louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05875935: Assessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data (ECoG)
Official title: Assessment of Awake Surgery With Electrocorticographic Recordings in the Management of Gliomas and Correlation With Imaging Data
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Electrocorticography
Karnofski Index
Glioma
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2023-05-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study proposes to analyze data from intraoperative ECoG recordings acquired during wakefulness interventions in order to identify the connection networks involved in cognitive functions. This study also proposes to correlate the ECoG data with the imaging data and to analyze the disturbances of the electrophysiological signals induced by the cortical and subcortical brain lesions: this will make it possible to establish a more detailed mapping of the tumor areas and to compare disturbances recorded to those recorded in healthy areas. Thus, this approach should make it possible to improve the quality of excision of glial lesions located in eloquent areas, while reducing the risk of neurological sequelae and thus improve the survival and quality of life of patients.


Eligibility criteria: Inclusion Criteria:

* Man or woman over 18 years-old
* Subject with a non-recurrent glial lesion requiring surgery in vigilant condition;
* Brain lesion located in the functional zone;
* Major not protected within the meaning of the law;
* Subject affiliated to a Health Insurance scheme;
* No medical contraindication to performing an MRI (pacemaker);
* No medical contraindication to surgery and anesthesia;
* Karnofski index\> 70;
* Subject having signed an informed consent.

Exclusion Criteria:

* Minor subject, pregnant or breastfeeding woman;
* Major subject subject under measure of legal protection, guardianship or deprived of liberty by judicial or administrative decision;
* Subject hospitalized without consent;
* Subject treated with antipsychotics (neuroleptic or lithium);
* Subject who has already been treated for his glial lesion by surgery and / or radiotherapy;
* Subject refusing to sign an informed consent.
* Subject wishing to discontinue participation in the study before completion;
* Subject for which the surgical intervention and / or the ECoG recording could not be carried out after admission to the operating room (whatever the reason).

Primary outcomes:
measure: electrocorticographic recordings
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Clairval Private Hospital
state: Paca
Study officials:
References:
Clinical trial NCT05086458: Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants
Official title: Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants: an Open-label Single-center Randomized Parallel Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gut Microbiota
Keywords: gut microbiota
probiotics
infant
cesarean section
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of probiotics on the gut microbiota of infants born by cesarean section.

Detailed description: This study aims to examine the impact of probiotics administration on the gut microbiota of infants born by cesarean section. Birth,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants born by cesarean section.

Eligibility criteria: Inclusion Criteria:

* Neonates born by caesarean section

Exclusion Criteria:

* Gestational weeks \<37 Birth weight \<2500g or ≥4000g History of asphyxia anoxia at birth With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases With infectious diseases

Primary outcomes:
measure: Change in gut microbiota at 42 days between no intervention group and experimental group.
timeFrame: 42 days
measure: Change in gut microbiota at 14 days between no intervention and experimental group.
timeFrame: 14 days
Secondary outcomes:
measure: Change in gut microbiota at birth between no intervention and experimental group.
timeFrame: birth
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Rong Yang
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Huanlong Qin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04936958: RETR(Osteomyelitis)
Official title: RETR(Osteomyelitis)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteomyelitis
Keywords: hematogenous
bone substitute
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who presented with osteomyelitis between 2017 and 2021 managed at the CRIOAc Lyon

Brief summary: This is a retrospective study describing the management of osteomyelitis in a referece center, with success and failures.

Detailed description: Chronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones (tibia, femur, humerus), responsible for significant morbidity with the risk of fracture and amputation. It is caused by the presence of bacteria in the bone marrow, sometimes responsible for an intraosseous abscess. Chronic osteomyelitis can have a hematogenous or more often exogenous origin, after trauma or surgery.

Despite the progress made in both antibiotics and surgical treatment, the probability of failure of this treatment (infectious recurrence) is of the order of 20%, and has unfortunately remained stable for more than 20 years.

An innovative treatment, Cerament-G (BONESUPPORT AB Laboratory, Sweden), a synthetic bone substitute composed of hydroxyapatite, calcium sulphate, and gentamicin (CE marking), fills the "dead space" which is formed during surgery, prevents this cavity filled with blood from becoming infected, and promotes the regeneration of the bone within this space, limiting the risk of fracture in the medium and long term. It also locally delivers very high doses of gentamicin for several weeks.

Eligibility criteria: Inclusion Criteria:

* Patients who presented with osteomyelitis between 2017 and 2021

Exclusion Criteria:

* Patients who objected to participating in the study

Primary outcomes:
measure: rate of osteomyelitis in BJI
timeFrame: between 2017 and 2021
measure: site of osteomyelitis
timeFrame: between 2017 and 2021
measure: bone defect size
timeFrame: between 2017 and 2021
measure: type of osteomyelitis
timeFrame: between 2017 and 2021
measure: rate of bacteria involved in osteomyelitis
timeFrame: between 2017 and 2021
measure: Description of patients
timeFrame: between 2017 and 2021
measure: Description of the follow up of the patients
timeFrame: between 2017 and 2021
measure: description of patients : medical treatment
timeFrame: between 2017 and 2021
measure: Description of patients : surgical treatment
timeFrame: between 2017 and 2021
measure: rate of patient treated with CERAMENT
timeFrame: between 2017 and 2021
measure: rate of treatment failure
timeFrame: between 2017 and 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT04173858: Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol
Official title: Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol. A One-year Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-induced Constipation
Keywords: Naloxegol, PAMORA
Lead sponsor: Kyowa Kirin Farmacéutica S.L.U.
Sponsor class: INDUSTRY
First posted: 2019-11-22
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ambulatory oncology patients in Spain with diagnosis of OIC.

Brief summary: Opioid-induced constipation (OIC) is a common feature in patients treated with strong opioids. Such medication is often prescribed together with a laxative (osmotic, emollient), with effectiveness depending on the individual patient. Peripherally-acting, mu-opioid receptor antagonists (PAMORAs), such as Naloxegol, have proven to be effective against OIC in patients with inadequate response to laxatives without reducing opioid analgesic effect. However, evidence regarding efficacy and safety on patients with cancer is still scarce. The objective of this study was to analyze the efficacy of naloxegol in a real-world setting by assessing Quality of Life outcomes, and to obtain data on its safety in the long term in patients with cancer.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Cancer
* Treatment with opioids
* OIC symptoms
* Inadequate response to laxatives
* Karnofsky equal or above 50
* Ambulatory
* Must be able to complete questionnaire forms

Exclusion Criteria: at the start of the study:

* Hypersensitivity to Naloxegol or vehicle
* Suspicion or high risk of gastrointestinal block
* High risk of GI perforation
* Severe liver failure
* Pregnancy or breastfeeding
* Use of potent CYP3A4 inhibitors
* Cognitive impairment

Primary outcomes:
measure: Assessment of Quality of Life
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of Constipation Symptoms
timeFrame: 15 days
measure: Assessment of Constipation Symptoms
timeFrame: 1 month
measure: Assessment of Constipation Symptoms
timeFrame: 3 months
measure: Assessment of Constipation Symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Torrejón De Ardoz
country: Spain
facility: Hospital Universitario de Torrejon
state: Madrid
Study officials:
References:
Clinical trial NCT02572258: Supplementary Food on Prevention of Moderate Malnutrition in Children
Official title: The Effect of Supplementary Food Cookies on Prevention of Moderate Malnutrition in Preschool Children in Rural Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate Acute Malnutrition (MAM)
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2015-10-08
Enrollment: 1048
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study will evaluate the impact of a supplementary food (cookies) in preventing the risk of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children.

Children will be divided in two groups; one will received the cookie plus 12 educative sessions and the other just the educative program. The study will last 12 months


Eligibility criteria: Inclusion Criteria:

* (2-5 years old), who are from low socioeconomic classes (E and D classes)
* reside in rural areas, and with WHZ- between \> -3 and ≤ -2, and
* informed consent given by the subject's mother or caregiver

Exclusion Criteria:

* Severe acute malnutrition (HAZ, WAZ and WHZ-scores ≤-3) based on the 2006 World Health Organization (WHO) reference values (24)
* Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter)
* (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours).
* Current consumption of other supplementary foods.
* Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled.

Primary outcomes:
measure: Weight (kg) for height (cm) Z-score
timeFrame: 12 months
Secondary outcomes:
measure: Weight (kg) gains
timeFrame: 12 months
measure: height (cm) for age (months) Z-score
timeFrame: 12 months
measure: weight (kg) for age (months) Z-score
timeFrame: 12 months
measure: Mid-upper arm circumference (cm) (MUAC)
timeFrame: 12 months
measure: height (cm) gains
timeFrame: 12 months
Other outcomes:
Locations:
city: Colonia Lomas De Chapultepec
country: Mexico
facility: Un Kilo de Ayuda
state: Distrito Federal
Study officials:
affiliation: Universidad Autónoma del Estado de México
name: Juan Talavera, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00927758: Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair
Official title: Pilot Study to Examine the Post-Dose Changes in Exhaled Nitric Oxide (eNO) Following Treatment With Fluticasone Propionate (FP)/Salmeterol (SAL) Combination Product Advair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 105
Sex: ALL
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: To examine the post-dose changes in exhaled Nitric Oxide (eNO) following treatment with inhaled Advair in subjects with chronic but stable asthma as defined in Global Initiative for Asthma (GINA) guidelines.


Eligibility criteria: Inclusion Criteria:

* must be able to speak, read, and understand English
* exhaled Nitrous Oxide levels must be greater than or equal to 60 ppb at screening and greater than or equal to 55 ppb at Visits 2, 9, and 16
* must have history of at least 6 months of chronic, but stable asthma
* except for the presence of asthma, subjects must be in general good health

Exclusion Criteria:

* past or present history of experiencing allergic reaction to medications used in this study
* subjects must not be receiving ongoing regular treatment with inhaled corticosteroids
* subjects must not have ragweed allergy
* subjects must have no recent history of respiratory infections for at least 1 month prior to screening and until the end of the study

Primary outcomes:
measure: Percentage Change From Baseline (for Each Treatment Cycle) in Exhaled Nitric Oxide (eNO)
timeFrame: Baseline to Day 7 of each treatment cycle (total duration about 8 - 10 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Iowa City
country: United States
facility: CompleWare
state: Iowa
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT03687658: Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating
Official title: Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Aim 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Binge Eating
Behavior
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2018-09-27
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the extent to which we can engage and manipulate putative targets within the self-regulation domain within and outside of laboratory settings in samples of smokers and overweight/obese individuals with binge eating disorder. This is the fourth phase of a study that aims to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.


Eligibility criteria: Inclusion Criteria:

* Understand English sufficiently to provide informed consent
* Right-handed
* Normal or corrected-to-normal vision and no color blindness
* Interest in engaging with Laddr to modify self-regulatory behavior

Additional Inclusion Criteria for Smoking sample:

* Smoke 5 or more tobacco cigarettes/day for past year
* BMI greater than or equal to 17 and less than 27

Additional Inclusion Criteria for Binge Eating Sample:

* BMI greater than or equal to 27 and less than 45
* Weight limit of 350 lbs
* Non-smoking (defined as no cigarettes in past 12 months-this includes former and never smokers)

Exclusion Criteria:

* Significant medical illness
* History of mental disorder due to a medical condition
* Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder)
* Current use of any medication for psychiatric reasons (including stimulants and mood stabilizers)

Additional Exclusion criteria for Binge Eating Sample:

* Lost weight in recent past (\>10 pounds in past 6 months)
* Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig)
* Currently on a special diet for a serious health condition
* Current engagement in psychotherapy for binge eating disorder

Additional Exclusion Criteria for Smoking Sample:

* Binge eating behavior
* Current engagement in psychotherapy for smoking behavior

Primary outcomes:
measure: Binge Eating Episodes - Loss of Control
timeFrame: 28 days
measure: Binge Eating Episodes - Overeating
timeFrame: 28 days
measure: Number of Cigarettes Smoked Per Day
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Center for Cognitive and Neurobiological Imaging
state: California
Study officials:
affiliation: Stanford University
name: Russell A Poldrack, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Patrick G Bissett, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00841958: Endocardial Stem Cells Approach Efficacy
Official title: Efficacy of the Endocardial Stem Cells Implantation in Ischemic Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Ischemia
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2009-02-12
Enrollment: 250
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to test that endocardial stem cells implantation in patients who have CAD, low ejection fraction and signs of HF without possibility of CABG and PCI or despite on previous revascularization improves long-term survival compared to MED alone


Eligibility criteria: Inclusion Criteria:

* Men and women who are not of childbearing potential
* Age 21-75 years.
* Patients with CAD, NYHA and CCS angina III-IV functional class
* LVEF less than 35% measured by echocardiography or SPECT within three months of study entry
* Unsuitable for initial or repeated conventional revascularization (CABG or PCI)

Exclusion Criteria:

* Failure to provide informed consent.
* Plan for PCI or CABG.
* Non-cardiac illness with a life expectancy of less than 3 year.
* Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
* Previous heart, kidney, liver, or lung transplantation.
* Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.
* Recent acute myocardial infarction (AMI) within 90 days of study entry
* Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment
* History of moderate to severe aortic stenosis or prosthetic aortic valve
* Permanent atrial fibrillation
* Thrombosis in LV, based on echocardiography data

Primary outcomes:
measure: Null Hypothesis (Ho): There is no survival benefit in the stem cells group compared to the control group ( isolate MED therapy). H0: Ө ≤ 1 Alternative Hypothesis (Ha): There is a survival benefit in the stem cells group. HA: Ө > 1
timeFrame: 2007-2010
Secondary outcomes:
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
affiliation: State Research Institute of Circulation Pathology
name: Evgeny A Pokushalov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pokushalov E, Romanov A, Chernyavsky A, Larionov P, Terekhov I, Artyomenko S, Poveshenko O, Kliver E, Shirokova N, Karaskov A, Dib N. Efficiency of intramyocardial injections of autologous bone marrow mononuclear cells in patients with ischemic heart failure: a randomized study. J Cardiovasc Transl Res. 2010 Apr;3(2):160-8. doi: 10.1007/s12265-009-9123-8. Epub 2009 Sep 24.
Clinical trial NCT01936558: The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees
Official title: The Origin of Phantom Limb Sensation and Phantom Limb Pain in Amputees
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exposure to Infrared Radiation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: Amputees / healthy subjects

Brief summary: With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each subject using the techniques of fMRI and meridian response.

Detailed description: This project will investigate two main hypotheses based on our previous studies on phantom limb sensation and phantom limb pain. The first hypothesis states that phantom limb sensation and phantom limb pain both correlate with the 'phantom limb', while the second one maintains that the phantom limb can interact with the patient's body by means of the meridian system. With the far infrared ray applied to the 'phantom limbs' in amputees and the corresponding normal legs in healthy subjects, the sensation of (phantom) limb will be assessed for each subject using the techniques of fMRI and meridian response. By analyzing the data collected from both groups, the investigators expect both hypotheses will be supported by the results of experiments in this project.

Eligibility criteria: Inclusion Criteria:

* Amputees: at least one arm or one leg amputated
* Healthy subjects: healthy person under 30 years old

Exclusion Criteria:

* with mental diseases

Primary outcomes:
measure: Resting functional MR images
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH department of orthopedics; NTU department of electrical engneering
Study officials:
affiliation: Department of orthopedics, NTUH
name: Rong-Sen Yang
role: STUDY_CHAIR
References: