louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03612427: Diastolic Blood Pressure and Lipid Profile in Infants
Official title: Diastolic Blood Pressure and Lipid Profile in Breastfed Vs. Formula Fed Infants ( As Early Indicators for Cardiovascular Disease ).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breastfeeding, Exclusive
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited outpatient clinic of Assiut pediatric hospital

Brief summary: The influence of early environmental factors, including nutrition, on future cardiovascular disease (CVD) risk and, in a broader view, the concept of early metabolic programming and future health have been extensively discussed during the past decades. Observational studies have suggested that formula-fed infants as compared with breastfed infants have an elevated risk of future CVD.

Detailed description: The influence of early environmental factors, including nutrition, on future cardiovascular disease (CVD) risk and, in a broader view, the concept of early metabolic programming and future health have been extensively discussed during the past decades. Observational studies have suggested that formula-fed infants as compared with breastfed infants have an elevated risk of future CVD, since they have faster early growth rate and higher risk of overweight, type 2 diabetes, high blood pressure, and unfavorable blood lipid profile in adult age. Formula-fed preterm infants have higher serum C-reactive protein (CRP) concentration, higher serum low-density lipoprotein to high-density lipoprotein (LDL:HDL) ratio, and higher serum apolipoprotein B to apolipoprotein A1 (apoB:apoA1) ratio in adolescence as compared with preterm infants receiving banked breast milk.

Eligibility criteria: Inclusion Criteria:

1. Breastfed infants
2. Formula-fed infants
3. Raw milk fed infants
4. Mixed fed infants

   1. Breast milk plus raw milk
   2. Breast milk plus formula

Exclusion Criteria:

1. Children with Cong. Heart Disease, family history of congenital hyperlipidemia and cases which prove hyperlipidemia of high levels (congenital).

Primary outcomes:
measure: Diastolic blood pressure
timeFrame: Around one year
Secondary outcomes:
measure: Serum cholesterol level
timeFrame: Around one year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: El-Shazly Ahmed, MBBCh
role: STUDY_DIRECTOR
References:
Clinical trial NCT06454227: Subcutaneous Lavage in Cesarean Section
Official title: Antiseptic Washing Prior to Skin Closure During Cesarean Delivery- a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Site Infection
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if antiseptic washing prior to skin closure during cesarean section reduces rates of surgical site infection.

intraoperative washing is a common practice in other surgical fields and several studies have shown efficacy in reducing postoperative infection rates. no randomized control trial has tested this intervention during cesarean section.

The main questions we aim to answer are:

Does subcutaneous antiseptic washing reduce the rates of surgical site infection? Does antiseptic washing improve scar healing? Does antiseptic washing reduce hospital stay, postpartum fever rates and readmission cases?

Researchers will compare subcutaneous antiseptic washing to no intervention to see if surgical site infection rates reduce

Participants will:

consent to participate in the trial Visit the postpartum clinic 30 days after surgery


Eligibility criteria: Inclusion Criteria:

* pregnant women undergoing cesarean delivery

Exclusion Criteria:

* pregnant women undergoing vaginal delivery

Primary outcomes:
measure: surgical site infection
timeFrame: 30 days after surgery
Secondary outcomes:
measure: hospital stay
timeFrame: 30 days after surgery
measure: wound healing
timeFrame: 30 days after surgery
measure: postpartum fever
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT03189927: BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study
Official title: BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Esophageal Stricture
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ELLA-CS , sro
First posted: 2017-06-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae

Detailed description: A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae. The follow-up will be 6 months form implantation. After 3 months a control endoscopy will take place to evaluate stent and degradation process.

Eligibility criteria: Inclusion Criteria:

* Subjects of both genders
* Age ≥ 18 years
* Appropriate cultural level and understanding of the study
* Willingness to participate voluntarily in the study and give written informed consent
* Refractory benign esophageal stricture with or without fistulae, i.e. the patient has to pass a minimum of 2 and a maximum of 10 failed esophageal dilations to the minimal diameter of 15-mm, using a pneumatic balloon dilator or Savary bougie, not complicated by or malignancy.
* Ability to undergo periodic endoscopic follow-up.

Exclusion Criteria:

* Pregnancy or breastfeeding
* Simultaneous participation in another clinical study
* Life expectancy of less than 12 months
* Malignant esophageal stricture
* Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
* Undergone an esophageal stent implantation before.

Primary outcomes:
measure: Incidence of treatment associated adverse events during follow-up (safety)
timeFrame: 6 months
measure: BD-Covered stent placement (feasibility): (1) ease of deployment at intended esophageal location and, (2) incidence of device related adverse events at moment of stent placement
timeFrame: 1 day
Secondary outcomes:
measure: Esophageal pain, measured with VAS during follow-up after stent placement
timeFrame: 6 months
measure: Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01158027: Evaluating Walking Kinetic of Children Who Suffer Central Nervous System (CNS) Damage
Official title: Evaluating Walking Kinetic of Children Who Suffer Central Nervous System (CNS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Walking Performance
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifteen children post-TBI and fifteen typically control.

Brief summary: The goal of the present study is to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, and typically developed controls.


Eligibility criteria: Inclusion Criteria:

1. post-severe closed head injury (Glasgow Coma Scale \[GCS\] score at admission to emergency room of ≤8) \[Kathryn 2008\].
2. at least one year post trauma.
3. ages 7 to 13 years.
4. independent ambulation (foot orthoses permitted).

Exclusion Criteria:

1. had received botulinum toxin for spasticity management or had undergone orthopedic surgery in the past six months.
2. unable to follow simple instructions.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04726527: Clinical Evaluation of Florbetapir in Primary Progressive Aphasia
Official title: Clinical Evaluation of Florbetapir F 18 (18F-AV-45) / Determinants of Neurodegenerative Decline in Primary Progressive Aphasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Progressive Aphasia
Alzheimer Disease
Dementia
Keywords: Alzheimer's Disease
Dementia
Primary Progressive Aphasia
Neurocognitive Disorders
Speech Disorders
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from other research projects at Northwestern's Mesulam Center. Some of these projects recruit participants from the local Chicagoland area and others recruit participants from across the United States.

Brief summary: The purpose of this research is to better understand how dementia affects activity in different parts of the brain.

Detailed description: This study is being done to examine the usefulness of Positron Emission Tomography (PET) imaging with florbetapir F 18 as a biomarker in the identification of amyloid-ß peptide (Aß) in the brain. Amyloid-ß peptide (Aß) accumulates in the brains of patients with Alzheimer's disease. Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a PET camera. The development of biomarker and imaging studies that track the development of PPA and reflect the change in people's bodies may help other people who have a similar medical problem in the future.

Eligibility criteria: Inclusion Criteria:

* Subjects who, in the opinion of the investigator, can tolerate the PET scan procedures

Exclusion Criteria:

* Clinically significant cardiovascular disease
* clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
* Pregnant
* Breastfeeding
* Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
* History of relevant severe drug allergy or hypersensitivity
* Patients who have received an investigational medication under an FDA Investigational New Drug (IND) protocol within the last 30 days.

Primary outcomes:
measure: Detecting amyloid burden in subjects with neurodegenerative diseases
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The Healthy Aging & Alzheimer's Research Care Center - University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Emily Rogalski, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05799027: Raman Spectroscopic Analysis of Bronchoscopic Biopsy for Diagnosing Lung Cancer
Official title: Raman Spectroscopic Analysis of Bronchoscopic Biopsy for Diagnosing Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to evaluate raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer in visible lesions in the airway. The main question it aims to answer are: the diagnostic efficacy raman spectroscopic analysis of bronchoscopic biopsy for diagnosing lung cancer.

The bronchoscopic biopsy sample of patients with visible lesions in the airway would undergo raman spectrum analysis.


Eligibility criteria: Inclusion Criteria:

* Patients who plan to undergo bronchoscopic biopsy or EBUS-TBNA
* Visible intratracheal lesions under bronchoscope
* Non-visible lesions suspected of lung cancer

Exclusion Criteria:

* The patient could not tolerate further examination aimed at clarifying the cause of the disease or refused to accept further examination aimed at clarifying the cause of the disease due to poor general condition, serious organ dysfunction, etc
* The patient has no definite diagnosis

Primary outcomes:
measure: To establish the sensitivities and specificities of Raman spectroscopic analysis of bronchoscopic biopsy for lung cancer.
timeFrame: 7 days after the biopsy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06664827: Blood Flow Restriction (BFR) Training on the Ulnar Collateral Ligament (UCL)
Official title: Outcomes of Blood Flow Restriction Training on the Ulnar Collateral Ligament
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Healthy Male and Female Subjects
Healthy Volunteers
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to identify any differences in elbow ulnar collateral ligament (UCL) relative thickness and joint space laxity in the dominant arm following an 8-week course of low intensity resistance exercises with blood flow restriction (BFR) exercises in healthy volunteers. The main questions it aims to answer are:

1. Do BFR exercises contribute to a change in the relative ligament thickness of the UCL, and changes in the ulnohumeral joint space?
2. Are there changes in arm strength following the 8-week strengthening protocol with/without BFR?

Participants will:

* Complete two BFR sessions a week for a total of eight weeks.
* Complete an exercise session with both arms (dominant arm will receive BFR) at each study visit.
* Have sonographs taken of the UCL at the first and last study visit.
* Complete strength assessments at the first and last study visit.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer
* Agree to complete all exercise sessions and program in its entirety
* Between the ages of 18-50 years old

Exclusion Criteria:

* Current or recent injury of the hand, elbow, or shoulder
* Outside of the ages of 18-50 years old
* Vascular compromise or previous vascular surgery
* History of DVT
* Current participation in other BFR research study
* Currently participating in a structured strength training program
* Any musculoskeletal conditions resulting in inability to exercise
* Participants may not be collegiate/professional baseball/softball players
* Vulnerable populations

Primary outcomes:
measure: Relative ligament thickness of the UCL
timeFrame: From baseline visit to end of treatment at 8 weeks
measure: Changes in the ulnohumeral joint laxity
timeFrame: At baseline visit and end of treatment at 8 weeks
Secondary outcomes:
measure: Changes in arm strength
timeFrame: From baseline visit to end of treatment at 8 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
References:
Clinical trial NCT02173327: Helm CPAP Versus Mask CPAP After Major Abdominal Surgery
Official title: Continuously Helm CPAP Versus Intermittent Mask CPAP After Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Insufficiency
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative pulmonal complications (Abbreviation - PPC) after major abdominal surgery remains a significant clinical problem delaying rehabilitation after surgery. CPAP is one approach to minimize the frequency and severeness of PPC.

In the investigators' organization intermittent mask CPAP every 2 hour, 15min, is used routineously after major abdominal surgery.

Recently new devices has been designed, which give the opportunity tip deliver continuously CPAP with out interruptions because of presumed better comfort. Therefore better patient compliance.

No studies to date have investigated the possible benefit of using continuously helm CPAP versus the traditional intermittent mask CPAP after major abdominal surgery.

The investigators' study will investigate if there are any benefits with continuously Helm CPAP Versus intermittent Mask CPAP After Major Abdominal Surgery.


Eligibility criteria: Inclusion Criteria:

* Elective major abdominal surgery

Exclusion Criteria:

* Severe lung disease. Airway deformity. Need for CPAP at home. Ongoing oxygen therapy. Cannot give informed consent.

Primary outcomes:
measure: PaO2/FiO2
timeFrame: 24 hours
Secondary outcomes:
measure: V/Q mismatch
timeFrame: 24 hours
measure: Postoperative complications
timeFrame: 30 days
measure: Length of stay
timeFrame: 30 days
measure: Admittance to the intensive care unit
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
Other outcomes:
measure: Total CPAP therapy time
timeFrame: 24 timer
measure: CPAP interruptions
timeFrame: 24 timer
measure: Comfort during CPAP therapy
timeFrame: 24 timer
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Christian R Mortensen, MD
role: STUDY_CHAIR
References:
citation: Osterkamp JTF, Strandby RB, Henningsen L, Marcussen KV, Thomsen T, Mortensen CR, Achiam MP, Jans O. Comparing the effects of continuous positive airway pressure via mask or helmet interface on oxygenation and pulmonary complications after major abdominal surgery: a randomized trial. J Clin Monit Comput. 2023 Feb;37(1):63-70. doi: 10.1007/s10877-022-00857-7. Epub 2022 Apr 16.
Clinical trial NCT02572427: Resident Training Enhanced by New Innovations: Teleintubation
Official title: Video Laryngoscopy for Enhancing and Maintaining Intubation Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asphyxia Neonatorum
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall goal of this study was to create a simulation environment with repeated practice for residents and intense, immediate feedback. Repeated simulations for neonatal resuscitation when coupled with clinical experience have been shown to improve resident confidence.The investigators sought to determine if resident exposure to individual training and video laryngoscopy using the C-MAC video laryngoscope would improve cognitive skills and decrease intubation times in a neonatal manikin. The primary outcome was time to intubation after one year. The secondary outcome was the ability to retain cognitive instruction related to intubation

Detailed description: Objective: Tracheal intubation of infants and children is a critical lifesaving skill, but many upper level pediatric residents are unable to successfully intubate neonates or pediatric patients in a timely manner. Simulation has been shown to be effective in teaching procedural skills, but it is not known if improvements in intubation skills can persist. The investigators sought to determine if video laryngoscopy could be used to enhance resident intubation skills that would be retained for one year.

Methods: There were 67 Pediatric and Internal Medicine/Pediatric residents, levels 1-4, who completed the study and were randomized by month of service into non-intervention (NI, n= 36) and intervention (IN, n=31) groups. IN residents observed the intubation portion of the Neonatal Resuscitation Program (NRP) training video and received cognitive instruction and 30 minutes of hands on instruction using a video laryngoscope. At the study's conclusion, 12 months after enrollment, residents completed a survey of intubations of live patients over the past year, a cognitive assessment of intubation, and were timed on intubating a manikin. Results were analyzed by Student's T-Test.

Eligibility criteria: Inclusion criteria:

* Pediatric residents

Exclusion criteria:

* Residents from other departments
* Neonatology fellows
* Medical students
* Medical school Faculty

Primary outcomes:
measure: Skill in Intubating Neonatal Manikin
timeFrame: Up to two minutes
Secondary outcomes:
measure: Knowledge Concerning Intubation of Neonates
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Arkansas
name: Richard W Hall, M.D.
role: PRINCIPAL_INVESTIGATOR
References: