louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01276860: The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
Official title: The Use of Psychomotor Vigilance Testing in the Assessment of Pediatric Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
OSA
PVT
Psychomotor Vigilance Testing
Psychomotor Vigilance Task
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Arkansas Children's Hospital Research Institute
First posted: 2011-01-13
Enrollment: 7
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Obstructive sleep apnea results in decreased attentiveness and response times in patients. The objective of this study is to quantify these consequences in pediatric OSA patients using an already established tool for examining the results of sleep deprivation and fragmentation: psychomotor vigilance testing. PVT has been used in children, but has not been studied in pediatric OSA patients. This study aims to employ PVT along the normal course of diagnosis and treatment of pediatric OSA patients in our clinical practice at Arkansas Children's Hospital. The investigators hypothesize that pediatric OSA patients will exhibit decreased PVT scoring when compared to children without OSA, and that PVT can be used to diagnose and monitor treatment outcomes in these patients.


Eligibility criteria: Inclusion Criteria:

* Healthy pediatric patients ages 6-18 years old
* with symptoms of OSA (snoring, pauses in sleep breathing, restless sleep, frequent arousals, excellive daytime sleepiness, morning headaches)
* with physical exam findings consistent with adenotonsillar hypertrophy
* those identified as good candidates for adenotonsillectomy
* who are to undergo a polysomnogram as part of their preoperative work-up

Exclusion Criteria:

* History of attention deficit disorder, developmental delay, or mental retardation
* Children taking any neurotropic medications (including antiepileptics, antidepressives, and stimulants)
* Children previously treated for OSA (surgically or medically)
* Children with significant comorbidities including other sleep-related disorders

Primary outcomes:
measure: Number of Participants Who Achieved Criteria of Obstructive Sleep Apnea in the PVT Assessment
timeFrame: 10-20 minutes each session, 3 sessions total
Secondary outcomes:
measure: Number of Participants Who Achieved Criteria of No Sleep Complaints in the PVT Assessment
timeFrame: 10-20 minute session, 1 session
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: UAMS, ACH
name: Gresham T Richter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05730660: Quercetin Phytosome® Chronic Fatigue Symptoms
Official title: Effectiveness of a 3-months Dietary Supplementation Based on Quercetin Phytosome®) for the Treatment of Chronic Fatigue Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Fatigue Symptoms
Sleep
Physical Performance
Body Composition
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether a 3-month period of quercetin supplementation (500 mg of Quercetin Phytosome®) is useful in the treatment of chronic fatigue, as assessed by the Fatigue Impact Scale (FIS-40). Secondary end points are sleep assessment through Pittsburgh Sleep Quality Index (PSQI) and muscle performance assessment through the Short Physical Performance Battery (SPPB) and body composition assessment using DXA.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years old
* Chronic fatigue symptoms recorded using a self-reported fatigue score assessed using the validated Fatigue Impact Scale (FIS- 40) that comprised chronic tiredness impacts related to physical, cognitive and psychosocial functions.

Exclusion Criteria:

* Patients with any active medical condition that explains chronic fatigue (untreated hypothyroidism, sleep apnea, narcolepsy, drug side effects, and iron deficiency anemia)
* Previous diagnosis not unequivocally resolved (chronic hepatitis, malignant tumors)
* Past neuropsychiatric disorders or current severe depressive disorder with psychotic or melancholy features, bipolar disorder, schizophrenia, delusional disorder, dementia, anorexia nervosa, bulimia nervosa
* Participation in another clinical trial of the same or different nature within 30 days prior to inclusion in the study
* Failure to provide signed informed consent
* Consumption of certain drugs/supplements that could affect outcome measures in the past 90 days or whose discontinuation could be a significant problem
* Anticoagulant treatment
* Pregnancy or breastfeeding
* Smoking, alcohol or substance abuse
* Obesity (BMI \> 30 kg/m²)

Primary outcomes:
measure: chronic fatigue symptoms
timeFrame: At baseline and after 3 months
Secondary outcomes:
measure: Sleep quality
timeFrame: At baseline and after 3 months
measure: Physical performance
timeFrame: At baseline and after 3 months
measure: Body composition
timeFrame: At baseline and after 3 months
measure: Life quality
timeFrame: At baseline and after 3 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).
Study officials:
References:
Clinical trial NCT05399160: Effect of Nurse-led Supportive Care on Quality of Life
Official title: Effect of Nurse-led Supportive Care on Quality of Life in Women With Breast Cancer: An Assessor-blinded, Parallel Group, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: Nurse-led care
Quality of life
Breast cancer
Lead sponsor: Izmir Bakircay University
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast cancer is the most common type of cancer in women with a high mortality rate in the world. The several methods are used in the treatment of breast cancer. One or more of these methods can be preferred according to the characteristics of women with breast cancer. Women may experience many different physiological and psychological symptoms during each treatment process.This situation negatively affects the quality of life of women with breast cancer. For this reason, there is a need for an intervention that could improve quality of life in women with breast cancer. In the literature, it is stated that nurse-led supportive care can be an effective nursing intervention to improve the quality of life in women with breast cancer.

Detailed description: This an assessor-blinded, parallel group randomized controlled trial aimed that investigating the effect of nurse-led supportive care on quality of life in women with breast cancer. This trial was conducted in the general surgery clinic of training and research hospital located in Turkey. All patients were women who had breast surgery.

Eligibility criteria: Inclusion Criteria:

* 18 years and older women,
* Stages II or III breast cancer
* Having breast cancer surgery
* Planned to receive chemotherapy
* Able to use a phone
* Who agreed to participate in the study

Exclusion Criteria:

* Having communication problems
* Having psychological diseases
* Receiving any supportive care

Primary outcomes:
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire-Core Questionnaire (QLQ-C30)
timeFrame: Change from Baseline Quality of Life score at 9th weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bakircay University Health Sciences Faculty
Study officials:
References:
Clinical trial NCT04350060: Improving the Quality of Dementia Care Through Innovative Redesign of the Memory Care Environment
Official title: Memory Care of the Future: Improving the Quality of Dementia Care Through Innovative Redesign of the Memory Care Environment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Research study is being done to demonstrate novel opportunities to transform the way the dementia community is cared for.


Eligibility criteria: Inclusion Criteria:

* Patients currently residing at Arbor Terrace memory care unit
* Patients diagnosed with dementia

Exclusion Criteria:

* Hospice patients with less than 30 days of life expectancy at the time of enrollment

Primary outcomes:
measure: Change in quality of life, as measured by the Quality of Life in Alzheimer's disease (QOL-AD)
timeFrame: every 2 weeks for up to one year
measure: Change in sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: every 2 weeks for up to one year
measure: Change in dementia related behaviors and delirium, as measured by the Neuropsychiatric Inventory-Questionnaire (NPI-Q)
timeFrame: every 2 weeks for up to one year
measure: Change in mood, as measured by the Patient Health Questionnaire 9 (PHQ-9)
timeFrame: every 2 weeks for up to one year
measure: Change in function and independence, as measured by the Katz Index of Independence in Activities of Daily living (KATZ)
timeFrame: every 2 weeks for up to one year
measure: Change in medication use
timeFrame: every 2 weeks for up to one year
measure: Change in falls
timeFrame: monthly for up to one year
Secondary outcomes:
measure: Change in caregiver burden, as measured by the Caregiver Strain Index (CSI)
timeFrame: 6 months
Other outcomes:
measure: Change in emergency room and hospitalizations
timeFrame: monthly for up to one year
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ying Ying Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00300560: Efficacy and Safety of Colistin for Therapy of Infections Caused by ESBL Producing K.Pneumoniae or E.Coli
Official title: Efficacy and Safety of Colistin for Therapy of Infections Caused by Extended Spectrum Beta-Lactamase(ESBL) Producing Klebsiella Pneumoniae or Escherichia Coli
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infections
Keywords: ESBL-producing E.coli Infections
ESBL-producing Klebsiella pneumoniae Infections
Colistin
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2006-03-09
Enrollment: 152
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: In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.

Detailed description: In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.The primary outcome is clinical response and secondary outcomes are microbiological response and adverse events.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 yr.
* Hospitalized to Siriraj Hospital
* Infections with ESBL-producing E.coli or K.pneumoniae
* Consent informed consent

Exclusion Criteria:

* Pregnancy or lactating mother
* Colistin allergy
* Neurologic diseases

Primary outcomes:
measure: Clinical response
Secondary outcomes:
measure: Microbiological response
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Visanu Thamlikitkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05912660: Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis
Official title: Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Disease
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Sicknessfund Burgenland
name: Landesklinikum Sankt Polten
First posted: 2023-06-22
Enrollment: 18882
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI) above 65 years of age with no other concomitant heart surgery and no coronary revascularization within 4 months before the index procedure were included.

Brief summary: The overall project aim is to study outcomes following aortic valve replacement with surgically implanted bioprostheses or TAVI by retrieving data from the main social security carriers in Austria for the years 2010-2020.


Eligibility criteria: Inclusion Criteria:

* isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI)

Exclusion Criteria:

* below 65 years of age
* coronary revascularization within 4 months before the index procedure
* concomitant heart surgery

Primary outcomes:
measure: all-cause mortality
timeFrame: 10 years
Secondary outcomes:
measure: reoperation
timeFrame: 10 years
measure: myocardial infaction
timeFrame: 10 years
measure: heart failure
timeFrame: 10 years
measure: stroke
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02886260: Establishing a Descriptive Cohort of Patients Cared for Operation on the Spine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Spinal Injuries
Spinal Diseases
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 250
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: patients with symptomatic spinal pathology requiring surgical or orthopedic treatment

Brief summary: This study aims to:

1. describe the monitoring of patients treated for spinal disorders.
2. create a comprehensive database of reliable and readily exploitable quickly to produce a library of cross publications between orthopedic surgery and neurosurgical services. This database will include clinical, functional , radiographic , educational, social and professional data.
3. obtain a cohort of patients in the comprehensive range of spinal pathologies.
4. standardize data collection in this cohort with similar national projects.


Eligibility criteria: Inclusion Criteria:

* The patient must be given free and informed consent and signed the consent
* The patient must be affiliated or beneficiary of a health insurance plan
* The patient is available for a 24-month follow-up
* The patient is at least 18 years old
* The patient has a symptomatic spinal pathology requiring surgical or orthopedic treatment

Exclusion Criteria:

* The patient is under judicial protection, guardianship or curatorship
* The patient refuses to sign the consent
* It is not possible to give informed information to the patient
* The patient does not fluently read French.
* the patient is not available for a 24-month follow-ip

Primary outcomes:
measure: Quality of life measured by the Oswestry Disability Index score
timeFrame: 24 months after surgical intervention
Secondary outcomes:
measure: Quality of life measured by the Oswestry Disability Index score
timeFrame: 6 weeks, 12 weeks, 6 months, 12 months, 36 months, 48 months after surgical intervention
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU Nimes
Study officials:
References:
Clinical trial NCT00041860: Modulation of Benzene Metabolism by Exposure to Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Cancer
Keywords: Benzene
Air pollution
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-07-22
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. To do so breath, urine, and blood samples prior to, during and after being exposed to benzene as well as benzene levels and benzene metabolites present are measured.

Detailed description: The research is to evaluate benzene metabolism after exposure at levels that can be found in the environment, such as the higher end concentrations in the air inside cars and buses while being driven in heavy traffic and inside private and public parking garages. To do so breath, urine, and blood samples prior to, during and after being exposed to benzene as well as benzene levels and benzene metabolites present are measured. The exposures take place in the Controlled Environmental Facility operated by the Environmental and Occupational Health Sciences Institute (EOHSI). This allows us to control the exact benzene air level and to use benzene containing 13C, a stable (non-radioactive) form of carbon, one of the atoms that make up benzene. Isotopes are different forms of the same atom. Using 13C will allow us to tell the difference between the benzene and the compounds it changes to in the body that come from our experiment compared to what is present in your body from other sources. In addition to just benzene exposure on some days the subject is also be exposed to methyl tertiary butyl ether (MTBE), another component of gasoline, to take an iron supplement pill and/or to take vitamins C and E pills. How benzene is metabolized or changed in the body will be compared for these differences to better understand how the body deals with benzene.


Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06531460: Nutritional Therapy Enriched With Omega-3 in Patients With Lung Resection
Official title: Effect of Perioperative Nutrition Enriched With Omega-3 on the Incidence of Infections in Oncologic Patients Following Lung Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Surgery
Keywords: lung cancer
omega-3
prehabilitation nutrition
perioperative nutrition
infections
inflammation response
Lead sponsor: National Institute of Respiratory Diseases, Mexico
Sponsor class: OTHER_GOV
First posted: 2024-08-01
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial
Primary purpose: PREVENTION

Brief summary: The aim of this study is to analyze the effect of enriched formula with omega-3 in the 30-day incidence infection and inflammatory response following lung resection surgery in lung cancer patients.


Eligibility criteria: Inclusion Criteria:

* Lung cancer diagnosis
* Elective surgery for lung resection schedule at least four days before surgery
* Signed informed consent.

Exclusion Criteria:

* Acute or chronic organ failure as hepatic or renal insufficiency
* Patients with fish-allergy
* History of any surgery within 3 months
* Immunocompromised patients

Primary outcomes:
measure: 30-day incidence infection
timeFrame: 30-day incidence infection following lung resection in lung cancer patients.
Secondary outcomes:
measure: Changes in prostaglandin E2
timeFrame: At the beginning of nutritional therapy and at day-4 following surgery
measure: Changes in Interleukin-6
timeFrame: At the beginning of nutritional therapy and at day-4 following surgery
measure: Changes in Tumor Necrosis Factor Alpha (TNF-α)
timeFrame: At the beginning of nutritional therapy and at day-4 following surgery
measure: Number of participants with therapeutic antibiotics prescription
timeFrame: During the hospital stay until 30-day
measure: Hospital lenght of stay
timeFrame: During the hospital stay until 90-day
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Respiratory Diseases
Study officials:
affiliation: National Institute of Respiratory Diseases
name: Ivan A Osuna-Padilla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05562960: Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP
Official title: Plasmapheresis in Amyotrophic Lateral Sclerosis With Autoantibody Against NRIP
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Plasmapheresis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patient with amyotrophic lateral sclerosis (ALS) having anti-NRIP autoantibody showed titer-dependent detrimental Effects. Plasmapheresis might benefit this subgroup of patients via removal of anti-NRIP autoantibody


Eligibility criteria: Inclusion Criteria:

1. Patients with amyotrophic lateral sclerosis (ALS) at the age more than 20 years and having plasma anti-NRIP autoantibody.
2. Agree to receive plasmapheresis intervention.
3. Agree to participate in the trial and receive serial examinations and follow up.

Exclusion Criteria:

1. Patients without plasma anti-NRIP autoantibody.
2. Patients requiring permanent ventilator support for ALS progression.
3. Not able to receive plasmapheresis or trial-related examinations.
4. Under pregnancy.
5. Blood fibrinogen level less than 50 mg/dl.
6. Specific ALS subtypes, including primary lateral sclerosis, progressive muscular atrophy, flail arm syndrome, or flail leg syndrome.

Primary outcomes:
measure: Change in ALSFRS-R decline
timeFrame: Before (3-month) and after (3-month) intervention
Secondary outcomes:
measure: Change in ALSFRS-R decline
timeFrame: Before (3-month) and after (6-month) intervention
measure: Changes in ALSFRS-R score
timeFrame: Day 0 to days 30, 90, and 180
measure: Change in force vital capacity
timeFrame: Before intervention and on day 90
measure: Change in compound motor action potentials
timeFrame: Before intervention and on day 90
measure: Changes in anti-NRIP titer
timeFrame: Day 0 to days 30, 90, and 180
measure: Any adverse effect under plasmapheresis
timeFrame: Within 6 months during and after plasmapheresis
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Li-Kai Tsai, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: