louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04664296: COVID-19 - SARS-CoV-2 Community Contamination in Children and Adults (Dyn3CEA_Nosocor)
Official title: Epidemiology of CoV-2 SARS Infections: Dynamics of Community Contamination in Children and Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection Viral
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 72
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospital-based population of children and adults:

* Hospitalized children, 0 to 17 years of age, 25 subjects, consecutive sample survey
* Hospitalized adults, 18 years and above, 50 matched subjects

Brief summary: Unlike other respiratory viruses such as influenza and Respiratory Syncytial Virus (RSV) where the child is the essential reservoir and central vector of intrafamilial contamination, the child is likely to be a small player in the transmission of Severe Acute Respiratory Syndrome CoronaVirus 2 (SRAS-CoV2) infection. This study aims to describe the age category of the first contact, within 14 days before the appearance of the first symptoms of the index case in order to describe the age categories of this first contaminant, globally, in the group of children and finally in the group of adults. This work is intended to provide food for discussion and to justify the distancing and containment measures imposed on children when their isolation has a deleterious impact that has now been established for some children.


Eligibility criteria: Inclusion Criteria:

1. Children after hospitalized in Hospices Civils de Lyon with Polymerase Chain Reaction (PCR) positive SARS-CoV2,
2. Adults hospitalized in Hospices Civils de Lyon and included in the NOSO-COR study with matching criteria described below.

   * Matching will be performed on family age characteristics and on the period of contamination included in the containment period to minimize bias, and if possible frequency matching according to admission in Intensive Care Unit ICU/Pediatric Intensive Care Unit (PICU), and to family structure (n of children / n of adults in the family).

Exclusion Criteria:

1. Any patient suspected of nosocomial infection.
2. Any patient death during the Covid-19 infection.
3. Any adult patient without children living home.
4. Opposition to participate.

Primary outcomes:
measure: Percentage of possible contaminants, adults, adolescents and children with Covid-19
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Reanimation Pediatrique
state: Rhone
Study officials:
References:
Clinical trial NCT03109496: The URT and Middle Ear Microbiota in Health and During Chronic OME
Official title: Study of the Upper Respiratory Tract Microbiota and the Potential of Probiotics for the Treatment of Chronic Otitis Media With Effusion.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Media With Effusion
Healthy
Keywords: OME
Otitis Media with Effusion
Microbiota
Microbiome
URT
Upper Respiratory Tract
Healthy URT microbiota
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2017-04-12
Enrollment: 82
Sex: ALL
Minimum age (years): 1
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 healthy participants vs 100 OME patients.

Brief summary: This study analyses which bacteria are present in the middle ear space and adjacent upper respiratory tract niches in healthy people and in patients suffering from chronic otitis media with effusion (OME; glue ear). The aim is to identify and isolate bacteria that are more common and more abundant in healthy people and to evaluate their potential to protect against bacteria commonly involved in OME and other upper respiratory tract infections.

To this end, samples will be collected from both groups (healthy vs OME) and analysed through sequencing of the bacterial 16S gene. In addition, samples obtained from healthy participants will be cultivated to isolate bacteria of interest.


Eligibility criteria: Inclusion Criteria:

* Controls: undergo a surgery that gives access to the middle ear space (at least 30 participants; e.g. cochlear implant recipients) or the adenoids.
* OME patients: have fluid accumulation in the middle ear space for 3+ months and receive ventilation tubes. May also undergo adenoidectomy.

Exclusion Criteria:

* Acute upper respiratory tract infections (including acute otitis media)
* Chronic upper respiratory tract infections (except OME in patient group)
* URT malformations (e.g. as seen in people with Down Syndrome or cleft palate)
* Cystic fibrosis
* Autoimmune diseases or immunodeficiency
* Pregnancy
* Use of antibiotics or steroids 1 week before surgery

Primary outcomes:
measure: Microbiota differences between the healthy and diseased URT and middle ear space
timeFrame: Appr. 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
citation: Jorissen J, van den Broek MFL, De Boeck I, Van Beeck W, Wittouck S, Boudewyns A, Van de Heyning P, Topsakal V, Van Rompaey V, Wouters I, Van Heirstraeten L, Van Damme P, Malhotra-Kumar S, Theeten H, Vanderveken OM, Lebeer S. Case-Control Microbiome Study of Chronic Otitis Media with Effusion in Children Points at Streptococcus salivarius as a Pathobiont-Inhibiting Species. mSystems. 2021 Apr 20;6(2):e00056-21. doi: 10.1128/mSystems.00056-21.
Clinical trial NCT06217796: Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation
Official title: A Single-Center, Open Label, Phase 4 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution (Mydcombi®) Administered With the Mydcombi Dispenser for Pupil Dilation (THE MIST-2.1 STUDY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mydriasis
Keywords: Mydriasis
Lead sponsor: Eyenovia Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects receive the same intervention
Primary purpose: DIAGNOSTIC

Brief summary: Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.

Detailed description: MydCombi is approved for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. The approved dose is 1 metered spray to the cornea of each eye to be dilated to be repeated after 5 minutes. This study will define the dilation of the pupil with ½ of the approved dose - a single metered spray to the cornea of each eye.

Eligibility criteria: Inclusion Criteria:

* Ability to provide signed written consent prior to participation in any study-related procedures.
* Ability to return for the study treatment visit.
* Photopic screening pupil diameter ≤ 3.5 mm in each eye.
* Females not of childbearing potential or negative pregnancy test

Exclusion Criteria:

* Pregnant or Lactating
* Clinically significant abnormalities of the eye
* Active eye disease
* Using medication that can effect pupil dilation

Primary outcomes:
measure: Mean Change in Pupil Diameter
timeFrame: 30 minutes
Secondary outcomes:
measure: 6.0 mm or Greater at 30 Minutes
timeFrame: 30 minutes
measure: 7.0 mm or Greater at 30 Minutes
timeFrame: 30 minutes
measure: Distribution of Pupil Diameters
timeFrame: 360 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: SUNY
state: New York
Study officials:
affiliation: Eyenovia Inc.
name: Greg Bennett, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT05335096: An AI-based mHealth Intervention to Improve HIV Testing
Official title: Developing an Artificial Intelligence (AI)-Based mHealth Intervention to Improve HIV Testing in Malaysia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Malaya
name: Fogarty International Center of the National Institute of Health
First posted: 2022-04-19
Enrollment: 296
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to develop an artificial intelligence (AI)-chatbot-based mobile health (mHealth) intervention to promote HIV testing in Malaysia.

Detailed description: A randomized controlled trial (RCT) will be conducted in Malaysia to assess the efficacy of an AI-chatbot-based mHealth intervention versus treatment as usual (TAU) with HIV testing as the primary outcome. The primary outcome will be the proportion of participants who get tested within 180 days.

Participants will be randomized to the chatbot group and TAU group. Participants in the intervention group will get access to an AI-chatbot and can interact with the AI-chatbot at any time. In each round of the interactive communication, the chatbot will provide automated personalized messages containing pre-exposure prophylaxis (PrEP), mental health, or HIV testing-related information, motivation and skills based on the participants' answers and will continuously update over time. The participants assigned to the TAU group will get access to an attention-chatbot and can interact with the attention-chatbot at any time. In each round of the interaction, the chatbot will provide pre-scripted time-attention health education messages to the participants.

In addition to the above interventions, the research assistant will manually sent to the participants' phone a piece of educational material and an online survey link every 30 days (at days 30, 60, 90, 120, 150 and 180). The primary outcome of HIV testing will be collected through the survey.

Eligibility criteria: Inclusion Criteria:

* Cis-gender male
* condomless sex with men in the past 6 months
* HIV status unknown or previously tested negative
* speaks Bahasa Malaysia or English.

Exclusion Criteria:

* Does not have a smartphone
* HIV status previously tested positive
* cannot speak Bahasa Malaysia or English

Primary outcomes:
measure: Number of participants that get tested for HIV within 180 days
timeFrame: up to 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaysia
Study officials:
affiliation: Yale University
name: Zhao Ni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02584296: Physical Activity as Self-Management Approach to Improve Health Outcomes in AML
Official title: Physical Activity as a Self-Management Approach to Improve Health Outcomes in Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Myeloid
Monocytic
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Massey Cancer Center
First posted: 2015-10-22
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Physical Activity as a Self-Management Approach to Improve Health Outcomes in Acute Myeloid Leukemia

Detailed description: Guided by the information-motivation-behavioral skills model and using a quasi-experimental cohort control research design, the primary aim of this study is to: Determine the feasibility of the biobehavioral self management approach (BSMA) program involving physical activity (PA) in patients receiving consolidation treatment for AML. The primary feasibility outcomes for this aim will be rates of recruitment, refusal, retention and attrition; in addition investigators will test methods and procedures of the prescribed BSMA PA program, including assessing adherence, participant acceptance and perceived benefit.

Eligibility criteria: Inclusion criteria:

* ≥18 years
* diagnosis of AML
* hospitalized for consolidation chemotherapy within 1 day (+/- 2 days)
* read and write in English
* able to stand independently
* not experiencing psychiatric neurological disorders (assessed through clinical team members) that would prevent obtaining consent.

Exclusion criteria:

* currently experiencing psychiatric or neurologic disorders that would prevent their ability to provide consent.

Primary outcomes:
measure: Rates of recruitment, refusal, retention, and attrition will be aggregated to determine the feasibility of the BSMA program for patients receiving consolidation treatment for AML.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Tara Albrecht, PhD, ACNP-BC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04275596: Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery
Official title: Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery: A Randomized Double-blinded Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anal Wound
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 2QR-complex is a patented molecule extracted from Aloe vera barbadensis leaves that blocks the adhesion of pathogenic microbes to human epithelial cells and tissues \[9\]. Anti-adhesion therapy such as 2QR-complex has been suggested as an alternative to antibiotics in the treatment of bacterial infections. 2QR-complex based products have already shown comparable efficacy to antibiotics in treating mucosal infections such as bacterial vaginosis.

In the present study we aim to assess the efficacy of 2QR-complex in pain relief and promotion of anal wound healing after anal surgery. We presumed that anal discomfort and prolonged healing after surgery for anal fissure, fistula, and hemorrhoids may in part be due to contamination of the wound with fecal bacteria that colonize at the surgical site. Therefore, we assumed that the use of topical anti-adhesive 2QR-complex-based product may serve to minimize this negative impact on wound healing.


Eligibility criteria: Inclusion Criteria:

* Adult patients of either sex with simple anal fistula, chronic anal fissure, or grade III/IV hemorrhoids will be included.

Exclusion Criteria:

* Patients with other anal conditions, diabetic patients, patients under steroid or immunosuppressive therapy will be excluded.

Primary outcomes:
measure: Time to complete anal Wound healing
timeFrame: Six weeks after surgery
Secondary outcomes:
measure: Anal pain
timeFrame: one week, one month, two months after surgery
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00757796: Obstructive Sleep Apnea Syndrome and Attention Executive Function Disturbances
Official title: Obstructive Sleep Apnea Syndrome and Attention Executive Function Disturbances
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-09-23
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 20 - 70 years with obstructive sleep apnea.

Brief summary: Studies demonstrate that sleep disturbances are associated with cognitive dysfunction and attention deficit. However the correlation between the severity of obstructive sleep apnea and the degree of cognitive dysfunction was not demonstrated. Our hypothesis is that patients suffering from a more severe sleep apnea will demonstrate a greater degree of cognitive dysfunction.

Detailed description: Studies demonstrate that sleep disturbances are associated with cognitive dysfunction and attention deficit. However the correlation between the severity of sleep disturbances and the degree of cognitive dysfunction was not demonstrated.We intend to study 80 patients with various degrees of obstructive sleep apnea. All patients will undergo executive cognitive tests as well as tests to assess for levels of depression, anxiety and attention.

Eligibility criteria: Inclusion Criteria:

1. Apnea hypopnea index\>5
2. Age 20 - 70 years

Exclusion Criteria:

1. Pregnant women
2. Known chronic cardiovascular or pulmonary disease
3. Patients s/p CVA or brain damage
4. Known depression or other psychiatric disorder
5. Patients with severe cognitive dysfunction (MMSE\<25)
6. Patients receiving stimulants, antipsychotic or anti-depression medications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02794896: Anesthetic Depth Effects Upon Immune Competent Cells
Official title: Hypnotic Depth Reduces Lymphocyte Proliferation to Natural Killer Cells, B-cells, Memory T-cells, Depresses Intracellular Oxidative Burst and Changes Protein Expression Pattern of Monocytes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunotoxicity
Anesthesia
Inert Gas Narcosis
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anesthesia depth affects the proliferation of lymphocytes to NK-cells and memory T-cells effect and the phagocytosis activity of macrophages in healthy patients. ASA 1-3 subjects undergoing extended shoulder surgery under continuous regional anesthesia randomly were assigned to a deep or a shallow anesthesia level (BIS \<35 or \>55) for more than an hour. Immune response is measured by lymphocyte proliferation as well as neutrophil and monocyte phagocytosis activity.

Detailed description: Blood samples were taken under minimal stress prior to anesthesia induction (T0), recovery (T1) and 12 weeks following hospital discharge (T2) from the respective anesthesia depth level. Bispectral index monitoring (BIS) was performed from the awake state to complete recovery in all subjects.

Hemoglobin concentration, leukocyte and lymphocyte counts were determined by routine automated laboratory techniques. Lymphocyte proliferation was analyzed by SASPA flow cytometry analysis. In brief, 100 µl EDTA blood were stirred with 10 µl FITC and PE marked antibody mixture containing CD3, CD4, CD8, CD 16, CD45, CD28, CD27, CD 56.

Monocyte and neutrophil phagocytosis activity was measured separately in macrophages of fresh heparinized whole blood using flow cytometric test kits.

Proteomics of monocytes was done synchronously.

Eligibility criteria: Inclusion Criteria:

* enrolment for longer shoulder surgery
* consent for the standard anesthesia form in combination with the interscalene plexus block
* ASA Status 1-3

Exclusion Criteria:

* sedative premedication
* severe immune deficiency (diabetes, steroid or antihistamine medication, cancer, chemotherapy,
* status post transplantation, drug and alcohol abuse),
* recent surgery (1 month) or blood transfusion

Primary outcomes:
measure: Depression of lymphocyte proliferation by CD expression pattern in SASPA-Test as given in a percentage from before anesthesia
timeFrame: 70-90 min
Secondary outcomes:
measure: Reduction of phagocytosis activity as a percentage of base line (prior to anesthesia)
timeFrame: 70-90 min
measure: Protein expression pattern of monocytes by proteomics analysis and mass spectrometry
timeFrame: 70-90 min
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medicine of Mannheim, Dept. Anesthesiology and Critical Care Medicine
Study officials:
affiliation: University of Mannheim
name: Thomas Frietsch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01221896: Input of C11-Choline PET/CT in Localization of Parathyroid Adenoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperparathyroidism
Keywords: Localization of a parathyroid adenoma in patients with primary hyperparathyroidism.
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with elevated PTH in search of a PTA

Brief summary: The purpose of the study is to determine a possible input of C11-Choline PET/CT in identification and localization of a parathyroid adenoma (PTA).

Preoperative localization of a PTA has been previously documented in multiple series, and is usually based on scintigraphy and on US.

Currently, the conventional technique for localization of a PTA is a dual-isotope scan with Tc99m-MIBI and Tc99m pertechnetate. This study is acquired over at least 3 hours, includes two i.v. injections and the patient has to stay 15-30 min per acquisition under the camera.

In addition, there is no anatomical imaging and further correlation with US is usually recommended.

In contrast, PET/CT study with C11-Choline takes as long as 10 min., includes one injection, and provides data of higher resolution of functional (PET) and anatomical imaging (CT).

Furthermore, dosimetric data shows that the total effective dose from Tc99mMIBI and Tc99m pertechnetate injection is (without CT): 0.5957 rem; and from C11-Choline injection and CT of a chest is: 0.3128 - 0.8628rem.


Eligibility criteria: Inclusion Criteria:

* Elevation of a calcium and parathyroid hormone in the serum

Primary outcomes:
measure: Improved localization of a parathyroid adenoma
Secondary outcomes:
measure: Facilitation of detection of the parathyroid adenoma at surgery
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
Study officials:
References: