louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03725956: Polysomnographic Findings in Nasal Polyposis
Official title: Effects of Endoscopic Sinus Surgery on Sleep Disorder in Patients With Chronic Rhinosinusitis With Polyps
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Obstructive Sleep Apnea
Keywords: Nasal polyposis
sleep
sinus surgery
polysomnography
quality of life
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-10-31
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: DIAGNOSTIC

Brief summary: Nasal polyposis (NP) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edematous polyps in the nasal cavity. Prevalence of NP among the chronic rhinosinusitis patients is 25-30 %. NP leads to significant limitations in physical, emotional and social aspects of life of the affected patients. Sleep disorder is frequently reported by those patients with impaired nasal breathing. Till now few studies have objectively assessed the impact of NP on sleep quality. the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent endoscopic sinus surgery for recalcitrant nasal polyposis (failure of a 4-month corticosteroid medical treatment) Social insured patient
* Patient willing to comply with all procedures of the study and its duration
* Patient giving consent

Exclusion Criteria:

* Patients with previous nasal surgery for nasal polyposis
* Patients with previous continuous positive airway pressure therapy for obstructive sleep apnea
* Non-coverage by the social security scheme
* Patient unable to receive informed information
* Refusal to sign the consent
* Person deprived of the liberty
* Person benefiting from a system of legal protection (guardianship...)

Primary outcomes:
measure: Change in Slow-wave sleep duration
timeFrame: 1 month before surgery and 3 months postoperatively
Secondary outcomes:
measure: change in total sleep duration
timeFrame: At 1 month before surgery and at 3 months postoperatively
measure: Change in the number of brief wakefulness
timeFrame: At 1 month before surgery and at 3 months postoperatively
measure: change in Apnea-hypopnea index
timeFrame: At 1 month before surgery and at 3 months postoperatively
measure: Change in time with oxygen desaturation below 90%
timeFrame: At 1 month before surgery and at 3 months postoperatively
measure: change in Epworth sleepiness scale scores
timeFrame: At 1 month before surgery and at 3 months postoperatively
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Claude Huriez, CHU
Study officials:
affiliation: University Hospital, Lille
name: Geoffrey Mortuaire, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06740656: Neuromuscular Complications of MEK Inhibitors: a French Case Series and a Systematic Review of the Literature
Official title: Neuromuscular Complications of MEK Inhibitors: a French Case Series and a Systematic Review of the Literature
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myositis
Myasthaenia Gravis
Neuropathy
Guillain Barré Syndrome
Parsonage Turner Syndrome
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neuromuscular complications treated with MEK inhibitors at a Neuromuscular Reference Center in France

Brief summary: MEK inhibitors (trametinib, cobimetinib, selumetinib or binimetinib) have been used since 2016 to treat metastatic melanoma, by targeting the MAPK pathway Neuromuscular complications (neuropathy, myasthenia or myositis) have been reported in patients treated with MEK inhibitors.

With the growing use of these new oncology therapies, neurologists, oncologists and other clinicians are likely to be increasingly confronted with MEK inhibitor-induced neuropathy, myasthenia or myositis.

Yet, so far, these complications have only been documented in a few single case reports.

Our aim was to characterize the neuromuscular complications associated with MEK inhibitors used either alone or in combination.


Eligibility criteria: Inclusion Criteria:

* Patients with neuromuscular complications of MEK inhibitors used alone or in combination
* Age \> 18 years

Exclusion Criteria:

* Refusal of data collection

Primary outcomes:
measure: Type of neuromuscular complications
timeFrame: up to 8 years
Secondary outcomes:
measure: Time to onset after introduction of MEK inhibitors
timeFrame: up to 8 years
measure: Severity of neuromuscular complications
timeFrame: up to 8 years
measure: Progression with or without treatment
timeFrame: up to 8 years
measure: Reintroduction of MEK inhibitors
timeFrame: up to 8 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHRU Nancy
name: Pauline Ducatel, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04443556: Effect of Continue RISS Block in Thoracotomy
Official title: Effect of Continue Rhomboid Intercostal and Subserratus Plane Block in Thorocotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Thoracotomy
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Thoracotomy is one of the most painful surgery. Acute postoperative pain increases postoperative morbidity and prolongs hospital stay and also may lead to developing a chronic pain syndrome. This study aimed to assess the efficacy of continuous rhomboid intercostal and subserratus plane (RISS) block by inserting a catheter under direct vision for controlling acute thoracotomy pain.

Detailed description: Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue RISS block. First catheter tip will be place towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be place in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age undergoing elective thoracic surgery
* American Society of Anesthesiologists (ASA) physical status I-III grade

Exclusion Criteria:

* Patient refusal
* History of psychiatric and cognitive disorders.
* Patients allergic to the drugs used in the study
* Emergent surgery

Primary outcomes:
measure: postoperative pain
timeFrame: postoperative 48 hour
Secondary outcomes:
measure: Analgesic consumption
timeFrame: Postoperative 48 hour
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Education and Training Hospital
Study officials:
References:
citation: Kozanhan B, Semerkant T, Esme H, Canitez A, Iyisoy MS. Evaluation of rhomboid intercostal and subserratus plane block under direct vision for postoperative analgesia in thoracic surgeries: a prospective, randomized controlled trial. Eur J Cardiothorac Surg. 2022 Nov 3;62(6):ezac498. doi: 10.1093/ejcts/ezac498.
Clinical trial NCT03181256: Early Detection of Lung Cancer
Official title: Early Detection of Lung Cancer in the Medically Underserved Population
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-06-08
Enrollment: 45
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current or former smokers

Brief summary: This research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical records may help doctors detect lung cancer at an earlier stage.

Detailed description: PRIMARY OBJECTIVES:

I. To provide screening for lung cancer in an underserved and high risk population for lung cancer.

II. To collect clinical and demographic information and research bio specimens prospectively on high risk individuals.

III. To analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer.

IV. To identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions.

V. To assess the association between patient characteristics and test results to the genetic and histological characteristics of lung preinvasive lesions and cancers.

VI. To describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention).

OUTLINE:

Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records.

Eligibility criteria: Inclusion Criteria:

* Current smoker or former smoker, if former smoker participants must have quit smoking within the past 15 years
* \>= 30 pack year of smoking history
* Participant is uninsured

Exclusion Criteria:

* History of diagnosis/treatment of lung cancer in the past 2 years
* History of head/neck or esophageal cancer in the last 1 year
* Inability to provide informed consent

Primary outcomes:
measure: Candidate biomarkers of risk or of early diagnosis
timeFrame: Up to 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Eric Grogan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02199756: Nanovectors to Prevent Placental Passage of Tocolytic Agents
Official title: Development of Nanovectors to Prevent Placental Passage of a Tocolytic Agent
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Labor
Keywords: Uterine contractions
Indomethacin
Nanovectors
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who will undergo elective cesarean section at term

Brief summary: The purpose of the study is to find out whether indomethacin encapsulated within a nanovector can stop contractions in pregnant human uterine tissue. Preterm delivery is a major contributor to newborn deaths. The treatment of preterm labor includes medications that stop contractions within the uterus, or womb. Indomethacin is effective in stopping uterine contractions, but crosses the placenta to the unborn baby causing problems for the baby. Nanovectors are used to direct the delivery of medications. If indomethacin can be delivered directly to the uterus using a nanovector, it may be an ideal medication to treat preterm labor. We hypothesize that nanovectors loaded with indomethacin will reduce uterine contractions.

Detailed description: This is a prospective observational study.

Subjects will undergo a biopsy from the middle of the upper margin of the uterine incision measuring 4 x 2 x 2 cm. This will be performed by the managing doctor at the time of cesarean section after delivery of the baby. Once the tissue is obtained, the site will be closed using sutures similar to the usual closure of the uterus at cesarean section. This biopsy will be taken to the laboratory to test whether the nanovector will increase or decrease contractions in the uterus. Once this test is finished, the tissue will be frozen and test for the absence or presence of the nanovector within the tissue.

