and survival prognosis of gastric cancer
timeFrame: 3years
Secondary outcomes:
measure: The kappa value; One-way analysis of variance; ICC
timeFrame: 1year
Other outcomes:
Locations:
city: Zheng Zhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
Study officials:
References:
Clinical trial NCT01863394: Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children 6-59 Months in Mirria District, Niger
Official title: Evaluation of Two Community Based Screening Strategies for Severe Acute Malnutrition in Children Aged 6-59 Months in the Mirria District, Niger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Screening
Malnutrition
Community Management of Acute Malnutrition
Lead sponsor: Alliance for International Medical Action
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2013-05-29
Enrollment: 4429
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to determine the efficacity of a community strategy for screening children 06-59 months old for Severe Acute Malnutrition (SAM) conducted by their mothers' compared with a community screening strategy conducted by Community Health Workers.


Eligibility criteria: Inclusion Criteria:

* children aged 06-59 months at the time of the study
* children who live in a village in the health district participating in the study

Exclusion Criteria:

* children whose legal guardian refuses to participate in the study

Primary outcomes:
measure: The coverage of the therapeutic nutritional program in the control and intervention health districts
timeFrame: 12 months
Secondary outcomes:
measure: Malnutrition program data for children referred by community health workers & mothers
timeFrame: 12 months
Other outcomes:
Locations:
city: Mirria
country: Niger
facility: Mirriah health district
state: Zinder
Study officials:
affiliation: Alliance for International Medical Action
name: Nikki BLACKWELL, FCICM
role: PRINCIPAL_INVESTIGATOR
affiliation: Alliance for International Medical Action
name: Isabelle Defourney, MBBS
role: STUDY_DIRECTOR
References:
citation: Ale FG, Phelan KP, Issa H, Defourny I, Le Duc G, Harczi G, Issaley K, Sayadi S, Ousmane N, Yahaya I, Myatt M, Briend A, Allafort-Duverger T, Shepherd S, Blackwell N. Mothers screening for malnutrition by mid-upper arm circumference is non-inferior to community health workers: results from a large-scale pragmatic trial in rural Niger. Arch Public Health. 2016 Sep 6;74(1):38. doi: 10.1186/s13690-016-0149-5. eCollection 2016.
Clinical trial NCT06733194: Complications of Bladder Augmentation in Children
Official title: Surgical Complications After Bladder Augmentation in Children: a Retrospective Study About 87 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurogenic Bladder Disorder
Spina Bifida
Complications of Surgical Procedures or Medical Care
Child, Only
Bladder Dysfunction
Keywords: Bladder Augmentation
Enterocystoplasty
Surgical Complications
Child
Retrospective Study
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 87
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with dysfunctional bladder

Brief summary: The goal of this observational study is to describe the complications in participants who underwent enterocystoplasty in childhood.

The main question\[s\] it aims to answer are:

* what kind of complications are there
* the kind of complications depending on the type of enterocystoplasty Participants data will be collected in the medical field. There is no comparison group.

Detailed description: From 1982 to 2020, all patients who had an enterocystoplasty in childhood were collected.

Complications were numbered depending on the type of enterocystoplasty and the investigators tried to find which risk factors exist.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent a enterocystoplasty before 18 years old

Exclusion Criteria:

* Patients who underwent a enterocystoplasty after 18 years old

Primary outcomes:
measure: Surgical complications of bladder augmentation in children depending on the type of enterocystoplasty
timeFrame: 38 years
Secondary outcomes:
measure: Impact of the participants' age on the occurrence of complications depending on the type of enterocystoplasty
timeFrame: 38 years
measure: Impact of the participants' sex on the occurrence of complications depending on the type of enterocystoplasty
timeFrame: 38 years
measure: Impact of the participants' type of neurogenic bladder on the occurrence of complications depending on the type of enterocystoplasty
timeFrame: 38 years
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand University Hospital
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Christelle Destinval
role: PRINCIPAL_INVESTIGATOR
References:
citation: Molina CA, Lima GJ, Cassini MF, Andrade MF, Facincani I, Tucci Junior S. Complications after bladder augmentation in children. Acta Cir Bras. 2016;31 Suppl 1:8-12. doi: 10.1590/S0102-86502016001300003.
Clinical trial NCT05624294: Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Does/ Mulelple Ascending Does Study of CS0159 to Evaluate the Safety, Tolerability, Pharmacokynetics, and Food Effect in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Primary Biliary Cholangitis
Lead sponsor: Cascade Pharmaceuticals, Inc
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled, single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety, tolerability, pharmacokynetics, pharmacodynamices, and food effect in Chinese healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy adult subjects of 18 years to 55 years.
2. Weight: Male≥50kg, female≥45kg BMI: 18\~32kg/m².
3. In good health, determined by having no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluation.
4. Subject signs IFC and dates and subject must understand and follow test procedures and restrictions.

Exclusion Criteria:

1. Subjects with special dietary requirements and cannot follow a uniform diet.
2. Pregnant or nursing females or females who have pregnancy plans during the trial or within 3 months after the trial.
3. Any subject with SARS-CoV-2 infection, based on a positive polymerase chain reaction for SARS-CoV-2.
4. History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.

Primary outcomes:
measure: Incidence and severity of adverse events [Safety and Tolerability]
timeFrame: Upto day 15
measure: Dose PK Parameter(C-max)
timeFrame: day 1, day 7
measure: Dose PK Parameter(AUC)
timeFrame: day 1, day 7
Secondary outcomes:
measure: Food effect PK Parameter(C-max)
timeFrame: day 10
measure: Food effect PK Parameter(AUC)
timeFrame: day 10
measure: QTc analysis
timeFrame: day 1, day 7
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
Study officials:
affiliation: Shanghai Xuhui Central Hospital
name: Yun Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05776394: Study on Hypertension and Frailty in the Older People
Official title: Study on Hypertension and Frailty in the Older People: the HYPER-FRAIL Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty
High Blood Pressure
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 150
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients

Brief summary: To estimate the linear association between daytime systolic blood pressure variability evaluated as standard deviation (SD) and frailty evaluated as Frailty index according to the Rockwood's accumulation of deficits model


Eligibility criteria: Inclusion Criteria:

* Diagnosis of hypertension according to the criteria of the European Society of Cardiology guidelines
* Consent of the patient (or legal representative) to participate in the study

Exclusion Criteria:

* Refusal of the patient or his/her legal representative
* Life expectancy of less than 6 months

Primary outcomes:
measure: Daytime systolic blood pressure variability
timeFrame: At baseline
Secondary outcomes:
measure: Nighttime systolic blood pressure variability
timeFrame: At baseline
measure: 24h systolic blood pressure variability
timeFrame: At baseline
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Luca
Study officials:
References:
Clinical trial NCT04449094: Emergence of the COVID 19 Epidemic in the City of Nice
Official title: Socio-demographic Factors and Emergence of the COVID 19 Epidemic in the City of Nice in 2020
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents in the city of Nice

Brief summary: Descriptive analysis of the appearance of the first cases of COVID 19 diagnosed in the city of Nice. Analysis of the association of socio-demographic factors with the viremia attack rate according to the district of residence.


Eligibility criteria: Inclusion Criteria:

* People resident in city of Nice at the COVID diagnosis

Primary outcomes:
measure: Attack rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References: