louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03051828: Physical Evaluation and Quality of Life in the Practice of Fencing in Breast Cancer Support
Official title: Practice of Fencing in Breast Cancer Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: fencing, cancer
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 30
Sex: FEMALE
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 opered for breast cancer followed at the Hospital Rene Dubos

Brief summary: The data collection of physical evaluations after regular practice of the fencing at patients having surgically been treated for breast cancer highlighted encouraging results both on the functional drawing, and on the improvement of the quality of life.

Detailed description: Recent scientific works show that a regular physical activity decreases the rate of second offense of breast cancer from 20 to 50 % at the women beforehand treated for breast cancer.

The objectives:

* participate as a supplement to the physiotherapist in the mobilization of the operated shoulder
* act in association with the surgical and medical team to release the adhesions superficial
* welcome these women hurt through a participative sports project
* get them a fencing adapted in a friendly atmosphere
* offer them personalized exchanges
* to propose a consequent energy expenditure but according to each and to the context
* have a practice of the operated side
* make them practise a sport with pleasure and without fatal effects

By the practice of the sports activity, investigators wish to help these people upset in their life to find the joy of life, to have projects, to find some pleasure to share moments of user-friendliness. Having led a fight against the disease to help them to lead a new fight of fencer happy to have a practice.

Eligibility criteria: Inclusion Criteria:

* patients operated for the breast cancer in the Hospital Rene Dubos
* patients who have sign a consent
* patients having supplied an aptitude certificate in fencing

Exclusion Criteria:

* patients who have a contraindication in the sport

Primary outcomes:
measure: quality of life questionnary
timeFrame: 20 sporting session, an average of one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rene Dubos Hospital
name: VAUTIER-RIT Sophie, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04814628: Assessment of Transnasal Humidified Rapid-insufflation Ventilatory Exchange (THRIVE) for Maternal Pre-oxygenation
Official title: Contribution of Transnasal Humidified Rapid-insufflation Ventilatory Exchange (THRIVE) to Optimize Maternal Pre-oxygenation and Anaesthetic Preparation Time for General Anaesthesia for Urgent Caesarean Section A Prospective Experimental Study on Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Pregnancy Related
Anesthesia
Keywords: maternal preoxygenation
ventilatory exchange
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main objective of this study is to determine if the use of transnasal humidified rapid-insufflation ventilatory exchange (THRIVE) can reduce by 90 seconds the time between the entry into the operating room of the volunteer and the moment when the anaesthetic drugs are ready and when the Oxygen Reserve Index has reached a plateau value for more than 10 seconds, a moment which would therefore allow the induction of general anaesthesia, compared to the pre-oxygenation with the face mask applied by the anaesthetist alone in charge of anaesthesia.


Eligibility criteria: Inclusion Criteria:

* major
* female
* affiliated to a social security scheme or beneficiary of such a scheme
* having voluntarily and informedly agreed to participate in the study.
* non-smoker
* free from pulmonary, cardiac and neurological pathologies
* have a normal functional respiratory test at baseline.

Exclusion Criteria:

* refusal to participate in the study
* non-French speaking volunteer
* obesity defined by a body mass index greater than 30 kilogram/meter² (kg/m²)
* current pregnancy
* Volunteer in period of exclusion from further research
* Person under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and liberty

Primary outcomes:
measure: time between when the volunteer enters the operating room and when the conditions for general anesthesia are met during pre-oxygenation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: time between volunteer enters the operating room and when the conditions for general anaesthesia are met during pre-oxygenation
timeFrame: through study completion, an average of 1 year
measure: number of medication errors during the preparation
timeFrame: through study completion, an average of 1 year
measure: number of deviations from appropriate anaesthetic practices observed during preparation
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Femme Mère Enfant
Study officials:
References:
Clinical trial NCT04806828: Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes
Official title: Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Keywords: Inguinal Hernia
Preoperative Score
Kingsnorth Score
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 400
Sex: MALE
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: All patients scheduled for a primary repair of inguinal hernia

Brief summary: To analyze and validate a preoperative score of difficulty of inguinal hernias and its correlation with postoperative outcomes


Eligibility criteria: Inclusion Criteria:

* Male sex
* Age \> 18 years
* Primary inguinal hernia
* Unilateral hernia
* Elective surgery

Exclusion Criteria:

* Recurrent inguinal hernia

Primary outcomes:
measure: Postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: Lenght of operation
timeFrame: Intraoperative
measure: Recurrences
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: José Antonio Pereira
Study officials:
affiliation: Parc de Salut Mar
name: José Antonio Pereira
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04371328: Emergency Management in a Dedicated Respiratory Unit of Patients With a Possible COVID-19 Infection
Official title: Emergency Management in a Dedicated Respiratory Unit of Patients With a Possible COVID-19 Infection (Unit "COVID Possible")
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Keywords: COVID 19
aspecific respiratory symptomatology
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 1860
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patient admitted to the RECOP unit for dyspnea will be inclued in this clinical trial

Brief summary: This research aims to improve knowledge of the epidemiology of patients consulting in the COvid Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out. It will be necessary to identify the diagnosis of the dyspneic patient and to define his virological status COVID before referring him to the appropriate units.

The investigatory propose an original strategy of dedicating entire care sectors to the care of patients admitted for dyspnea in our ER. These units will be named RECOP units.

This study would improve epidemiological knowledge of COVID-19 and ability to receive these patients within the SU.


Eligibility criteria: Inclusion Criteria:

* All patients over the age of 15 admitted to the RECOP unit for dyspnea

Exclusion Criteria:

* Patient admitted to shock for respiratory distress requiring immediate respiratory support.
* Patient under justice safeguard

Primary outcomes:
measure: Describe the characteristics of patients admitted to reCOP units according to their virological status vis-à-vis COVID-19
timeFrame: 30 days
Secondary outcomes:
measure: Develop a predictive model of the risk of being COVID for patients admitted to the emergency room for dyspnea
timeFrame: 0 days
Other outcomes:
measure: Virological status
timeFrame: 30 days
measure: Mortality status
timeFrame: 30 days
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Frédéric Balen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03683628: Treatment of Intermittent Claudication by G-CSF-mobilized PB-MNC
Official title: Treatment of Intermittent Claudication by G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intermittent Claudication
PAD
Atherosclerotic Ischemic Disease
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months

Detailed description: This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with intermittent claudication. Forty PAD patients who presented with intermittent claudication will be randomized into 2 groups. The control group will be treated by medication and walking exercise 3 times/ week. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication and walking exercise 3 times/ week. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months in the control group and day of randomization, 1 , 3, 6 and 12 months after injection of PB-MNC in the experiment group. Pain free walking distance will be evaluated at the day of randomization, 1 , 3, 6 and 12 months by pedometer.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic arterial occlusive disease who presented with intermittent claudication

Exclusion Criteria:

* Recent myocardial infarction
* Severe valvular heart disease
* After organ transplantation
* Cardiomyopthy( EF\< 25%)
* Liver failure
* Coagulopathy
* HIV
* Pregnancy

Primary outcomes:
measure: Pain free walking distance
timeFrame: 3 month
Secondary outcomes:
measure: Ankle brachial index (ABI)
timeFrame: 1,3,6,12 month
measure: Toe brachial index (TBI)
timeFrame: 1,3,6,12 month
measure: Transcutaneous oxygen measurement (TCOM)
timeFrame: 1,3,6,12 month
measure: 36-Item Short Form Health Survey (SF36)
timeFrame: 1,3,6,12 month
measure: Pain free walking distance
timeFrame: 1,6,12 month
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Nuttawut SERMSATHANASAWADI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01637428: The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome
Official title: The Use of Intermittent Pneumatic Compression Device for Symptomatic Relief in Patients With Post Thrombotic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Post Thrombotic Syndrome
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The use of ActiveCare+S.F.T 3rd generation (an Intermittent Pneumatic Compression Device) will improve quality of life in patients suffering from Post Thrombotic Syndrome compared to compression stockings which is the current gold standard of care.


Eligibility criteria: Inclusion Criteria:

* patients who have developed post Thrombotic leg symptoms after a deep vein thrombosis event.

Exclusion Criteria:

* admitted patients
* Patients who suffer from peripheral artery disease.
* Patients with an acute deep vein thrombosis.
* s/p leg skin transplant
* Patients with an active leg infection
* Patients who aren't capable of operating the device.

Primary outcomes:
measure: Quality of life (Veins-QOL)
timeFrame: 1 month
Secondary outcomes:
measure: Villalta Scale
timeFrame: 1 month
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Medical Center
Study officials:
affiliation: Hematology departement, Haddash medical Center, Jerusalem, Israel
name: Galia Spectre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05311228: The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
Official title: The Efect of Azithromicyn on Bronchopulmonary Displasia in Extremely Preterm and Very Preterm Infant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bronchopulmonary Dysplasia
Intraventricular Hemorrhage
Necrotizing Enterocolitis
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups, one group intervention and one group control
Primary purpose: PREVENTION

Brief summary: This study was to see the effectiveness of azithromycin in preventing the incidence of bronchopulmonary dysphasia in extremely preterm and very premature infants. Inclusion criteria were infants with a gestational age of 25-31 weeks 6 days who experienced respiratory distress and their families had agreed to participate in the study, then randomized. The intervention was in the form of giving azithromycin in the intervention group and no intervention was carried out in the control group and then followed up to 36 weeks PMA


Eligibility criteria: Inclusion Criteria:

* premature infant 25-31 weeks 6 days with respiratory distress,

Exclusion Criteria:

* multiple congenital anomaly

Primary outcomes:
measure: Bronchopulmonaty Dysplasia
timeFrame: BPD mild room air until 36 weeks PMA, BPD moderate use of oxygen <30% until 36 weeks PMA, BPD severe use of oxygen >30% until 36 weeks PMA
Secondary outcomes:
measure: Intraventricular hemorrhage
timeFrame: 1 days-7 days, and 6 weeks
measure: Necrotizing Enterocolitis
timeFrame: 1 days-36 weeks PMA
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: University of Indonesia
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT06065228: Therapeutic Endpoint in Pediatric IBD Conditions
Official title: Development of a Therapeutic Endpoint in Pediatric IBD Conditions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohn Disease
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study proposes to enroll patients diagnosed with IBD in a longitudinal design.

Brief summary: The purpose of this clinical study is the development of physiologic endpoint of inflammation in pediatric patients diagnosed with inflammatory bowel disease (IBD), specifically subtypes Crohn's disease (CD) and ulcerative colitis (UC). The novel medical device evaluates the patient's sensory response to each of the three sensory nerve fiber types. Data from the device provides an assessment of disease activity and a more precise approach to treatment.


Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 6 years of age at screening.
* Documentation of an IBD diagnosis as evidenced by history

Exclusion Criteria:

* Documented history of eye disease precluding pupillometry
* Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.

Primary outcomes:
measure: The primary objective of this study is the measurement of the nociceptive index for clinical output.
timeFrame: 1 Year
Secondary outcomes:
measure: The secondary objective of this study is the characterization of the nociceptive index in IBD populations in response to standard of care interventions.
timeFrame: 1 Year
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Health System
state: District of Columbia
Study officials:
References:
Clinical trial NCT04840628: The Relationship Between the Neural Drive and Intrinsic Positive End-expiratory Pressure
Official title: The Relationship Between the Nreural Drive and Intrinsic Positive End-expiratory Pressure of the Chronic Obstructive Pulmonary Disease Patients With Respiratory Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: neural respiratory drive
Intrinsic Positive End-expiratory Pressure
Chronic Obstructive Pulmonary Disease Patients
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 10
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: the chronic obstructive pulmonary disease patients with respiratory failure
Primary purpose: OTHER

Brief summary: To investigate the relation the nreural drive and intrinsic positive end-expiratory pressure(PEEPi) of the chronic obstructive pulmonary disease(COPD) patients with respiratory failure.In present study the PEEPi of COPD patients was increased by increasing the resistance of the respiratory system, the change of the neural drive was recorded.

Detailed description: To investigate the relation the nreural drive and intrinsic positive end-expiratory pressure(PEEPi) of the chronic obstructive pulmonary disease(COPD) patients with respiratory failure.The diaphragm electromyogram (EMGdi) represents the neural drive to the diaphragm.A multi-pair esophageal electrode catheter was used to record the EMGdi.The PEEPi was assessed by the by the balloon-catheter in the multi-pair esophageal electrode catheter. In present study the PEEPi of COPD patients was increased by increasing the resistance of the respiratory system, the change of the neural drive( EMGdi) was obtained from the a multi-pair esophageal electrode catheter All the signal recorded in the computer. The relation the nreural drive assessed by EMGdi and intrinsic positive end-expiratory pressure(PEEPi) would be analysed.

Eligibility criteria: Inclusion Criteria:

chronic obstructive pulmonary disease patients with respiratory failure

Exclusion Criteria:

1. Heart failure
2. cardiac dysrhythmia
3. Loss of consciousness

Primary outcomes:
measure: neural respiratory drive assessed by the root mean square of diaphragm electromyogram (EMGdi) of the chronic obstructive pulmonary disease patients with respiratory failure
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: 1State Key Laboratory of Respiratory Disease, National clinical research center for respiratory disease, Guangzhou Institute of respiratory health. 2The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT00696228: High Fat Diet: Oxidative and Cardiovascular Effects
Official title: High Fat Diet: Oxidative Effects and Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Robert C. Atkins Foundation
First posted: 2008-06-12
Enrollment: 144
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test the effects of a modified Atkins high fat diet on endothelial function, insulin resistance and energy balance.

Detailed description: To test the effects of a modified Atkins high fat diet on endothelial function, insulin resistance and energy balance.

Eligibility criteria: Inclusion Criteria:

* BMI 30-39.9
* Female
* Age 21-40

Exclusion Criteria:

* Smoker
* Comorbid Disease

Primary outcomes:
measure: endothelial function
timeFrame: 4 months
Secondary outcomes:
measure: energy balance and body composition
timeFrame: 4 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Heidi J Silver, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Niswender KD, Fazio S, Gower BA, Silver HJ. Balanced high fat diet reduces cardiovascular risk in obese women although changes in adipose tissue, lipoproteins, and insulin resistance differ by race. Metabolism. 2018 May;82:125-134. doi: 10.1016/j.metabol.2018.01.020. Epub 2018 Jan 31.
citation: Silver HJ, Kang H, Keil CD, Muldowney JA 3rd, Kocalis H, Fazio S, Vaughan DE, Niswender KD. Consuming a balanced high fat diet for 16 weeks improves body composition, inflammation and vascular function parameters in obese premenopausal women. Metabolism. 2014 Apr;63(4):562-73. doi: 10.1016/j.metabol.2014.01.004. Epub 2014 Jan 17.