Eligibility criteria: Inclusion Criteria:

* Pregnant women undergoing elective cesarean section who are greater than 37 weeks

Exclusion Criteria:

* Known infection

Primary outcomes:
measure: Uterine contractions
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital Texas Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Jerrie S Refuerzo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02134756: Impact of Nutritional Supplementation on Aerobic Performance and Fatigue
Official title: Impact of Nutritional Supplementation on Aerobic Performance and Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Performance
Fatigue
Keywords: Supplement impact
Performance
Fatigue
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day intervention on aerobic exercise performance and fatigue.

The hypothesis is that supplementation with NutraStem Active® improve aerobic performance and reduce subjective measures of fatigue.

Detailed description: Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day intervention on aerobic exercise performance and fatigue.

The hypothesis is that supplementation with NutraStem Active® improve aerobic performance and reduce subjective measures of fatigue.

The basic protocol includes baseline assessment of fitness and participation in a vigorous session of exercise immediately before and 30 days after consumption of the experimental supplement or placebo.

The exercise task is intended to be fatiguing and demanding but is not expected to create failure.

The supplement makes claims related to boosting exercise performance and reducing fatigue.

The study design will determine if these outcomes are in fact present in a group of healthy, young, and active adults.

The primary dependent measures are perceived exertion during exercise and levels of fatigue measured on multiple non-exercise days.

Eligibility criteria: Inclusion Criteria:

* healthy
* physically active
* non-smoker

Exclusion Criteria:

* known cardiovascular, pulmonary, or metabolic disease
* body mass index greater than 35

Primary outcomes:
measure: Perceived Exertion
timeFrame: 28 days
Secondary outcomes:
measure: Perceived Fatigue
timeFrame: 28 days
measure: Perceived Energy
timeFrame: 28 days
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Health and Exercise Science Laboratory
state: Florida
Study officials:
affiliation: University of South Florida
name: Marcus W Kilpatrick, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Danielle Williams
role: STUDY_DIRECTOR
References:
Clinical trial NCT01170156: Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre
Official title: Fluid Leakage Past Tracheal Tube Cuff : Effect of Suctioning Manoeuvre
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Sedation
Respiration, Artificial
Keywords: deep sedation
respiratory resuscitation
Hi-Lo Evac tube
suctioning manoeuvre
Lead sponsor: Centre Hospitalier de Roanne
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The leakage of oropharyngeal secretions around high-volume low-pressure tracheal tube cuffs is usually considered as a major risk factor for bacterial tracheal colonization and subsequent development of ventilator-associated pneumonia. The rate of leakage around the cuff is related to the pressure differential across the cuff, namely the difference between the pressure of the subglottic fluid above the cuff and the tracheal pressure under the cuff. Consequently, positive end-expiratory pressure (PEEP) improves the sealing around the cuff towards fluid leakage. However, this preventive effect of PEEP is compromised during prolonged mechanical ventilation by tracheal suctioning manoeuvre, which may enhance fluid leakage, by decreasing tracheal pressure. Indeed, in a benchtop model, a suctioning manoeuvre, without disconnection of the ventilator, induced a constant fluid leakage past a high-volume low-pressure tracheal tube cuff when performed with a high level of suction pressure (- 400 mbar) and a large size of suction catheter size (16 French).

Detailed description: This clinical study aims to confirm these experimental data in patients under mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

* intubated with a Hi-Lo Evac tube since less than 48 hours
* under continuous sedation
* written consent signed

Exclusion Criteria:

* hemodynamic instability
* allergy of blue dye

Primary outcomes:
measure: Presence of blue dye in the trachea and/or the bronchi after the suctioning manoeuvre.
timeFrame: 48 hours after the beginning of the mechanical ventilation
Secondary outcomes:
Other outcomes:
Locations:
city: Roanne
country: France
facility: CH de Roanne
Study officials:
affiliation: CH de Roanne
name: Pascal BEURET, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beuret P, Philippon B, Fabre X, Kaaki M. Effect of tracheal suctioning on aspiration past the tracheal tube cuff in mechanically ventilated patients. Ann Intensive Care. 2012 Nov 7;2(1):45. doi: 10.1186/2110-5820-2-45.
Clinical trial NCT03203356: Adrenal Function in GHD Children
Official title: Evaluation of Adrenal Function Before and After GH Treatment in GHD Affected by GH Deficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Treatment
Adrenal; Functional Disturbance
Keywords: growth hormone
children
adrenal function
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 consecutive children with short stature and overt idiopathic GHD and 30 children with constitutional short stature without endocrine disease

Brief summary: To evaluate in children affected by idiopathic GHD the adrenal function both at baseline and after 6 and 12 months of GH treatment.

Detailed description: The relationship between the growth hormone (GH)-insulin like growth factor (IGF)-I system and the hypothalamic-pituitary-adrenal (HPA) axis is complex and not univocal. Both a stimulatory and neutral effect of IGF-I on HPA axis has been demonstrated in in vitro models and in healthy subjects, respectively. The effect of GH on the 11beta-hydroxysteroid dehydrogenases (11beta-HSD) isozymes is always to be considered in patients affected by GHD both at diagnosis and during GH treatment. Indeed, in peripheral tissues, corticosteroid hormone action is partially determined by the activity of 11beta-HSD, two isozymes of which interconvert hormonally active cortisol and inactive cortisone. 11beta-HSD2 inactivates cortisol to cortisone in the kidney, whilst 11beta-HSD1 performs the reverse reaction activating cortisol from cortisone in the liver and adipose tissue.

For these reasons, many data are available about the evaluation of adrenal function in patients affeceted byGHD, but most of them come from patients with organic GHD or adult patients, while few and discordant data are available on pediatric GHD patients. We aimed to evaluate, through insulin tolerance test, the adrenal function in about 30 children with overt diagnosis of idiopathic GHD both at baseline and after 6 and 12 months of GH treatment.

Eligibility criteria: Inclusion Criteria:

* prepubertal children with overt idiopathic growth hormone deficiency

Exclusion Criteria:

* Children with organic growth hormone deficiency or under treatment with glucocorticoids

Primary outcomes:
measure: Evaluation of adrenal function in GHD children at baseline and in control group
timeFrame: baseline
measure: Change in adrenal function in GHD children during GH therapy
timeFrame: 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Endocrinology - University of Palermo
Study officials:
References:
Clinical trial NCT03319056: Indoor Air and Children Health Study
Official title: Cardiopulmonary Health Effects of Indoor Air Purification and Different Indoor Environmental Factors Among School Children in Beijing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Disease
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this study is to investigate the cardiopulmonary health effects of indoor air purification and different indoor environmental factors among school students in Beijing.

Detailed description: This randomized, double-blind crossover study was conducted to explore the cardiopulmonary effects of ionization air purification among 48 children in Beijing. Real or sham purification was performed in classrooms for 5 weekdays in a random order with a 2-month wash-out period. During the study periods, different indoor environmental factors were monitored including size-fractionated particulate matter (PM), black carbon (BC), ozone, carbon dioxide (CO2), negative air ions (NAI), noise, temperature and relative humidity, which were controlled as confounders in the analysis of the effects of indoor air purification. In addition, we analyzed the cardiopulmonary effects of those environmental factors on the children.

Eligibility criteria: Inclusion Criteria:

* living in Beijing for more than two consecutive years;
* living in school dormitories from Monday to Friday.

Exclusion Criteria:

* suffering any health condition;
* having asthma or thoracic surgery history.

Primary outcomes:
measure: Levels of lung function indicators
timeFrame: 10 weekdays for intervention (active or sham) and 2 wash-out months
Secondary outcomes:
measure: Changes in autonomic cardiac function
timeFrame: 10 weekdays for intervention (active or sham) and 2 wash-out months
measure: Level of respiratory inflammation
timeFrame: 10 weekdays for intervention (active or sham) and 2 wash-out months
measure: Changes in ST-segment elevation
timeFrame: 10 weekdays for intervention (active or sham) and 2 wash-out months
measure: Levels of oxidative stress in Exhaled Breath Condensate (EBC)
timeFrame: 10 weekdays for intervention (active or sham) and 2 wash-out months
measure: Levels of urinary metabolomics
timeFrame: 10 weekdays for intervention (active or sham) and 2 wash-out months
Other outcomes:
Locations:
city: Beijing
country: China
facility: School of Pubic Health, Peking University
state: Beijing
Study officials:
affiliation: Peking University
name: Furong Deng, PhD&MD
role: PRINCIPAL_INVESTIGATOR
References: