louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03956758: HIV Prevention During Chemsex
Official title: The Reflexive Logics Structuring the Report to HIV Prevention of MSM Practicing ChemSex in the Context of Circulation of the PreP
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Men Having Sex With Other Men
Keywords: MSM
Chemical sex
HIV prevention
HIV pre-exposure prophylaxis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSM living in Montpellier with negative HIV status, having at least one sexual intercourse under drug use during the last 12 months

Brief summary: In 2016, the number of discoveries of HIV seropositivity is estimated at about 6000 in France. Men who have sex with men (MSM) account for 44% of these infections (68% in the Occitanie region). For the past ten years, there have been new practices of sexual drug use among MSM referred to as Chemsex. These practices expose to sexual risks but also to those related to the consumption of drugs making this population more at risk to get infectious contaminations. In the "PREVAGAY study" conducted in Montpellier in 2015, about 30% of MSM included said they had consumed at least one psychoactive product before or during sex during the last 12 months. In addition, this percentage was significantly higher among HIV-positive men (51% versus 24% of HIV-negative men) and 1% (N = 9) had practiced Slam (Sexual Injection). The results of this study also showed that PreP (Prophylaxis Pre-exposure to HIV) was known by 52% of MSM included and 4% (N = 4) had already used it in the last 12 months. Several observations are needed: many ChemSex users do not use the PreP despite the fact that its effectiveness has been proven in many studies.

The social sciences have been studying the HIV epidemic since its emergence. In the era of HIV chronic disease, the sociologist Gabriel Girard wanted to question the pessimistic observation of epidemiological studies in his thesis work. Some contradictory logics explains this epidemiology of HIV which is maintained, particularly in Montpellier despite the arrival of the PreP.

The main objective of our study is to explore the reflexive logic structuring the report to HIV prevention by MSM practicing ChemSex in Montpellier, in the context of the appearance and dissemination of the PreP.


Eligibility criteria: Inclusion Criteria:

* Men who have sex with men (MSM)
* living in Montpellier
* using chemsex drugs at least one during sexual intercourse

Exclusion Criteria:

* under 18 years
* seropositive HIV

Primary outcomes:
measure: report to HIV
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Montpellier
name: Clemence GIRARD, Medical intern
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04565158: Sleep in Women With Bilateral Salpingo-Oophorectomy
Official title: Assessment of Sleep Disruption in Women With Bilateral Salpingo-Oophorectomy - A SCORE Ancillary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bilateral Salpingo-oophorectomy
Keywords: salpingo-oophorectomy
sleep
cognitive decline
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 71
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases: Women who underwent bilateral salpingo-oophorectomy prior to natural menopause Controls: Women who did not undergo bilateral salpingo-oophorectomy prior to natural menopause

Brief summary: The purpose of this research study is the compare objective and subjective sleep characteristics in women who have undergone removal of both ovaries (bilateral salpingo-oophorectomy) before natural menopause compared to women who did not undergo this procedure.


Eligibility criteria: Inclusion Criteria:

* Women who participate in the parent SCORE studies (NCT03821857)

Exclusion Criteria:

* Night shift workers will be excluded

Primary outcomes:
measure: prevalence of sleep disorders
timeFrame: 2 years
measure: prevalence of short sleep duration
timeFrame: 2 years
measure: prevalence of poor sleep quality
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: exploratory correlation between sleep measures and cognitive function
timeFrame: 2 years
measure: exploratory correlation between sleep measures and neuroimaging
timeFrame: 2 years
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Naima Covassin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02372058: Transcutaneous Bilirubinometry in Neonates With Bilicare System
Official title: Transcutaneous Bilirubinometry in Neonates With Bilicare System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Lead sponsor: Gerium Medical
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 103
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.

Detailed description: Neonatal hyperbilirubinemia or newborn jaundice impacts over 85% of all newborns \[1\]. Regardless of the mechanism, excessive hyperbilirubinemia has been traditionally treated with phototherapy to minimize any probable risk of developing bilirubin-induced neurotoxicity. However, earlier and more recent data suggest that pre-discharge bilirubin screening for risk of significant hyperbilirubinemia, whether due to a rapid bilirubin production or an earlier age of onset, has impacted the guidelines for clinical use of phototherapy \[1, 2\]. In this study, we plan to test the performance of a novel transcutaneous device (BiliCareTM) first for screening for bilirubin levels at postnatal age of 6 to 48 hrs; and possibly also, to substitute the use of this measurement for total plasma/serum bilirubin (TB). This device applies a novel light transmission technology that has the potential to measure bilirubin as a point-of-care test in the subcutaneous tissue, and then uses an internal algorithm to calculate bilirubin levels in the skin. In this proposalstudy, we will to assess the clinical performance of the BiliCare by correlating measurements made by this device to near-concurrent measure of total plasma/serum bilirubin at normative ranges (mean, median, range and inter-quartile ranges ) for all term and late-preterm newborns (including those who are at-risk for jaundice and / or being administered with phototherapy) born to families of diverse race and ethnic backgrounds.

Eligibility criteria: Inclusion Criteria:

* Parental informed consent
* Male and female newborns with a GA ≥ 35 wks
* Enrollment at age \> 6 hrs until neonatal discharge.
* Pre-phototherapy

Exclusion Criteria:

* Infants requiring respiratory assistance (such as mechanical ventilation)
* Severe or life-threatening congenital anomalies
* Hematomas at the point of measurement on both ears
* Neonates undergone blood transfusion

Primary outcomes:
measure: BiliCare TcB Result Compared to TSB Result
timeFrame: 30 minutes within taking the blood draw for TSB (either before or after the blood draw)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Einstein Medical Center
name: David Schutzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05603858: End Button Tenodesis in Failed Developmental Dysplasia of the Hip Surgery
Official title: The Role of End Button Tenodesis in the Management of Failed Developmental Dysplasia of the Hip Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthopedic Disorder
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 3
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be examined for:

Length of both lower limbs in relation to each other. Length of both lower limbs according to patient age. Presence of hump related to the outer surface of the hip Presence of pain, abnormal gait, Trendlenburg test Radiographic evaluation (antero posterior and frog pelvis views)

An addition to the steps of the open reduction, the following were done:

1. Trans articular suturing
2. End button tenodesis

Brief summary: Adequate growth and development of the hip depends on two main factors: concentric positioning of femoral head into the acetabular cavity and adequate balance in growth between tri-radiate and acetabular cartilage. Any alteration in these two conditions leads to a hip dysplasia \& dislocation


Eligibility criteria: Inclusion Criteria:

- Patient with Developmental dysplasia of the hip (DDH) with :

* Age: up to 9 years old.
* Recurrent DDH .
* Failed open reduction through medial approach in the management of DDH.
* Traumatic hip dislocation .

Exclusion Criteria:

* • Paralytic hip dislocation .

  * Post septic hip dislocation.
  * Refusal to participate in this study.

Primary outcomes:
measure: modified Harris Hip Score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zhang S, Doudoulakis KJ, Khurwal A, Sarraf KM. Developmental dysplasia of the hip. Br J Hosp Med (Lond). 2020 Jul 2;81(7):1-8. doi: 10.12968/hmed.2020.0223. Epub 2020 Jul 6.
citation: Schaeffer EK, Study Group I, Mulpuri K. Developmental dysplasia of the hip: addressing evidence gaps with a multicentre prospective international study. Med J Aust. 2018 May 7;208(8):359-364. doi: 10.5694/mja18.00154.
Clinical trial NCT01675258: Identifying Saliva Markers of Patients With Stomach, Colorectal (Including Pre-cancer Polyp) and Pancreatic Cancers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Colorectal Cancer and Pre-cancer Polyps
Pancreatic Cancer
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients identified with gastric, colorectal (including pre-cancer polyps) or pancreatic cancer

Brief summary: Colorectal cancers account for 783,000 new cases and cause 437,000 deaths per year across the world. Diagnosis in the early stages improves survival rates. Up to now, these cancers are mostly diagnosed only at later stages of the disease's course through histoimmune staining and molecular biology processes on the tissues biopsied from the gastrointestinal system under invasive diagnostic procedures of colonoscopy.

Oral fluid presents a large protein complexity and has been recently used as a diagnostic biofluid for oral, as well as systematic diseases. Using oral fluid as a bio-marker for the colorectal cancer can be advantageous as it contains gastrointestinal fluids, in addition to bacteria and bacteria lysate, which can also serve as a bio-markers' source for colorectal cancers. Proteomic technologies provide the tools needed to discover and identify disease-associated biomarkers.

The aim of the present study is to identify salivary bio-markers in patients suffering from colorectal cancers.


Eligibility criteria: Inclusion Criteria:

* Has not yet started treatment for the identified cancer

Exclusion Criteria:

* medically compromised patients
* congenital syndromes
* being treated with radiotherapy or chemotherapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Moti Moskovitz, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Eyal Shtayer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Avi Levin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang L, Farrell JJ, Zhou H, Elashoff D, Akin D, Park NH, Chia D, Wong DT. Salivary transcriptomic biomarkers for detection of resectable pancreatic cancer. Gastroenterology. 2010 Mar;138(3):949-57.e1-7. doi: 10.1053/j.gastro.2009.11.010. Epub 2009 Nov 18.
Clinical trial NCT06057558: Airway Microbiome of Cystic Fibrosis Patients
Official title: Studying the Airway Microbiome of Cystic Fibrosis Patients and the Potential of Probiotics for the Airways
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Keywords: microbiome
lactobacilli
probiotics
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: With this study, the investigators first want to investigate the respiratory tract microbiome of cystic fibrosis patients. To achieve this, the investigators will collect longitudinal samples of saliva, throat and sputum and process these to determine the microbial composition and compare them over a timecourse of a year. Secondly, the investigators aim to study the influence of a topical microbiome therapy (throat spray) on the microbiome of the upper and lower respiratory tract in cystic fibrosis patients after administration for 6 weeks. Bacterial and cytokine profiles of salivary, throat and sputum samples will be monitored before, during and after intervention.


Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis patients
* \>6 years for intervention part of the study

Exclusion Criteria:

-

Primary outcomes:
measure: Microbial composition of saliva, throat and sputum samples using 16S rRNA sequencing
timeFrame: Change of microbial composition over one year (observational)
measure: Transfer of L. casei AMBR2 to the oropharyngeal cavity and lungs after administration of the throat spray
timeFrame: Transfer of probiotic over 6 weeks
Secondary outcomes:
measure: Changes in microbiome of the oropharyngeal region and lungs after administration of the throat spray
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks
measure: Influence on general health
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks
measure: Changes in cytokine levels (e.g. IL-10, IL-4, IL-5, IL-13) in saliva, oropharynx and sputum samples, and cytokine and antibody levels in blood samples
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
Study officials:
affiliation: University Hospital, Antwerp
name: Kim Van Hoorenbeeck
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiteit Antwerpen
name: Sarah Lebeer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02769858: The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression
Official title: The Effects of Light Therapy on Circadian Rhythms, Sleep, and Mood in Postpartum Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Postpartum
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study aims to establish the feasibility of light therapy for postpartum depression delivered via Re-Timer, demonstrate its preliminary efficacy, and illuminate relationships between circadian shifts and mood changes using a novel, home-based circadian biomarker assessment paradigm (salivary dim light melatonin onset; DLMO).


Eligibility criteria: Inclusion Criteria:

* Within 6 months postpartum
* Meet DSM-V diagnostic criteria for MDD
* Score ≥ 20 on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder version (SIGH-SAD).

Exclusion Criteria:

* current diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V
* past history of mania/hypomania,
* chronic medical conditions associated with depression (e.g., thyroid conditions)
* ocular or retinal pathology
* history of seizures or epilepsy
* color blindness
* Lupus
* currently taking an antibiotic, medication that contains hydrochlorothiazide, or isotretinoin (Accutane).

Primary outcomes:
measure: Change From Baseline Score of the Hamilton Depression Rating Scale-Seasonal Affective Version (SIGH-SAD) at 5 Weeks
timeFrame: After five weeks of light therapy
measure: Change From Baseline Score of the Edinburgh Postnatal Depression Scale (EPDS) at 5 Weeks
timeFrame: After five weeks of light therapy
measure: Change From Baseline Time of Dim Light Melatonin Onset (DLMO) at 5 Weeks
timeFrame: After five weeks of light therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Leslie Swanson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swanson LM, Burgess HJ, Zollars J, Todd Arnedt J. An open-label pilot study of a home wearable light therapy device for postpartum depression. Arch Womens Ment Health. 2018 Oct;21(5):583-586. doi: 10.1007/s00737-018-0836-z. Epub 2018 Mar 30.
Clinical trial NCT05268458: Myocarditis After SARS-CoV2-Vaccination
Official title: Myocarditis After SARS-CoV2-Vaccination: An International Patient Registry on Clinical Manifestations and Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocarditis and Cardiomyopathy
Keywords: SARS CoV-19
Vaccination
Lead sponsor: Theresien Hospital Mannheim
Sponsor class: OTHER
Collaborators: name: University Hospital Heidelberg, GER
name: GRN Hospital Weinheim, GER
name: McGill University Health Care Montreal, CA
name: Foothills Medical Centre Calgary, CA
name: Sunnybrooks Research Institute Toronto, CA
name: Unity Health St. Michael's Hospital Toronto, CA
First posted: 2022-03-07
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with SARS-CoV-2 Vaccine-associated Myocarditis.

Brief summary: Background The novel coronavirus disease 2019 (COVID-19) caused by an infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly become a global pandemic with more than 190.000.000 infections and 4.250.000 reported deaths worldwide.

SARS-CoV-2 vaccination plays an important role in containing the pandemic and the possible adverse complications of COVID-19. Large clinical trials have proven the safety and efficacy of the vaccines currently in use. Systemic reactions usually were mild, self-limiting and could be observed more often in younger vaccine recipients. Cases of myocarditis after vaccination have been reported for various vaccines. The new vaccines for SARS-CoV-2 also seem to be affected by this adverse reactions. The pathophysiology is uncertain so far.

Aim Aim of this study is a systematic registration of myocarditis cases associated with SARS-CoV-2 vaccination which were diagnosed and/or treated in participating centers. The main goal of this study is the characterization of clinical manifestations and prognosis of the disease.

Study Design Patient history, laboratory tests and cardiovascular imaging data of patients with suspected SARS-CoV-2 - vaccine associated myocarditis are documented. Patients with clinical suspicion of troponin-positive myocarditis within 30 days after receiving SARS-CoV-2 vaccine without evidence for apparent other causes e.g. infectious or autoimmune etiology were included. Clinical follow-up data is acquired.


Eligibility criteria: Inclusion Criteria:

* SARS-CoV-2 Vaccine-associated Myocarditis (\< 30 days after vaccination) confirmed by cardiac MRI without evidence of alternative etiology (infectious, auto-immune myocarditis).

Exclusion Criteria:

* missing individual consent

Primary outcomes:
measure: Combined Primary Endpoint
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Theresienkrankenhaus
state: Baden Württemberg
Study officials:
affiliation: Theresien Hospital Mannheim
name: Marco Ochs, MD
role: PRINCIPAL_INVESTIGATOR
References: