louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05181345: Effect of Sleep Debt on Neurophysiological Responses to Heat Exposure
Official title: Effect of Sleep Debt on Neurophysiological Responses to Heat Exposure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heat; Excess
Sleep Disorder
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed of healthy young male and female.

Brief summary: Many people are required to work in stressful situations combining sleep debt and hot environmental conditions. If the effect of sleep debt on cognitive performance is proven, this effect could be increased, during heat exposure, through the deleterious effects of sleep debt on thermoregulatory abilities. These alterations may favour the occurrence of accidents.

The changes in cognitive performance induced by hyperthermia are also poorly characterised and often not dissociated from the effects of dehydration. Little is known about the effects of the combination of sleep debt and heat exposure on mental performance. Describing and understanding the alterations induced by this combined situation could provide a better understanding of the mechanisms explaining the deterioration of performance in hot conditions and promote the development of appropriate countermeasures.


Eligibility criteria: Inclusion Criteria:

* 18 to 35 years old
* Body Mass Index between 18 and 27 kg/m2
* Body weight ≥ 54 kg

Exclusion Criteria:

* Presence or history of medical pathology (cardiological, renal, hepatic, cutaneous, intestinal, neurological...)
* Presence of a significant deviation from the normal values observed on the electrocardiogram
* History of heat stroke
* Known intolerance to heat (e.g. migraine sufferers)
* Presence of a contraindication to blood sampling, notably low venous capital, belonephobia
* Inability to ingest a capsule or refusal of the rectal probe
* Habitual consumption of caffeine \> 500 mg per day
* Alcohol consumption greater than the equivalent of 3 glasses of wine per week
* Consumption of narcotics
* Smoking \> 0.5 packet of cigarettes per day
* Undergoing habitual medication
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Number of errors at the Stroop test
timeFrame: Through study completion (25 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
Study officials:
References:
Clinical trial NCT05805345: Clinical Comparison of Toric Contact Lenses Fit Characteristics
Official title: Clinical Comparison of Toric Contact Lenses Fit Characteristics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Astigmatism
Refractive Errors
Keywords: Contact Lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the fit characteristics between four Alcon commercially available toric contact lenses.

Detailed description: Subjects will be expected to attend 3 visits including the screening visit. The total duration of a subject's participation in the study will be approximately 19 days.

Eligibility criteria: Key Inclusion Criteria:

* Successful wear of toric soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Able to be fit with contact lenses within the available range of sphere, cylinder power, and axes (based on lens availability).
* Best Corrected Visual Acuity (BCVA) better than or equal to 0.10 (logMAR) in each eye.
* Willing to stop wearing habitual contact lenses during in-office visits.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Current spherical, monovision or multifocal lens wearer.
* Protocol-specified biomicroscopy findings at screening.
* Current or history of herpetic keratitis in either eye.
* Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Distance VA with study lenses
timeFrame: 30 mins (± 15 mins), each product
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kurata Eyecare Center
state: California
city: Longwood
country: United States
facility: Omega Vision Center P.A.
state: Florida
city: Maitland
country: United States
facility: Kindred Optics at Maitland Vision
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care LLC
state: Kansas
city: Granville
country: United States
facility: ProCare Vision Centers, Inc.
state: Ohio
city: Memphis
country: United States
facility: Optometry Group, PLLC
state: Tennessee
city: Wichita Falls
country: United States
facility: Clarke EyeCare Center
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_CHAIR
References:
Clinical trial NCT04437745: To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
Official title: A Multicenter, Randomized, Rater-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Volume Defects in the Mid-face
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face


Eligibility criteria: Inclusion Criteria:

* Male or female adults 18 to 65 years of age (inclusive)
* 3 (moderate) or 4 (severe) on MFVDA-SRS
* sign the written informed consent form

Exclusion Criteria:

* have streptococcal disease or bleeding disorder
* have an active or infective skin disease, scars, or tumor on mid-face
* have congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases
* have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent procedures/treatment
* have undergone temporary facial dermal filler within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months
* have a medical history of hypertrophic cicatrix or keloid
* have radiation therapy experience on mid-face
* have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine, hyaluronic acid products, or Streptococcal protein

Primary outcomes:
measure: Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate
timeFrame: 26 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Xiaojun Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01743547: The Effects Of Yoga On Quality Of Life Among A Population Of Ovarian/ Fallopian Tube/ Primary Peritoneal Cancer Patients Receiving Chemotherapy: A Feasibility Study
Official title: THE EFFECTS OF YOGA ON QUALITY OF LIFE AMONG A POPULATION OF OVARIAN/ FALLOPIAN TUBE/ PRIMARY PERITONEAL CANCER PATIENTS RECEIVING CHEMOTHERAPY: A FEASIBILITY STUDY
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ovarian Cancer
Keywords: Women
Yoga
Ovarian Cancer
Lifestyle
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study to establish the feasibility of an eight-week yoga intervention and to estimate the effect size on QoL in female patients with ovarian, fallopian tube and primary peritoneal malignancies receiving chemotherapy for the treatment of primary or recurrent cancer.

Detailed description: The primary objective of this study was to determine the feasibility of implementing a yoga program among gynecologic cancer patients receiving chemotherapy. The investigators concluded that it is not feasible due to the lack of participation and difficulty in recruiting patients. Of 25 consented patients, 16 agreed to participate in the control arm, 9 agreed to participate in the Yoga classes. Three (3) of those 9 changed their minds and withdrew consent. Of the 6 remaining patients, only 3 attended at least 1 of the 8 classes.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of epithelial ovarian/fallopian tube/primary peritoneal cancer
* Participant must be age 18 or older
* Participants must be 6 weeks post-surgery
* Participant must be currently receiving chemotherapy or beginning a regimen within the next four weeks
* Participant must be willing to attend the intervention sessions
* All subjects must have given signed, informed consent prior to registration in the study.

Exclusion Criteria:

* Participant has practiced yoga more than 4 times in the last year
* Participant has a surgical procedure scheduled during the 8 weeks that they would be part of the intervention
* Participant has an ECOG performance status less than or equal to two

Primary outcomes:
measure: All patients included in the study will be assessed for response to treatment; the primary outcome is change in QoL domains after yoga class intervention. Planned subgroup analysis: stratification by participation category
timeFrame: Total study duration is anticipated to require approximately 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT03921047: Characterization of T-cell Repertoire in Patients With Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant
Official title: Characterization of T-cell Repertoire in Patients With AML Undergoing HSCT Through Next-Generation Sequencing of T Cell Receptor Alpha (TCRA) and T Cell Receptor Beta (TCRB) Genes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-04-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AML scheduled to undergo HSCT

Brief summary: This research trial studies characterization of T-cell repertoire through next-generation sequencing in patients with acute myeloid leukemia undergoing stem cell transplant. Characterizing T-cell repertoire may help to understand if immune system plays a significant role in high risk patients with acute myeloid leukemia.

Detailed description: PRIMARY OBJECTIVES:

I. Characterize the T cell receptor (TCR) repertoire in acute myeloid leukemia (AML) patients before and after receiving hematologic stem cell transplantation (HSCT).

II. Identify molecular changes (germline variants and somatic mutations) that contribute to shaping the TCR repertoire.

OUTLINE:

Patents undergo collection of blood samples before, on day 100, and 1 year after HSCT. Donors undergo collection of blood at the time of HSCT for ribonucleic acid (RNA)-based next generation sequencing of TCRA and TCRB genes.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of AML scheduled to undergo HSCT at University of Southern California (USC)

Exclusion Criteria:

* Inability to provide consent because of severe mental disorders
* Donor unwilling to provide consent

Primary outcomes:
measure: Time to diagnosis of acute graft versus (vs.) host disease (aGVHD)
timeFrame: Up to 4 years
measure: Time to diagnosis of relapse
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Houda Alachkar, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00502398: Is There Intravascular Hemolysis in Patients With Pulmonary Hypertension?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Artery Hypertension
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2007-07-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Patients with hemolytic disorders (e.g. sickle cell anemia or thalassemia) are known to develop pulmonary hypertension. Hemolysis is where red blood cells are destroyed and their contents released into the circulation. It is thought that these red-cell contents cause constriction and thrombosis of the blood vessels in the lungs. Conversely, it is possible that patients with pulmonary hypertension have hemolysis.

In this study we will be drawing blood from a range of patients and normal controls for a panel of blood tests related to hemolysis.


Eligibility criteria: Inclusion Criteria:

One of the following four conditions :

* Pulmonary artery hypertension
* Obstructive sleep apnea with pulmonary hypertension
* Lung transplant candidates without pulmonary hypertension
* Normal Controls

Exclusion Criteria:

* Known hemolytic disorder
* Recent blood loss (\<3 months)
* Recent blood transfusion (\<3 months)
* Liver disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Pulmonary Institute, Rabin Medical Center (Beilinson campus)
Study officials:
affiliation: Rabin Medical Center
name: Mordechai Kramer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01739998: Health Benefits of Functional Oil (Mega 3 Fatty Acids From Fish Oil) on Obese People
Official title: Randomized, Double-blind, Controlled Study to Evaluate the Efficacy of Omega 3 Fatty Acids on Different Inflammatory Markers in Obese Subjects With Dietary Intervention for Weight Lost
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Examine the effects and safety of functional oil (olive oil with omega 3 fatty acids from fish oil) on different inflammatory markers in obese subjects with dietary intervention for weight lost.


Eligibility criteria: Inclusion Criteria:

* Men and women from 30 to 75 years old.
* Body mass index (BMI) ≥ 30 kg/m2
* Signed informed consent.

Exclusion Criteria:

* Individuals with special diet due to disease as celiac disease, chronic renal failure, etc.
* Individuals with Diabetes Mellitus insulin dependent.
* Individuals with disorders associated with eating behaviour.
* Individuals with mental disease or low cognitive function.
* Individuals with consumption of drugs to weight lost.
* Individuals treated with drugs whose direct effect is on lipid profile (statins, fibrates, diuretics, corticosteroids or oral anti-inflammatory).
* Individuals with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.)
* Pregnant women or lactating.
* Individuals with recurrent infections.
* Individuals with regular consumption of anti-inflammatory or glucocorticoids.
* Individuals with consumption of oil fish supplements (except if they gave up its consumption 1 month before).
* Individuals with fish allergy.
* Individuals with consumption of more than two fatty fish servers twice a week.
* Individuals with physical problems complying with the recommendations of physical activity and diet indicated.

Primary outcomes:
measure: Inflammatory markers
timeFrame: 2 months
Secondary outcomes:
measure: Anthropometric parameters
timeFrame: 0.1 and 2 months
measure: Lipid profile
timeFrame: 0.1 and 2 months
measure: Hormonal Parameters
timeFrame: 0.2 months
measure: Oxidative Stress Parameters
timeFrame: 0 and 2 months
measure: Glucosa Metabolism
timeFrame: 0, 1 and 2 months
measure: Depression Test
timeFrame: 0 and 2 months
measure: Motivation and Satiety Parameters
timeFrame: 0 and 2 month
measure: Adeherence and Tolerance parameters
timeFrame: up to 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05671198: Sonographic Diaphragm Function in AECOPD
Official title: Ultrasound of the Diaphragm As Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Copd
Keywords: diaphragm
COPD
thoracic ultrasound
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our population consists of 18-years or older patients who are hospitalised primarily due to AECOPD without respiratory acidosis.

Brief summary: The study will be conducted as a single-center, prospective cohort study. The primary objective of this study is to investigate the responsiveness of sonographic parameters of diaphragm to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.

Detailed description: To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis, we propose a prospective cohort design.

After inclusion, participants will have assessment of diaphragm function (excursion, thickness, thickening fraction) using ultrasound within 48 hours of admission to the emergency ward, striving to assessment within 24 hours of admission. Additionally, dyspnea grade will be assessed using validated questionnaires.

Further diagnostic work-up and treatment for AECOPD is performed at the discretion of the treating physician.

Both ultrasound measurements and dyspnea grade questionnaires will be repeated when the participant is reported suitable for hospital discharge by the treating physician.

Eligibility criteria: Inclusion Criteria:

* Hospitalisation primarily because of severe acute exacerbation of COPD
* COPD, according to GOLD 2018 definition
* Post-bronchodilator FEV1/FVC \< 0,70 and FEV1% \< 80%pred. within last 5 years

Exclusion Criteria:

* Respiratory acidosis (pH \< 7.35 ánd PaCO2 \> 6 kPA)
* Need for (non-)invasive ventilation based on other criteria (e.g. severe hypoxia) upon presentation.
* Established diagnosis of diaphragm diaphragm paralysis.
* Inability for diaphragm imaging (e.g. mechanical ventilation, or unable to follow vocal instructions).
* Those not able or unwilling to give written informed consent.
* Pregnant women

Primary outcomes:
measure: - To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.
timeFrame: from admission till hospital discharge (expected median of 5 days based on experience)
Secondary outcomes:
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Klinieken
state: Overijssel
Study officials:
affiliation: UMCG
name: Marieke Duiverman, M.D. PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02738398: FDG PET/CT in Lung Cancer Staging
Official title: Optimizing Lung Cancer Nodal Staging With FDG PET/CT Through Improved Image Acquisition and Reconstruction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective study of the effects of image acquisition and reconstruction parameters on accuracy of FDG PET/CT mediastinal nodal staging in NSCLC


Eligibility criteria: Inclusion Criteria:

* Adult patients, at least 18 years of age
* Patients with NSCLC diagnosis who have been referred for a clinical FDG PET/CT staging scan as part of their standard of care
* Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

* Inability to tolerate additional imaging time in the opinion of the investigator or treating physician.
* Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation and there is no additional cost associated with the additional study imaging time. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care or their ability to undergo the standard clinical FDG PET/CT scan. This should negate any undue influence or coercion. Children, fetuses, neonates, or prisoners are not included in this research study

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Daniel Pryma, MD
role: PRINCIPAL_INVESTIGATOR
References: