louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06614738: Microbial and Environmental Factors Associated with Polyps Development in Familial Adenomatous Polyposis (MicrobEnvironment in FAP)
Official title: Microbial and Environmental Factors Associated with Polyps Development in Familial Adenomatous Polyposis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Familial Adenomatous Polyposis
Keywords: Familial adenomatous polyposis
microbiota
colorectal cancer
nutrition
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with proven familial adenomatous polyposis genetically operated (total colectomy with ileoanal or ileorectal anastomosis), included in the national POLYPOSE database and with regular endoscopic follow-up with upper and lower GI endoscopy at Hôpital Edouard Herriot, Lyon, France or Hôpital de la Croix-Rousse, Lyon, France

Brief summary: Familial adenomatous polyposis (FAP) is an autosomal dominant inherited disorder linked to a mutation in the APC gene, associated with the development of multiple colonic and duodenal adenomas, which in 100% of cases progress to colorectal cancer (CRC) if left untreated. Management of affected patients is usually based on prophylactic total colectomy with or without rectal preservation, followed by regular endoscopic surveillance of the duodenum and rectum or ileal reservoir. However, there is considerable inter- and intra-familial variability in the rate of adenoma appearance and development for identical mutations. This strongly suggests the additional role of environmental factors. Recently, the gut microbiota has been identified as a co-factor of carcinogenesis in patients with FAP, but no prospective evaluation of the association between the incidence and severity of adenomatous proliferations and a microbiological signature has been studied, particularly at duodenal level in operated patient.


Eligibility criteria: Inclusion Criteria:

* ≥18 years
* Non-opposition obtained
* Prophylactic colectomy for at least 2 years in the context of APC-related familial adenomatous polyposis with ileorectal or ileoanal anastomosis
* Included in the national POLYPOSE database
* Regular endoscopic follow-up with upper and lower GI endoscopy at Hôpital Edouard Herriot or Hôpital de la Croix-Rousse
* Having performed at least 2 endoscopies as part of follow-up

Exclusion Criteria:

* Antibiotic therapy within 2 months prior to stool sampling
* Taking probiotics for less than 1 month
* Person deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Fecal microbiota composition
timeFrame: Within 48 hours of endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
References:
Clinical trial NCT02518438: The Analgesic Efficacy of Wound Infiltration With Tramadol
Official title: A Randomized Trial of the Analgesic Efficacy of Wound Infiltration With Tramadol After Cesarean Delivery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Tramadol
Postoperative analgesia
Infiltration
Cesarean section
Lead sponsor: Yeditepe University Hospital
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This double-blind, randomized trial examined whether tramadol wound infiltration decreased postoperative pain following cesarean delivery under general anesthesia or reduced the need for analgesics in the immediate postoperative period. Patients in the tramadol group consumed significantly less morphine at all time intervals than those in the control group. The investigators suggest that the use of wound infiltration with tramadol may be a useful technique in patients who undergo cesarean section under general anesthesia to reduce postoperative pain, improve recovery, and facilitate early contact of mothers with their babies.


Eligibility criteria: Inclusion Criteria:

* Nulliparity
* Gestation age between 37-40 weeks
* CS under general anesthesia

Exclusion Criteria:

* Pre-eclampsia
* Cardiovascular problems
* Allergy to any of the study medications
* Chronic preoperative pain
* Regular analgesic use

Primary outcomes:
measure: The primary outcome measure in this study was cumulative morphine consumption.
timeFrame: postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University Hospital
state: Kozyatagı
Study officials:
References:
Clinical trial NCT00351338: Nutritional Deficiencies in the Bariatric Patients
Official title: Preoperative Nutritional Deficiencies in the Bariatric Surgery Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbid Obesity
Nutritional Deficiency
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-07-12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Although morbidly obese subjects have larger than regular caloric intake, there is evidence that they suffer from nutritional deficiencies at a higher rate than the general population, probably because they eat mostly "unhealthy food."


Eligibility criteria: Inclusion Criteria:

* All morbidly obese subjects who are surgery candidates

Exclusion Criteria:

* Previous bariatric operations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization,
Study officials:
affiliation: Hadassah Medical Organization Israel
name: Andrei Keidar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01867138: Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin
Official title: Clinical Outcome of Newborn Infants With Suspected Nosocomial Coagulase-negative Staphylococcal Sepsis Treated With Cefazolin or Vancomycin. A Non-inferiority, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nosocomial Neonatal Sepsis
Keywords: Coagulase negative staphylococcus
nosocomial neonatal sepsis
cefazolin
vancomycin
newborn
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2013-06-03
Enrollment: 109
Sex: ALL
Minimum age (years): 4
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial sepsis probably caused by Coagulase-negative staphylococcus.

The investigators hypothesized that newborn infants with the presumptive diagnosis of nosocomial sepsis who received cefazolin as empiric treatment would have a clinical outcome not inferior to that of those treated with vancomycin.


Eligibility criteria: Inclusion Criteria:

* Newborn infants older than three days of life with suspected bacterial sepsis and according to attending physicians, with an indication for initial treatment with vancomycin and at least one blood culture taken prior to receiving the antimicrobial treatment.

Exclusion Criteria:

* previous treatment with vancomycin during the week before,
* infants referred from other hospitals and, upon admission, were being treated with antibiotics.

Primary outcomes:
measure: Clinical outcome of infants
timeFrame: Seven to ten days after starting antibiotics
Secondary outcomes:
measure: Percentage of infants initially assigned to cefazolin group that were switched to vancomycin.
timeFrame: Within 72 hours of starting treatment
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Capital
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Jose M Cernadas, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02242708: The Effectiveness of Autonomic Nervous System, Sleep Quality, and Immune Regulation for Shift Nurses Practicing Alternative Nostril Breathing
Official title: The Effectiveness of Autonomic Nervous System, Sleep Quality, and Immune Regulation for Shift Nurses Practicing Alternative Nostril Breathing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shift Nurses
Lead sponsor: Chang Bing Show Chwan Memorial Hospital
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the efficacy of shift nurses practicing alternative nostril breathing to improve life quality, autonomic nervous system and immune status.

Detailed description: Breathing is regulated by autonomic nervous system. It is well-known that breathing exercise can regulate autonomic nervous function and promote relaxation. However, the mechanism for better immunity and sleep quality is not clear. We postulate that alternative nostril breathing might benefit nurses after undergoing shift work. The benefits could be due to improvement of autonomic nervous function, sleep quality, and even immune function.

The study design will include a randomization of two groups, with a control group and one experimental groups for 3 months (12 weeks). The control group will do normal breathing. The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.

The study primary endpoints are 1) to improve autonomic nervous function, 2) to improve sleep quality and 3) to enhance human immunity.

We anticipate to reach the primary endpoints and publish the primary results in one year.

Eligibility criteria: Inclusion Criteria:

* Shift nurses

Exclusion Criteria:

* Upper respiratory tract infection such as nasal congestion, runny nose, coughing, wheezing, nosebleeds, fever and other symptoms.

Primary outcomes:
measure: Improve sleep quality.
timeFrame: Change from baseline in sleep quality at 3 months.
Secondary outcomes:
measure: Enhance human immunity
timeFrame: Change from baseline in human immunity at 3 months.
measure: Improve autonomic nervous function
timeFrame: Change from baseline in autonomic nervous function at 3 months.
Other outcomes:
Locations:
city: Changhua County
country: Taiwan
facility: Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Study officials:
affiliation: Chang Bing Show Chwan Memorial Hospital
name: Kuender D. Yang, PhD
role: STUDY_DIRECTOR
affiliation: Chang Bing Show Chwan Memorial Hospital
name: Ming-Ho Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02338908: Dry Needling and Exercises in Shoulder Pain
Official title: Effectiveness of Dry Needling and Eccentric Exercises in Unspecific Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: dry needling
trigger point
eccentric exercise
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
Collaborators: name: Hospital General Universitario Gregorio Marañon
First posted: 2015-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Shoulder pain is highly prevalent in the society. The role of muscle tissues in this pathology has received increasing interest. Some studies have proposed the role of myofascial trigger points in this population. The purpose of the current clinical trial is to compare the effects of physiotherapy treatment consisting of an eccentric exercise protocol versus the same physical therapy program plus the addition of trigger point dry needling (TrP-DN) on pain and function in patients suffering from unspecific shoulder pain.


Eligibility criteria: Inclusion Criteria:

* Unilateral non-traumatic shoulder pain
* Shoulder pain from at least 3 months
* Shoulder pain of more than 4 points on a NPRS

Exclusion Criteria:

* bilateral shoulder symptoms
* younger than 18 or older than 65 years
* history of shoulder fractures or dislocation
* cervical radiculopathy
* previous interventions with steroid injections
* fibromyalgia syndrome
* previous history of shoulder or neck surgery
* any type of intervention for the neck-shoulder area during the previous year

Primary outcomes:
measure: Changes in disability between baseline and follow-up periods
timeFrame: Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention
Secondary outcomes:
measure: Changes in shoulder pain between baseline and follow-up periods
timeFrame: Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: César Fernández-de-las-Peñas
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: César Fernández-de-las-Peñas, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arias-Buria JL, Fernandez-de-Las-Penas C, Palacios-Cena M, Koppenhaver SL, Salom-Moreno J. Exercises and Dry Needling for Subacromial Pain Syndrome: A Randomized Parallel-Group Trial. J Pain. 2017 Jan;18(1):11-18. doi: 10.1016/j.jpain.2016.08.013. Epub 2016 Oct 5.
Clinical trial NCT02119208: Effects of the Intensity and the Timing of the Physical Activity in a Primary School
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Energy Intake
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1. In natural environment, the moderate-intensity break will allow a reduction of the caloric intake at the dinner more important than for the light-intensity break
2. In natural environment, the break taken juste before dinner will allow a reduction of the caloric intake at the diner more important than earlier in the day.


Eligibility criteria: Inclusion Criteria:

* Children aged of approximately 5 years old of a of a nursery class of the school Jacques-Barclay, St-Mathieu

Exclusion Criteria:

* Present allergy of the foods in the lunch
* having a handicap or a limitation that avoid walking, running or tkaing part of the physcial activity courses at the school.
* Having a potential surgery
* Having a metabolic disease or taking drugs that could have an impact on the results of the study
* Be vegetarian
* Having intestinal disorders

Primary outcomes:
measure: Caloric intake at the breakfast, lunch and diner (kj)
timeFrame: 3 days per condition
Secondary outcomes:
measure: Anthropometric measures
timeFrame: At preliminary visit
Other outcomes:
Locations:
city: St-Mathieu
country: Canada
facility: École Jacques-Barclay
state: Quebec
Study officials:
References:
Clinical trial NCT04885608: PReGe in Outdoor Fitness Parks
Official title: Therapeutic Exercise for Older Adults: Revitalization and Postural Balance in Outdoor Fitness Parks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Keywords: Therapeutic exercise
Fraility
Functional capacity
Postural balance
Lead sponsor: University of Salamanca
Sponsor class: OTHER
Collaborators: name: Excelentísimo Ayuntamiento de Salamanca
First posted: 2021-05-13
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Older people have been one of the most affected by the Covid-19 pandemic. Restrictive measures to prevent the spread of the virus have affected the lifestyle of older people, which have reduced their level of physical activity. A sedentary lifestyle has negative health consequences, such as increased frailty and decreased functional capacity. The aim of the study is to apply a program of therapeutic exercise in outdoor fitness parks to prevent the complications of sedentary lifestyle. Community-dwelling older adults belonging will participate in an outdoor program to keep security measures and prevent contagion.


Eligibility criteria: Inclusion Criteria:

* People over 60 year who decide to participate voluntarily.
* Acceptance of Informed Consent.
* Municipal registration in Salamanca.
* Responsible declaration of good health.
* Absence of symptoms compatible with Covid-19.

Exclusion Criteria:

* Presence of absolute or relative contraindications to physical exercise.
* Presence of serious balance limitations, such as severe neurological, visual or musculoskeletal disorders.
* Presence of difficulties to carry out the tests of the Initial Assessment.
* Participate in another physical activity program.
* Incidents or pathologies suffered during the intervention that interfere with the study.

Primary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change from baseline to 16 weeks follow-up.
measure: 2 minute stair test
timeFrame: Change from baseline to 16 weeks follow-up.
measure: Borg Rating of Perceived Exertion Scale
timeFrame: Change from baseline to 16 weeks follow-up.
measure: IPAQ-E Questionnaire
timeFrame: Change from baseline to 16 weeks follow-up.
Secondary outcomes:
measure: Sex
timeFrame: Baseline
measure: Date of birth
timeFrame: Baseline
measure: Medication
timeFrame: Baseline
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Universidad de Salamanca
Study officials:
affiliation: University of Salamanca
name: Fausto J Barbero-Iglesias, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01068808: The Development of Allergic Rhinitis in Children Previously Diagnosed as Nonallergic Rhinitis
Official title: The Development of Allergic Rhinitis in Children Previously Diagnosed as Nonallergic Rhinitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis (Disorder)
Keywords: Nonallergic rhinitis
Allergic rhinitis
Development
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-02-15
Enrollment: 175
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patient from pediatric allergy clinic will be selected.

Brief summary: The purpose of this study is to evaluate development of allergic rhinitis in children with nonallergic rhinitis.

Detailed description: Rhinitis is a common condition associated with significant effects on quality of life. Rhinitis may be divided into two groups, those with concurrent allergy (allergic rhinitis, AR) and those without allergy but who still suffer from nasal symptoms (nonallergic rhinitis, NAR).

Evidence indicated that adult with NAR can have de novo sensitization to aeroallergen (24%), suggesting that patients with NAR might evolve to AR. Thus the purpose of this study is to evaluate development of allergic rhinitis in children with nonallergic rhinitis.

Eligibility criteria: Inclusion Criteria:

* Children between the age of 1 year and 15 years with the diagnosis of nonallergic rhinitis who are attending the pediatric allergy clinic during Jan 2005 - Dec 2007.

Exclusion Criteria:

* Patients who have allergic rhinitis and underlying disease eg.chronic renal disease, liver disease, heart disease, cancer.

Primary outcomes:
measure: To evaluate the development of AR in children who were previously diagnosed with NAR
timeFrame: 24 months
Secondary outcomes:
measure: To determine the persistence and severity of the symptoms, new comorbidities and triggering factors in children with nonallergic rhinitis
timeFrame: 24 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
name: Orathai Piboonpocanun, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veskitkul J, Vichyanond P, Visitsunthorn N, Jirapongsananuruk O. The development of allergic rhinitis in children previously diagnosed as nonallergic rhinitis. Am J Rhinol Allergy. 2013 Jan;27(1):43-7. doi: 10.2500/ajra.2013.27.3839.
Clinical trial NCT01786408: A Study to Compare Analytes in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
Official title: A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick Using the SAFE-T-FILL Capillary Blood Collection System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes
Anemia
Lead sponsor: Seventh Sense Biosystems
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will involve an investigational device, the Seventh Sense Biosystems TAP20-C. The TAP20-C device collects small amounts of blood from the forearm which can then be used for blood testing. The study will also involve collecting blood by fingerstick which is a common way of collecting blood. The SAFE-T-FILL Capillary Blood Collection system and the Terumo Capiject 1.5 mm Blade Safety Lancet will be used for this. The study will compare the concentrations of glucose, hemoglobin, and HbA1C in blood samples collected with the two different blood collection methods. Additional information will be collected about how the TAP20-C device performs.


Eligibility criteria: Inclusion Criteria:

Healthy Subject Group

1. Male and female volunteers 18 years of age or older

Diabetic Subject Group

1. Male and female volunteers 18 years of age or older
2. Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report

Exclusion Criteria:

1.Subjects who are pregnant or nursing mothers by self report 2.Subjects who have eaten or consumed sugar-containing drinks in the 2 hours before blood sample collection begins 3.Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested 4.Subjects with a missing index or middle finger on either hand or a missing forearm 5.Subjects who have known allergies to titanium

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Primary outcomes:
measure: Non-Inferiority of Analyte Levels
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Seventh Sense BIosystems
state: Massachusetts
Study officials:
References: