louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02706522: Effect of Oral Carbohydrate on Serum S-100β Protein and Development of Postoperative Delirium in Elderly Patients
Official title: Effect of Oral Carbohydrate on Serum S-100β Protein and Development of Postoperative Delirium in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Inflammation
Delirium
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 3
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to evaluate the effects of preoperative carbohydrate intake on perioperative neuroinflammation and development of delirium.

Detailed description: Perioperative insulin resistance may primarily contribute to development of postoperative delirium in high risk patients. Preoperative administration of oral carbohydrate reduces insulin resistance. The investigators aimed to investigate the influence of carbohydrate loading on the serum level of S-100β, a surrogate marker of delirium, and the incidence of postoperative delirium in elderly patients.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing total hip replacement or total knee replacement surgery

Exclusion Criteria:

* Diabetes
* Dementia
* Gastro-esophageal reflux
* Upper gastrointestinal motility disorder
* Inflammatory bowel disease
* Intraperitoneal malignancy history
* Inability to perform cognitive function test

Primary outcomes:
measure: serum S-100β level
timeFrame: Postoperative 1 hr
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02481622: First Event of Infection by HIV-1 of Uterine Vaginal Tissue
Official title: Inhibition by the Antibody, First Event of Infection by HIV-1 of Uterine Vaginal Tissue
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infection of the Uterine Vaginal Tissues
Keywords: HIV infection
vaginal tissues
uterine tissues
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women whose age ≤50 years and ≥18 years, for which surgery type laparoscopy or hysterectomy is necessary as part of a benign pathology.

Brief summary: This non-interventional study aims to characterize the cells infected with HIV over time in different types of vagino-uterine tissue.


Eligibility criteria: Inclusion Criteria:

* Patients whose age ≤50 years and ≥18 years
* Patients for which surgery like laparoscopy or hysterectomy is necessary as part of a benign pathology.

Exclusion Criteria:

* Patients under 18 years

Primary outcomes:
measure: identification of the first HIV-infected cells by a histological analysis
timeFrame: after surgery, up to 3 weks
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: INSERM U1109 - Institut de Virologie 3, rue Koeberlé - 67000 Strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Jeanine OHL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNISTRA
name: Christiane OHL, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05765422: The Influence of Endurance Sports Activity on the Oral Microbiota of Young Adults.
Official title: Sport and Health a Pilot Study: Impact of Endurance Physical Activity on the Microbiological Homeostasis of the Oral Cavity of Young Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Microbial Colonization
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The oral cavity is an easily accessible anatomical site that accurately reflects the health of the individual. The mouth is considered an early indicator of biological aging, leading to the identification of oral biomarkers predictive of future alterations. Current data show that the oral health of high level athletes is globally altered with an increase in cariogenic indexes, an increased incidence of periodontitis, dental trauma and dry mouth syndromes. Few studies have focused on the oral microbiota compared to mouthguards used in rugby or boxing which seem to induce dysbiosis, a recent study shows an effect of ketogenic diet on bacterial changes in the mouth of endurance athletes. This project focuses on the impact of intensive sport practice on oral health and the identification of oral biomarkers associated with physical activity. The objective of this study is to investigate the impact of the amount of endurance sport practice on oral microbiota and oral health in young adults. the hypothesis is that a sedentary lifestyle and high-level sport induce depletion and/or changes in the oral microbiota compared to regular physical activity.


Eligibility criteria: Inclusion Criteria:

* Be between 18 and 30 years old
* If practicing sports, it must be an endurance sport as main activity (cycling or running)

Exclusion Criteria:

* Practice more than 3 hours of swimming per week
* Have taken anti-inflammatory drugs, less than 48 hours before the study
* Have taken antibiotics and/or probiotics, less than 3 weeks before the study

Primary outcomes:
measure: Analysis of the oral microbiota in healthy individuals engaged in endurance physical activity at different levels.
timeFrame: 3 years
Secondary outcomes:
measure: Quantification of salivary inflammatory markers in healthy individuals who perform endurance physical activity at different levels.
timeFrame: 3 years
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
Clinical trial NCT03203122: Intense Pulsed Light Therapy for Hidrosadenitis Suppurativa
Official title: The Effect of Intense Pulsed Light Assisted Hair Removal Therapy on Mild and Moderate Cases of Hidrosadenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hidradenitis Suppurativa
Acne Inversa
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized to treatment in either left or right side, using the other side as control.
Primary purpose: TREATMENT

Brief summary: 6 monthly treatments with IPL laser in patients with Hidradenitis Suppurativa. The effect in measured on several severity scores.

Detailed description: Patient suffering from bilateral HS in the axilla or groin area are threated with IPL laser monthly for 6 months.

Patients are randomized to treatment in either left or right side, the other side works as control.

No sham treatment, but observers are blinded.

Eligibility criteria: Inclusion Criteria:

* Bilateral HS in the axilla or groin area
* Fitzpatrick skin type I-II

Exclusion Criteria:

* Pregnant
* Unable to understand or communicate with study personnel

Primary outcomes:
measure: HiScore
timeFrame: After 6 treatments i.e. 6 months
Secondary outcomes:
measure: Sartorius score
timeFrame: after 6 treatments i.e. 6 months
measure: Physician global assesment
timeFrame: after 6 treatments i.e. 6 months
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: University hospital Zealland
Study officials:
References:
Clinical trial NCT06048822: Enhancing Cancer Survivorship With Pickleball
Official title: Project Rally: Enhancing Cancer Survivorship With Pickleball
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate the feasibility and acceptability of a pickleball program for cancer survivors and their family members or friends. The program is designed to increase physical activity, improve wellness, and allow individuals to work together to learn and practice the sport.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* History of a cancer diagnosis excluding squamous and basal cell skin cancers
* Able to speak and read English
* Able to provide informed consent
* Able to pass a 2023 Physical Activity Readiness Questionnaire+ (PAR-Q+) (with appropriate physician clearance(s), as necessary)
* History of cancer diagnosis will be required for cancer survivor group; friend or family partners can be (but do not need to be) cancer survivors.

Exclusion Criteria:

* Screen failure for exercise safety based on 2023 PAR-Q+
* For cancer survivor group, history of squamous and basal cell skin cancers

Primary outcomes:
measure: Number of Participants Recruited - Feasibility
timeFrame: 12 months
measure: Number of Participants who Complete Baseline Data Collection and Follow up Data Collection - Feasibility
timeFrame: 6 months
measure: Average Pickleball Session Attendance - Feasibility
timeFrame: 6 months
measure: Participant Evaluation of Feasibility and Acceptability - Acceptability
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Nathan Parker, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04887922: Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery
Official title: The Effect of Preoperative and Postoperative Incentive Spirometry in Patients Undergoing Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abdominal Surgery
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: * Prior to surgery, participants will be randomized into three groups: (1) control group with no IS, (2) standard IS, and (3) digital IS + text message.
* Following surgery, patients will be re-randomized into two groups: (1) standard IS, and (2) digital IS + text message.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to determine the efficacy of incentive spirometry (IS) to improve pulmonary function in the preoperative and postoperative surgical setting. The investigators hypothesize that IS will improve pulmonary function for patients undergoing major abdominal surgery when controlling for protocol compliance. Additionally, the investigators hypothesize that a digital IS device enabled with a text message-based mobile health intervention will improve pulmonary pre-habilitation and rehabilitation, as well as postoperative compliance with the IS device.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo major abdominal surgery with expected postoperative length of stay of 48 hours or more.
* Access to a smartphone.
* At least 18 years of age.
* Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Younger than 18 years of age
* No access to a smartphone

Primary outcomes:
measure: Change in Forced Expiratory Volume in One Second Parameter (FEV1)
timeFrame: From baseline to day-of-surgery preoperative
Secondary outcomes:
measure: Change in Forced Vital Capacity (FVC)
timeFrame: From baseline to day-of-surgery preoperative
measure: Change in Pulse Oximetry
timeFrame: From baseline to day-of-surgery preoperative
measure: Change in Forced Expiratory Volume in One Second Parameter (FEV1)
timeFrame: From day 1 to postoperative day 3
measure: Change in Forced Vital Capacity (FVC)
timeFrame: From day 1 to postoperative day 3
measure: Change in Pulse Oximetry
timeFrame: From day 1 to postoperative day 3
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Chet Hammill, M.D., MCR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03058822: Relative Bioavailability of BMS-931699 From Prefilled Syringe Compared to Drug in Vial
Official title: A Randomized, Open-label, Parallel-group, Single Subcutaneous Dose, Relative Bioavailability Study of the Pharmacokinetics of Lulizumab (BMS-931699) From Prefilled Syringe (Process A) Compared to Drug in Vial (Process A) in Healthy Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A Phase 1, relative bioavailability study of BMS-931699 from prefilled syringe compared to drug in vial


Eligibility criteria: Inclusion Criteria:

* Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
* All participants must have hemoglobin, hematocrit, and platelets within normal limits at screening
* All participants must have activated partial thromboplastin time, prothrombin time, and international normalized ratio within normal limits at screening

Exclusion Criteria:

* Any current or past history or risk for tuberculosis:
* Active tuberculosis requiring treatment within the previous 3 years. All participants will be required to have a QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test performed at screening. Also excluded are participants with evidence of a past tuberculosis infection without documented adequate therapy. Participants with a positive QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test at screening will not be eligible for the study. A QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test performed within 4 weeks of dosing on Day 1 is acceptable as long as there is documentation of a negative result.
* Current clinical, radiographic, or laboratory evidence of active tuberculosis
* A history of herpes zoster

Primary outcomes:
measure: Relative bioavailability of BMS-931699 following a single subcutaneous dose from prefilled syringe relative to drug in vial in healthy participants
timeFrame: 43 days
Secondary outcomes:
measure: Safety and tolerability of BMS-931699 following a single prefilled syringe or drug in vial subcutaneous dose in healthy participants by assessing adverse events and other physical assessments throughout study conduct
timeFrame: 43 days
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01653522: The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine
Official title: The Impact of Triptan and Doxycycline on Neuroinflammatory Biomarkers in Acute Migraine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Migraine Disorders
Headache, Migraine
Migraine
Migraine Headache
Migraine With Aura
Migraine Without Aura
Headache Disorders, Primary
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of triptans and doxycycline on neuroinflammatory markers in acute migraine.

Detailed description: Increased inflammatory cytokines and matrix metalloproteinases (MMPs) have been recently implicated in migraine. Inflammation may be a key player in the pathophysiology of migraine by altering blood-brain barrier (BBB) function. As an inflammation induced MMP, MMP-9 is involved in both BBB disruption and neuropathic pain, and is largely derived by neutrophil degranulation during neutrophil-BBB interaction. The tetracycline group of antibiotics may suppress MMP production and neutrophil degranulation. This study aims to investigate known neuroinflammatory biomarkers with a focus on BBB breakdown during acute migraine attacks and assess marker responses to conventional treatment (triptans) and novel MMP targeted therapy (doxycycline). This pilot project data will supplement future projects investigating novel therapeutic strategies such as MMP inhibitors in both migraine acute treatment and prevention.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of migraine with or without aura that fulfill the 2nd Edition of The International Headache Classification (ICHD-II) criteria
* Active prescription for an oral triptan medication to abort acute migraines

Exclusion Criteria:

* Tetracycline group or other anti-inflammatory medication use in the preceding three months
* Pregnant

Primary outcomes:
measure: Serum neuroinflammatory marker concentrations
Secondary outcomes:
measure: Headache intensity (four-point scale)
measure: Number of participants with adverse events as a measure of safety and tolerability
measure: Time to headache relief
measure: Time to headache recurrence
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Shaheen E Lakhan, MD, PhD, MEd, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05946122: Effect of Atorvastatin as a Renal Protection in Patients With Systemic Inflammatory Response Syndrome Using Renal Arterial Resistive Index
Official title: Effect of Atorvastatin as a Renal Protection in Patients With Systemic Inflammatory Response Syndrome Using Renal Arterial Resistive Index
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Renal Protection
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 106
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Offering renal protection in systemic inflammatory response syndrome by atorvastatin


Eligibility criteria: Inclusion Criteria:

* Patients ( male and female) with systemic inflammatory response ( total leucocytic count \>12,000 mm3'. temperature \>38 C, Heart rate \>90 b/min and respiratory rate\>20 cycle).

Exclusion Criteria:

* Hemodynamic instability
* Pre-admission chronic kidney disease.
* Intra-vascular coagulopathy
* Patients with myopathy.

Primary outcomes:
measure: Acute kidney injury
timeFrame: one week
Secondary outcomes:
measure: renal resistive vascular index
timeFrame: one week
measure: APACHE score ( acute physiology and chronic health evaluation)
timeFrame: one week
measure: length of ICU stay
timeFrame: two weeks
Other outcomes:
Locations:
city: Minia
country: Egypt
facility: Mina Maher Raouf
state: Minia University
Study officials:
References:
Clinical trial NCT03437122: Project A3sc - An Atlas of Airways at a Single Cell Level
Official title: Project A3sc - An Atlas of Airways at a Single Cell Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory System
Keywords: lung, nasal mucosa, respiratory mucosa
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The increasing incidence of chronic respiratory diseases is a public health problem affecting hundreds of thousands of people around the world, including children. Directly exposed to atmospheric aerocontaminants (pollution, allergens), the respiratory tracts represent a complex ecosystem that involves different cells that develop complex interactions with the surrounding connective tissue but also with their rich immune environment and with the microbiota. Although a pathophysiological continuum is postulated between the nasal and bronchial airways in certain diseases, such as allergic diseases, we have identified broad gradients in gene expression between nasal and bronchial samples. This is why cellular variability throughout the respiratory tree needs to be studied in detail.

The sequencing of RNAs specifically present in a particular cell, and its comparison with neighboring cells, allows us to document precise cellular contributions and intercellular relationships. Our project will establish protocols to stabilize airway swabs by brushing and/or biopsy, under conditions that will then allow the analysis of gene expression profiles at the single cell level (single cell RNA sequencing).

The development of the "single cell" stabilisation and analysis protocol will first be carried out on primary respiratory epithelium cultures and then extended to respiratory specimens taken from healthy volunteers. Through sampling at several levels of the respiratory tree, variations in expression along the tracheobronchial axis will be fully documented. Finally, the interaction between the epithelial compartment and the immunological compartment will be studied by analyzing gene expression on a single cell in different physiopathological contexts.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years and \<40 years
* non-smoker
* absence of known acute or chronic disease
* absence of symptoms suggestive of progressive disease
* normal clinical examination

Exclusion Criteria:

* recent rhino-bronchial infection (\<6 weeks)
* mental disability
* pregnant women (a urine test will be performed for all women of childbearing age)

Primary outcomes:
measure: Number of samples usable
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Sylvie LEROY, Dr
role: PRINCIPAL_INVESTIGATOR
References: