louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01022931: Epidemiology and Clinical Presentation of H1N1 Infection in Children in Geneva
Official title: Evaluation of a New Virus(Influenza A H1N1/09) in Children: Epidemiology, Clinical Presentation and Outcome, and Response to Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Immunosuppressed
Asthmatic
Neuromuscular Diseases
Keywords: Influenza A H1N1
Children
Epidemiology
Treatment
Oseltamivir
Genetics
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2009-12-01
Enrollment: 200
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children seen at the emergency ward

Brief summary: This study aims to identify clinical symptoms and outcomes, as well as response to anti-viral treatment in children living in Geneva, with influenza A/ H1N1 infection during the current pandemic.


Eligibility criteria: Inclusion Criteria:

* suspicion of H1N1 infection

Exclusion Criteria:

* Not available for a 30 days follow-up

Primary outcomes:
measure: ABCB1 polymorphisms
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Children's Hospital of Geneva, HUG
state: GE
Study officials:
affiliation: University Hospitals of Geneva
name: Klara M Posfay-Barbe, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06510231: Inspiratory Muscle Training in HFpEF
Official title: Inspiratory Muscle Training in Heart Failure With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-07-19
Enrollment: 68
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: This study is being done to determine how inspiratory muscle training impacts inspiratory muscle function during exercise in heart failure patients.


Eligibility criteria: Inclusion Criteria:

* ≥18 yrs of age
* Receiving SGLT2 inhibitors and spironolactone (and beta-blocker use for HFpEF patients with hypertension) for \>3 months
* NYHA symptoms I-III
* Body mass index ≤40 kg/m2
* Currently non-smokers with \<20 pack year history
* Able to exercise (i.e. without significant orthopedic limitations or musculoskeletal disorders limiting their ability to exercise)

Exclusion Criteria:

* Sustained ventricular tachycardia and/or ventricular fibrillation within 21 days of visit 1
* Second or third degree heart block
* Body mass index \>40 kg/m2
* Current smokers and/or smoking history \>20 pack years
* Pregnant women (testing will be done by research team if requested)
* Glomerular filtration rate of \<30 mL/min/1.73m2 (initial screen via clinical record within the past 6 months and this will be assessed on Visit 1)
* Individuals who are not able to engage in exercise
* Uremia, history of allergy to iodides
* Peripheral artery disease
* Alanine transaminase and/or aspartate transaminase greater than 2 times the upper limit of normal (via clinical record within the past 6 months)
* Asthmatic patients with a low symptom perception and suffer frequency, severe exacerbations or with an abnormally low perception of dyspnea
* Ruptured eardrum or any other condition of the ear
* History of spontaneous pneumothorax or osteoporosis with a history of rib fractures
* History of lidocaine allergy.

For individuals agreeing to undergo dual energy x-ray absorptiometry (DEXA) scanning for measurement of body composition as part of their study visit, additional exclusion criteria apply: recently administered gastrointestinal contrast or radionuclides; severe degenerative changes or fracture deformity in measurement areas; or inability to attain correct position and/or remain motionless for the measurement period.

Primary outcomes:
measure: Change in inspiratory muscle blood flow demand
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Change in locomotor muscle blood flow
timeFrame: Baseline, 8 weeks
measure: Change in exercise tolerance
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Joshua Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05179031: Assessment of the Glycemic Responses to Nutritional Products
Official title: Determination of the Postprandial Glycemic Response and Glycemic Index of Nutritional Products: A Randomized Controlled Clinical Trial in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response
Keywords: Glycemic response
Glycemic index
Nutritional products
Healthy individuals
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
Collaborators: name: INQUIS Clinical Research
First posted: 2022-01-05
Enrollment: 13
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: This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤ 65 years
* Body mass index (BMI) between 18.5 and 27 kg/m²

Exclusion Criteria:

* Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2)affect the results.
* Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Major trauma or surgical event within 3 months of screening.
* Known intolerance, sensitivity or allergy to test products.
* Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
* History of cancer in the prior two years, except for non-melanoma skin cancer.

Primary outcomes:
measure: The glycemic index of nutritional products
timeFrame: 9 test days (test days will be separated by at least 1 day in between tests for each participant)
Secondary outcomes:
measure: The postprandial glucose levels at each time point after each test product compared with the mean of the 3 references
timeFrame: 9 test days (test days will be separated by at least 1 day in between tests for each participant)
measure: The postprandial incremental area under the curve (iAUC) after each test product compared with the mean of the 3 references
timeFrame: 9 test days (test days will be separated by at least 1 day in between tests for each participant)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: INQUIS Clinical Research, Ltd
state: Ontario
Study officials:
References:
Clinical trial NCT02814331: Electrohaemodynamic Activity in Epileptic Children : Combined Video-EEG and Near-infrared Spectroscopy (NIRS) Analysis
Official title: Electrohaemodynamic Activity in Epileptic Children: Combined Video-EEG and Near-infrared Spectroscopy (NIRS) Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Video-EEG
near-infrared spectroscopy (NIRS)
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 23
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between the ages of 6 and 18 years with drug-refractory partial epilepsy, presenting interictal spikes on standard EEG recordings.

Brief summary: Evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis to spatial localization of epileptogenic foci

Detailed description: This study is designed to evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of epileptogenic foci in order to perform multimodal mapping and localization of interictal spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG electrode implantation strategy prior to surgery in children with drug-refractory partial epilepsy.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 6 and 18 years
* with drug-refractory partial epilepsy, presenting interictal spikes on standard EEG recordings.

Exclusion Criteria:

* Children with a serious congenital malformation.
* Refusal from one of the parents or the child.
* Children with generalized epilepsy or diffuse interictal spikes.
* Children with severely impaired general status and vital functions.
* Children with dermatosis of the face or scalp.
* Children under the age of 6 years or adults over the age of 18 years.

Primary outcomes:
measure: multimodal high-resolution EEG-NIRS
timeFrame: Day 0
Secondary outcomes:
measure: Functional MRI
timeFrame: Day 0
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Fabrice WALLOIS, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02469831: Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy
Official title: The Impact of Deep Versus Moderate Neuromuscular Block on Respiratory System Mechanics and Metabolic Changes During Laparoscopic Cholecystectomy a Double-Blind Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Laparoscopic Cholecystectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to investigate the differences between deep continuous muscle relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in respect to metabolic changes and respiratory mechanics.


Eligibility criteria: Inclusion Criteria:

* more than 18 years
* undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* previous surgeries,
* a history of venous or arterial diseases,
* BMI (≥30 kg/m2),
* Allergy to rocuronium.
* Significant liver dysfunction.
* Significant renal dysfunction (S-creatinine \> 200 umol/l).
* Neuromuscular disease that might impair neuromuscular blockade
* Pregnant or breastfeeding.
* Indication for rapid sequence induction.
* Inability to informed consent

Primary outcomes:
measure: respiratory mechanics (Dynamic compliance)
timeFrame: intraoperative
Secondary outcomes:
measure: surgeon satisfaction (scale from 1 to 5)
timeFrame: intraoperative
measure: postoperative pain (VAS score)
timeFrame: postoperative for 6 hours
measure: postoperative nausea and vomiting
timeFrame: postoperative for 6 hours
measure: completion of surgical procedure
timeFrame: intraoperative
measure: metabolic changes (blood lactate)
timeFrame: intraoperative
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Al Rajhy liver hospital
state: اسيوط
Study officials:
affiliation: Assiut University
name: Osama ibraheim, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: MOSTAFA ABBAS, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: AHMED TAHA, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04668131: Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
Official title: Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: dry eye
pain
acupuncture
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is designed as a prospective, randomized, open, controlled clinical trial. For the first time, acupuncture was applied to the treatment of dry ocular neuropathic pain. Its mechanism was discussed by comparing the efficacy between acupuncture and artificial tears.


Eligibility criteria: Inclusion Criteria:

* According to the DEWS diagnostic criteria, the OSDI score ≥ 13, with positive signs of dry eye (SIt ≤ 10mm/5min or TBUT ≤ 10s) or CFS positive;
* VAS\>0;
* Signed informed consent.

Exclusion Criteria:

* Patients with dry eye who have had irritants directly irritating the ocular surface in the past 3 days;
* Eyeball infections, allergies, deformities, abnormal movements
* Any history of eye surgery
* Have had eye trauma or fundus laser treatment within 3 months
* Used drugs that affect tear production such as antihistamines, antidepressants, etc. within 30 days
* Suffer from systemic diseases that affect tear production, including Sjogren's syndrome, diabetes, mental illness, malignant tumors, etc.

Primary outcomes:
measure: Visual Analogue Score
timeFrame: The treatment period for each enrolled subject is one month
Secondary outcomes:
measure: OSDI
timeFrame: The treatment period for each enrolled subject is one month
measure: TBUT
timeFrame: The treatment period for each enrolled subject is one month
measure: SIt
timeFrame: The treatment period for each enrolled subject is one month
measure: CFS score
timeFrame: The treatment period for each enrolled subject is one month
measure: Density and curvature of corneal subbasal nerve
timeFrame: The treatment period for each enrolled subject is one month
measure: Tear pain factor content
timeFrame: The treatment period for each enrolled subject is one month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References:
Clinical trial NCT01658631: Evaluation of Nexfin During Anesthesia and in Intensive Care (NexfinEval)
Official title: Evaluation of Nexfin During Induction of General Anesthesia and in Intensive Care During a Passive Legs Raising Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 97
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 undergoing major surgery with the need for an invasive blood pressure measurement and ICU patients requiring a passive legs raising test

Brief summary: The purpose of this study is to compare the non invasive measurement of arterial pressure (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter)

* during induction of general anesthesia,
* during a leg raising test in the Intensive Care Unit


Eligibility criteria: Inclusion Criteria:

* Age \>18
* ASA II, III or IV
* weight between 40 and 180 kg; BMI \< 35
* normal Allen's test and/or hand Doppler examination.

Exclusion Criteria:

* cardiac arrhythmias,
* history of vascular surgery or vascular implant in the upper limb
* Raynaud disease

Primary outcomes:
measure: Arterial pressure measurement
timeFrame: Blood pressure will be followed for the duration of induction of anesthesia, an expected average of 20 minutes, or for the passive legs raising test, an expected average of 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
References:
citation: Weiss E, Gayat E, Dumans-Nizard V, Le Guen M, Fischler M. Use of the Nexfin device to detect acute arterial pressure variations during anaesthesia induction. Br J Anaesth. 2014 Jul;113(1):52-60. doi: 10.1093/bja/aeu055. Epub 2014 Apr 25.
Clinical trial NCT03944031: A Study of the Effects of LY3372689 on the Brain in Healthy Participants
Official title: Assessment of Brain O-GlcNAcase (OGA) Enzyme Occupancy After Single Oral Doses of LY3372689 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]LSN3316612 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-05-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study uses imaging to evaluate how LY3372689 binds to a protein in the brain. This study will be conducted in healthy participants and will last up to approximately 25 days after enrollment. Screening must be completed within 28 days prior to enrollment.


Eligibility criteria: Inclusion Criteria:

* Overtly healthy males or females who cannot get pregnant
* Have a body mass index (BMI) of at least 18.5 kilogram per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Have veins and arteries suitable for protocol required blood sampling

Exclusion Criteria:

* Have a history of head injury or contraindications to undergoing magnetic resonance imaging (MRI) examination
* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously participated or withdrawn from this study
* Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
* Have long exposure to sunlight routinely or use tanning beds regularly
* Participate in regular vigorous exercise

Primary outcomes:
measure: Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)
timeFrame: Predose Scan (Days -14 to -1)
measure: Percent OGA EO
timeFrame: Postdose Scan 1 (Days 1 - 4)
measure: Percent OGA EO
timeFrame: Postdose Scan 2 (Days 2 - 4)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Invicro, Institute for Neurodegenerative Disorders
state: Connecticut
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04893031: Effect of Tocilizumab on Intensive Care Patients With COVID-19 Pneumonia, a Retrospective Cohort Study
Official title: Effect of Tocilizumab on Intensive Care Patients With COVID-19 Pneumonia, a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tocilizumab
COVID-19
Critical Care
Mortality
Keywords: tocilizumab
COVID-19
Critical Care
Mortality
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were diagnosed with COVID-19 and were admitted to intensive care unit

Brief summary: Although its safety and efficacy in the COVID-19 patient population are still unclear, tocilizumab is one of treatment. Tocilizumab is a U.S. Food and Drug Administration approved IL-6 receptor antagonist widely used to treat CRS secondary to the chimeric antigen receptor T cell. In this study the investigators will evaluate the efficacy of Tocilizumab, an IL-6 antagonist administered in the early period in intensive care patients with COVID-19 pneumonia followed by hypoxic and systemic inflammation is predominant, but who do not support mechanical ventilation.

Detailed description: With this study, the investigators will evaluate the efficacy of Tocilizumab, an IL-6 antagonist administered in the early period in intensive care patients with COVID-19 pneumonia followed by hypoxic and systemic inflammation is predominant, but who do not support mechanical ventilation.

With this study, those with signs of hypoxia and systemic inflammation followed by COVID-19 pneumonia (SpO2 \<90% on room air together with the elevation of any two of the systemic inflammatory markers such as CRP, LDH and Ferritin) and / or acute bilateral infiltrates on chest radiograph and tocilizumab the patients who received treatment and those who received standard therapy will be compared.

In the study, cases followed up with COVID-19 pneumonia and respiratory failure between March 2020 and March 2021 will be retrospectively evaluated. Tocilizumab was applied as 400 mg - 800 mg iv (depending on weight). A second dose could be given 12-24 h later if the patient's condition had not improved. Primary end point was determined as intensive care mortality.

Eligibility criteria: Inclusion Criteria:

* All patients were admitted to intensive care unit, diagnosed with COVID-19 pneumonia

Exclusion Criteria:

* Patients who require mechanical ventilation in intensive care admission
* Cases who received tocilizumab after being intubated during follow-up even though they were not intubated at admission
* patients for whom tocilizumab is contraindicated

Primary outcomes:
measure: Rates of intensive care mortality in the groups
timeFrame: 28 Day
Secondary outcomes:
measure: Rates of needed of mechanical ventilation in the groups
timeFrame: 28 Day
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
References: