louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03265262: The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy
Official title: Evaluation of Technical and Predictive Value of the Basophil Activation Test for Food Allergy Diagnosis in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: FOOD ALLERGY
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 110
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Background: The need for an oral food challenge (OFC) surrogate is growing in line with the continuous increase in the prevalence and severity of paediatric food allergy. The basophil activation test (BAT) has recently been reported as a promising tool for predicting the outcome of OFC in children.

Objective: We make the hypothesis that BAT might improve the sensitivity of food allergy diagnosis and spare part of current OFC in paediatric patients attending allergy departments in Marseille APHM University hospitals.

Methods: BAT will be performed in parallel with OFC in 100 paediatric patients receiving OFC during a diagnostic or follow-up procedure.

Expected results: Good concordance of BAT and OFC results leading to potential OFC replacement by BAT in at least 50% of the study population


Eligibility criteria: Inclusion Criteria:

* Age 0 - 18 years
* Attending La Timone Paediatric Hospital for OFC
* Social insurance
* Parents and if possible child have received information and signed the consent form

Exclusion Criteria:

* Patients not receiving an OFC
* Lack of social insurance
* Inability to understand the study information
* Unwilling to participate

Primary outcomes:
measure: BAT positive and negative predictive values as compared with OFC
timeFrame: 2 years
Secondary outcomes:
measure: BAT quantitative results as compared with the minimal reacting dose for OFC
timeFrame: 2 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References:
citation: Arif-Lusson R, Agabriel C, Carsin A, Cabon I, Senechal H, Poncet P, Vitte J, Busnel JM. Streamlining basophil activation testing to enable assay miniaturization and automation of sample preparation. J Immunol Methods. 2020 Jun-Jul;481-482:112793. doi: 10.1016/j.jim.2020.112793. Epub 2020 May 6.
Clinical trial NCT03013062: Relation Between Mean Pulmonary Artery Pressure and Pulmonary Acceleration Time and Comparison With Previous Formulae
Official title: Derivation of New Formula Relating Pulmonary Acceleration Time and Mean Pulmonary Artery Pressure in Indian Population and Comparison With Previous Formulas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Hypertension
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2017-01-06
Enrollment: 50
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: \> 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure

Brief summary: Since the pulmonary artery hypertension is defined based on MPAP and the two previous formulae relating MPAP and PAT were derived in western population, the investigator planned to conduct a prospective study to derive a new formula for measuring MPAP from PAT in Indian population and compare the accuracy of all the three formulae

Detailed description: After obtaining ethics committee approval and informed patient consent, minimum 25 patients \> 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure will be enrolled in this study.The demographics and the preoperative echocardiographic measurement will be noted. In the operating room, once the intravenous access is obtained, central venous catheterisation and pulmonary artery catheterisation will be done as per the institutional protocol. Once the Transthoracic echocardiogram (TTE) is performed patient will be induced with opioids, intravenous or inhalational agents, and muscle relaxant according to the patient clinical and hemodynamic condition. Once the patient airway is secured with tracheal tube, transesophageal echocardiogram (TEE) will be performed before and after bypass, which is routine in all patients undergoing cardiac surgery in the institution. Echocardiographic images will be analysed by two separate echocardiographers to detect inter-individual variability. Patient blood pressure and heart rate will be maintained within 20% of their baseline value throughout surgery. Based on the patient condition at the end of surgery, extubation will be done in the operating room or in intensive care unit (ICU) after a period of elective ventilation.

Eligibility criteria: Inclusion Criteria:

* 18 years of age who are undergoing cardiac surgery with the invasive monitoring of pulmonary artery pressure

Exclusion Criteria:

* Patients with known right ventricular outflow tract obstruction, intra-cardiac shunt lesions will be excluded

Primary outcomes:
measure: Pulmonary acceleration time
timeFrame: Till post-extubation, an average of 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
affiliation: PGIMER, CHANDIGARH
name: GANESH KUMAR M
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00318162: Trial of Low-Dose Naltrexone for Children With Pervasive Developmental Disorder (PDD)
Official title: Randomized Double-Blind Trial of Low-Dose Naltrexone for Children With PDD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pervasive Developmental Disorder
Keywords: autism
PDD
LDN
naltrexone
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Jerusalem Institute for Child Development
First posted: 2006-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will examine the effects of low-dose naltrexone (LDN) on children with autistic spectrum disorders. The investigators hope to show a positive effect on social functioning and language.

Detailed description: Fifty children aged three to six years will be recruited for the study. They will be randomly assigned to receive either LDN or placebo for two months after which the treatment groups will be switched over. Assessments of functioning will be obtained from a video-taped play session, and by parent and teacher questionnaires at baseline, after two months and after four months.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of PDD

Primary outcomes:
measure: play observation
measure: Autism Behavior Checklist (ABC) questionnaire
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Jerusalem Institute for Child Development
Study officials:
affiliation: Jerusalem Institute for Child Development
name: David S Wilensky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02110862: Scintigraphic Evaluation of IPAA Function in Patients With Ulcerative Colitis
Official title: Scintigraphic Evaluation of IPAA Function in CU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Ulcerative colitis

Brief summary: The aim of this study is to evaluate scintigraphic methods as objective factors for functional outcome in patients treated with ileal-pouch-anal anastomosis (IPAA). The gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the functional outcome.


Eligibility criteria: Inclusion Criteria:

* Ulcerative colitis patients

Primary outcomes:
measure: Gastrointestinal transit-time
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Mie Kjaer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01597362: Three Laparoscopic Access Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Gynecological Pathology
Keywords: laparoscopy
trocars
veress
open
direct
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2012-05-14
Enrollment: 608
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study compares the Veress needle technique, the Direct trocar insertion and the Open technique with each other, in terms of minor complications, in elective laparoscopic procedures for benign pathologies.


Eligibility criteria: Inclusion Criteria:

* not-obese adult patients referred for scheduled laparoscopic and gynecologic procedures,
* benign pathology
* no previous abdominal surgery
* Age range was 18-70 years

Exclusion Criteria:

* obesity, defined as a body mass index (BMI) \> 30 kg/m2
* previous abdominal surgery by laparoscopy or laparotomy
* history of PID
* irritable Bowel Syndrome
* suspicion of malignancy or malignancy at the histological examination

Primary outcomes:
measure: minor complications
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Angioli R, Terranova C, De Cicco Nardone C, Cafa EV, Damiani P, Portuesi R, Muzii L, Plotti F, Zullo MA, Panici PB. A comparison of three different entry techniques in gynecological laparoscopic surgery: a randomized prospective trial. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):339-42. doi: 10.1016/j.ejogrb.2013.09.012. Epub 2013 Sep 23.
Clinical trial NCT05122962: Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
Official title: Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tetralogy of Fallot
Congenital Heart Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-11-17
Enrollment: 220
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: This will be a prospective study of patients with congenital heart disease receiving care at Mayo Clinic Rochester, MN.

Brief summary: This study is being done to determine the mechanism(s) contributing to the onset of symptoms (i.e. shortness of breath and/or palpitations) as well as changes in heart structure in patients with congenital heart disease (CHD)


Eligibility criteria: Inclusion Criteria:

* Moderate (or greater) PR based on quantitative Doppler echocardiography.
* Repaired TOF
* Congenital Heart Disease diagnosis including but not limited to Ebstein's anomaly, coarctation of the aorta (COA), Fontan palliation, transposition of the great arteries, congenitally corrected transposition of the great arteries.

Exclusion Criteria:

* Pregnant Women
* Unable to undergo CMRI

Primary outcomes:
measure: Right Heart Remodeling
timeFrame: 24 Months
Secondary outcomes:
measure: Incident arrhythmias
timeFrame: 24 Months
measure: Aerobic Capacity
timeFrame: 24 Months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alexander Egbe, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00881062: Investigate Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose in Healthy Females
Official title: A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C}-Proellex Following Single Oral Dose Administration in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: ABSORPTION
METABOLISM
EXCRETION
Keywords: ABSORPTION
METABOLISM
EXCRETION
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-15
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study was to determine the ADME and metabolites of Proellex following a single oral dose of 25 mg.

Detailed description: The purpose of this study is to determine the absorption, metabolism, and excretion kinetics of Proellex and to determine and characterize metabolites present in plasma and urine following a single oral dose of 25 mg. The 25 mg dose selected for this study has been included in all previous clinical trials. This dose was well tolerated and demonstrated efficacy against uterine fibroids and endometriosis.

Eligibility criteria: Inclusion Criteria:

* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator
* 1 to 2 bowel movements per day.

Exclusion Criteria:

* Significant history or significant clinical manifestation (as determined by the Investigator) of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* Participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to check-in
* Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to check-in
* Donation of blood from 30 days prior to Screening through Clinic Discharge, inclusive, or of plasma from 2 weeks prior to Screening through clinic discharge, inclusive
* Receipt of blood products within 2 months prior to check-in

Primary outcomes:
measure: To assess the pharmacokinetics (PK) of a single dose of Proellex and its metabolites using [14C]-Proellex
timeFrame: 14 days
Secondary outcomes:
measure: To characterize and identify metabolites of [14C]-Proellex in plasma and urine
timeFrame: 14 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit Inc.
state: Wisconsin
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre van As, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03267862: Scleral Response to Intraocular Pressure (IOP)
Official title: Scleral Response to Intraocular Pressure (IOP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Keywords: biomarker
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: glaucoma patients presenting for routine care

Brief summary: The study evaluated changes in the depth of the lamina cribrosa at different eye pressures.

Detailed description: Participants were glaucoma patients who during routine care were observed at different eye pressures. Images taken with an optical device that is routinely used in such patients were analysed.

Eligibility criteria: Inclusion Criteria:

* glaucoma patients

Exclusion Criteria:

* non-glaucoma patients

Primary outcomes:
measure: Anterior lamina cribrosa depth change
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00222391: Influence of Thoracic Epidural Anesthesia on Skin Sympathetic Activity and Heart Rate Variability
Official title: Influence of Thoracic Epidural Anesthesia on Skin Sympathetic Activity and Heart Rate Variability in Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Surgery
Abdominothoracic Surgery
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of the study is to evaluate the impact of epidural anesthesia on sympathetic activity in surgical patients. The study investigates whether a segmental sympathetic block can be determined and can be correlated to level of the sensoric blockade.


Eligibility criteria: Inclusion Criteria:

* elective surgery
* combined anesthesia with thoracic epidural anesthesia 8 (Th6-9
* Body-mass-index \< 30

Exclusion Criteria:

* Fever, Hypothermia, SIRS
* Microangiopathy
* Neuropathy
* Sensomotoric deficits

Primary outcomes:
measure: Hemodynamic parameters
Secondary outcomes:
measure: Level of sensoric block
measure: skin temperature
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Anesthesia and Intensive Care, University Hospital Muenster
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, University Hospital Münster
name: Henrik Freise, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freise H, Meissner A, Lauer S, Ellger B, Radke R, Bruewer M, Brodner G, Van Aken HK, Sielenkamper AW, Fischer LG. Thoracic epidural analgesia with low concentration of bupivacaine induces thoracic and lumbar sympathetic block: a randomized, double-blind clinical trial. Anesthesiology. 2008 Dec;109(6):1107-12. doi: 10.1097/ALN.0b013e31818db16c.
Clinical trial NCT03848091: Prosthesis Infection and One-step Exchange: Pretreatment by Targeted Antibiotic Therapy in At-risk Patients
Official title: Prosthesis Infection and One-step Exchange: Pretreatment by Targeted Antibiotic Therapy in
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prosthetic Joint Infection
Antibiotic Resistant Infection
Keywords: bone and joint infection
Antibiotic pretreatment
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having had a antibiotic pretreatment targeted before a one step exchange arthroplasty managed at the Croix-Rousse Hospital

Brief summary: One-step exchange arthroplasty is more and more used in the treatment of chronic infections, especially in patients at risk anesthetic.

This strategy is not recommended in patients infected with multidrug-resistant organisms or difficult to treat because of a risk of bacterial persistence on the new implant.

Antibiotic pretreatment by a narrow-spectrum molecule and for which resistance acquisition is difficult might be of interest to try to reduce the inoculum and avoid contamination of the new implant.


Eligibility criteria: Inclusion Criteria:

* patients having had a antibiotic pretreatment targeted before a one step exchange arthroplasty

Exclusion Criteria:

* none

Primary outcomes:
measure: Rate of Treatment Failure
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Secondary outcomes:
measure: rate of use of this strategy
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
measure: rate of bacteria responsible for infection
timeFrame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: HCL
name: Tristan Ferry, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02359591: The Development of Child Development Checklist Multimedia System and Its Clinical Evaluation
Official title: The Development of Child Development Checklist Multimedia System and Its Clinical Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development Checklist
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 390
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: guardians whose child is between 3 months and 7 years old

Brief summary: 【Background\& Purpose】In order to early detect the problems a child might have during his/her development, an effective screening tool is of great needs. The \[Taipei City Child Development Screening checklist\] is often used to serve this process. This text version is mainly distributed to the parents to fill out during their child regular check-ups to the hospitals and clinics. The drawbacks of this checklist is that it lacks of active participation of the target population, and the text version limits its usage to people who are not familiar with Chinese characteristics, such as those new inhabitant. These lead to low screening rates therefore causing delayed early intervention. 【Purpose】The purpose of this study was to design and develop the multi-media graphic version of the \[Taipei City Child Development Screening checklist\] based on its original text version.【Method】The developed muti-media system will be checked for is validity. Thirty parents/legal guardians of children in each target age groups will be recruited randomly for the clinical reliability evaluation.


Eligibility criteria: Inclusion Criteria:

* For parents/primary caregivers whose children are between 3 months and 7 years old can participate.

Exclusion Criteria:

* Any visual impairment.

Primary outcomes:
measure: 13 developmental milestones questionnaire
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Univ.
Study officials:
affiliation: Chang Gung Medical Hospital
name: Chang Gung Medical Hospital Chang Gung Medical Hospital
role: STUDY_DIRECTOR
References:
citation: Cheng HK, Chen LY, Cheng CH, Ju YY, Chen CL, Tseng KC. A Multimedia Child Developmental Screening Checklist: Design and Validation. J Med Internet Res. 2016 Oct 24;18(10):e277. doi: 10.2196/jmir.6249.