louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04865900: Prevalence of Perimyocarditis After Covid-19 Vaccine
Official title: Prevalence of Perimyocarditis After Covid-19 Vaccine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perimyocarditis
Covid19
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-04-29
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient Registries from local Health Maintenance Organizations

Brief summary: The aim of this study is to determine whether there is a higher prevalence of perimyocarditis after undergoing vaccination for Covid-19.


Eligibility criteria: Inclusion Criteria:

* Patients planning Pfizer-BioNTech BNT162b2 vaccination against Covid19

Exclusion Criteria:

* Patients infected with Covid19

Primary outcomes:
measure: Elevated Troponin
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Saif Abu-Moch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02805400: Neurocognitive Performance During Space Flight. Validation of a Test Battery
Official title: Neurocognitive Performance During Space Flight. Validation of a Test Battery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Novespace
First posted: 2016-06-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The main objective of this experiment is to evaluate the alterations in brain cortical activity induced by micro- and hypergravity conditions.

A secondary objective is to correlate changes in brain cortical activity and brain oxygenation level with neurocognitive performance.

Another secondary objective is to differentiate between the influences of hemodynamic and electro cortical changes and the influence of stress on cognitive performance alterations


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 65
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Persons with prior serious injuries to their head
* Persons who take any medication or drugs influencing their central nervous system or cognitive performance
* Pregnant women

Primary outcomes:
measure: brain cortical activity induced by micro- and hypergravity conditions : Electro cortical power in alpha frequency ranges (EEG-LORETA)
timeFrame: baseline
measure: Brain tissue oxygenation ( oxy- or deoxygenated hemoglobin values) NIRS
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen CHU
Study officials:
affiliation: CHU CAEN
name: Pierre DP Denise, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06056700: Emotional Intelligence In Pregnancy and the Puerperium and Baby Blues Symptoms: A Randomized Clinical Trial
Official title: Emotional Intelligence In Pregnancy and the Puerperium and Baby Blues Symptoms: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Baby Blues Symptoms
Lead sponsor: Universidad del Norte
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Milwaukee
name: University of Castilla-La Mancha
First posted: 2023-09-28
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Emotional intelligence pertains to the capacity for making decisions and adjusting to life's fluctuations, an attribute influenced by emotional conditions. Several scenarios impact nearly 80% of females, influencing their nurturing abilities. This study aimed to analyze the effectiveness of the "Happy in My Maternity" project in reducing baby blues symptoms in postnatal women. Methods: Employing a randomized clinical trial, hybrid interventions based on mobile application and i-person were conducted as part of an educational and emotional regulation curriculum. Enrollment encompassed the well-being of women. The program retained thirty-five participants, with thirty-four constituting the control cluster. The Trait-Meta Mood Scale (TMMS-24) questionnaire evaluation was administered to gauge emotional intelligence.


Eligibility criteria: Inclusion Criteria:

i) to have between 28 and 38 weeks of pregnancy, ii) pregnant women with follow-up and control at the participant hospital iii) women who signed their consent to participate in the study

Exclusion Criteria:

i) Women with high-risk pregnancies ii) Women suffering from psychiatric disorders before pregnancy such as anxiety, affective or disruptive behavior disorders

Primary outcomes:
measure: Baby Blues Symptoms Relief
timeFrame: 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Esmeralda Santacruz-Salas
state: Castilla
Study officials:
References:
Clinical trial NCT05935800: The Effect of the COVID-19 Pandemic on Frailty in Liver Transplant Candidates
Official title: The Effect of the COVID-19 Pandemic on Frailty in Liver Transplant Candidates
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Frailty
Sarcopenia
COVID-19
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Age 18 years and older Underwent pre-transplant frailty assessment (PFA) at MDMC 369 liver transplant candidates who underwent pre-transplant frailty assessments at the Liver Institute at Methodist Dallas from April 1, 2018 to February 28, 2022. The study data will be divided into cohorts: pre-COVID and COVID. Specifically, the pre-COVID period will consist of the dates between April 1st, 2018 and March 12, 2020, while the COVID period will consist of the dates between March 13, 2020 and February 28th, 2022.

Brief summary: Frailty is associated with higher rates of morbidity, mortality, and failure to rescue after major surgical procedures \[1\]. Sarcopenia is degenerative loss of skeletal muscle mass and strength. It is a key component of physical frailty and is associated with poorer post-surgical outcomes due to decreased patient strength and vitality.

Detailed description: This study seeks to examine whether the SARS-CoV-2 (COVID-19) pandemic, an ongoing global health crisis that was declared a national emergency by the US Federal Government on March 13, 2020, has exacerbated both frailty and sarcopenia in a population of liver transplant candidates.

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older Underwent pre-transplant frailty assessment (PFA) at MDMC

Exclusion Criteria:

* Not a patient at Liver Institute at Methodist Dallas

Primary outcomes:
measure: To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia
timeFrame: 2 years
measure: To determine the impact of the COVID-19 pandemic on the incidence of sarcopenia
timeFrame: 2 years
Secondary outcomes:
measure: Changes in number of comorbidities between pre- and during/post-pandemic periods
timeFrame: 1 year
measure: Changes in type of comorbidities between pre- and during/post-pandemic periods
timeFrame: 1 year
measure: Changes in severity of comorbidities between pre- and during/post-pandemic periods
timeFrame: 1 year
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Parvez Mantry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05813600: Efficacy and Safety of Nirmatrelvir/Ritonavir for Treating Omicron Variant of COVID-19
Official title: To Evaluate the Efficacy and Safety of Nirmatrelvir/Ritonavir in the Treatment of the Omicron Variant of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Omicron Variant of COVID-19
Keywords: Nirmatrelvir/Ritonavir
COVID-19
Lead sponsor: Wenzhou Central Hospital
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the efficacy and safety of Nirmatrelvir/Ritonavir in the treatment of the Omicron variant of COVID-19. The main question it aims to answer is: Whether the use of the drug can help patients recover from COVID-19.

Patients in both groups were given Lianhua Qingwen Capsule orally, 3 times/day, 6 g/time. oral antipyretic (ibuprofen suspension 10ml) and symptomatic supportive treatment for body temperature \>38.5 ℃. The study group was given Nirmatrelvir 300mg/Ritonavir 100mg orally, q12h, for 5 days, and the control group not given any antiviral drugs.


Eligibility criteria: Inclusion Criteria:

* Confirmation of COVID-19 infection within 24h and positive nasopharyngeal swab for COVID-19 nucleic acid RNA；
* Age ≥12 years and weight ≥ 40Kg；
* Subjects of fertility must agree to use highly effective contraceptive methods.

Exclusion Criteria:

* Previous history of COVID-19 treatment；
* The known history of active liver disease；
* Patients on renal dialysis or have moderate to severe impaired renal function；
* The known human immunodeficiency virus (HIV) infection;
* Suspected or confirmed concurrent active systemic infections other than COVID-19 infection；
* Allergy or other contraindication to any component of the study intervention;
* Any drug or substance that is currently or expected to be used that is a high reliance on CYP3A4 enzyme clearance or strong CYP3A4 enzyme inducers；
* pregnant or breastfeeding women.

Primary outcomes:
measure: Nasal swab COVID-19 nucleic acid tests
timeFrame: On days 4, 7, 9 and 11 of treatment
measure: Virus turn negative
timeFrame: From date of randomization until the date of first documented progression, assessed up to 5 months
measure: Hospital stays
timeFrame: From date of randomization until the date of first documented progression, assessed up to 5 months
measure: Adverse drug reaction
timeFrame: From date of randomization until the date of first documented progression, assessed up to 5 months
measure: COVID-19 nucleic acid re-positive
timeFrame: From date of randomization until the date of first documented progression, assessed up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Xiangao Jiang
state: Zhejiang
Study officials:
References:
Clinical trial NCT06620952: Effect of the "O-ring" Technique in Reducing Cerebrospinal Fluid Leak in Posterior Fossa Surgery: an Explorative Study
Official title: Effect of the "O-ring" Technique in Reducing Cerebrospinal Fluid Leak in Posterior Fossa Surgery: an Explorative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posterior Fossa Surgery
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated for a disease located in posterior fossa for which a RS, KR or CH approach has to be performed. Patients between January 2018 and October 2023 will be considered for the study.Lacking of clinical, radiological and surgical data represented exclusion criteria.

Brief summary: Posterior fossa surgery represents on of the most demanding procedure in neurosurgery. Retrosygmoid (RS), key-hole retrosygmoid (KR) and cerebellar hemispheric (CH) are the most common approaches used to access in this area. Despite they are not technically difficult to perform, these approaches can be burdened by postoperative cerebrospinal fluid (CSF) leakage, both at short and long-term follow-up, with an high risk of meningitis. Many techniques were employed to avoid this risk, but it can still be estimated between 2% and 11% according to literature1-4. Spena et al. reported a CSF leakage rate of 6.8% in a previous experience5. As a consequence, newer efforts are necessaries to avoid this potentially lethal complication. By this explorative study, we want to retrospectively analyzed our experience with a newer technique of bone closure, called O'Ring, in patients subdued to posterior fossa surgery by RS, KR and CH approaches, focusing on postoperative CSF leakage (primary objective), wound complications and subcutaneous CSF collections (secondary objectives).


Eligibility criteria: Inclusion Criteria:

* age ≥18 years,
* availability of pre- and postoperative radiological and clinical data,
* a follow-up period of at least 3 months.

Exclusion Criteria:

* Lacking of clinical, radiological and surgical data

Primary outcomes:
measure: to estimate incidence of postoperative CSF leakage
timeFrame: 7 days
Secondary outcomes:
measure: to estimate incidence CSF leakage at 1- and 3-months of follow-up.
timeFrame: 1 and 3 months
measure: to estimate the incidence of wound complications postoperatively and at 1- and 3-months
timeFrame: 1 and 3 months
measure: to estimate the incidence of subcutaneous CSF collections postoperatively and at 1 and 3-months radiological follow-up
timeFrame: 1 and 3 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: SC Neurochirurgia, Fondazione IRCCS Policlinico San Matteo
Study officials:
References:
Clinical trial NCT03389152: SWE Liver Stiffness as a Predictor of Progression of Chronic Liver Diseases
Official title: Evaluation of SWE as a Predictive Tool for Progression of Chronic Liver Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Fibroses
Lead sponsor: SuperSonic Imagine
Sponsor class: INDUSTRY
Collaborators: name: University of Bonn
First posted: 2018-01-03
Enrollment: 2148
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: Patients with suspected or confirmed chronic liver disease of viral and/or steatotic origin, requiring a percutaneous liver biopsy, and who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease.

Brief summary: This study is a multicenter individual patient-based meta-analysis that will assess the performances of liver stiffness measurements performed with supersonic shear imaging shearwave elastography (SSI-SWE) in patients with liver fibrosis to predict progression of chronic liver disease.


Eligibility criteria: Inclusion Criteria:

* Patients who had received a liver ultrasound exam at baseline for a suspected chronic fibrotic liver disease of viral and/or steatotic origin,
* Patients who had reached the age of majority in their countries, at baseline,
* Patients with a baseline liver biopsy for histological evaluation of liver fibrosis with a length ≥ 15 mm paraffin sections (except if cirrhosis),
* Patients for whom a minimum length of clinical follow-up from baseline of 1 year had been recorded

Exclusion Criteria:

* Cause of chronic liver disease other than viral, ALD or NAFLD ( hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...)
* Any systemic, viral hepatitis and HIV co-infection

Primary outcomes:
measure: Liver disease progression rate
timeFrame: Minimum of 28 days follow-up
measure: Mortality rate
timeFrame: Minimum of 28 days follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Herrmann E, de Ledinghen V, Cassinotto C, Chu WC, Leung VY, Ferraioli G, Filice C, Castera L, Vilgrain V, Ronot M, Dumortier J, Guibal A, Pol S, Trebicka J, Jansen C, Strassburg C, Zheng R, Zheng J, Francque S, Vanwolleghem T, Vonghia L, Manesis EK, Zoumpoulis P, Sporea I, Thiele M, Krag A, Cohen-Bacrie C, Criton A, Gay J, Deffieux T, Friedrich-Rust M. Assessment of biopsy-proven liver fibrosis by two-dimensional shear wave elastography: An individual patient data-based meta-analysis. Hepatology. 2018 Jan;67(1):260-272. doi: 10.1002/hep.29179. Epub 2017 Nov 15.
Clinical trial NCT00005552: Isocyanate Dermal Exposures in Autobody Shops
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lung Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To characterize the skin route of exposure to the allergen hexamethylene diisocyanate (HDI) in the auto body industry.

Detailed description: BACKGROUND:

Isocyanates account for the highest number of reported cases of occupational asthma in the United States and developed countries. Prevention, however is limited by inadequate knowledge of isocyanate routes of exposure, exposure patterns, mechanisms of sensitization and other causal factors. The Survey of Painters and Repairers of Auto Bodies by Yale (SPRAY), a five-year cross-sectional epidemiologic survey of painters and repairers of autobodies at Yale was therefore initiated to address these questions. At the outset of Spray, it was not known how frequent skin contact among the painters might be. Moreover, there is new and exciting data from animal studies demonstrating that dermal rather than respiratory contact may be crucial to immune sensitization leading to asthma. Little is known, so far, about dermal exposure in autobody shops and its modifiers, especially the effectiveness of personal protective equipment (PPE) in preventing workers from skin contamination by isocyanates.

DESIGN NARRATIVE:

The study was ancillary to the SPRAY study and was integrated into it. The overall design was a cross-sectional investigation of 20 shops with 120 workers. This would allow a better understanding of the complex basis for asthma risk in these workers, and better recommendations to autobody shops and workers on protective measures for isocyanate dermal exposures.

Specific aims included: 1) Qualitatively and quantitatively assessing surface and skin contamination of HDI; 2) Identifying modifiers that affected surface and skin contamination, and specifically evaluating the effectiveness of personal protective equipment in protecting the skin from isocyanate contamination; 3) Exploring the relationships of dermal exposure with airborne exposure, biomarkers of systemic absorption and skin sensitization, and asthma-developing risk.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Mark Cullen
References:
citation: Liu Y, Sparer J, Woskie SR, Cullen MR, Chung JS, Holm CT, Redlich CA. Qualitative assessment of isocyanate skin exposure in auto body shops: a pilot study. Am J Ind Med. 2000 Mar;37(3):265-74. doi: 10.1002/(sici)1097-0274(200003)37:33.0.co;2-o.
Clinical trial NCT05808452: AMO CROC Study: Self-medication and Dental Pain of Pulpal and Peri-apical Origin. Qualitative Study
Official title: AMO CROC Study: Self-medication and Dental Pain of Pulpal and Peri-apical Origin. Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Self Medication
Keywords: Dental anxiety
Qualitative
Behaviors
Self Medication
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population included in the study will be comprised of Adults visiting the odontology unit for dental pain due to acute pulpitis Adults in need of dental treatment under general anesthesia recruitment will be done during dental consultations. Their non opposotion to participate to the study will be

Brief summary: Adult patients with dental anxiety or phobia constitute a population for which access to dental care is difficult and this situation is often associated with am low socio-economic status. According to the literature, these patients avoid conventional care, make greater use of emergency services, and self-medicate when experiencing dental pain. Moreover, little is known in the literature about the use of self medication in France, although it is known that in the general population does self medicate a lot. The objective of this study is to better understand the self-medication behaviors of patients in order to improve their care. This work aim at characterizing a population of adults in need of treatment for dental pain of pulpal or periapical origin and anxious or phobic adults in need of for dental treatment under general anesthesia. Self-medication behaviors will be studied in qualitative research during recorded interviews.


Eligibility criteria: Inclusion Criteria:

* Adults visiting the odontology unit for dental pain due to acute pulpitis or in need of dental treatment under general anesthesia
* Speaking French
* Able to give his/her informed consent
* Affiliated to the health social security system

Exclusion Criteria:

* Adults under guardianship or curatorship
* Adults refusing to participate

Primary outcomes:
measure: self medication behaviors description
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
city: Riom
country: France
facility: CH de Riom
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Pierre-Yves COUSSON
role: PRINCIPAL_INVESTIGATOR
References: