louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06209450: Sutured vs Sutureless Mesh Fixation for Onlay Ventral Hernia Repair
Official title: Sutured vs Suturless Mesh Fixation for Onlay Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventral Hernia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison beta sutured and suturless mesh fixation for ventral hernia regarding recurrence rates and complications rate

Detailed description: Ventral hernia repair is common procedure with over 250000 repairs each year in the unites states . Most ventral hernias are repaired using tension free type of repair using mesh that bridge the defect and reinforce the abdominal wall .

The mesh fixation technique has impact on recurrence rates,chronic pain and complications rates . Suturless ventral hernia repair with sealing agent fixation proved to be durable with comperable complication profile to other techniques.

Eligibility criteria: Inclusion Criteria:

* ventral hernia
* both sexes

Exclusion Criteria:

* obstructed or complicated ventral hernia
* incisional hernia
* recurrent hernia
* multiple ventral hernia
* large hernia more than 5 cm

Primary outcomes:
measure: Complications
timeFrame: One year after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06336850: Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement
Official title: Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Diseases
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies.

Detailed description: Patients undergoing EUS-guided liver biopsy may qualify to participate in this study. The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS- Portal Pressure Gradient Measurement (PPGM) in patients with liver disease referred for EUS-guided liver biopsy.

Eligibility criteria: INCLUSION CRITERIA

* Age 18 years or older
* Patient who has been referred for EUS procedure and direct PPG measurement and -undergoing EUS-guided liver biopsy
* History of liver disease or suspected cirrhosis and considered for PPGM

EXCLUSION CRITERIA

* Patient is less than 18 or greater than 85 years of age
* Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
* Patient is unwilling or unable to sign and date the informed consent
* Patient for whom endoscopic procedures are contraindicated.

Primary outcomes:
measure: Portal Pressure Gradient Measurements from Hepatic and Portal Veins
timeFrame: 2 years
Secondary outcomes:
measure: Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension
timeFrame: 2 years
measure: Clinical significance between portal pressure gradient measurement and portal hypertension
timeFrame: 2 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Prashant Kedia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02980250: Multi-Center Study of Different Doses Domperidone in Feeding Intolerance
Official title: A Clinical Multi-Center Study of Efficacy Analysis in Different Doses of Domperidone in Feeding Intolerance of Premature Infant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Feeding Intolerance
Premature Birth
Domperidone Overdose
Gastric Retention
Keywords: feeding intolerance
premature infant
domperidone
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial Maternal and Child Health Hospital
name: Shen-Zhen City Maternity and Child Healthcare Hospital
name: Maternal and Child Health Hospital of Foshan
name: Guangzhou Panyu Central Hospital
First posted: 2016-12-02
Enrollment: 118
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical multi-center study is to determine whether different doses of domperidone are effective in the treatment of feeding intolerance in premature infant

Detailed description: the premature infant have been divided into four group.The first group take the 0.2mg/kg/tds domperidone as treatment ,while the other group take the 0.4mg/kg/tds domperidone,0.6mg/kg/tds domperidone and the placebo respectively .

An objective index has been decided to evaluate the severity of feeding intolerance in the premature infant. 3kg/kg 5% glucose will be injected into the gastric tube .The residual glucose will be drawed out from the gastric tube. The residual percentage is the main result of the study.

The main result will be compared by the secondary result to help to explain the accuracy. The secondary result is the percentage of residual milk drawed out from the gastric tube from how many milk the infant take 3 hours ago.

Any adverse effect will be recorded and analysed to figure out whether is associate with the domperidone.

Eligibility criteria: Inclusion Criteria:

* the residual milk and glucose over 55%
* abdominal distention or vomiting;
* Reduce,delay or disruption of enteral feeding

Exclusion Criteria:

* Four weeks before the start of this study had participated in other clinical trials
* pulmonary hypertension;
* Infants with necrotizing enterocolitis
* Gastrointestinal tract malformation, congenital heart disease
* Pre-existing QT extend/between long QT syndrome;
* ascites
* Have been used or will use drugs suppress CYP3A4
* Other risk factors for prolong the QT

Primary outcomes:
measure: the residual glucose percentage
timeFrame: 7 days
Secondary outcomes:
measure: the percentage of residual milk
timeFrame: 7 days
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 1 month
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hosiptal
name: WeiMing Huang, professor
role: STUDY_CHAIR
References:
Clinical trial NCT03393650: Protein Supplementation and Mixed Power Training on Muscle Function and Functional Capacities in Elderly Men
Official title: Effect of Protein Supplementation Combined With Mixed Power Training on Muscle Function, Composition, Phenotype and Functional Capacities Compared to Mixed Power Training Alone in Elderly Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dynapenia
Aging
Physical Impairment
Keywords: exercise
protein
muscle function
aging
Lead sponsor: Université du Québec a Montréal
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 100
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigate the effect of 12 weeks mixed power training (power and functional exercises) combined with a protein supplementation (30g/d) or not (placebo) on physiological characteristics of muscle and functional capacities in elderly men.

Detailed description: Life habits are know to be able to prevent the loss of functional capacities and muscle function during aging process. More specifically, protein intake is important to maintain muscle function in older adults. Another non pharmacological intervention and well recognized for its efficacy, it's exercise training.

Recently, it has been observed than muscle quality is more important to maintain physical autonomy than muscle mass per se. In addition, muscle quality is more related to functional capacities than muscle mass.

Due to this recent finding, it has been proposed that muscle power training would be the best exercise intervention to prevent the loss of mobility.

Eligibility criteria: Inclusion Criteria:

* Elderly men
* 60 years and older
* Sedentary men
* Not obese (BMI \<30 kg/m2)
* Living in free-living community

Exclusion Criteria:

* Not able to follow an exercise program (doctor authorization: XAAP)
* Having Lactose intolerance
* Having Pace marker
* Having Metabolism disorder
* No weight stable since the last 6 months
* No stable medication (same dose and type since at least 6 months)

Primary outcomes:
measure: Change in walking speed
timeFrame: Change from Baseline walking speed at 12 weeks measure in all subjects
Secondary outcomes:
measure: Change in lower limb muscle quality
timeFrame: Change from Baseline lower limb muscle quality at 12 weeks measure in all subjects
Other outcomes:
measure: Change in mitochondrial activity
timeFrame: Change from Baseline mitochondrial activity at 12 weeks measure in half of the subjects
Locations:
Study officials:
affiliation: Université du Québec a Montréal
name: mylene aubertin-leheudre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01212250: Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
Official title: A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2010-09-30
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients of cirrhosis aged 18 to 75 years who have no esophageal varices will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year.


Eligibility criteria: Inclusion Criteria:

* Patients of cirrhosis aged 18 to 75 years who have no esophageal or gastric varices.

Exclusion Criteria:

* Any contra-indication to beta-blockers
* Any past EVL or sclerotherapy
* Any past history of surgery for portal hypertension
* Significant cardio or pulmonary co-morbidity
* Any malignancy
* Refusal to participate in the study

Primary outcomes:
measure: the proportions of patients who develop esophageal varices at 1 year in each group.
timeFrame: 1 year
Secondary outcomes:
measure: Number of patient dying in a period of one year
timeFrame: 1 year
measure: Number of patients needing discontinuation of therapy due to adverse effects.
timeFrame: 1 year
measure: Reduction in Hepatic Venous Pressure Gradient in both groups
timeFrame: 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences (ILBS)
state: Delhi
Study officials:
References:
Clinical trial NCT05718050: Mandibular Flexure in Patients
Official title: Mandibular Flexure: An In-vivo Study in Dentate Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Flexure
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The flexion of the mandible (MF) is a multifactorial phenomenon that occurs simultaneously with mandibular movements determining changes in the shape of the mandible. mandibular flexure (MF) may cause complications and failures in both conventional and implant-supported fixed dental prostheses (FDP) especially when a long-span prosthesis is planned to connect the anterior to the posterior region of the mandible. Previous studies reported increased biomechanical stress at the prosthetic and implant level, poor passivity of fit, impression distortion, pain during function, de-cementation of the prosthesis, porcelain chipping, prosthetic screw loosening and fracture, bone resorption and implant fracture. The aim of this study is to quantify the dimensional changes related to MF by means of a cone beam computed tomography (CBCT) between maximum opening (MO) and maximum intercuspation (OVD) positions. The null hypothesis was that there is no significant difference in terms of length and width of the mandible between maximum intercuspation and maximum opening positions.


Eligibility criteria: Inclusion Criteria:

* Dentate patients,
* 18 years of age or older,
* Good health
* Need of implant treatment

Exclusion Criteria:

* active periodontitis with tooth mobility
* neuromuscular disorders
* temporomandibular joint disorders
* parafunctional habits
* systemic condition preventing surgery
* history of oro-maxillofacial radiation therapy
* history of drug or alcohol abuse
* heavy smoking
* uncontrolled diabetes
* pregnancy
* lactation.

Primary outcomes:
measure: Mandibular Flexure in Occlusal Vertical Dimension (OVD)
timeFrame: 24 hours
measure: Mandibular Flexure in maximum opening (MO)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Puebla
country: Mexico
facility: Benemérita Universidad Autónoma de Puebla
Study officials:
References:
Clinical trial NCT04490850: COVID-19 Seroprevalence Study in French Guiana
Official title: COVID-19 Seroprevalence Study in French Guiana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronavirus Infection
Severe Acute Respiratory Syndrome
SARS-CoV Infection
Covid19
Keywords: SARS-CoV-2
COVID-19
Serology
French Guiana
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Institut Pasteur de la Guyane
name: Laboratoire de biologie médicale, Institut Pasteur de la Guyane
name: Laboratoire de biologie médicale de Kourou, French Guiana
name: Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni, French Guiana
name: Eurofins
name: Centres Délocalisés de Prévention et de Soins, Centre Hospitalier Andrée Rosemon de Cayenne, Frech Guiana
First posted: 2020-07-29
Enrollment: 3541
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.

Detailed description: Serological surveys measuring anti-severe acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) antibodies in the population to assess the extent of the infection and the COVID-19 immunity of the population in French Guiana.

This study is a interventional study that present minimal risks and constraints.

The results of the study will allow estimation of COVID-19 virus infection, severity and attack rates, as well as inform public health responses and policy decisions in the French Guiana territory.

Eligibility criteria: Inclusion Criteria:

* Person going to a prevention and care center or medical biology analysis laboratory as part of the care, regardless age, regardless of an acute or previous infection with COVID-19;
* State of health compatible with a blood sample as defined in the protocol

Exclusion Criteria:

* Inability to consent
* Person under guardianship or curatorship
* Known pathology or a health problem contraindicated with the collect of blood sample.

Primary outcomes:
measure: Measure of the COVID-19 immunity of the population
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of the level of asymptomatic and pauci-symptomatic infections
timeFrame: 1 year
Other outcomes:
Locations:
city: Cayenne
country: French Guiana
facility: Centre Hospitalier Andrée Rosemon
city: Cayenne
country: French Guiana
facility: Laboratoire de biologie méicale, Institut Pasteur de la Guyane
city: Cayenne
country: French Guiana
facility: Laboratoires Eurofins Guyane
city: Kourou
country: French Guiana
facility: Laboratoire de biologie médicale de Kourou
city: Saint-Laurent du Maroni
country: French Guiana
facility: Laboratoire de biologie médicale du Centre hospitalier de Saint-Laurent du Maroni
Study officials:
affiliation: Institut Pasteur de la Guyane, Head of Epidemiology Unit
name: Claude Flamand, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00941850: A Study of Triple-site Ventricular Pacing in Patients Who Have Not Responded to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy
Official title: TRIple-site VENTricular Pacing in Non-responders to Conventional Dual Ventricular Site Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Cardiac resynchronizton therapy
CRT
Heart failure
Dyssynchrony
Echocardiography
Pacemakers
Nonresponders
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2009-07-20
Enrollment: 20
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: Patients are randomised to receive ongoing optimised device and medical therapy or triple ventricular site resynchronisation. The hypothesis states that patients receiving triple-site resynchronization will exhibit a better response.


Eligibility criteria: Inclusion Criteria:

* Implanted with a CRT device \> 6 months previously according to current and conventional CRT indications
* Device optimization \> 1 months previously
* Aged 18yrs or older
* Able to attend outpatient follow up

Exclusion Criteria:

* Recent MI (\<2 months)
* Women who are pregnant or planning pregnancy
* Severe co morbid illness (where patients are not expected to survive duration of follow up period or where repeated outpatient visits may not be in best interest of patients)
* Upgrade procedure is contraindicated for safety reasons.
* Class IV inotropic agents
* Patient unwilling to comply with required follow-up protocol including randomization scheme

Primary outcomes:
measure: Proportion of responders in each group. o Clinical response will be defined according to the Packer score o Echocardiographic response will be defined as a 10% relative reduction in left ventricular end systolic volume at six months
timeFrame: 6 months
Secondary outcomes:
measure: NYHA class
timeFrame: 3 and 6 months
measure: ECHO parameters (LVEDV/ESV, LVEF, MR severity, dyssynchrony indices: time to peak velocity/strain/deformation/time to minimal volume)
timeFrame: 3 and 6 months
measure: MVO2 max
timeFrame: 6 months
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University of Leicester HNS trust
state: England
Study officials:
affiliation: University of Leicester
name: GAndre Ng, MB ChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03354650: Epidemiology of Neonatal Sepsis in Neonatal Intensive Care Unit in Assiut University Children Hospital
Official title: Epidemiology of Neonatal Sepsis in Infants Admitted to Neonatal Intensive Care Unit in Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal SEPSIS
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 100
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All admitted male and female infant from the birth to the day 30 after birth

Brief summary: Neonatal sepsis is an important cause of morbidity and mortality in the pediatric age group . It is one of the leading causes of death in the first 28 days of life both in the developed and developing countries.

Detailed description: More than 40% of under-five deaths globally occur in the neonatal period, resulting in 3.1 million newborn death each year.

The majority of these deaths usually occur in low income countries . On the other hand, the survivors of neonatal sepsis are vulnerable to short- and long term neurodevelopmental morbidity .

Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life. It includes various systemic infections of the newborn such as septicemia, meningitis, pneumonia, arthritis, osteomyelitis, and urinary tract infections. Superficial infections like conjunctivitis and oral thrush are usually not included under neonatal sepsis.

Diagnosis of sepsis in neonates is challenging due to nonspecific signs and symptoms. The salient clinical features include systemic signs of infection such as fever, hypothermia, tachycardia, failure to thrive, lethargy, irritability, restlessness In addition, laboratory diagnosis until recently was time-consuming. This, therefore, necessitates the initiation of empirical antibiotic therapy pending a definitive diagnosis .

Neonatal sepsis is caused by Gram-positive and Gram-negative bacteria and Candida. The diversity of organisms causing sepsis varies from region to another and changes over time even in the same place .

Eligibility criteria: Inclusion Criteria:

• All admitted inborn and out born neonates during this study period will be screened for sepsis

Exclusion Criteria:

• All cases that mimic neonatal sepsis such as;

* Inborn errors of metabolism
* Congestive heart failure
* Hemolytic Disease of Newborn
* Hypoxic ischemic encephalopathy
* Congenital Diaphragmatic Hernia
* Intra cranial hemorrhage
* Respiratory Distress Syndrome

Primary outcomes:
measure: Incidence of neonatal sepsis
timeFrame: up to 4 months
measure: prevalence of neonatal sepsis
timeFrame: up to 4 months
Secondary outcomes:
measure: risk factors and causative organisms of neonatal sepsis
timeFrame: up to 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Gehan Mo Kamal El_Din, Professor
role: STUDY_CHAIR
References: