louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02592460: Postoperative Pain and Polyamines-poor Diet (DOLAMINE)
Official title: Impact on Pain of a Preoperative Polyamines-poor Diet After Orthopedic Surgery of the Foot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 542
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: Animal studies have shown that the level of pain sensitivity is highly dependent on the amount of polyamines in food. This fundamental observation of a nutritional approach to pain led the authors to develop diets completely depleted in polyamines whose anti-nociceptive properties have been confirmed in animals.

Postoperative pain after foot surgery are currently fairly well controlled but at the cost of a high consumption of grade II analgesics which is associated with a high rate of side effects (nausea, vomiting ...). The investigators' hypothesis is that a diet low in polyamines may have an additive effect on pain control and reduce the consumption of level 2 analgesics.

The objective of this study is to show the efficacy of a polyamines-poor diet on postoperative pain in ambulatory surgery of the foot.


Eligibility criteria: Inclusion Criteria:

* foot ambulatory orthopedic surgery
* surgery scheduled at least 10 days after the inclusion consultation

Exclusion Criteria:

* other diet susceptible to interfere with the poor or high-polyamines diets (e.g. diabetic patients)
* contraindication to tramadol or to NSAIDs
* pregnant or breastfeeding woman
* patient under legal protection
* patient's opposition to participate in the study
* poor understanding of French
* absence of affiliation to social security
* participation to another study

Primary outcomes:
measure: Percentage of patients whose worst pain, as measured on an visual analogic scale ranging from 0 mm to 100 mm, was at least once rated as 30 mm or more.
timeFrame: Eight days after surgery
Secondary outcomes:
measure: Percentage of patients with a need for grade II analgesics
timeFrame: Eighth day after surgery
measure: Overall tramadol consumption , expressed in mg.
timeFrame: Eight days after surgery
measure: Worst pain, expressed in mm, measured on an visual analogic scale ranging from 0 mm to 100 mm
timeFrame: Eight days after surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe hospitalier Diaconesses Croix Saint Simon
state: Ile De France
Study officials:
References:
Clinical trial NCT05457660: Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization
Official title: Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colostomy
Ileostomy
Home Hospitalization
Keywords: Home Hospitalization
Colostomy
Ileostomy
Lead sponsor: Fondation Sante Service
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stoma : Colostomy and Ileostomy

Brief summary: The goalf of the study is to have a basis about QOL for colo-stoma and ileo-stoma for patients which are hospitalized at home. The QOL measurement is done with a questionnaire of several items made by stomatherapist and also using EQ5D QOL form.

After reviewing of the data, our goal is to create or improve some solutions to improve their QOL during their home hospitalization.


Eligibility criteria: Inclusion Criteria:

* Colo-stomy or Ileo-stomy patient
* Patient hospitalized at home by Fondation Sante Service (Fr)
* 18 YO or more
* Non-opposition to the study

Exclusion Criteria:

* Patient not able to read or properly understand the Information Consent Form and not able to complete the questionnaire for any reason.

Primary outcomes:
measure: Measuring the quality of life of colostomized or ileostomized patients in home hospitalization
timeFrame: 4 months
Secondary outcomes:
measure: Identify patient issues and needs.
timeFrame: 4 months
measure: Analyze the results by subgroups of patients: according to the type of stoma (ileostomy vs. colostomy; temporary stomy vs. permanent stoma), age of the stoma, age, pathology.
timeFrame: 4 months
Other outcomes:
Locations:
city: Levallois-Perret
country: France
facility: Fondation Santé Service
Study officials:
References:
Clinical trial NCT07015060: Pathogenic Mechanisms Involved in the Initiation and Progression of Systemic Sclerosis
Official title: Pathogenic Mechanisms Involved in the Initiation and Progression of Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Scleroderma (Limited and Diffuse)
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Identify rare variants in candidate genes and pathways identified in familial SSc, in patients with sporadic SSc.

Perform (spatial) transcriptomic and proteomic analyses of affected skin from patients with and without cutaneous fibrosis, for the patterns and levels of expression/activation of candidate genes and pathways.

Test for dysregulation of expression/activation of candidate genes and pathways in live cells isolated from the blood and skin biopsy of patients, and for the impact of these dysregulations on cell appearance, behavior and function.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with one of the following:

  * Limited SSc
  * Limited cutaneous SSc
  * Diffuse cutaneous SSc
* Patients followed regularly in consultations at CUSL.
* Patients between ages 18-80.

Exclusion Criteria:

* Other (co-occurring) autoimmune/autoinflammatory disease
* Pregnancy
* Participants with temporary or definitive disabilities to give consent
* Participants unable to sign or read the inform consent form

Primary outcomes:
measure: Identify rare variants in candidate genes and pathways in SSC patients (blood and skin biopsy)
timeFrame: Through the entire study, approximately during 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Université Catholique de Louvain
name: Nisha Limaye, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05715060: Sternal Closure in Children After Cardiac Surgery
Official title: Stainless Steel Wire vs. Polydioxanone "PDS" at Sternal Closure in Children After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Heart Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 45
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: comparison between stainless steel wires and PDS in closure of sternum in children after cardiac surgery in terms of sternal dehiscence, infection \& cosmetic outcome

Detailed description: Median sternotomy is considered to be the gold standard incision in cardiac surgery. Sternotomy has to be performed properly to avoid short- and long-term morbidity and mortality. The surgical technique is well established and certain principles are recognized to be crucial to minimize complications. The identification of the correct landmarks, midline tissue preparation, osteotomy with the avoidance of injury to underlying structures like pleura, pericardium and ectatic ascending aorta, and targeted bleeding control are important steps of the procedure. As important as the performance of a proper sternotomy is a correct sternal closure. An override or shift of the sternal edges has to be avoided by placing the wires at a proper distance from each other without injuring the thoracic pedicle. The two sternal halves have to be tightly re-approximated to facilitate healing of the bone and to avoid instability, which is a risk factor for wound infection. With a proper performance of sternotomy and sternal closure, instability and wound infections are rare and depend on patient-related risk factors . Conventional closure uses stainless steel wire sutures which may not be the ideal approach as sternal wound infection and mediastinitis are troublesome complications following this method which are major causes of morbidity and mortality of patients. Availability of delayed absorbable sutures such as polydioxanone sutures (PDS) for sternal closure allows us to test the efficacy of it in prevention of these complications.

Eligibility criteria: Inclusion Criteria:

* Infants \& children up to 5 years old underwent open heart surgery in Assiut University heart hospital

Exclusion Criteria:

* Older than 5 years old

Primary outcomes:
measure: Sternal stability
timeFrame: up to 2 years
Secondary outcomes:
measure: cosmetic outcome (prominent wire)
timeFrame: up to 2 years
measure: Wound infection
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University heart hospital
Study officials:
References:
Clinical trial NCT05608460: Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study
Official title: Pediatric Cervical Spine Clearance: A Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Spine Fracture
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 15700
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any participant less than 18 years old after blunt trauma

Brief summary: A prospective multicenter observational study, led by Dr. Katie Russell of Intermountain Primary Children's Hospital, that will examine the sensitivity, specificity, negative, and positive predictive values of CT scan and plain films in diagnosing cervical spine injury that requires treatment. This study is funded by the Primary Children's Hospital foundation.


Eligibility criteria: Inclusion Criteria:

* Any participant less than 18 years old after blunt trauma
* Seen by trauma service
* With cervical spine imaging (XR, CT, or MRI)

Exclusion Criteria:

* CT scan from outside facility is poor quality and not repeated (\<63-channel, cuts \>3mm, no reformats, motion artifact)
* No radiology over reads by participating institution

Primary outcomes:
measure: Predictive Values of CT, XR, and MRI
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital
state: California
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital
state: Utah
Study officials:
affiliation: University of Utah
name: Katie Russell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02316860: The Diagnostic Performance of Tilt Test in Athletes
Official title: The Diagnostic Performance of Tilt Test in Athletes and a Novel Strategy for Its Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2014-12-15
Enrollment: 140
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In the present study the investigators evaluate the sensitivity and specificity of passive tilt test in athletes, as well as their haemodynamic responses and autonomic nervous system activity during head-up tilt. Moreover, the investigators try to apply a novel algorithm for the improvement of diagnostic yield of tilt test in athletes.

Detailed description: We examine athletes with a history of reflex syncope and athletes without history of reflex syncope.All subjects undergo a tilt test, for the evaluation of haemodynamics, heart rate variability (HRV) and baroreflex sensitivity.

Eligibility criteria: Inclusion Criteria:

* 14-40 years old,
* more than 5 years of exercise training experience and competition at a regional level at different sports

Exclusion Criteria:

* smoking,
* recent alcohol consumption,
* presence of any chronic disease and use of drugs

Primary outcomes:
measure: sensitivity and specificity of tilt test in athletes as measured by the occurence of syncope/presyncope during tilt test
timeFrame: 30 min
Secondary outcomes:
measure: Parameters of haemodynamics during tilt test
timeFrame: 30 min
measure: Parameters of heart rate variability during tilt test
timeFrame: 30 min
measure: Parameters of baroreflex sensitivity during tilt test
timeFrame: 30 min
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece
Study officials:
affiliation: Laboratory of Sports Medicine, Sports Medicine Division, Aristotle University of Thessaloniki, Thessaloniki, Greece
name: Evangelia Kouidi, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00444860: ZOSTAVAX(R) Local Registration Trial (V211-019)
Official title: A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX(R) in Healthy Adults in Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella Virus Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.


Eligibility criteria: Inclusion Criteria:

* Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent
* All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test

  * Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Levels In The Postmenopausal Range As Determined By The Laboratory, Or 12 Months Of Spontaneous Amenorrhea
* A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination

  * Acceptable Methods Of Birth Control Are: Intrauterine Device, Diaphragm With Spermicide, Contraceptive Sponge, Oral Contraceptive Pills, Condom, Tubal Ligation, And Vasectomy
* Subject Must Sign Informed Consent Prior To Any Study Procedure
* Subject Must Be afebrile (\<38.3 °C Oral) On Day Of Vaccination
* Any Underlying Chronic Illness Must Be In Stable Condition

Primary outcomes:
measure: The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed.
timeFrame: prevaccination and 4 weeks postvaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Yao CA, Chen LK, Huang KC. The immunogenicity and safety of zoster vaccine in Taiwanese adults. Vaccine. 2015 Mar 24;33(13):1515-7. doi: 10.1016/j.vaccine.2015.01.085. Epub 2015 Feb 11.
Clinical trial NCT00646594: Atlantis Symbicort
Official title: A Two Stage Randomized, Open-Label, Parallel Group, Phase III, Multicenter, 7 Month Study to Assess the Efficacy & Safety of SYMBICORT pMDI Adminstered Either as Fixed or as an Adjustable Regimen Versus a Fixed Regimen of Advair in Subjects 12 Yrs of Age and Older With Asthma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
inhaled cortocisteroids
Symbicort
budesonide/formoterol
Advair
fluticasone/salmeterol
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 1200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma
* Baseline lung function tests as determined by protocol
* Required and received treatment with inhaled corticosteroids within timeframe and doses specified in protocol

Exclusion Criteria:

* Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a beta-blockers
* Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Primary outcomes:
measure: Asthma control assessed by asthma exacerbations
timeFrame: Continuosly throughout the treatment period
Secondary outcomes:
measure: Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.
timeFrame: Daily and at 1, 3 and 6 months after start of treatmen
measure: Use of medical resources and medication for the treatment of asthma.
timeFrame: Throughout the treatment period
measure: Investigate safety profile of Symbicort compared to Advair
timeFrame: 1, 3 and 6 months after start of treatment and 1 week after end of tretment
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Mitchell Golmand, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Catherine Bonuccelli
role: STUDY_CHAIR
References:
citation: O'Connor RD, Patrick DL, Parasuraman B, Martin P, Goldman M. Comparison of patient-reported outcomes during treatment with adjustable- and fixed-dose budesonide/formoterol pressurized metered-dose inhaler versus fixed-dose fluticasone propionate/salmeterol dry powder inhaler in patients with asthma. J Asthma. 2010 Mar;47(2):217-23. doi: 10.3109/02770900903497154.
Clinical trial NCT03373994: Perfusion and Hypoxia Evaluation in Tumors Using 18F-FDG PET/CT
Official title: Tumor Perfusion and Hypoxia Evaluation and Comparation in 18F-FDG PET/CT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perfusion and Hypoxia
Keywords: FDG, perfusion, hypoxia, tumor, PET
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tumor patients aged more than 18 years with a histological confirmed diagnosis were eligible in our research. And all patients signed a written informed consent.

Brief summary: Investigators want to use 18F-FDG PET/CT imaging to reflect tumor perfusion and hypoxia.

Detailed description: Perfusion and hypoxia were independent prognositic parameters for tumor patients. Developing a method that can evaluate tumor perfusion and hypoxia noninvasively and conveniently was in urgent need. 18F-FDG PET/CT imaging could reflect tumor hypoxia in 60min balanced imaging was proved and accepted. Moreover, FDG could diffuse out of the vasculature and through cell membranes passively and rapidly due to its lipophilicity, its regional uptake at initial times is expected to reflect tumor perfusion. So, investigators want to use 18F-FDG PET/CT imaging to evaluate tumor perfusion and hypoxia simutaniously，in order to guide the clinical diagnosis and treatment.

Eligibility criteria: Inclusion Criteria:

* 1.solid tumor proved by pathology(d\>3.0cm);
* 2.age\>18-year-old;
* 3. Karnofsky performance status \>70;
* 4.sign the informed consent.

Exclusion Criteria:

* 1.There are obvious metal implants near the tumor;
* 2.Can not lie still for 15 minutes.
* 3.Pregnancy.

Primary outcomes:
measure: Correlation of the distribution of FDG between initial-time and balanced-time PET/CT
timeFrame: 2018.1
Secondary outcomes:
measure: SUVs in initial-time and balanced-time PET/CT
timeFrame: 2018.1
Other outcomes:
Locations:
city: Harbin
country: China
facility: Yingying Sun
state: Heil
Study officials:
affiliation: The Fourth Hospital of Harbin Medical University
name: Baozhong Shen, Dr
role: STUDY_CHAIR
References: