louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04647539: Emerging Invasive Fungal Infections in Critically Ill Patients
Official title: Emerging Invasive Fungal Infections in Critically Ill Patients: Epidemiological Trends, Clinical Features and Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fungal Infection
ICU Acquired Weakness
Keywords: Emergind invasive fungal infection
mucormycosis
ICU
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients majeurs hospitalisés en reanimation et présentant une infection fongique invasive autre qu'une candidose ou une aspergilloses

Brief summary: Rationale: Beside Candida and Aspergillus, emerging invasive fungal infections (EIFIs) are increasing in intensive care setting and are associated with high morbidity and mortality. However, data are scarce, particularly in ICU settings and for EIFIs other than mucormycosis.

Objectives: to describe epidemiological trends and clinical features of EIFIs in intensive care units (ICU) and to assess their outcome.

Methods: All records of adult patients diagnosed with an EIFI in a medical ICU between 2006 and 2019 were analyzed retrospectively. In-ICU mortality was assessed, then factors associated with mortality were identified. Survival at day-90 was calculated by the Kaplan-Meier method.


Eligibility criteria: Inclusion criteria:

- Adults (≥ 18 years old) with at least 1 positive culture for molds other than candida and aspergillosis

Exclusion criteria:

- Age \< 18, pregnancy

Primary outcomes:
measure: mortality
timeFrame: at ICU admission
Secondary outcomes:
measure: Mucormycosis
timeFrame: at ICU admission
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH Montpellier
name: Romaric Larcher, MD, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05673239: Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients
Official title: Effects of L-carnitine Therapy on the Heart of Maintenance Hemodialysis Patients: A Multicenter, Prospective, Non-randomized, Controlled Real-world Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Dialysis
Keywords: Renal Dialysis
Cardiac Function Tests
real-world study
multicenter
prospective
non-randomized
controlled
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 1008
Sex: ALL
Minimum age (years): 18
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 study is intended to be a multicenter, prospective, non-randomized, controlled real-world study. Patients receiving L-carnitine injection were included in the experimental group and the control group according to whether they received L-carnitine injection. Patients receiving L-carnitine injection were included in the experimental group, and those receiving L-carnitine injection were included in the control group.To observe the effects of L-carnitine on cardiac function in hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* Maintenance hemodialysis patients;
* 18 years\<80 years;
* Have clear consciousness and independent behavior ability;
* Before dialysis, the total carnitine concentration was less than 40 umol/L, or the free carnitine concentration was less than 35 umol/L.

Exclusion Criteria:

* Acute cardiovascular and cerebrovascular diseases occurred within 1 month;
* Infectious diseases occurred within 1 month; Treatment with glucocorticoid or immunosuppressant;
* Patients who have used L-carnitine within 2 weeks.
* Hematological system tumor or tumor;

Primary outcomes:
measure: Change from baseline in Left ventricular ejection fraction
timeFrame: baseline and week 12
Secondary outcomes:
measure: Change from baseline in Brain natriuretic peptide level
timeFrame: baseline ,week 4 and week 12
measure: Change from baseline in left ventricular short axis shortening rate
timeFrame: baseline and week 12
measure: Change from baseline in stroke volume
timeFrame: baseline and week 12
measure: Change from baseline in the ratio of peak E to peak A of mitral valve blood flow velocity in early and late diastolic periods
timeFrame: baseline and week 12
measure: Change from baseline in serum albumin
timeFrame: baseline and week 12
measure: Change from baseline in upper arm circumference
timeFrame: baseline and week 12
measure: Change from baseline in prealbumin
timeFrame: baseline and week 12
measure: Change from baseline in hemoglobin
timeFrame: baseline and week 12
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT05298839: Effect of COVID-19 Infection on the Performance of Adolescent Professional Overhead Athletes
Official title: Effect of COVID-19 Infection on the Performance of Adolescent Professional Overhead Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Sport Performance, Professional Overhead Athletes
Keywords: COVID-19
sport performance
adolescent athletes
overhead sport
Lead sponsor: Atılım University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 47
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Professional athletes

Brief summary: COVID-19 is known to also cause damage outside the pulmonary system, particularly the cardiovascular and the musculoskeletal system. The studies on the effects of COVID-19 infection on different populations may provide valuable information for health professionals. Derangements in the cardiorespiratory and musculoskeletal systems which normally direct effect on the sports performance of athlete together with physical inactivity during COVID-19 infection are the main factors that may decrease the performance of the professional athletes. Although it may be well anticipated that COVID-19 will reduce sports performance; there are scarce studies in the literature. The aim of this study is to compare the sports performance of adolescent athletes that has COVID-19 infection with those did not.

Detailed description: Extensor muscle endurance, flexor muscle endurance and the lateral core muscle endurance were evaluated. All tests were performed by a chronometer and test was terminated as the position was lost and the time passed was recorded. Hand grip strength was measured by Jamar hand dynamometer. Health ball throwing test was used to evaluate upper extremity open kinetic chain and explosive power. Pro-agility test was used to evaluate the agility. Step test was performed for 3 minutes with a 30 cm high step board.

Eligibility criteria: Inclusion Criteria:

* Basketball, volleyball, handball, tennis and American football players
* Between 12 to 20
* Performing sports-specific training more than two times a week at least for 1 year

Exclusion Criteria:

* Vertebral, upper or lower extremity injury within the last 6 weeks or had undergone a surgery

Primary outcomes:
measure: Core Muscle Endurance
timeFrame: June 2021- August 2021
measure: Jamar hand dynamometer
timeFrame: June 2021- August 2021
measure: Upper Extremity Functional Performance
timeFrame: June 2021- August 2021
measure: Reaction Time
timeFrame: June 2021- August 2021
measure: Agility Performance
timeFrame: June 2021- August 2021
measure: 3 Minutes Step Test
timeFrame: June 2021- August 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Atılım University
Study officials:
References:
Clinical trial NCT02185339: Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics
Official title: Effects of Deep Versus Moderate Neuromuscular Blockade on Intraoperative Respiratory Mechanics in Patients Undergoing Laparoscopic Renal Surgery: a Prospective, Randomized, Parallel Design Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopic Renal Surgery
Laparoscopy
Muscle Relaxation
Keywords: Respiratory mechanics
Respiratory function test
Hemodynamics
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-07-09
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of the current study is to compare intraoperative respiratory mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative hemodynamics and postoperative pulmonary function between the two groups.


Eligibility criteria: Inclusion Criteria:

* ASA I or II patients scheduled to undergo laparoscopic renal surgery

Exclusion Criteria:

* BMI ≥35 kg/m2
* Known neuromuscular disease
* History of chronic obstructive pulmonary disease
* Asthma
* Pneumothorax
* Bronchopleural fistula
* Previous lung surgery
* Previous retroperitoneal surgery
* Hemodynamic instability
* History of cardiopulmonary disease
* Renal insufficiency

Primary outcomes:
measure: Thoracopulmonary Compliance
timeFrame: intraoperative
Secondary outcomes:
measure: Arterial Oxygen Tension/Inspired Oxygen Fraction
timeFrame: intraoperative
measure: Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference
timeFrame: intraoperative
measure: Estimated Dead Space
timeFrame: intraoperative
measure: Pulmonary Shunt
timeFrame: intraoperative
Other outcomes:
measure: Stroke Volume Variation
timeFrame: intraoperative
measure: Cardiac Index
timeFrame: intraoperative
measure: Surgical Condition
timeFrame: At completion of pneumoperitoneum surgery
measure: Postoperative Pain
timeFrame: Postoperative 2 days
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Sang-Hyun Hong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02628639: Optimizing the Evaluation of Awareness in Disorders of Consciousness
Official title: Using High-resolution Electroencephalography to Optimize the Evaluation of Awareness in Patients With Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disorders of Consciousness
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate whether personalized stimulations can improve the detection of electrophysiological signs of awareness in patients with disorders of consciousness.


Eligibility criteria: Inclusion Criteria:

* patients in a vegetative state or a minimally conscious state
* agreement from families

Exclusion Criteria:

* patients with akinetic mutism or locked-in syndrome
* patients in a coma
* patients with damages in the inner or middle ear
* contraindication to a high-density electroencephalography exam

Primary outcomes:
measure: Number of participants showing differences of electrophysiological activity after personalized but not standard stimulation protocols
timeFrame: standard stimulations: 28 days after recruiting patients
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Service douleur - soins palliatifs
name: Régis Aubry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pazart L, Gabriel D, Cretin E, Aubry R. Neuroimaging for detecting covert awareness in patients with disorders of consciousness: reinforce the place of clinical feeling! Front Hum Neurosci. 2015 Feb 17;9:78. doi: 10.3389/fnhum.2015.00078. eCollection 2015. No abstract available.
citation: Gabriel D, Henriques J, Comte A, Grigoryeva L, Ortega JP, Cretin E, Brunotte G, Haffen E, Moulin T, Aubry R, Pazart L. Substitute or complement? Defining the relative place of EEG and fMRI in the detection of voluntary brain reactions. Neuroscience. 2015 Apr 2;290:435-44. doi: 10.1016/j.neuroscience.2015.01.053. Epub 2015 Jan 30.
Clinical trial NCT06665139: the Thickness of the Muscles and Pain in Impingement Syndrome
Official title: The Relationship Between the Thickness of the Muscles Stabilizing the Scapula and Pain in Impingement Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Impingement Shoulder
Impingement Syndrome
Pain, Shoulder
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-30
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with impingement and meeting the criteria will be included, while the healthy group will consist of hospital staff who do not have shoulder pain and who are not diagnosed with a shoulder-related disease.

Brief summary: Pain intensity will be measured with visual analog scale. Sonographic severity grade of shoulder impingement syndrome, serratus anterior muscle, upper trapezius and middle trapezius will be measured with USG in patients diagnosed with impingement and meeting the criteria and healthy volunteers.

Detailed description: Patients diagnosed with impingement and meeting the criteria will be included, while the healthy group will consist of hospital staff who do not have shoulder pain and who are not diagnosed with a shoulder-related disease. Pain intensity will be measured with VAS (visual analog scale), the sonographic severity grade of shoulder impingement syndrome, the serratus anterior muscle, the upper trapezius and the middle trapezius will be measured with USG.

Eligibility criteria: Inclusion Criteria:

* 18-65 years
* Cognitive ability to understand test instructions
* Symptom duration longer than 1 month
* At least two positive Neer, Hawkins and painful arch tests

for healty volunteers

* 18-65 years
* cognitive ability to understand test instructions
* negative impingment test

Exclusion Criteria:

* Fibromyalgia
* cervical radiculopathy
* those who have received injections or physical therapy in the last month
* Those with a disorder that may affect shoulder joint range of motion and muscle mass (previous fracture, surgery, subluxation)
* BMI over 35
* inflammatory disease

Primary outcomes:
measure: sonographic severity grade of shoulder impingment syndrome
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cansın Medin Ceylan
state: Bahcelievler
Study officials:
affiliation: Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
name: cansın medin ceylan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06975839: Local Metformin Gel and Impacted Lower Third Molar
Official title: Evaluate the Efficacy of Local Metformin Gel Application Following Surgical Removal of Mandibular Third Molar
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Impacted Third Molar Tooth
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 36
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: * Completed medical and dental history will take for all patients and the position of the impacted teeth will evaluate by panoramic films. Patients will fully inform about the treatment procedures, follow-up examinations and complications of surgical procedures.
* The study will be carried out as a randomized controlled clinical trial. Randomly, by the use of predefined computer-generated randomization table, the eligible patients will be randomized in equal proportions between Study group: patients will receive 1% Metformin gel in the socket following removal of the impacted third molar and Control group: patients will receive placebo gel 2% hydroxymethyl cellulose.All surgeries will be performed under complete aseptic conditions. Before surgery, the patient's mouth will be rinsed with a chlorhexidine digluconate solution 0.2% for 2 minutes. Surgery will carry out under local anesthesia consisting of 4% articain hydrochloride with 1:100,000 adrenaline.
* Full thickness mucoperiosteal flap will be raised to expose sufficient bone on lateral and distal aspect of the impacted molar. Removal of bone will be done with stainless steel bur under Constant irrigation with normal saline while removing bone to prevent thermal necrosis.
* When necessary, sectioning of crown and roots will be performed with a fissure bur. After tooth extraction, the alveolus will be inspected, curetted, and irrigated with 0.9% sterile saline solution.
* Surgical removal of impacted mandibular third molar will be done,1% metformin gel or placebo gel in the socket following removal of the impacted third molar .
* The mucoperiosteal flap will be repositioned and sutured with 3-0 black silk suture.


Eligibility criteria: Inclusion Criteria:

* • Age ≥18ys

  * no systemic disease
  * impacted mandibular third molar class II position B on Pell- Gregory classification

Exclusion Criteria:

* • history of metabolic or systemic diseases affecting bone or healing process,

  * local infection,
  * tobacco use,
  * oral contraceptive,
  * pregnancy and lactation
  * patients who had taken analgesics or anti-inflammatories for 1 week prior to enrollment in the study

Primary outcomes:
measure: bone dentisty
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03598439: Randomized Influenza Vaccine Evaluation of Immune Response
Official title: Randomized Open-Label Trial to Compare Immunogenicity of Egg-Based and Non-Egg Based Quadrivalent Influenza Vaccines Among Adults 18-64 Years of Age (US Flu Vaccine Effectiveness Serologic Study, 2018-19 and 2019-20)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Influenza
Keywords: influenza vaccine
adults
Immune response
Lead sponsor: Marshfield Clinic Research Foundation
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2018-07-26
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Licensed influenza vaccines are manufactured with a variety of technologies. The majority are split, inactivated vaccines derived from egg-adapted, high growth reassortant viruses. Two US licensed products do not use egg-adapted viruses: Flucelvax (mammalian cell culture) and FluBlok (recombinant). There is increasing evidence that egg propagation induces virus mutations that impair the immune responses to circulating viruses. However, the impact of egg-propagation on clinical vaccine effectiveness is uncertain, and there is no preferential recommendation for any specific influenza vaccine product or technology. A direct comparison of serologic response to egg based and non-egg based vaccines in adults has not been performed. This randomized trial will compare serologic responses to the egg- and non-egg A(H3N2) vaccine component. The study cohort will be followed for two influenza seasons to evaluate sequential vaccination effects on immune response.


Eligibility criteria: Inclusion Criteria:

* Aged 18-64 years
* Marshfield Clinic patients living in or around Marshfield, Wisconsin since July 2015
* Willing and able to give informed consent and comply with study requirements

Exclusion Criteria:

* Receipt of 2018-19 influenza vaccine prior to study enrollment
* Known to be pregnant at the time of enrollment
* Current participation or plans to participate in another clinical trial involving an experimental agent
* Presence of a contraindication to influenza vaccination
* Plans to relocate outside the geographic location in the next two years

Primary outcomes:
measure: Post-vaccination titer
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Marshfield
country: United States
facility: Marshfield Clinic - Marshfield Center
state: Wisconsin
Study officials:
References:
Clinical trial NCT05376839: A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment
Official title: A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Multiple Doses of Cedirogant (ABBV-157) in Subjects With Mild, Moderate and Severe Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: Cedirogant
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the pharmacokinetics and safety of cedirogant following oral administration of multiple doses in adult participants with hepatic impairment and normal hepatic function.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) is ≥ 18.0 to \< 40 kg/m2
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile (except liver function tests for subjects with hepatic impairment), and 12-lead ECG

Exclusion Criteria:

* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests (except liver function tests for subjects with hepatic impairment) at screening that is assessed as likely to interfere with the objectives of the trial or the safety of the subject.
* History or evidence of active TB or latent TB infection
* Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of cervix

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to 18 Days
measure: Time to maximum observed plasma concentration (Tmax)
timeFrame: Up to 18 Days
measure: Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours after dosing (AUC0-24)
timeFrame: Up to 18 Days
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: Up to 44 Days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami /ID# 246573
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Ctr /ID# 246052
state: Florida
city: San Antonio
country: United States
facility: TX Liver Inst, Americ Res Corp /ID# 246572
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: