louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04832893: Use of Masks on Metabolic Parameters and Inspiratory Muscle Strength During Aerobic Exercise
Official title: Effects of Different Masks on Metabolic Parameters, Inspiratory Muscle Strength and Perceived Effort During Low Intensity Aerobic Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Masks
Lead sponsor: Universidad Francisco de Vitoria
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study will be to assess the effects of the use of masks on inspiratory muscle strength, metabolic parameters, heart rate, subjective perception of effort and the sensation of dyspnea before, during and after an aerobic test of 30 minutes long and a fixed load at lactate threshold. A randomized study of repeated measures will be carried out. A total sample of 35 active participants will be recruited. All participants will carried out a lactate threshold test and then 3 visits to the laboratory (separated at least 48 hours from each other) in order to perform 3 test of 30 minutes long without mask, with a surgical mask or with a FFP2 respirator (in a randomized order) at an intensity around lactate threshold intensity. Maximal inspiratory pressure, oxygen saturation, heart rate, blood lactate concentration, subjective perception of effort and dyspnea will be assessed before, during and after the 3 fixed intensity tests.


Eligibility criteria: Inclusion Criteria:

* carrying out at least 2 days of physical activity per week

Exclusion Criteria:

* cardiac disease
* pulmonary disease
* chronic inflammatory disease
* sedentary behaviour

Primary outcomes:
measure: Inspiratory muscle strength
timeFrame: change from baseline inspiratory muscle strength after the 30 minutes test
Secondary outcomes:
measure: lactate concentrations
timeFrame: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
measure: oxygen saturation
timeFrame: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
measure: heart rate
timeFrame: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
measure: rate of perceived effort
timeFrame: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
measure: sensation of dyspnea
timeFrame: change from baseline after 10 minutes, 20 minutes and 30 minutes during the test
Other outcomes:
Locations:
city: Pozuelo de Alarcón
country: Spain
facility: Universidad Francisco de Vitoria
state: Madrid
Study officials:
affiliation: Universidad Francisco de Vitoria
name: Davinia Vicente Campos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07027293: The Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
Official title: Evaluation of the Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Airway Management Assessment
Supraglottic Airways
Supraglottic Airways for General Anesthesia
Laryngeal Mask Airways
Keywords: Supraglottic airway device
i-gel
Classic laryngeal mask airway
Elderly patients
Airway management
Head position
General anesthesia
Insertion success
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 70
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This prospective, randomized, double-blind clinical study aims to evaluate the insertion success of two supraglottic airway devices, the classic Laryngeal Mask Airway (LMA) and the I-gel, in different head and neck positions in elderly patients undergoing elective urological surgery under general anesthesia. A total of 120 patients aged over 70 years with ASA physical status I-III will be randomly assigned to one of four groups: standard position with I-gel, right lateral rotation with I-gel, standard position with classic LMA, and right lateral rotation with classic LMA. The study will compare insertion time, ease and success of placement, number of attempts, hemodynamic responses, oropharyngeal leak pressures, fiberoptic scores, and airway-related complications. The findings aim to provide clinical guidance on the optimal use of supraglottic airway devices in geriatric patients in various head positions.


Eligibility criteria: Inclusion Criteria:

* ASA classification I-III
* Age over 70 years

Exclusion Criteria:

* Known or anticipated difficult airway
* Contraindications for the use of a supraglottic airway device
* Patients scheduled for endotracheal intubation

Primary outcomes:
measure: Insertion Time of Supraglottic Airway Device
timeFrame: 1-10 minutes
measure: Number of attempts for LMA replacement
timeFrame: 15-200 seconds
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03186911: The Impact of E-liquid Nicotine Content on Reinforcement in Current Smokers
Official title: The Impact of E-liquid Nicotine Content on Reinforcement in Current Smokers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tobacco Use
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-06-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Participants will complete a phone screen and then one laboratory session. After completing in-person screening assessments, eligible participants will complete additional questionnaires. Participants will then choose an e-liquid flavor to use for the rest of the session. Participants will then sample two e-liquids that vary in nicotine content from little or no nicotine to a moderate level of nicotine, and questionnaires evaluating the subjective effects of each one. Participants will then complete a preference assessment where they choose between the two e-liquids. Participants will be blind to the nicotine contents.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Daily cigarette smoking
* Have tried vaping devices on a minimum of one lifetime occasion

Exclusion Criteria:

* Unwilling to use a vaping device during the session
* Break alcohol level \> 0.01 (g/dL)
* Pregnant, trying to become pregnant, or breastfeeding
* Systolic BP greater than or equal to 160 mm/Hg or below 90 mm/Hg
* Diastolic BP greater than or equal to 100 mm/Hg or below 50 mm/Hg
* Heart rate greater than or equal to 105 bpm or lower than 45 bpm
* A current upper respiratory infection, recent cardiac event (in the last year), Buerger disease, irregular heartbeat or arrhythmia within the last year, previous allergic or adverse reaction to nicotine

Primary outcomes:
measure: Product Evaluation Questionnaire
timeFrame: One Day
Secondary outcomes:
measure: Preference Assessment
timeFrame: One Day
measure: Perceived Health Risk Questionnaire
timeFrame: One Day
measure: Vaping Purchase Task
timeFrame: One Day
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Eric C Donny, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06449911: The Efficacy of Microfocused Ultrasound Technique in the Treatment of Facial Skin Laxity
Official title: Efficacy and Safety of High Intense Focused Ultrasound for Treating Middle and Lower Face and Submental Region Laxity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Middle and Lower Face and Submental Region Skin Laxity
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective study of 20 Chinese patients with lower facial laxity treated by High Intense focused ultrasound (HIFU). Response will be assessed via paired comparison of pretreatment and posttreatment photographs by two independent dermatologists, grading on a 5-point Subject Global Aesthetic Improvement Scale (SGAIS) for skin laxity. Quantitative analysis of submental lifting will also be performed. Patient's level of "sagging" and "volume loss", satisfaction and tolerance will be documented.


Eligibility criteria: Inclusion Criteria: healthy male or female, aged 30-60 years, seeking improved jawline definition, and/or reduction of submental skin laxity and were willing and able to provide informed consent.

Exclusion Criteria: Pregnancy or lactation, severe sun damage, excessive skin laxity on the lower face and neck, keloid scarring or open wounds in the treatment areas, severe or cystic facial acne, history of cosmetic treatments in the area to be treated (skin tightening procedure within the past year; injectable filler or botox within the past 6 months; ablative or nonablative resurfacing/rejuvenating laser treatment or light treatment within the past 6 months; dermabrasion or deep facial peels within the past 6 months), isotretinoin treatment within the past 6 months, and inability to understand the treatment protocol or to give informed consent.

Primary outcomes:
measure: 5-point Subject Global Aesthetic Improvement Scale (SGAIS) for skin laxity
timeFrame: 6 months after HIFU treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT05347511: Study of the Pronostic Impact of Immunohistochemical, Histological and Radiological Factors in Patients With Primary Central Nervous System Lymphoma.
Official title: Study of the Pronostic Impact of Immunohistochemical, Histological, Radiological and Molecular Factors in Patients With Primary Central Nervous System Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rare Disease With Poor Outcome
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 94
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults' immunocompetent patients treated at the University Hospital of Nancy are included if they had a DLBCL's PCNSL diagnosed between January 2011 and December 2019, without regard to the clinical outcome.. All the patients are included in the LOC network database (Lymphomes oculo-cerebraux) and had given their written consent for the use of their samples for studies. Biological and clinical data will be collected for each patient from original medical charts.

Brief summary: Primary Central Nervous System Lymphoma (PCNSL) have a specific mutational profile in comparison to systemic diffuse large cells lymphoma (DLBCLs) that can be related to the expression of immunohistochemical markers as cyclon, NPM1, CD30, and P53 which could be predictive factor for prognosis and/or chemotherapy response. The main objective of this study is to identify new prognostic factors and new potential therapeutic targets.

The secondary objectives are to correlate the histological, the radiological and the clinical's informations of these patients.


Eligibility criteria: Inclusion Criteria:

* PCNSL diagnosed between January 2011 and December 2019, without regard to the clinical outcome.
* Age \> 18

Exclusion Criteria:

* Systemic DLBCL

Primary outcomes:
measure: correlation between the survival and the expression of Cyclon, NPM1 and CD30.
timeFrame: 17/10/2022
Secondary outcomes:
measure: the correlation between the molecular abnormalities and the expression of Cyclon, NPM1 and CD30
timeFrame: 17/10/2022
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03409211: Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis
Official title: Patterns After Administration of MCFAs in Psoriasis and Psoriatic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Psoriatic Arthritis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a proof-of-principle, placebo-controlled, open label study to assess the improvement in the Treg counts and PASI Scores with PEVCO given at 1000 mg four times daily in patients with PsO (subjects may or may not have PsA) , who have active disease and are not currently receiving other therapy (as defined by the inclusion/exclusion criteria) compared to healthy subjects.

The patients and healthy controls will receive placebo or PEVCO for a total of 9 weeks (3 weeks for placebo, followed by 6 weeks for PEVCO). No topical or systemic medications will be used during this period.


Eligibility criteria: Inclusion Criteria:

* Have an active \[psoriatric plaque \>2cm

Exclusion Criteria:

* History of sensitivity to study compound or any of their excipients
* Previous intolerance to PEVCO or related compounds
* Current (within 3 months of screening) treatment with DMARDs
* Current (within 3 months of screening) treatment with biologic therapies (including but limited to anti-TNF,anti-IL-17, anti-IL-12/23)
* Current antibiotic treatment (within 3 months of screening)
* current consumption of probiotics (within 3 months of screening)
* Severe hepatic impairment (eg, ac-sites and/or clinical signs of coagulopathy)
* Renal failure (eGFR ,30 or require dialysis) by history
* History of other autoimmune or inflammatory skin disease
* Current immunodeficiency state (cancer, HIV, others)
* Current immunodeficiency state (cancer, HIV, Other)
* Concern for inability of the patient to comply with study procedure, and or follow up (alcohol or drug abuse)

Primary outcomes:
measure: Change in % of Treg Cells in Blood
timeFrame: 6 Weeks
Secondary outcomes:
measure: Increase in Medium Chain Fatty Acids (MCFA) content in the stool
timeFrame: 12 Weeks
measure: Improvement in skin disease severity PASI scores 50
timeFrame: 12 Weeks
measure: Improvement in skin disease severity PASI scores 75
timeFrame: 12 Weeks
measure: Improvement in skin disease severity PASI scores 90
timeFrame: 12 Weeks
measure: Improvement in the tender joint/swollen joint (TJ/SJ) counts at 6 weeks.
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jose Scher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03493711: Differences Between Breastfed and Formula Fed Infants
Official title: Microbiota Differences Between Breastfed and Formula Fed Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 158
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants

Brief summary: This study will help us learn how a child's diet affects growth and development.

Detailed description: This study will see how infants diet affects their growth and development. Up to 170 infants will be enrolled for one visit.

Eligibility criteria: Inclusion Criteria:

* Exclusive breast feeding or cow milk formula feeding during the first 3 months of life.
* For formula feeders, exclusively on Similac Advance Formula for at least 1 month prior to visit
* Age 2.5-3.5 months

Exclusion Criteria:

* Infants born to mother with preexisting medical conditions.
* Infants born to mother with medications during pregnancy known to influence fetal growth.
* Infants born to smoking, alcohol drinking or drug use mothers during pregnancy.
* Preterm

Primary outcomes:
measure: The role of microbiota in gut
timeFrame: 2.5-3 months
measure: The role of microbiota in immune system development
timeFrame: 2.5-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
affiliation: Arkansas Children's Nutrition Center
name: Aline Andres, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00646711: Pediatric Switch Study for Children and Adolescent Patients With Epilepsy
Official title: A 14 Day Randomized, Open-Label, Cross-Over, Single Center, Outpatient Study of Depakote Delayed-Release or Depakote Sprinkle vs. Divalproex Sodium Extended-Release in Child and Adolescent Patients With Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pediatric Epilepsy
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-28
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.


Eligibility criteria: Inclusion Criteria:

* Male or female patient with a clinical diagnosis of epilepsy considered stable by the investigator.
* Must be in good physical health, on the same dose of all medications, including Depakote and other AEDs, for 2 week period prior to randomization.
* Minimum body weight of 37 lbs.

Exclusion Criteria:

* Six-month history of drug or alcohol abuse.
* Status epilepticus within 6 months prior to screening.
* Abnormal platelet or ALT/AST levels.

Primary outcomes:
measure: Number of seizures
timeFrame: 2 weeks
measure: Number of Adverse Events
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT01912911: Evaluating the Efficacy and Feasibility of a Novel Wireless ECG Recording System in Monitoring Patients After Atrial Fibrillation Ablation Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Persistent Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing A-fib ablations.

Brief summary: The investigators goal in this study is to examine the feasibility and efficacy of AliveCor iphone case monitoring device in monitoring patients after AF ablation by comparing transmissions using Alive Cor with transmissions from a traditional transtelephonic monitor (TTM).

A secondary goal is to assess the ease of use of AliveCor device compared to traditional TTM system from the patient's perspective


Eligibility criteria: Inclusion Criteria:

1. Male or female between \> 18 and \< 75 years of age
2. Paroxysmal or persistent atrial fibrillation
3. Scheduled to undergo an AF ablation procedure
4. Already has iPhone 4 or iPhone 4S with data plan
5. Willing to use the iPhone Alive Cor case
6. Written informed consent

Exclusion Criteria:

1. Unable or unwilling to use the Alive Cor case for their iPhone or iPhone 4S
2. Residing outside the United States

Primary outcomes:
measure: The proportion of AF/flutter events detected by the AliveCor device will be compared to events detected by the TTM for each episode.
timeFrame: 3 months
Secondary outcomes:
measure: Amount of transmissions from smartphone in comparison with traditional TTM method
timeFrame: 3 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic HVI
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Khaldoun Tarajki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04328311: The Impact of Watermelon Juice on Blood Pressure
Official title: The Impact of Watermelon Juice on Blood Pressure in Young Healthy Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Aging
Keywords: Watermelon
L-citrulline
Blood pressure
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: L-citrulline is found naturally in watermelon. Recently interest has increased for this amino acid due to potential health benefits. Notably, L-citrulline has the potential to lead to dilation of blood vessels due to its involvement in the production of nitric oxide.

The study will be an acute single blind, randomised controlled, crossover intervention study in healthy, young volunteers. Participants receive either the test watermelon drink or control drink (water). Blood samples and vascular measures (by a single-cuff based method) will be measured at baseline. Vascular measures will be repeated at 15-minute intervals between 0-2 hours and a second blood sample will be drawn at 1.5 hours to coincide with the estimated peak plasma L-citrulline. Citrulline, arginine and nitric oxide metabolites will be measured in the blood samples.


Eligibility criteria: Inclusion Criteria:

* Males and females
* 18-30 years
* Healthy (as per exclusion criteria)
* Able to understand information sheet
* Willing to comply with the study protocol
* Able to give informed consent.

Exclusion Criteria:

* Medical history of myocardial infarction
* Medical history of angina
* Medical history of thrombosis
* Medical history of stroke
* Medical history of cancer
* Medical history of high cholesterol
* Medical history of liver diseases
* Medical history of renal diseases
* Medical history of respiratory diseases
* Medical history of bowel diseases
* Medical history of diabetes
* Medical history of other endocrine disorders
* BMI \<18.5 kg/m2 or \>25 kg/m2
* Blood pressure \<90/60 or \> 140/90 mmHg
* Current use of antihypertensive medication
* Pregnant or lactating
* Alcohol intake \> 14 units/week
* Cigarette smoker (or quit within the last 6 months)
* Vigorous exercise \> 3 times/ week

Primary outcomes:
measure: Change in blood pressure
timeFrame: At baseline (t= 0 hours) and 15 minute intervals until t= 2 hours.
Secondary outcomes:
measure: Change in NOx (nitric oxide metabolites)
timeFrame: At baseline (t= 0 hours) and t=1.5 hours.
measure: Change in l-arginine
timeFrame: At baseline (t= 0 hours) and t=1.5 hours.
measure: Change in l-citrulline
timeFrame: At baseline (t= 0 hours) and t=1.5 hours.
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: UK
Study officials:
References: