louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02451046: Usefulness of Alpha-GST in Liver Transplantation
Official title: Predictive Ability of Alpha-GST to Detect Graft Primary Dysfunction After Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Evidence of Liver Transplantation
Keywords: Liver transplantation
Primary dysfunction
Lead sponsor: Beaujon Hospital
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing liver transplantation at Beaujon hospital (APHP, Clichy, France)

Brief summary: The primary objective of this study was to evaluate the ability of plasma alpha-GST measurements in liver donor (at the time of organ removal) to predict primary dysfunction in liver recipient. The secondary objective was to study the relationship between alpha-GST levels in the plasma of the liver transplant recipient and early graft function recovery.

Detailed description: Graft primary dysfunction (PDF) after liver transplantation is enhanced by the increasing use of extended-criteria allografts. This complication is burdened with high mortality and morbidity rates among liver transplant recipients. Alpha-GST is a short-life hepatocyte enzyme that may be an interesting biomarker for liver injury. A recently developped ELISA technique may allow fast and easy measurement of alpha-GST plasma concentration (Fastpack IP α-GST Immunoassay, Qualigen Inc., Carlsbad, CA). This study aims to evaluate the ability of plasma alpha-GST measurements in liver donor to predict PDF in liver recipient. Methods: Observational study conducted in one center (Beaujon hospital, APHP, Clichy, France). Measurements of plasma levels of alpha-GST using Fastpack IP α-GST Immunoassay (Qualigen Inc., Carlsbad, CA) at the time of organ removal in liver donor and daily from day 0 to day 7 after liver transplantation in recipients.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* undergoing liver transplantation at Beaujon hospital (APHP, Clichy, France )

Exclusion Criteria:

* age \>70 years and \<18 years

Primary outcomes:
measure: Primary dysfunction (PDF) of liver graft
timeFrame: First week
Secondary outcomes:
measure: Early graft function recovery.
timeFrame: First week
Other outcomes:
Locations:
city: Clichy
country: France
facility: Réanimation hépato-digestive
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Catherine Paugam-Burtz, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03249246: Epidemiology of Sepsis in Turkish ICUs.
Official title: Epidemiology of Sepsis in Turkish ICUs :a National Point Prevalence Multi-centre Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Septic Shock
Severe Sepsis
Keywords: Sepsis
ICU
Point prevalence
Lead sponsor: Turkish Intensive Care Society
Sponsor class: OTHER
Collaborators: name: Turkish Society of Intensive Care, Sepsis Study Group
First posted: 2017-08-15
Enrollment: 1499
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients (\>18 yr)present on the participating ICU or admitted to participating ICUs on study day

Brief summary: The prevalence and mortality of sepsis in Turkey is not know at large. Turkish Society of Intensive Care Medicine, Sepsis Study Group conducted a multi-centre,point prevalence survey to determine the prevalence, causative micro-organisms and outcome of sepsis in Turkish ICUs.


Eligibility criteria: Inclusion Criteria:All patients present on or admitted to participating ICU on study day.

Exclusion Criteria:

* Age\<18 years
* Patients who underwent cardiovascular surgery.

Primary outcomes:
measure: Prevalence of sepsis
timeFrame: Up to 12 weeks.
Secondary outcomes:
measure: Mortality rate of sepsis
timeFrame: Mortality at 30 days
Other outcomes:
Locations:
Study officials:
References:
citation: Rhodes A, Phillips G, Beale R, Cecconi M, Chiche JD, De Backer D, Divatia J, Du B, Evans L, Ferrer R, Girardis M, Koulenti D, Machado F, Simpson SQ, Tan CC, Wittebole X, Levy M. The Surviving Sepsis Campaign bundles and outcome: results from the International Multicentre Prevalence Study on Sepsis (the IMPreSS study). Intensive Care Med. 2015 Sep;41(9):1620-8. doi: 10.1007/s00134-015-3906-y. Epub 2015 Jun 25.
citation: Falagas ME, Rafailidis PI, Kofteridis D, Virtzili S, Chelvatzoglou FC, Papaioannou V, Maraki S, Samonis G, Michalopoulos A. Risk factors of carbapenem-resistant Klebsiella pneumoniae infections: a matched case control study. J Antimicrob Chemother. 2007 Nov;60(5):1124-30. doi: 10.1093/jac/dkm356. Epub 2007 Sep 20.
citation: Fleischmann C, Scherag A, Adhikari NK, Hartog CS, Tsaganos T, Schlattmann P, Angus DC, Reinhart K; International Forum of Acute Care Trialists. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med. 2016 Feb 1;193(3):259-72. doi: 10.1164/rccm.201504-0781OC.
citation: Baykara N, Akalin H, Arslantas MK, Hanci V, Caglayan C, Kahveci F, Demirag K, Baydemir C, Unal N; Sepsis Study Group. Epidemiology of sepsis in intensive care units in Turkey: a multicenter, point-prevalence study. Crit Care. 2018 Apr 16;22(1):93. doi: 10.1186/s13054-018-2013-1.
Clinical trial NCT02484846: Impaired Vigilance, and Its Effects on Cognition and Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Feeding Behavior
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
First posted: 2015-06-30
Enrollment: 50
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: Fifty healthy, young participants (10 male, 40 female) completed two 3-hour study sessions that were at least five days apart. The first session was a baseline. The sleep intervention took place on the night prior to Session 2, where the amount of time in bed was manipulated to be 60-130% of the individual's habitual sleep time. Within both sessions, subjective (Stanford Sleepiness Scale, SSS) and objective (Psychomotor Vigilance Test, PVT) alertness were measured. During the middle of each session, a 40-minute ad libitum meal opportunity allowed participants to eat from eight different food items. Food healthfulness, caloric density, distribution and number of calories were measured and compared to alertness levels.


Eligibility criteria: Inclusion Criteria:

* Age: 18-45 years
* BMI: 20-29 kg/m²
* Eat breakfast at least 5 days per week
* Wake time occurs between 5\&10AM at least 5 days per week
* Time in bed for sleep between 5\&10 hours at least 5 days per week

Exclusion Criteria:

* Dietary restrictions that prohibit them from selecting one of the food choices offered in the study (e.g., gluten allergies, diabetes, vegan diet, dairy avoidance, allergies to the respective food choices available),
* are currently on a calorie-restricted diet, or
* are currently at a weight that is less than 20% of their highest weight within the last three years.
* Participation in shift work within 7 nights of the experiment
* Diagnosed as having severe sleep apnea syndrome, narcolepsy or chronic insomnia
* Diagnosed as having an eating disorder
* Active serious health condition
* Regularly taking vigilance-related medication (e.g., ADHD prescribed medication)
* Typically consume more than 600 mg of coffee or more than 10 cigarettes per day

Primary outcomes:
measure: Total calories consumed
timeFrame: 45 minutes
Secondary outcomes:
measure: Alertness
timeFrame: 15 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: Pardi D, Buman M, Black J, Lammers GJ, Zeitzer JM. Eating Decisions Based on Alertness Levels After a Single Night of Sleep Manipulation: A Randomized Clinical Trial. Sleep. 2017 Feb 1;40(2). doi: 10.1093/sleep/zsw039.
Clinical trial NCT04261946: Post Operative Quality of Life After Patulous Eustachian Tube Treatment
Official title: Post Operative Quality of Life Assesment After Patulous Eustachian Tube Surgical Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eustachian Tube Patulous
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient consulting in IUFC (NICE) with a unilateral disabling patulous eustachian tube surgically treated

Brief summary: Patulous eustachian tube (ET) is a usually asymptomatic poorly known ET pathology. When it becomes so and thus impairs the eardrum (retraction pockets, cholesteatoma) or patients' quality of life (QoL), therapeutic management is proposed. The surgical treatment has diversified in recent years but remains dominated by filling spaces around the ET (autologous fat and/or septal cartilage grafting). Efficiency is traditionally objectivized by dynamic otoscopy, tubomanometry and audiometry, but QoL must also be taken into account and its postoperative assesment was the objective of this work.

Materials and Methods This is a unicentric retrospective study conducted from November 2016 to March 2019 on all patients with a disabling patulous ET, single or bilateral, managed surgically by autologous fat and/or septal cartilage grafting in investigators ENT department. Patients for whom a concomitant procedure was performed were excluded from the study.

The post-operative QoL assessment was performed using the Glasgow Benefit Inventory (GBI), postoperative self-administered questionnaire validated in ENT, including a general, physical and social evaluation. Predictive factors for QoL improvement were investigated among pre-, per- and post-operative clinical data.


Eligibility criteria: Inclusion Criteria:

* any surgically treateble patient with a unilateral patuluos eustachian tube

Exclusion Criteria:

* any patient for whom an other surgical step than the eustachian tube one was needed,
* bilateral desease ,cholesteatoma

Primary outcomes:
measure: Postoperative quality of life
timeFrame: quality of life score in beetwen 2 and 12 month postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Institut Universitaire de la Face et du Cou
Study officials:
References:
Clinical trial NCT00554346: A Randomized, Double Blind, Placebo-controlled Study to Assess the the Preemptive Benefit of Etoricoxib in Patients Receiving Anterior Cruciate Ligament Reconstruction
Official title: A Randomized, Double Blind, Placebo-controlled Study to Assess the the Preemptive Benefit of Etoricoxib in Patients Receiving Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operational Pain
Keywords: COX-2; post-operative ; sports injury; surgical pain
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-11-06
Enrollment: 64
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post surgical pain associated with ligament reconstruction may persist for few days after the surgical procedure. Arcoxia is a new anti-inflammatory and analgesic drug that alleviate pain through oral administration. This study will test the safety and efficacy of Arcoxia in the management of post-operational pain in patients receive the ligament reconstruction surgery.


Eligibility criteria: Inclusion Criteria:

1. Men and women age ranged from 16\~35 who have anterior cruciate ligament injury and/or associated injuries are scheduled for ACL reconstruction surgery.
2. Patient agrees to participate into this study and is willing to sign the patient informed consent form.

Primary outcomes:
measure: Pain at rest at different timepoint after surgical procedures
timeFrame: From baseline(preoperation) to 3 days after
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ching Chuan Jiang, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01552746: From ACute To Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy
Official title: From Acute to Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Postoperative shoulder pain
Persisting postoperative pain
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Vejle Hospital
First posted: 2012-03-13
Enrollment: 60
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: Consecutive patients, scheduled for elective lobectomy of the lung at Odense University Hospital

Brief summary: Shoulder pain is a well known problem after thoracical surgery. The pathogenesis of the pain is uncertain, but mainly a mix of referred pain and mechanical strain to the shoulder. It is believed to last a few days. Persisting shoulder pain after thoracical surgery is a problem 1 year after surgery, but it is unknown if it is related to acute postoperative shoulder pain.

The purpose of the study is to systematically describe postoperative shoulder pain after lobectomy and examine the time progress up to 1 year after surgery.

Detailed description: Further study details are provided by Departement V, Odense University Hospital

Eligibility criteria: Inclusion Criteria:

* Patients for elective lobectomy
* 18 years or older at the day of the operation
* Satisfactory abilities to speak and read danish

Exclusion Criteria:

* Previous Thoracical Surgery.
* Patients with diseases in the nervous system.
* Patients with preoperative shoulder pain, neuropathies or sensory disturbances in the arm or shoulder.
* Patients who are reoperated in the thorax in the study period or any other body-region within the first 4 postoperative days.

Primary outcomes:
measure: Shoulder Pain
timeFrame: 12 months
measure: Shoulder range of motion
timeFrame: 12 months
Secondary outcomes:
measure: Thoracical Pain
timeFrame: 12 months
measure: Presence of allodynia and hyperalgesia on the shoulder on the operated side.
timeFrame: 1. postoperative day
measure: Quantitative sensory testing values on the shoulder
timeFrame: 12 months
measure: Hospital Anxiety and Depression Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Departement V of anesthesia and intensive care, Odense University Hospital
Study officials:
affiliation: Departement V of anesthesia and intensive care, Odense University Hospital
name: Morten R Eckhardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04139746: Pneumatic Retinopexy for Severe Bullous Retinal Detachment
Official title: Pneumatic Retinopexy Preceded by Drainage of Subretinal Fluid for the Treatment of Severe Bullous Retinal Detachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retina Detachment
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 58
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy and safety outcomes of scleral buckling (SB) and drainage-injection-pneumoretinopexy (DIP), a modified pneumatic retinopexy technique, in which, before injecting the gas, the drainage of the subretinal fluid is performed with a simultaneous injection of balanced salt solution (BSS) in the vitreous chamber, for the treatment of severe superior bullous rhegmatogenous retinal detachment (SBRD).


Eligibility criteria: Inclusion Criteria:

* provision of written informed consent;
* phakic patients aged \< 60 years with no or minimal media opacity;
* single or multiple retinal breaks (within 1 clock hour) between 8 to 4 o'clock hours;
* patients' capability to maintain suggested head positioning for 5 days after the procedure.

Exclusion Criteria:

* retinal detachment with poor subretinal fluid (absence of severe SBRD);
* holes, lattice degeneration or traction within the inferior 4 clock hours;
* posterior retinal break, situated behind the equator, not suitable for cryotherapy;
* any sign of PVR or severe glaucoma;
* myopia above 10 diopters.

Primary outcomes:
measure: Anatomical reattachment of the retina
timeFrame: 12-month
Secondary outcomes:
measure: Refractive error change
timeFrame: 12-month
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
state: BS
Study officials:
References:
Clinical trial NCT04358146: Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)
Official title: Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux in Children
Keywords: Reflux
Lead sponsor: United Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Statitec
First posted: 2020-04-24
Enrollment: 346
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.

Detailed description: The study duration is 1 month and 2 days. It is possible to add 2 additional months (optional).

The 2 first days (from D-3 to D0) correspond to the pre-selection period. These 2 days are followed by the follow-up month (from D0 to D30). It is possible to add an optional follow up of 2 months (form D30 to D90).

Eligibility criteria: Inclusion Criteria:

* ≥ 2 regurgitation episodes per day during the last 2 weeks and ≥ 4 regurgitation episodes per day in average during the last 2 days,
* exclusive or predominant formula feeding
* whose parents signed informed consent

Exclusion Criteria:

* preterm infants or birthweight \<2500g
* Post enteritis lactose intolerance
* Suspected or diagnosed cow's milk protein allergy requiring an eviction diet
* Use of medications that may interfere with regurgitation or gastrointestinal transit (such as alginates, laxatives, antibiotics...). All these medications have to be stopped at least 7 days before inclusion visit (V1)
* Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject

Primary outcomes:
measure: Frequency of regurgitation
timeFrame: Day 14
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Athens, Athens Children's Hospital "AGIA SOFIA"
name: Alexandra Papadopoulou
role: STUDY_DIRECTOR
References:
Clinical trial NCT04298346: Neurological Fate, Prematurity and Genetic Susceptibility Factors
Official title: GENIMOC : Neurological Fate, Prematurity and Genetic Susceptibility Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polymorphism, Restriction Fragment Length
Premature
Infertility of Cervical Origin
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 27
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children born prematurely at term \<34 weeks between 2008 and 2015, and presenting with cerebral palsy at the age of 2 years within the Growing Together Network in Pays de Loire.

Matching by a propensity score to a population of control children with a comparable probability of developing cerebral palsy but whose examination at 2 years is optimal

Brief summary: This study could help identify aggravating or protective genetic polymorphisms associated with cerebral palsy. Populations of premature babies at different risk of cerebral palsy could thus be individualized with an impact on their monitoring and on the pathophysiological understanding of the processes leading to neurological lesions.


Eligibility criteria: Inclusion Criteria:

* children born prematurely at term \<34 weeks between 2008 and 2015
* assessed at the age of 2 within the Growing Together Network in Pays de Loire
* parental consent for the collection of data from their child and for intraoral sampling for the search for genetic factors.

Exclusion Criteria:

* children who died after the age of 2
* children who refused and / or whose parents refused to participate in the study

Primary outcomes:
measure: Identify a polymorphism associated with the risk of developing cerebral palsy at 2 years in a regional population of premature infants of gestational age <34 weeks gestation.
timeFrame: 2 years
Secondary outcomes:
measure: Identify a specific polymorphism of certain forms of cerebral palsy
timeFrame: 2 years
measure: Develop a prognosis algorithm for the occurrence of cerebral palsy for personalized monitoring in a population at risk.
timeFrame: 2 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
References: