louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06458920: Social Facilitation of Emotion Regulation in Adolescence
Official title: Social Facilitation of Emotion Regulation in Adolescence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: During one MRI scan, participants will spend part of the time regulating emotion on their own and part of the time regulating emotion with the help of a friend
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this project is to test whether regulating emotions with help from a friend is more effective and long-lasting in adolescents than regulating alone, and to characterize age-related differences in the neural mechanisms supporting social versus cognitive emotion regulation. Participants will complete a psychology experiment while undergoing fMRI scanning.

Detailed description: Participants will complete a novel paradigm during functional magnetic resonance imaging (fMRI) to examine whether adolescents (N = 50) and adults (N = 50) are more effective at down-regulating negative affect when a friend provides them with reinterpretations of negative stimuli (i.e. social reappraisal), as compared to when they reinterpret stimuli alone (i.e., cognitive reappraisal). Specifically, participants will look at pictures of upsetting events while undergoing fMRI scanning. For some pictures, they will be instructed to just look at the image. For other pictures, they will be told to listen to their friend's voice as their friend helps them to regulate their emotions. For other pictures, they will be told to regulate their emotions on their own. The primary comparison of interest is how participants regulate emotion on their own versus when their friend helps them.

Eligibility criteria: Inclusion Criteria:

* Adolescent participants must be 13-15 year of age
* Adult participants must be 20-25 years of age
* Proficient in English

Exclusion Criteria:

* Auditory, visual or cognitive impairment
* Any health conditions that are contraindicated for MRI

Primary outcomes:
measure: Negative affect
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References:
Clinical trial NCT04046120: Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers
Official title: Comparison of the Effectiveness of Two Medical Compression Bandage Application Techniques by Measuring Interface Pressures Depending on Whether or Not the Heel is Included in Patients With Open Venous Ulcers: Non-inferiority, Controlled, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Ulcer
Keywords: varicose ulcer
compression bandages
patient compliance
heel
methods
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 102
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 importance of wearing medical compression to heal the venous ulcer has already been shown. However, no studies have been carried out on variations in medical compression tape and their impact on interface pressures which explains the lack of consensus on how to lay, including or not to include the heel. Studies on adherence to patients with medical compression have been carried out showing that one of the determining factors is comfort. The investigators therefore wish to conduct a randomized open prospective quantitative study comparing these two modes: including or not the heel .


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Patient with at least one venous ulcer progressing for at least 4 weeks
* Patient coming for a specialized outpatient consultation called "vascular wound" at Nantes University Hospital
* Informed consent to participate in the study
* Social security insurance affiliation

Exclusion Criteria:

* Patients under guardianship
* Patient with major cognitive disorders incompatible with follow-up of protocol
* Pregnancy
* Patient with an open leg ulcer with a Systolic Pressure Index \< 0.8

Primary outcomes:
measure: Interface pressure V3
timeFrame: 48 hours after the bandage is applied (between week 4 and week 6)
Secondary outcomes:
measure: Ankle circumference
timeFrame: Day 0 and the last day (between week 4 and week 6)
measure: Interface pressure V2
timeFrame: 48 hours before the last visit of the protocol. (Between 4 and 6 weeks)
measure: Interface pressure V2 and V3
timeFrame: 48 hours before the last visit of the protocol and at the last visit of the protocol (Between 4 and 6 weeks)
measure: Patient satisfaction: questionnaire
timeFrame: At the last visit of the protocol (Between 4 and 6 weeks)
measure: Number of bandage repairs
timeFrame: Day 0
Other outcomes:
Locations:
city: Nantes
country: France
facility: Chu de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Anne POTTIER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06980220: Impact of Perineal Massage With Lubricating Gel During Expulsion on Perineal Outcomes
Official title: Impact of Perineal Massage With Lubricating Gel During Expulsion on Perineal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perineal Massage
Perineum/Injuries
Labor, Obstetric
Episiotomy
Lead sponsor: Centre Hospitalier de Gonesse
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will select participants from primiparous women (first-time mothers) who have delivered through spontaneous vaginal births at the hospital. The population will consist of women with singleton pregnancies who are undergoing vaginal delivery without any complications requiring instrumental intervention or preterm delivery. The study will focus on a cohort of women who have received care from midwives, ensuring consistency in the delivery approach. Participants will be selected based on the inclusion criteria outlined and will be monitored for perineal outcomes, including the occurrence of perineal tears and postpartum pain.

Brief summary: The primary goal is to assess whether this practice reduces the incidence and severity of perineal tears. Secondary objectives include evaluating the impact of the massage on perineal pain in the postpartum period and on the episiotomy rate. Participants will include primiparous women with singleton pregnancies who delivered spontaneously via vaginal birth. Exclusion criteria include instrumental deliveries, breech presentations, and preterm births. Data will be collected through a questionnaire filled out by midwives immediately after birth, as well as additional data extracted from medical records. All data will be anonymized using a birth number code. The questionnaire collects information on whether a perineal massage was performed, the type of product used, the birth position, use of warm compresses, performance of the Ritgen maneuver, and perineal outcomes. The medical record will provide demographic and clinical data, including the mother's age, BMI, labor duration, pushing time, newborn weight, and head circumference. The study aims to provide evidence on whether perineal massage with gel at expulsion is an effective strategy to prevent severe perineal trauma and improve postpartum recovery.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Spontaneous vaginal delivery
* Primiparous women (first-time mothers)

Exclusion Criteria:

* Instrumental births
* In-seat births
* Premature births

Primary outcomes:
measure: Rate of Perineal Tears Following Perineal Massage with Lubricating Gel at Expulsion
timeFrame: 15/10/2023 - 15/05/2024
Secondary outcomes:
Other outcomes:
Locations:
city: Gonesse
country: France
facility: France
Study officials:
References:
Clinical trial NCT04173520: ELRIAH Score: A Simple Score for HCC Risk Stratification in CHC Patients With Cirrhosis or Advanced Liver Fibrosis Who Achieved SVR Following DAA Therapy
Official title: ELRIAH Score: A Simple Score for HCC Risk Stratification in CHC Patients With Cirrhosis or Advanced Liver Fibrosis Who Achieved SVR Following DAA Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HCC
Lead sponsor: Egyptian Liver Hospital
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 2326
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: 2326 CHC patients (638 patients with F3 and 1734 with F4 stage)

Brief summary: aimed to develop a scoring system to assess risk of developing HCC in a large cohort of chronic hepatitis C (CHC) patients with advanced hepatic fibrosis (F3) or cirrhosis (F4) with sustained virological response (SVR) after receiving direct acting antivirals (DAAs).

Detailed description: Current guidelines recommend biannual surveillance for hepatocellular carcinoma (HCC) in all patients with cirrhosis. However, risk of HCC incidence is not the same for different patients. The study aimed to develop a scoring system to assess risk of developing HCC in a large cohort of chronic hepatitis C (CHC) patients with advanced hepatic fibrosis (F3) or cirrhosis (F4) with sustained virological response (SVR) after receiving direct acting antivirals (DAAs).

Eligibility criteria: Inclusion Criteria:

* no history of previous HCC
* SVR after DAAs treatment

Exclusion Criteria:

* history of previous HCC

Primary outcomes:
measure: Rate of HCC incidence after viral clearance
timeFrame: 12-45 months after SVR
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03001674: Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure
Official title: Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to develop normative hemodynamic data (means and standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and 3D-echocardiographic analyses.


Eligibility criteria: Inclusion Criteria:

* Male or females between 18-75 years of age
* NYHA Class III-IV heart failure at the time of MEGA deployment
* Stage C-D systolic heart failure
* Non-ischemic cardiomyopathy
* Preserved right ventricular function defined by 2D-echocardiography
* Clinically indicated left and right heart catheterization and MEGA-IABP placement
* Clinically indicated MEGA-IABP support for 12 hours minimum

Exclusion Criteria:

* Ischemic cardiomyopathy
* Active myocardial ischemia or acute coronary syndrome
* Severe peripheral vascular disease
* Severe aortic or mitral valve insufficiency
* Severe aortic or mitral valve stenosis
* Right ventricular failure
* Inability to tolerate left and right heart catheterization
* Severe hemodynamic instability defined as a systolic BP \<80mmHg despite vasopressor/inotropic support
* Sustained ventricular tachycardia (\>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours
* Pacemaker dependent rhythm
* Left ventricular thrombus
* Rapid atrial fibrillation (HR\>120 bpm)
* Unable to provide informed consent
* Pregnancy

Primary outcomes:
measure: Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Navin Kapur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00266474: Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis
Official title: Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Sinusitis
Keywords: Cystic Fibrosis with Chronic Rhinosinusitis
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2005-12-16
Enrollment: 187
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL

Brief summary: Aim of the study is to detect the prevalence of chronic rhinosinusitis and the colonisation with Pseudomonas aerug. in the upper airways in patients with cystic fibrosis.


Eligibility criteria: Inclusion Criteria:

* Subject has a confirmed diagnosis of cystic fibrosis

Exclusion Criteria:

* current systemic therapy against Pseudomonas aeruginosa

Primary outcomes:
measure: Pathogen colonization in upper and lower airways
timeFrame: 3yrs
measure: Sinonasal symptoms (SNOT-20)
timeFrame: 3 yrs
measure: rhinomanometry and rhinoscopy
timeFrame: 3yrs
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich-Schiller-Universität
state: Thüringen
Study officials:
affiliation: University of Jena
name: Jochen G. Mainz, M.D.
role: STUDY_CHAIR
References:
citation: Mainz JG, Naehrlich L, Schien M, Kading M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tummler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11.
Clinical trial NCT06159374: Effects of Physical Training in Altered Environmental Conditions on Exercise Performance
Official title: Effects of Physical Training in Altered Environmental Conditions (in a Hypoxic Thermoclimatic Chamber) on Exercise Capacity and Selected Physiological Responses of the Human Body
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxia, Altitude
Cold Exposure
Heat Exposure
Keywords: training
exercise
human performance
aerobic capacity
anaerobic capacity
maximal oxygen uptake
muscle power
Lead sponsor: University School of Physical Education, Krakow, Poland
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 128
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of the study is to evaluate the physiological-biochemical effects of physical training under artificially altered climatic conditions (using a hypoxic thermoclimatic chamber) in particular to determine the effect of such training on exercise capacity and physiological response, including the effect of training in high-performance athletes. The study will evaluate the effects of physical training and the simultaneous application of hypoxia and heat/cold on aerobic and anaerobic capacity and the physiological response of the human body. The aim of the study is to find the most favourable environmental conditions for physical training in order to maximise physical performance.


Eligibility criteria: Inclusion Criteria:

absence of medical contraindications to high-intensity physical exertion. The medical examination is required (included an exercise ECG, blood tests to exclude anemia or low hemoglobin and iron concentration)

Exclusion Criteria:

any training (including hypoxia training or exposure) performed in the 6 months prior to the beginning of the intervention

Primary outcomes:
measure: Measurement of aerobic capacity (endurance)
timeFrame: 7 days before training and 7-10 days after the training. Training will last 4 weeks.
measure: Measurement of anaerobic capacity
timeFrame: 7 days before training and 7-10 days after the training. Training will last 4 weeks.
measure: Blood analysis
timeFrame: Before (10 min) and after (3 min) the first and last training. The training will last 4 weeks and will consist of 12 workouts
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: University School of Physical Education in Cracow
Study officials:
affiliation: Departament of Physiology and Biochemistry
name: Marcin Maciejczyk, Prof. dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT04417920: Express Implant Versus Trabeculectomy After Late Failure Trabeculectomy
Official title: Express Implant Versus Trabeculectomy in a Fibrotic Bleb With Late Failure After Previous Trabeculectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Express valve
Failed Trabeculectomy
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 28
Sex: ALL
Minimum age (years): 42
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare between outcome of Express implant and subscleral trabeculectomy (SST) in management of glaucoma after previous trabeculectomy with a fibrotic bleb.

Detailed description: Trabeculectomy is the main glaucoma surgery. Despite the good decline in intraocular pressure (IOP) that occur rapidly after the procedure, there is still failure occurring due to progressive subconjunctival fibrosis, with associated increased IOP.

If the bleb is revived by needling with adjunctive 5-fluorouracil (5FU) and mitomycin C (MMC) that used intraoperatively for the majority of these cases , the associated rise in IOP was controlled if the revision occured early within the first three months after surgery. But less success occurred if the bleb revision was delayed.

If these interventions fail, alternative approaches include new augmented trabeculectomy or aqueous shunt implantation.

Express shunt allows aqueous to pass from anterior chamber to subconjunctival space like trabeculectomy .Express shunt is a non valved shunt, It has an advantage of less traumatic, less complications, low diffuse bleb and high success rate.

Eligibility criteria: Inclusion Criteria:

* elevated intraocular pressure (IOP) with fibrotic bleb despite previous SST since more than 4 months
* follow up 12mo after the second surgery

Exclusion Criteria:

* SST failure other than fibrotic bleb were also excluded
* follow up less than 4mo after the first surgery, and those less than 12mo after the second surgery

Primary outcomes:
measure: change of intra ocular pressure (IOP)
timeFrame: one year follow up
Secondary outcomes:
measure: Visual acuity changes by Decimal
timeFrame: one year follow up
measure: Glaucomatous visual field (VF) changes in median deviation by decibels (dB)
timeFrame: one year follow up
measure: Changes in optic Cup-to-Disc ratio by Volk+90 non-contact lens
timeFrame: one year follow up
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Tharwat Mokbel
state: AlDakahlia
Study officials:
affiliation: Gamal Abd El Nasr st. - Shebin ElKoum - Menofia
name: Faried Wagdy, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT05340920: Relevance of Sensitization to Fenugreek in Children
Official title: Relevance of Sensitization to Fenugreek in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergy to Fenugreek
Keywords: allergy
children
legumes
sensitization
diagnostic
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 50
Sex: ALL
Minimum age (years): 1
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 aged from 1 to 17 years old, sensitized to fenugreek with an evaluation of their tolerance to fenugreek by an oral food challenge

Brief summary: The prevalence of allergy to legumes is inscreasing, especially in children and for some of these legumes, little is known and there are not included in the list of priority allergen. The overall goal of this study is to improve knowledge about fenugreek allergy. The principal aim is to evaluate the prevalence of allergy to fenugreek confirmed by a positive oral food challenge in children sensitized to fenugreek. The secondary objectives are to describe the case of allergy to fenugreek (co-allergies, severity, age..), to evaluate diagnostic values of skin prick-tests and specific IgE and to compare the molecular profile of specific IgE to peanut between sensitization to fenugreek without allergy and sensitization with a confirmed allergy


Eligibility criteria: Inclusion Criteria:

* Children for whom an oral food challenge to fenugreek has been performed between the 1st January 2017 and the 15th April 2022 and for whom skin prick test and/or specific IgE to fenugreek are avalaible

Exclusion Criteria:

* patient over 18 years old
* undeterminate oral food challenge

Primary outcomes:
measure: Oral food challenge to fenugreek
timeFrame: 2017-2022
measure: skin prick-test to fenugreek
timeFrame: 2017-2022
measure: specific IgE to fenugreek
timeFrame: 2017-2022
Secondary outcomes:
measure: severity of allergy
timeFrame: 2017-2022
measure: molecular profile for peanut allergy
timeFrame: 2017-2022
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Centre Hospitalo-Universitaire de Nancy
Study officials:
affiliation: centre hospitalo-universitaire de Nancy
name: Amandine Divaret-Chauveau, MD
role: PRINCIPAL_INVESTIGATOR
References: