louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04396613: Wound Closure Techniques in Primary Spine Surgery
Official title: Assessment of Wound Closure Techniques in Primary Spine Surgery Using SPY Intra-operative Angiography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Injuries
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The Researchers are trying to determine if there is a difference in blood flow around a wound site when comparing three different types of wound closure techniques.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Primary diagnosis of spinal stenosis
* Surgical indication for 1 or 2 level posterior spinal decompression or fusion

Exclusion Criteria:

* Pregnant or Breastfeeding
* Previous posterior spinal surgery
* Systemic corticosteroid use
* Long-term anticoagulation treatment
* Diagnosis of diabetes mellitus
* Diagnosis of peripheral arterial disease
* Current smoker
* Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis
* Iodine Allergy

Primary outcomes:
measure: Lowest perfusion - 10 Adjacent
timeFrame: Baseline
Secondary outcomes:
measure: Lowest perfusion - 10 Alongside
timeFrame: At time of procedure
measure: Average perfusion - 10 Alongside
timeFrame: At time of procedure
measure: Average perfusion - 10 Adjacent
timeFrame: At time of procedure
measure: Lowest perfusion - 20 Adjacent
timeFrame: At time of procedure
measure: Lowest perfusion - 20 Sides
timeFrame: At time of procedure
measure: Average perfusion - 20 Sides
timeFrame: At time of procedure
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Arjun Sebastian
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05956613: Post Operative Pain of Partial Pulpotomy Using a Bioceramic Material in Patients With Symptomatic Irreversible Pulpitis
Official title: Evaluation of Postoperative Pain After Partial Pulpotomy Versus Full Root Canal Treatment in Managing Young Permanent Molars With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Endodontic Disease
Keywords: bioceramic material, pulpitis, partial pulpotomy
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess post-operative pain of partial pulpotomy using a newly introduced Bioceramic material in young patients with symptomatic irreversible pulpitis at 24, 48, 72 hours postoperatively using visual analogue scale (VAS). The main question\[s\] it aims to answer are:

• In patients with symptomatic irreversible pulpitis does the use of bioceramic material in partial pulpotomy decrease amount of post operative pain in comparison to conventional root canal treatment?

Participants will record the intensity of pain at 24,48, 72 hours postoperatively.


Eligibility criteria: 1. Inclusion criteria :

   1. Subject's age between 9-14 years.
   2. Both male and female subjects.
   3. Medically free and healthy subjects.
   4. Mandibular molar teeth.
   5. Teeth with symptomatic irreversible pulpitis.
   6. Teeth with mature closed apices.
2. Exclusion Criteria:

   1. Teeth with acute dentoalveolar abscess.
   2. Subjects having more than one tooth that require root canal treatment.
   3. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
   4. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
   5. Teeth with periodontal disease or pulp calcification.
   6. Subjects taking chronic pain medications.

Primary outcomes:
measure: Post operative pain
timeFrame: after 24 hours
measure: Post operative pain
timeFrame: after 48 hours
measure: Post operative pain
timeFrame: After 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Dentistry, October 6 University
Study officials:
References:
Clinical trial NCT02009813: Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.
Official title: Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Keywords: Insulin resistance
Inflammation
Hypoxia
Lead sponsor: University of Adelaide
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Obesity is an epidemic in Western society and is the biggest risk factor for insulin resistance and type 2 diabetes. The investigators have recently shown that exposure to hyperbaric oxygen (HBO) leads to an increase insulin sensitivity in males ubjects and that this improvement can be measured in all men, not just those with diabetes. The aim of this study is to investigate the time course of this effect and explore the mechanisms involved. The investigators suspect that insulin sensitivity as measured by hyperinsulinaemic-euglycaemic clamp will be increased within the time-frame of one 2-hour hyperbaric oxygen exposure, and that the improvement will be measurable in females as well as males.


Eligibility criteria: Inclusion Criteria:

* Overweight to obese (BMI 25-35 kg/m2)
* Age \>18 years (no specific upper age limit)
* Fit to enter hyperbaric chamber as assessed by hyperbaric physician.

Exclusion Criteria:

* Personal history of Diabetes
* Personal history of major psychiatric disorders
* UIse of prescribed or non-prescribed medications which may affect glucose homeostasis (e.g. steroids),
* Uncontrolled asthma,
* Current fever or upper respiratory infections
* Individuals who regularly perform high intensity exercise (\>2 week),
* Pregnancy, lactation and women who are planning to become pregnant
* Current intake of \>140g alcohol/week,
* Current smokers of cigarettes/cigars/marijuana,
* Current inatke of any illicit substance,
* Claustrophobia
* has donated blood within past 3 months.

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 2 hours
Secondary outcomes:
measure: Hypoxia and inflammatory markers
timeFrame: 2 hours
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
Study officials:
affiliation: University of Adelaide
name: Leonie K Heilbronn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Adelaide
name: David Wilkinson, BMBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen M, Liu B, Wilkinson D, Hutchison AT, Thompson CH, Wittert GA, Heilbronn LK. Selenoprotein P is elevated in individuals with obesity, but is not independently associated with insulin resistance. Obes Res Clin Pract. 2017 Mar-Apr;11(2):227-232. doi: 10.1016/j.orcp.2016.07.004. Epub 2016 Aug 11.
Clinical trial NCT02698813: Safety Study of Filler Agent Composed of Umbilical Cord Mesenchymal Stem Cells and Hyaluronic Acid
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Senescence Wrinkles, Acne, Pitting Scar
Lead sponsor: South China Research Center for Stem Cell and Regenerative Medicine
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal of this study is to evaluate the safety and exploratory efficacy of the injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid for the improvement of wrinkles, acne, pitting scar and so on.


Eligibility criteria: Inclusion Criteria:

1. Male or female over 18 years;
2. Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
3. Suitable for the medical history and physical examination like the following preoperative laboratory tests results: complete blood count, coagulation, biochemistry, electrocardiogram, hepatogram and β-human chorionic gonadotropin (hCG) for women of childbearing age.

Exclusion Criteria:

1. Patients unable to undergo surgery liposuction with Klein technique as those with severe cardiovascular disease, severe coagulation disorders including thrombophilia and pregnancy;
2. Have history or active dermal diseases, inflammation, or any related disease;
3. Had invasive aesthetic treatments or surgeries history 6 months before the treatments;
4. Had physical or chemical aesthetic treatments 1 months before the study starts;
5. Have a known history of allergic reactions like hypersensitivity to hyaluronic acid;
6. Patients with limited understanding of the procedure or have poor compliance with the study or follow-up schedule;
7. Pregnant or lactating;
8. Use of drugs;
9. Patients with preoperative results considered inadequate.

Primary outcomes:
measure: Proportion of patients with non-serious and serious adverse events
timeFrame: Change from baseline up to week 12 after injection.
Secondary outcomes:
measure: Wrinkle Severity Rating Scale (WSRS) Evaluation
timeFrame: Change from baseline at week 2, 6 and 12.
measure: Global Aesthetic Improvement Scale (GAIS) Evaluation
timeFrame: Change from baseline at week 2, 6 and 12.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06269913: A Novel Iron-Based Supplement for Athletes Aged 18-25: Phase II
Official title: Novel Iron-Based Supplement for Active Young Women With Sub-Optimal Iron
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Iron Deficiencies
Keywords: iron
microbiota
endurance. exercise
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Mitacs
name: Natural Sciences and Engineering Research Council, Canada
First posted: 2024-02-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females.

Detailed description: Current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. As a solution, we have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the efficacy of a yeast-iron complex in improving iron status, gut microbiome, and exercise performance in young, endurance-trained females with sub-optimal iron status. Participants will consume 40mg of elemental iron every second day for 8 weeks. Before and after supplementation,participants will be assessed for exercise capacity (VO2max), iron status, and the current state of the gut microbiome. each week during supplementation, participants will complete a survey in in which they will report feelings of stress and recovery as well as gastrointestinal symptoms.

Eligibility criteria: Inclusion Criteria:

* cis-gendered female 18-25years old
* sub-optimal iron status (ferritin ≤45mcg/ L)
* At least 1 year past the age of menarche
* Engage in moderate to vigorous endurance activity for at least 3 hours a week

Exclusion Criteria:

* Supplemented with iron iron (\>5mg/day), prebiotics, or probiotics in last 3 months
* antibiotic use in last 3 months
* - Energy availability \>30 kcal/kg lean body mass

Primary outcomes:
measure: Iron Status
timeFrame: 4 weeks, 8 weeks
measure: Hemoglobin
timeFrame: 4 weeks, 8 weeks
measure: Upper Gut Microbiome
timeFrame: 4 weeks, 8 weeks
measure: Lower Gut microbiome
timeFrame: 4 weeks, 8 weeks
Secondary outcomes:
measure: Exercise Capacity
timeFrame: 8 weeks
measure: Hemoglobin Mass
timeFrame: 8 weeks
measure: Gastrointestinal Symptoms 1
timeFrame: Weekly for 8 weeks
Other outcomes:
measure: Gastrointestinal Symptoms 2
timeFrame: Weekly for 8 weeks
measure: Sleepiness
timeFrame: Weekly for 8 weeks
measure: Stress and Recovery
timeFrame: Weekly for 8 weeks
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Jane Shearer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00954213: A Study of a Developmental,Individual-Difference,Relationship-Bases/Floortime Intervention for Children With Autistic
Official title: A One-year Prospective Follow-up Study of a DIR/ Floortime Parent Training Intervention for Pre-school Children With Autistic Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Thirty eight autistic spectrum disorder children age 2-6 years recruited into the study. The new treatment intervention is based on the DIR Model. Parents will be coached at the start and then every 3-4 months for 1 year. Outcome will be measured at the first session and at the end of the study using Functional Emotional Assessment Scale and Childhood Autism Rating Scales, Functional Emotional Level, and parent satisfaction rating.

Hypothesis of the study: Children who get additional treatment of DIR/floortime show much improvement in climbing the developmental "ladder" and declining in the autistic behaviors.


Eligibility criteria: Inclusion Criteria:

* clinical criteria for Autistic Disorders according to DSM IV
* child is 2 - 6 years of age

Exclusion Criteria:

* children with additional medical diagnosis (e.g., genetic syndromes, diagnosed hearing impairment, diagnosed visual impairment or seizures)
* children who are geographically inaccessible for follow-up visits
* their parents are not literate or known chronic psychiatric or physical illness in the parents

Primary outcomes:
measure: The Functional Emotional Assessment Scale (FEAS) Ratings (the child part)
timeFrame: 1 year
Secondary outcomes:
measure: The Childhood Autism Rating Scale (CARS) Clinical rating of the children (6 point scale related to Greenspan's six Functional Development Level -FDL) Satisfaction of the effectiveness of the intervention of their child (Six-point Likert scale)
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Kingkaew Pajareya
state: Bangkok
Study officials:
affiliation: Rehabilitation Medicine, Siriraj Hospital, Bangkok, Thailand
name: Kingkaew Pajareya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01236313: Aortic Wall and Left Ventricular Mechanics: Echocardiographic and Hemodynamic Analysis
Official title: Aortic Wall and Left Ventricular Mechanics: Echocardiographic and Hemodynamic Analysis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Disease
Cardiac Valve Disease
Keywords: TEE
Cardiac Surgery
Pulse Pressure
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2010-11-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing bypass and/or valve surgery with general anesthesia

Brief summary: The purpose of this study is to prospectively determine the relationship between the dimensions of the aorta (the large artery taking off the heart) and blood pressure during cardiac surgery.

Detailed description: The purpose of this study is to prospectively determine the relationship between the dimensions of the aorta (the large artery taking off the heart) and blood pressure during cardiac surgery. Measurements of the aorta are obtained by an ultrasound-based imaging technique called transesophageal echocardiography (TEE), which is routinely performed during cardiac surgery. TEE is an instrument used to monitor the heart and is standard of practice at Weill Cornell Medical College.

Eligibility criteria: Inclusion Criteria:

* elective CABG, valvular procedure

Exclusion Criteria:

* non-sinus rhythm (atrial fibrillation, flutter, paced rhythm), pre-operative presence of intra-aortic counterpulsation device, synthetic aortic graft.

Primary outcomes:
measure: Measure the dimensions of the aorta and compare with blood pressure measurements
timeFrame: 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Nikolaos Skubas, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00884013: New York City (NYC) Health eHearts Pay for Quality Pilot
Official title: Program Evaluation of New York City Health eHearts Pay for Quality Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Diabetes
Smoking
Ischemic Cardiovascular Disease
Keywords: Pay for Quality
Provider
Clinical Decision Support
Quality Reporting
Quality Measurement
Lead sponsor: New York City Department of Health and Mental Hygiene
Sponsor class: OTHER_GOV
Collaborators: name: Robin Hood Foundation
First posted: 2009-04-20
Enrollment: 84
Sex: MALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Primary Care Providers that have adopted an electronic health record in New York City in non-hospital based practices.

Brief summary: Do monetary incentives in small independent primary care practices improve the delivery of preventive services as recommended by U.S. Preventive Services Task Force (USPSTF) guidelines for cardiovascular health?

Detailed description: The NYC DOHMH received a private donation from the Robin Hood Foundation to provide monetary incentives to small practices for improving their delivery of preventive services in neighborhoods experiencing health disparities.

Practices recruited by NYC DOHMH to adopt an electronic health record will be randomized to receive monetary incentives for improving both patient outcomes and delivery of care on: aspirin therapy, blood pressure control, cholesterol control, and smoking cessation intervention. The set of quality measures are referred to the ABCS.

The NYC DOHMH will be collecting provider surveys on their experience on quality measurement and participation in other pay-for-performance programs, as well as transmit aggregated information on their performance on the ABCS to DOHMH on a monthly basis.

Eligibility criteria: Inclusion Criteria:

* Primary Care Providers

Exclusion Criteria:

* Specialists
* Pediatricians
* Obstetricians
* Gynecologists

Primary outcomes:
measure: percent of patients eligible for quality measures (ABCS)
timeFrame: 1 year
Secondary outcomes:
measure: use of EHR clinical reminders
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: New York City Departemnt of Health and Mental Hygiene
state: New York
Study officials:
affiliation: NYC DOHMH
name: Farzad Mostashari, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bardach NS, Wang JJ, De Leon SF, Shih SC, Boscardin WJ, Goldman LE, Dudley RA. Effect of pay-for-performance incentives on quality of care in small practices with electronic health records: a randomized trial. JAMA. 2013 Sep 11;310(10):1051-9. doi: 10.1001/jama.2013.277353.
Clinical trial NCT00900913: Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral Nerve Excitability
Official title: Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-05-13
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of intravenous ropivacaine and lidocaine on the receptive field of primary sensory afferents and their influence on the vascular bed.

\*Trial with medicinal product


Eligibility criteria: Inclusion criteria:

1. Male
2. Age: 18 - 65 years
3. Weight: 50-100kg
4. Height: 155-195cm
5. Signed and dated informed consent
6. Sufficient command of German language

Exclusion criteria:

1. Contraindications to the class of drugs under study
2. Vulnerable subjects (intellectually or mental impaired)
3. Known hypersensitivity to class of drugs or the investigational product
4. Drug abuse
5. Known peripheral neuropathies
6. Diabetes mellitus
7. Chronic alcohol consumption
8. Congestive heart disease
9. Participants of other studies during study period
10. Smoker

Primary outcomes:
measure: Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Clinical Trial Center
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References: