louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03955718: Developing and Testing Motherly App: a Smartphone Application to Promote Mothers' Mental Health
Official title: Developing and Testing Motherly: An Automated Gamified Smartphone Application to Promote Mothers' Mental Health
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Maternal Depression
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: Fundação Maria Cecilia Souto Vidigal
First posted: 2019-05-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators plan to develop and test Motherly, a smartphone app to promote maternal mental health and child development. The Motherly app is visually appealing aimed at engaging the user with a minimalistic layout. The app will offer a gamified experience ideal for engaging youth in behaviors that can promote mental health, such as stimulating pleasure, productivity, and physical activities, connecting with peers, and eating healthy food. Pregnant women aged 16-34 living in Brazil will participate in the clinical trial to test the efficacy of the intervention.


Eligibility criteria: Inclusion Criteria:

* Literate women in the first or second trimester of pregnancy
* Living in Brazil
* Owning a functional smartphone for personal use with Android or iOS operational system

Exclusion Criteria:

* High-risk pregnancy

Primary outcomes:
measure: Maternal depression
timeFrame: At 3 months of the child's age
Secondary outcomes:
measure: Quality of sleep: Bergen Insomnia Scale
timeFrame: Monthly up to 3 months of the child's age
measure: Quality of maternal diet: questionnaire
timeFrame: Monthly up to 3 months of the child's age
measure: Physical activity
timeFrame: Monthly up to 3 months of the child's age
measure: Psychological well-being
timeFrame: Monthly up to 3 months of the child's age
measure: General well-being
timeFrame: 3 months of the child's age
measure: Maternal anxiety
timeFrame: 3 months of the child's age
measure: Maternal self-efficacy: General Self-efficacy Scale
timeFrame: 3 months of the child's age
measure: Quality of stimulation and support available to the child in the home environment: Home Observation for Measurement of the Environment
timeFrame: 3 months of the child's age
measure: Maternal parenting stress
timeFrame: 3 months of the child's age
measure: Child development
timeFrame: After child birth up to 3 months of the child's age
measure: Child developmental milestones
timeFrame: 3 months of the child's age
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Daniel Fatori
Study officials:
References:
Clinical trial NCT04512118: CT Abnormalities Evocative of Lung Infection Are Associated With Lower 18F-FDG Uptake in Confirmed COVID-19 Patients
Official title: CT Abnormalities Evocative of Lung Infection Are Associated With Lower 18F-FDG Uptake in Confirmed COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Presence of COVID-19 Compatible CT Abnormalities
Keywords: COVID19
18F FDG PET
lung infection
CT
seriological tests
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with suspicion of lung involvement in COVID19 context

Brief summary: CT signs that are evocative of lung COVID-19 infections have been extensively described, whereas 18F-FDG-PET signs have not. Our current study aimed to identify specific COVID-19 18F-FDG-PET signs in patients that were (i) suspected to have a lung infection based on 18F-FDG-PET/CT recorded during the COVID-19 outbreak and (ii) whose COVID-19 diagnosis was definitely established or excluded by appropriate viral testing.


Eligibility criteria: Inclusion Criteria:

* Patient coming to nuclear medicine for 18F-flurodesoxyglucose (FDG) positron emission tomography computed tomography (PET-CT) with suspicion of lung involvement
* patient affiliated to a social security scheme or equivalent
* adult patient having been informed of the study

Exclusion Criteria:

* patient with a negative covid 19 test

Primary outcomes:
measure: Visual analysis of pulmonary lobes
timeFrame: 1 day
Secondary outcomes:
measure: Measurement of metabolic activity
timeFrame: 1 day
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU of Nancy
state: Grand Est
Study officials:
References:
Clinical trial NCT02707718: Biomarkers for the Early Identification of Sepsis in the Emergency Department
Official title: Early Biomarkers of Sepsis Identification in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: sepsis
biomarker
prognostic
emergency department
diagnosis
Lead sponsor: Pitié-Salpêtrière Hospital
Sponsor class: OTHER
Collaborators: name: Institut Pasteur
name: Bio-Rad Laboratories
First posted: 2016-03-14
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients attending the ED and suspected to have sepsis

Brief summary: Monocentric prospective study on consecutive patients attending the emergency department and suspected to have sepsis. Blood sampling for the measurement of a panel of biomarkers of interest in sepsis.

Detailed description: The management of patients admitted to the emergency department (ED) requires investigative biological parameters that help clinicians to make the right diagnosis.

Sepsis concerns patients with infection associated with a systemic inflammatory response. While this inflammatory profile is observed in many clinical situations in the ED, the challenge is to characterize in these patients suspected of sepsis those who have a real infection.

Currently, no individual biomarker of sepsis is sufficiently discriminant. The objective of this study is to measure in patients suspected of sepsis in the emergency department, a combination of biomarkers (covering several distinct pathophysiological pathways) that could provide high specificity and sensitivity for the diagnostic and prognostic. The originality of this study is that compared with patients admitted to intensive care units, patients investigated for suspected sepsis in the ED are seen earlier in their medical history and usually before any therapeutic intervention (intravenous fluids, antibiotics, catecholamines) interfering with several biomarkers of interest.

Eligibility criteria: Inclusion Criteria:

* patient attending the ED and suspected to have sepsis by the emergency physician after clinical exam

Exclusion Criteria:

* patient minor under 18-year
* pregnancy
* anticipated no follow-up possible (homeless...)
* Refusal to participate
* patient under curators, prisoner

Primary outcomes:
measure: sepsis diagnosis
timeFrame: 30-day after inclusion
Secondary outcomes:
measure: severe outcome defined by: severe sepsis and/or septic shock and/or ICU admission and/or death in the 30-day follow-up
timeFrame: 30-day after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpêtrière
city: Paris
country: France
facility: Institut Pasteur
Study officials:
affiliation: ARCEAR
name: pierre Hausfater, Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02993718: Sedation by Dexmedetomidine and Propofol
Official title: Comparison of the Upper Airway Patency by Dexmedetomidine and Propofol Used for Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Spinal
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Under the hypothesis that dexmedetomidine sedation would result in less upper airway obstruction, we evaluated the occurrence of upper airway collapse or the requirement of airway intervention in patients with obstructive sleep apnea during dexmedetomidine or propofol sedation.


Eligibility criteria: Inclusion Criteria:

* Surgery under spinal anesthesia
* Intraoperative sedation
* American Society of Anesthesiology physical status 1 or 2
* Apnea/hypopnea index 5-14/h in Watch-PAT 200 analysis

Exclusion Criteria:

* Anatomical defects on upper respiratory tract
* Psychotic disorder
* Drug addition
* Alcohol addition
* body mass index ≥ 35 kg/m2

Primary outcomes:
measure: The occurrence of upper airway obstruction
timeFrame: During the sedation period, an average of 3 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
citation: Shin HJ, Kim EY, Hwang JW, Do SH, Na HS. Comparison of upper airway patency in patients with mild obstructive sleep apnea during dexmedetomidine or propofol sedation: a prospective, randomized, controlled trial. BMC Anesthesiol. 2018 Sep 5;18(1):120. doi: 10.1186/s12871-018-0586-5.
Clinical trial NCT04999618: A New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology
Official title: DOUBLE-SKIN: a New Approach in Laser Surgery Using the Regenerative Solution in Children Diagnosed With Vascular Pathology: a Randomised, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vascular Diseases
Vascular Malformation
Capillary Malformation-Arteriovenous Malformation
Port-Wine Stain
Sturge-Weber Syndrome
Vascular Tumor
Keywords: Vascular Diseases
Laser treatment
Capillary Malformation
Port-Wine Stain
Vascular Tumor
Lead sponsor: Center for Vascular Pathology, Moscow
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Laser treatment (LT) is the first-line treatment for Vascular Pathology. However even when LT is based on the selective photothermolysis it causes the first-degree burns. While being typically benign by affecting only the epidermis, or outer layer of skin, the burn site is remaining red, dry, and very painful. As Haemoblock contains nanoparticles of silver and is known for both bactericidal and bacteriostatic effects, it likely decreases the potential for infection postoperatively. Furthermore, after fibrin replaces the superficial structure "Hemoblock-albumin", the polyacrylate matrix is plasmolyzed which initiates the cascade of signals required for the tissue regeneration processes. Objective of the study was to examine the effect of the Regenerative Solution "Hemoblock" in lowering postoperative complications in children diagnosed with Vascular Pathology undergoing a laser surgery if delivered with transdermal patches.


Eligibility criteria: Inclusion Criteria:

* clinically diagnosed Vascular Pathology

Exclusion Criteria:

* age
* severe allergic reaction

Primary outcomes:
measure: Preventing negative outcomes of postoperative infection
timeFrame: Early postoperative period and at 3 weeks
Secondary outcomes:
measure: Preventing prolonged functional recovery
timeFrame: Early postoperative period and at 3 weeks
Other outcomes:
measure: Preventing likelihood of mental health issues
timeFrame: Early postoperative period and at 3 weeks
Locations:
city: Moscow
country: Russian Federation
facility: The Vascular Anomalies Center (VAC) "Hemangioma"
Study officials:
affiliation: The Vascular Anomalies Center (VAC) "Hemangioma",
name: Ekaterina M Listovskaya, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: The Vascular Anomalies Center (VAC) "Hemangioma"
name: Dmitry V Romanov, MD
role: STUDY_CHAIR
affiliation: Moscow Regional Research Institute of Blood
name: Alexander Plotkin, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01178918: Non-specific Response to H1N1 Vaccine
Official title: Enhanced Non-Specific T Lymphocytes Response to Influenza A (H1N1) AS03-Adjuvanted Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza H1N1
Keywords: Influenza H1N1
Vaccine
Adjuvant
T Lymphocytes
Non-specific response
Interleukin-2
Non-specific T cell response
Lead sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.

Brief summary: This is a prospective observational study with recruitment of healthy volunteers from consecutive recipients of H1N1 influenza vaccine at the University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.

The purpose of this study is to evaluate certain safety aspects of adjuvanted influenza H1N1 vaccines.


Eligibility criteria: Inclusion Criteria:

* Recipients of H1N1 influenza vaccine.
* Healthy individuals with no signs of influenza or other infectious disease.

Exclusion Criteria:

* Signs of influenza or other infectious disease in 1 month before study participation.

Primary outcomes:
measure: T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination
timeFrame: At 3 weeks after vaccination
measure: T Cell Immune response monitoring after Influenza A (H1N1) AS03-Adjuvanted Vaccination
timeFrame: At 11 weeks after vaccination.
Secondary outcomes:
Other outcomes:
Locations:
city: Golnik
country: Slovenia
facility: University Clinic of Respiratory and Allergic Diseases
Study officials:
References:
Clinical trial NCT00692718: N-3 Fatty Acids for the Prevention of Atrial Fibrillation in Patients With Acute Heart Failure
Official title: N-3 Fatty Acids for the Prevention of Atrial Fibrillation in Patients With Acute Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Heart Failure
Acute Myocardial Infarction
Lead sponsor: Osaka General Medical Center
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our study is to investigate the effect of N-3 Fatty Acids for the prevention of atrial fibrillation in patients with acute heart failure or acute myocardial infarction


Eligibility criteria: Inclusion Criteria:

* sinus rhythm patients with acute heart failure or acute myocardial infarction

Exclusion Criteria:

* pregnancy,allergy to epadel

Primary outcomes:
measure: detection of atrial fibrillation on ECG monitoring
timeFrame: anytime during hospitalization
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00954018: Microbial Community Composition and Metabolism in Cystic Fibrosis
Official title: Respiratory Microbial Community Composition and Metabolism in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
name: Harvard Medical School (HMS and HSDM)
First posted: 2009-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cystic fibrosis patients will be contacted during clinical care visits and inpatient hospitalizations.

Brief summary: Scientist have begun to realize that many types of bacteria often live together as a complex community, and the investigators wish to apply that idea to the bacteria in the respiratory system of people with Cystic Fibrosis (CF). It is possible that the survival of the many millions of bacteria in the CF lung depends on the production of special chemicals that might be made only by very few types of bacteria. If that is true, medicines that interfere with those chemicals could treat the lung infections that cause trouble for nearly all people with CF. The investigators wish to study the production of several potentially critical chemicals by the respiratory bacteria and to examine the effect of those chemicals on the makeup of the entire community of bacteria. To detect all the bacteria in that community, the investigators will use new methods that use bacterial genetic information and can detect hundreds of different types of bacteria in respiratory samples of individual CF patients.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of Cystic Fibrosis
* 2 to 55 years of age

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hosptital, Boston
state: Massachusetts
Study officials:
References:
Clinical trial NCT06550518: Real-life Second-line Epirubicin-Paclitaxel Regimen as Treatment of Relapsed Small-Cell Lung Cancer : EpiTax Study.
Official title: Real-life Second-line Epirubicin-Paclitaxel Regimen as Treatment of Relapsed Small-Cell Lung Cancer : EpiTax Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Small Cell Lung Carcinoma
Keywords: Small-cell Lung Cancer
Epirubicin
Paclitaxel
Cerebral Efficacy
Real-life
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (age ≥18 years) with histologically or cytologically SCLC diagnosis was confirmed who received at least one cycle with a epirubicin-paclitaxel doublet treated between January 2010 and December 2020 in one of the three centers (Brest University Hospital Center, Quimper Hospital Center and Landerneau Hospital Center)

Brief summary: Initial chemosensitivity is known concerning SCLC but relapse is almost systematic, especially at a metastatic stage. Brain metastasis are identified around 40 to 50% during the evolution of the disease. Concerning the efficacy of epirubicin combined with paclitaxel from the second-line treatment, data is lacking more particularly about specific response on brain metastasis.

In this retrospective multicentric observational study in real life conditions, we try to evaluate systemic and specific cerebral efficacy and safety of a regimen combining epirubicin and paclitaxel in patients treated between 2010 and 2020 for a small cell lung carcinoma from the second-line treatment.


Eligibility criteria: Inclusion Criteria:

* Adults (age ≥18 years)
* Histologically or cytologically SCLC diagnosis
* Treated with epirubicin-paclitaxel doublet between January 2010 and December 2020

Exclusion Criteria:

* Opposition to participate registered
* Patients under legal protection
* Patients afflicted by another subtype of lung carcinomas
* SCLC not treated with the epirubicin-paclitaxel doublet

Primary outcomes:
measure: Progression-free survival
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Objective response rate
timeFrame: 1 year
measure: Disease control rate
timeFrame: 1 year
measure: Intracranial control rate
timeFrame: 1 year
measure: Toxicities
timeFrame: 1 year
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Landerneau
country: France
facility: Hôpital de Landerneau
city: Quimper
country: France
facility: CHIC
Study officials:
References:
Clinical trial NCT06502418: Acupuncture to Managed Pain During Induced Labor with Cook's Balloon
Official title: Impact of Acupuncture on Pain Management During Induced Labor with Cook's Balloon At the Beaumont Maternity in Roubaix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Induction
Keywords: Acupuncture therapy
Labor induction
Pain management
Lead sponsor: Centre Hospitalier de Roubaix
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In France, labor induction rate is above 25.8%. Labor induction with Cook's balloon is a non-hormonal mechanical method but this technique can provide pain.

At Roubaix's maternity, midewifes can adminitred acupuncture therapy to help to manage this pain.

No studies where found about an effect of acupuncture therapy on pain provoked by labor induction with Cook's balloon.

Detailed description: Investigators aim to demonstate that acupuncture therapy during labor induction with Cook's balloon can reduced pain and improved patient's experience. Investigators will use 7 acupuncture points (YIN TANG/ 4 GI bilateral/ 36 E bilateral and 5TR bilateral) before the application of the balloon. A visual analog scale will be used before and after balloon insertion to collect pain level.

a questionnary will be filled by patient to collect their experiences. Investigators will collect data about analgesia, failed of induction and cesarean section to see effect of acupuncture on them.

Patients will be randomised.

Eligibility criteria: Inclusion Criteria:

* pregnant woman with a gestational age of 37 weeks and above
* age\>=18 years old
* having medical indication to be labor induced by Cook's Balloon
* speaking French
* agreeing to participate by signing informed consent form

Exclusion Criteria:

* patient having contraindication for the use of Cook's balloon
* patients under curatorship and/or guardianship

Primary outcomes:
measure: Impact of 7 acupuncture points on pain
timeFrame: Day 1
Secondary outcomes:
measure: Evaluate the consumption of analgesics between the 2 groups
timeFrame: Day 1
measure: Evaluate experiences of the patient during labor induction between the 2 groups
timeFrame: Day 1
measure: Comparison of cesarean section rate, balloon failure rate and induction duration between the two groups
timeFrame: Day 2
Other outcomes:
Locations:
city: Roubaix
country: France
facility: CH de Roubaix
Study officials:
References: