louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01954810: Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children
Official title: Assessment of Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With a Single Dose of JE-CV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Japanese Encephalitis
Keywords: JECV
IMOJEV
Booster response
Children
antibody response
Duration
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 88
Sex: ALL
Minimum age (years): 72
Maximum age (years): 80
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study has aim to describe the immune response to the second dose of Japanese encephalitis chimeric vaccine (JECV) in children previously vaccinated with one dose of JECV 5 years ago.

Detailed description: This is a prospective study to demonstrate the boosting antibody response in children previously vaccinated with one dose of JECV 5 years ago.

Eligibility criteria: Inclusion Criteria:

1. Subject who was vaccinated with 1 dose JE-CV in JEC02 and participated in 5 year follow-up in JEC05 trial and finished year 5 of follow-up.
2. Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative.
3. Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures
4. In good general health, based on medical history and physical examination

Exclusion Criteria:

1. Participation in another clinical trial investigating a vaccine which need to have vaccination or blood draw within the 4 weeks preceding the trial vaccination except JEC05
2. Planned participation in another clinical trial during the Day0-Day28 period
3. Receipt of live vaccine within 4 weeks preceding the trial vaccination
4. Planned receipt of any vaccine in the 4 weeks following the trial vaccination
5. Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
6. Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
7. Chronic illness or any underlying illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion

Primary outcomes:
measure: Neutralizing antibody titers after JECV vaccination
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Department of Pediatrics, Faculty of Medicine, Khon Kaen University
state: Khon Kaen
Study officials:
affiliation: Khon Kaen University
name: Pope Kosalaraksa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03731910: Short-term MRI for Treatment Response Evaluation/Prediction of HCC Treated With TARE
Official title: Short Term Magnetic Resonance Imaging (MRI) for Treatment Response Evaluation and Prognosis Prediction in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Radioembolization (TARE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: MRI
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Dongkook Lifesicence
First posted: 2018-11-06
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to investigate the value of early change at MRI in HCC treated with TARE, for evaluation/prediction of treatment response and prognosis.


Eligibility criteria: Inclusion Criteria:

* Intermediate or locally advanced HCC according to Hong Kong Liver Cancer guideline
* Scheduled for transarterial radioembolization (TARE)
* sign informed consent

Exclusion Criteria:

* Any absolute or relative contra-indication of contrast-enhanced MRI
* History of other local treatment before TARE in 3 weeks

Primary outcomes:
measure: Treatment response mRECIST
timeFrame: 1 month after last MRI
Secondary outcomes:
measure: Tumor diffusion
timeFrame: 1 months after last MRI
measure: Tumor perfusion
timeFrame: 1 months after last MRI
measure: Treatment response LI-RADS
timeFrame: 1 months after last MRI
measure: Treatment response volumetric
timeFrame: 1 months after last MRI
measure: Time to Progression
timeFrame: 24 months after TARE
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01603810: Evaluating In Vivo OCT Imaging for Periocular Basal Cell Carcinoma
Official title: An Investigation of the Correlation Between OCT and Histology in Defining the Margins of Periocular Basal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Basal Cell Carcinoma
Keywords: Basal cell carcinoma
Optical Coherence Tomography
Lead sponsor: Maidstone & Tunbridge Wells NHS Trust
Sponsor class: OTHER
First posted: 2012-05-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with periocular basal cell carcinoma

Brief summary: Optical coherence tomography (OCT) is an imaging technique which shows the internal structure of living tissue (in vivo). It is safe, quick and painless to perform, and does not damage the tissue in any way. Recent advances in the technology mean that it can now be used to take images of the internal structure of the skin. This is useful because certain conditions, such as skin cancers, alter this structure. At present a suspected skin cancer is identified by taking a sample (a biopsy) which is analysed under the microscope to confirm the diagnosis. The cancer is then excised including a margin of apparently healthy-looking skin around it to ensure that the entirety of the tumour is removed. The excised tumour is then analysed again under a microscope to confirm that it was indeed completely removed (histology), after which a further operation is required to repair the defect.

The purpose of this study is to evaluate OCT imaging of a particular type of skin cancer called a basal cell carcinoma (BCC), and in particular BCCs affecting the skin around the eyes (periocular). The study will compare the ability of OCT to define the margin of the BCC with the current 'gold standard' of histology. OCT could potentially improve the investigators ability to define the margins of the tumour before surgery and become a guide for minimally invasive surgery. The preservation of healthy tissue represents a priority, particularly in the area of the skin surrounding the eye.


Eligibility criteria: Inclusion Criteria:

* Adults of any age or gender who have capacity to give informed consent, and who have periocular basal cell carcinoma requiring surgical excision

Exclusion Criteria:

* Children, vulnerable adults, inability to give informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
state: Kent
Study officials:
affiliation: Maidstone & Tunbridge Wells NHS Trust
name: Henry B Smith, FRCOphth
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01728610: Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms
Official title: Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms (IBS-2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: irritable bowel syndrome
probiotic
pain
bloating
diarrhoea
constipation
Lead sponsor: Danisco
Sponsor class: INDUSTRY
First posted: 2012-11-20
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to analyse the effect of a probiotic supplement on functional intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).

Detailed description: The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on functional intestinal symptoms among subjects diagnosed with IBS according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life, anxiety and depression and adequate relief will be assessed as with questionnaires as outcome measures. The intestinal microbiota will be analysed from faecal samples.

Eligibility criteria: Inclusion Criteria:

* Subjects aged 18 to 65 fulfilling Rome III criteria for IBS will be recruited. Sufficient general health and orientation for participating in the study is required and will be evaluated by the MDs.

Exclusion Criteria:

* Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health.

Primary outcomes:
measure: Change in functional bowel symptoms
timeFrame: 0 weeks, 4 weeks, 12 weeks
Secondary outcomes:
measure: Change in quality of life
timeFrame: 0 weeks, 4 weeks, 12 weeks
measure: Change in anxiety and depression
timeFrame: 0 weeks, 4 weeks and 12 weeks
measure: Adequate relief
timeFrame: Weekly over 3 month intervention
measure: Change in faecal microbiota
timeFrame: 0 weeks, 4 weeks, 12 weeks
measure: Safety of investigational product
timeFrame: Throughout the intervention phase
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Mehiläinen Töölö
city: Turku
country: Finland
facility: Mehiläinen Turku
Study officials:
affiliation: Herttoniemi Hospital
name: Lea Veijola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DuPont Nutrition and Health
name: Arthur Ouwehand, PhD
role: STUDY_CHAIR
affiliation: DuPont Nutrition and Health
name: Sampo Lahtinen, PhD
role: STUDY_CHAIR
affiliation: DuPont Nutrition and Health
name: Anna Lyra, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02899481: Role of Intrapartum Ultrasound in Instrumental Delivery
Official title: Role of Intrapartum Ultrasound in the Efficacy of an Instrumental Delivery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstetric Labor Complications
Lead sponsor: University of Lisbon
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 222
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Investigators will perform a multicentric randomized controlled trial comparing the effect of transabdominal and transperineal ultrasound in pregnant women in the second stage of labor, in whom it was decided an operative delivery. Our objective is to evaluate the impact of intrapartal ultrasound measurements, as an auxiliary to clinical evaluation, in the efficacy of an instrumental delivery.


Eligibility criteria: Inclusion Criteria:

* pregnant women at term, in labor (≥ 37 weeks of gestation dated by a first trimester ultrasound
* live singleton pregnancy
* fetus in a cephalic presentation
* in the second stage of labor, after the decision to perform an instrumental delivery

Exclusion Criteria:

* fetal malformations
* emergency situation

Primary outcomes:
measure: Maternal and neonatal morbidity
timeFrame: 2 years
measure: Neonatal morbidity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Norte - Hospital Santa Maria
Study officials:
affiliation: University of Lisbon
name: Joana Barros, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02194881: Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation
Official title: Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation - Efficacy and Safety Results After the First Year of Treatment in the Real Life Setting.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
CFTR
G551D mutation
Novel treatments
Potentiator
Ivacaftor
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Vaincre la Mucoviscidose
First posted: 2014-07-18
Enrollment: 57
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CF aged 6 or older and cared in French CF centres

Brief summary: The purpose of this study is to determine whether the treatment with Ivacaftor remains effective and safe in the patients with cystic fibrosis (and at least one G551D CFTR mutation) in the real life setting, after the drug has been approved by the Health authorities.

Detailed description: The aims of our study are:

1. to describe the treated population at initiation of treatment,
2. to evaluate clinical parameters during the year before Ivacaftor was started, at initiation of treatment and during at least one year of treatment, until June 2014.
3. to evaluate the tolerance and safety of this treatment.

Eligibility criteria: Inclusion Criteria:

* French patients with CF aged 6 or older who are homozygous or heterozygous for the G551D mutation
* Treated with Ivacaftor
* First prescription of Ivacaftor before June 1st 2013 (including patients randomized in the VX770 clinical trials)

Exclusion Criteria:

* CF patients younger than 6 years old
* CF patients who have received lung transplantation
* CF patients without a G551D mutation.

Primary outcomes:
measure: FEV1 (in liters and in % predicted)
timeFrame: until one years after initiation of treatment
Secondary outcomes:
measure: pulmonary exacerbations
timeFrame: until one years after initiation of treatment
measure: number of hospitalizations and number of days of hospitalization per year
timeFrame: until one year after initiation of treatment
measure: number of antibiotic treatments and number of days of antibiotic treatments
timeFrame: until one year after initiation of treatment
measure: respiratory colonization
timeFrame: until least one year after initiation of treatment
measure: nutritional status
timeFrame: until one year after initiation of treatment
measure: Adverse events
timeFrame: until one year after initiation of treatment
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Dominique Hubert, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02790281: A Study to Investigate Interleukin-6 (IL-6) and IL-6/Soluble IL-6 Receptor (sIL-6R) Complex Levels in Subjects With Active Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-06-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women seeking medical support due to present, active moderate to severe ulcerative colitis or Crohn's disease (newly diagnosed or during disease relapse).

Brief summary: The purpose of this study is to measure IL-6 and IL-6/sIL-6R complex levels in subjects with active moderate to severe ulcerative colitis or Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with active moderate to severe ulcerative colitis (\*partial Mayo ≥ 5) or Crohn's disease (Harvey \& Bradshaw ≥ 8) \*partial Mayo: 9-point scale that excludes the endoscopic components of the Mayo score

Exclusion Criteria:

* Presence of another inflammatory disease, except for mild cutaneous psoriasis
* Concomitant gastrointestinal infection or otherwise serious infection including Crohn's disease infectious complication
* Treatment with Infliximab, Adalimumab, Certolizumab Pegol or other immune-modulating biologics within 8 weeks prior to the visit
* Having a known or suspected gastrointestinal or otherwise serious infection within 8 weeks prior to the visit
* Concomitant diagnosed or suspected malignant disease

Primary outcomes:
measure: Exploratory: Levels of IL-6/sIL-6R Complex
timeFrame: At Day 1
measure: Exploratory: Levels of IL-6
timeFrame: At Day 1
measure: Exploratory: Levels of C-reactive Protein (CRP)
timeFrame: At Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev hospital (there may be other sites in this country)
city: Lund
country: Sweden
facility: Skane University Hospital (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT01772381: Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean Section in Term Fetus
Official title: Dexamethasone in Prevention of Respiratory Morbidity in Elective Caesarean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transient Tachypnea of the Newborn
Keywords: Dexamethasone, term, elective cesarean section
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2013-01-21
Enrollment: 600
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Introduction: Babies born at term by elective caesarean section (CS) and before onset of labor are more likely to develop respiratory complications than babies born vaginally. In developing countries resources are scarce and it is difficult to provide expensive treatments as neonatal care.

Aim of the Work: To assess the effect of prophylactic dexamethasone administration before elective cesarean section at term in reducing neonatal respiratory complications.

Patients and methods: 600 women were included in the study and were planned to have elective caesarean section. 300 received dexamethasone 12 mg twice, 12 hours apart 48 hours before delivery. 300 patients were the control group.

The outcomes were: incidence of admission to neonatal intensive care unit (NICU), incidence of transient tachypnea of newborn (TTN), the incidence of respiratory distress syndrome (RDS) and the need for mechanical ventilation.

Detailed description: Dexamethasone which is a long acting corticosteroid can be used prior to elective cesarean section to decrease neonatal respiratory morbidity by enhacing fetal lung maturity.

Eligibility criteria: Inclusion Criteria:

* Previous caesarean section
* Complete 37 week calculated from the first day of the last menstrual period.

Exclusion Criteria:

* Obstetric complications such as pre-eclampsia, antepartum hemorrhage or known fetal anomaly.
* Hypertensive patients.
* Chronic disease e.g. diabetes mellitus.
* Known renal disease.
* Pre-operative infection.

Primary outcomes:
measure: Special care baby unit
timeFrame: 24 hours
Secondary outcomes:
measure: Severity of respiratory distress
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Noha H Rabei, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sotiriadis A, McGoldrick E, Makrydimas G, Papatheodorou S, Ioannidis JP, Stewart F, Parker R. Antenatal corticosteroids prior to planned caesarean at term for improving neonatal outcomes. Cochrane Database Syst Rev. 2021 Dec 22;12(12):CD006614. doi: 10.1002/14651858.CD006614.pub4.
Clinical trial NCT03389581: The Effect of Awareness on Preoperative Anxiety
Official title: The Effect of Awareness on Preoperative Anxiety Before Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Anesthesia
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-01-03
Enrollment: 799
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elective surgery for any reason

Brief summary: In the majority of patients, anxiety and fear are observed at different levels before surgery. Preoperative anxiety was reported in 60-80% of the patients who underwent surgery. This anxiety and fear can be attributed to many factors. Some of these are mainly anesthesia, previous experience of the patient, personality traits, concerns about surgical intervention, and postoperative pain. Patients' anxiety levels can be influenced by a variety of factors, including previous experience, type of hospital arrival, sex, age, and type of surgery.Anesthesia-related awareness among the experiences of anesthesia is described in the literature. In a study of 20,402 patients in the United States, the awareness rate was 0.13%. Being aware is that the patient is awake during the surgery and recalls seeing bad dreams. At that time the patient could not specify this because he was immobile. Being awake is that the patient is awake and showing it through his movements. The patient may not remember this situation later. It is a condition that can always be overlooked in previous experience, which is an important parameter of anxiety in the preoperative period. The patients included in the study were planned to use the modified Brice awareness score, first mentioned in 1970 as the name of the person who used the anesthesia and anesthesia for awareness. In this study, investigators aim to reveal the effect of anesthesia awareness on preoperative anxiety in patients with previous anesthesia story.

Detailed description: in this study will include 300 patients. 300 patients will be enrolled in the anesthesia outpatient clinic scheduled for elective surgery for any reason at the age of 18-65 years. Patients with dementia and psychiatric disorders, anxiolytic and psychiatric drug users and patients who can not receive written approval will be excluded from the study.

Eligibility criteria: Inclusion Criteria:

* all patients between 18-70 yr

Exclusion Criteria:

* dementia
* psychiatric disorders
* using antipsychotic

Primary outcomes:
measure: awareness
timeFrame: preoperative visit before surgery
Secondary outcomes:
measure: anxiety
timeFrame: preoperative visit before general anesthesia
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Siences Diskapi Yildirim Beyazit T&R hospital
Study officials:
References: