louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05854420: Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion
Official title: Modified Anterior Lamellar Recession for All Grades of Upper Eyelid Trachomatous Cicatricial Entropion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Entropion
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 68
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to assess the combination of anterior lamellar recession (ALR) with blepharoplasty, suprasternal fixation, and internal eyelash bulb extirpation of aberrant lashes posteriorly located in patients with any grade of upper eyelid trachomatous cicatricial entropion


Eligibility criteria: Inclusion Criteria:

* All patients presented with upper lid trachomatous cicatricial entropion associated with rubbing lashes.
* Patients having a history of argon laser ablation, electrolysis, epilation, or past unsuccessful surgery were also included

Exclusion Criteria:

* Patients with a follow-up period of fewer than 12 months.
* Patients with very severe UCE and required posterior lamellar grafts.
* Patients with etiology other than trachoma.
* Patients with dysplastic lashes without entropion were excluded

Primary outcomes:
measure: Success rate
timeFrame: 3 months post operative
measure: Success rate
timeFrame: 6 months post operative
measure: Success rate
timeFrame: 9 months post operative
measure: Success rate
timeFrame: 12 months post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Damieta
country: Egypt
facility: Ehab tharwat
state: New Damietta
Study officials:
References:
Clinical trial NCT05279482: Comparison Between Different Doses of Steroids in COVID-19 Patients
Official title: Comparison Between Standard Dose Methyl Prednisolone and Megadose Methyl Prednisolone as Regards Outcome in SARS.COV.2 Patients in Intensive Care Unit : Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Pneumonia, Viral
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SARS.COV.2. admitted in intensive care unit

Brief summary: aim of this study is to compare between standard dose methyl prednisolone and mega dose methyl prednisolone as regards outcome reflected by mortality rate, percentage of mechanically ventilated patients and icu length of stay of covid 19 patients admitted in intensive care unit.

Detailed description: Retrospective study for comparison between standard dose methyl prednisolone and mega dose methyl prednisolone as regards outcome reflected by mortality rate ,percentage of mechanically ventilated patients and icu length of stay of covid 19 patients admitted in intensive care unit.

Previous studies suggested that cytokine release syndrome could be involved in the pathophysiology of critical SARS.COV.2 resulting in death so early suppression of cytokine storm may be lifesaving in critical patients.

Eligibility criteria: Inclusion Criteria:

* All icu admitted covid 19 patients with positive PCR, diagnosed by CT chest and needing oxygen therapy

Exclusion Criteria:

* Not requiring oxygen therapy
* Negative PCR
* Uncontrolled blood sugar or DKA
* Patients on long term steroids therapy

Primary outcomes:
measure: 28 days mortality rate
timeFrame: 1 month
Secondary outcomes:
measure: mechanical ventilation and icu length of stay
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university hospitals
city: Cairo
country: Egypt
facility: Faculty of medicine, Ain Shams University
Study officials:
References:
Clinical trial NCT03766282: Pharmacokinetics in Extracorporeal Membrane Oxygenation
Official title: Pharmacokinetics of Antibiotics, Sedative and Analgesic During Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Extracorporeal Membrane Oxygenation
Pharmacokinetics
Keywords: Pharmacokinetics
extracorporeal membrane oxygenation
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are undergoing ECMO

Brief summary: The main purpose of the present study is to investigate the risk factors that affect drug pharmacokinetic (PK) during extracorporeal membrane oxygenation (ECMO). To advance understanding of PK variance and improve the patients outcomes during ECMO.

Detailed description: Ex vivo experiments for drug stability testing and ECMO circuits testing in animal models.PK studies in healthy animals and critically ill animal models with or without ECMO to define the PK alterations. Clinical PK studies in critically ill patients on ECMO.

Eligibility criteria: Inclusion Criteria:

* Patients who are undergoing ECMO for respiratory and or cardiac dysfunction
* Clinical indication for the antibiotics
* Clinical indication for the sedatives and analgesics

Exclusion Criteria:

* No consent
* Known allergy to study drug
* Pregnancy
* Massive fluid resuscitation (\>50% blood volume transfused) in the previous 8 hours.
* Therapeutic plasma exchange in the preceding 24 hours

Primary outcomes:
measure: The median observed peak concentration(Cmax)
timeFrame: one-dose period
measure: The median observed through concentration(Cmin)
timeFrame: one-dose period
measure: Volume of distribution(Vd)
timeFrame: one-dose period
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: one-dose period
measure: Inter-compartmental clearance (Q)
timeFrame: one-dose period
measure: Clearance(CL)
timeFrame: one-dose period
Secondary outcomes:
measure: Development of strategies for drug administration in critically ill patients receiving ECMO
timeFrame: one-dose period
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Chen Wang
role: STUDY_CHAIR
References:
citation: Wang Q, Zhang Z, Liu D, Chen W, Cui G, Li P, Zhang X, Li M, Zhan Q, Wang C. Population Pharmacokinetics of Caspofungin among Extracorporeal Membrane Oxygenation Patients during the Postoperative Period of Lung Transplantation. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e00687-20. doi: 10.1128/AAC.00687-20. Print 2020 Oct 20.
Clinical trial NCT01107782: Sildenafil and Uteroplacental Perfusion
Official title: Phase 2 Study of Fetal Growth Retardation Treatment by Sildenafil
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Fetal Growth Retardation
Keywords: sildenafil
FGR
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-04-21
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether sildenafil is effective and safe in the treatment of fetal growth restriction.

Detailed description: Fetal growth retardation affects up to 8% of all pregnancies and has massive short term (increased fetal morbidity and mortality) and long-term (increased incidence of cardiovascular disorders in adulthood) health implications.

Doppler waveform analysis of these pregnancies suggests compromised uteroplacental circulation and placental hypoperfusion.

Our aim is to assess if sildenafil citrate could improve vasodilatation in FGR pregnancies.

Sildenafil citrate may offer a potential therapeutic strategy to improve uteroplacental perfusion in FGR.

Animal studies suggest that phosphodiesterase-5 (PDE5) inhibitors, such as sildenafil citrate, may improve uterine blood flow .

Eligibility criteria: Inclusion Criteria:

* FGR pregnancies in 24-37 weeks of GA

Exclusion Criteria:

* vasodilator agents usage
* history of cardiovascular morbidity specially of right heart side
* drug or alcohol abusers
* systolic BP more than 210 mm Hg or diastolic BP more than 120 mm Hg

Primary outcomes:
measure: Uteroplacental Perfusion
timeFrame: 2 hours after sildenafil ingestion
Secondary outcomes:
measure: fetal growth
timeFrame: after 6 months
measure: umbilical artery blood gass assessment
timeFrame: immediately after birth
measure: effect on fetal well being
timeFrame: 2 hours after sildenafil
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran UMS
Study officials:
affiliation: Iranian's ministery of health
name: marzieh vahid dastjerdi, M.D.
role: STUDY_CHAIR
affiliation: resident of OB&GYN
name: Sayedeh Afagh Hosseini, MD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01855282: Assessment of an Intervention to Prevent Obesity and Diabetes in Latino Farm Workers
Official title: Pasos Saludables: A Pilot Intervention to Prevent Obesity and Diabetes Among Latino Farm Workers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Diabetes Type II,
Overweight,
Obesity,
Behavioral Intervention,
Latino, farm worker
randomized controlled intervention
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study to assess the effectiveness of a culturally appropriate behavioral intervention to reduce obesity levels and ultimately the risk of developing diabetes type II in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into an intervention or control arm of the study. The intervention participants received weekly classes for 10 weeks with education on diabetes, diet and physical activity and practical exercises. Both control and intervention were measured for weight, waist circumference, fasting blood glucose and interviewed before and after the study intervention. The main hypothesis was that intervention, but not control participants, would experience reduction in body measurements after the intervention.

Detailed description: A more detailed description is not desired as noted above.

Eligibility criteria: Inclusion Criteria:

* Aged 18 -60
* BMI between 20 -38
* Willing to attend 10 weekly education sessions
* Able to speak and understand Spanish
* Have medical insurance

Exclusion Criteria:

* Fasting blood glucose about 126mg/dL unless physician attests fit to participate
* Pregnancy or trying to conceive, or breastfeeding
* Diabetic
* On therapeutic diets
* On medications that affect weight
* If spouse / cohabitant already in the study
* Not a farm worker working for the Reiter Affiliated Companies

Primary outcomes:
measure: Change in BMI
timeFrame: Before intervention and after (12-14 weeks after first assessment)
Secondary outcomes:
measure: Change in Waist Circumference
timeFrame: Measured before and after intervention (12 - 13 weeks after first assessment
Other outcomes:
measure: Change in fasting blood glucose
timeFrame: Measured before intervention and after (12-13 weeks after first assessment)
Locations:
city: Oxnard
country: United States
facility: Reiter Affiliated Companies
state: California
city: Watsonville
country: United States
facility: Reiter Affiliated Companies
state: California
Study officials:
affiliation: University of California, Davis
name: Marc B Schenker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitchell DC, Andrews T, Schenker MB. Pasos Saludables: A Pilot Randomized Intervention Study to Reduce Obesity in an Immigrant Farmworker Population. J Occup Environ Med. 2015 Oct;57(10):1039-46. doi: 10.1097/JOM.0000000000000535.
Clinical trial NCT01530282: Non-invasive Measurements of Elastance and Resistance
Official title: Non-invasive Respiratory Mechanics Assessment During Spontaneous / Assisted Breathing: The ERNI (Elastance, Resistance, Non Invasive Measurements) Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Respiratory Insufficiency
Keywords: Respiratory Insufficiency [C08.618.846]
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 15
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 study aims to assess the agreement between respiratory mechanics parameters measured noninvasively by means of brief airways occlusions at the beginning of inspiration and the reference parameters obtained with standard techniques of esophageal and gastric pressure under static and dynamic conditions in a mixed population of ICU patients mechanically ventilated in pressure support ventilation mode.


Eligibility criteria: Inclusion Criteria:

* intact respiratory drive;
* PaO2/FiO2 ratio \> 150 with a positive end-expiratory pressure (PEEP) ≤ 8 cmH2O;
* pH between 7.35 and 7.45;
* patient alert, conscious, and cooperative with a Glasgow Coma Scale ≥ 10.

Exclusion Criteria:

* infection, sepsis or septic shock; (with fever no)
* hemodynamic instability;
* respiratory centres depression;
* esophageal deformity, or gastric/esophageal illnesses;
* previous recent gastric/esophageal surgery.

Primary outcomes:
measure: Non-invasive respiratory mechanics measurement
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesia and Intensive Care Medicine, University of Turin, Italy
name: Vito Marco VM RANIERI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05969782: The Enzen Trial: Comparison of Evar Endoprosthesis: Endurant Versus Zenith
Official title: The Enzen Trial: Comparison of EVAR Outcomes With Endurant Versus Zenith Endoprosthesis: a Prospective Analysis.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aortic Aneurysm
Aortoiliac Atherosclerosis
Keywords: aneurysm
aortic
aortic disease
Lead sponsor: Hospital do Servidor Publico Estadual
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PAtiens with infra-renal aortoiliac aneurysms submitted to EVAR.

Brief summary: A prospective, non-randomized trial of patients submitted to EVAR for aortoiliac aneursym using Endurant II (Medtronic) or Zenith (Cook).

Detailed description: A prospective, non-randomized trial of patients submitted to EVAR for aortoiliac aneursym using Endurant II (Medtronic) or Zenith (Cook).

The patients will be evaluated in a follow-up, regarding overall mortality rate, perioperative mortality rate and outcomes, such as Endoleaks and reinterventions.

Eligibility criteria: Inclusion Criteria: Aortoiliac infra-renal aneurysms.

-

Exclusion Criteria: Thoracoabdominal aortic aneurysms, pararenal and supra-renal aortic aneurysms

* Patients not suitable for EVAR.

Primary outcomes:
measure: Perioperative Mortality rate
timeFrame: 30 days
Secondary outcomes:
measure: Reinterventions
timeFrame: 2 years
measure: Endoleaks
timeFrame: 2 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Servidor Público Estadual de São Paulo
state: SP
Study officials:
References:
Clinical trial NCT04140682: Proportional Assisted Ventilation and Pressure Support Ventilation in Adult Patients With Prolonged Ventilation
Official title: Comparison of Proportional Assisted Ventilation and Pressure Support Ventilation in Adult Patients With Prolonged Mechanical Ventilation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Respiration, Artificial
Keywords: Proportional assist ventilation
Pressure support ventilation
Weaning
Prolonged mechanical ventilation
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective randomized controlled trial was conducted to collect patients with prolonged mechanical ventilation. Patients were randomly assigned to receive PAV+ or PSV as weaning mode. Weaning outcomes were compared between 2 groups.

Detailed description: Pressure support ventilation (PSV) the most frequently used mode of ventilator support in intensive care units, but has several demerits. Proportional assist ventilation with load-adjustable gain factors (PAV+) is a promising mode with better patient synchrony and weaning advantages. However, weaning outcome of PAV+ in patients with prolonged mechanical ventilation has not been evaluated before. We conducted a prospective randomized controlled trial in a tertiary medical center. This study aimed to compare the effectiveness between PAV+ and PSV for weaning adult patients with prolonged mechanical ventilation.

Eligibility criteria: Inclusion Criteria:

* Patients with prolonged mechanical ventilation and transfer to respiratory care center, age of 20 years or older, at least 1 time of extubation failure or spontaneous breathing trial failure in ICU, stable hemodynamics, no vasopressor use, FiO2 = 0.40 or less, external positive end-expiratory pressure = 5 cmH2O or less, PaO2 \> 60 mmHg, and body temperature \< 38ºC (within 24 hours).

Exclusion Criteria:

* Patients with bronchopleural fistulas, central neurological disorders, hemodialysis, and those with pressure support level already \< 15 cmH2O.

Primary outcomes:
measure: 28-day weaning success rate
timeFrame: 28 days
Secondary outcomes:
measure: Weaning duration
timeFrame: up to 28 days
measure: Hospital length of stay
timeFrame: up to 123 days
measure: Weaning success at discharge
timeFrame: up to 123 days
measure: Hospital mortality
timeFrame: up to 123 days
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Chiu-Fan Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04729582: Autologous Muscle Stem Cell Therapy for Treatment of Congenital Urinary Incontinence in Epispadias Patients
Official title: Combined Phase 1 and 1/2a Clinical Trial Evaluating the Safety and Efficacy of an Autologous Muscle Stem Cell Therapy in the Treatment of Urinary Incontinence in Isolated Epispadias
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Urinary Incontinence
Epispadias, Male
Keywords: Isolated epispadias
Urinary incontinence
Muscle stem cell therapy
Autologous cell therapy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2021-01-28
Enrollment: 21
Sex: MALE
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized placebo-controlled clinical trial
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to evaluate the safety and efficacy of an autologous muscle stem cell therapy in the treatment of congenital urinary incontinence in isolated epispadias.

Detailed description: Epispadias is the mildest form of exstrophy-epispadias complex (EEC); a congenital malformation disorder involving the midline abdominal and genitourinary structures. Patients with epispadias have a defect in the urethral sphincter resulting in urinary incontinence. This trial investigates the injection of autologous primary human muscle stem cells into the urethral sphincter with the aim of repairing the defect and restore the anatomic ability for continence.

Eligible participants will undergo muscle biopsy during a routine cystoscopy. Acquired muscle tissue is used for the isolation and expansion of muscle stem cells ex-vivo. Muscle stem cells are injected into the urethral sphincter under visual control using cystoscopy. Participants are assessed for safety and efficacy for a minimum of 12 months post-intervention.

Eligibility criteria: Inclusion Criteria:

* Male
* Isolated epispadias
* Aged ≥ 3 years
* Urinary incontinence as defined according to the International Children´s Continence Society
* Informed consent

Exclusion Criteria:

* Acute or chronic inflammatory local or systemic disease
* Coagulation Disorder
* Previous adverse reaction to anesthesia
* Congenital heart defect, cardiac arrhythmia

Primary outcomes:
measure: Prevalence of Intervention-related Adverse Events
timeFrame: Upto 12 months post-intervention
measure: Change in Leak Point Pressure (LPP)
timeFrame: Six months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Clinic for Pediatric Urology in cooperation with University Hospital Regensburg, St. Hedwig Hospital
city: Ulm
country: Germany
facility: Pediatric Urology, Department for Urology University of Ulm
Study officials:
affiliation: Pediatric Urology, Department for Urology University of Ulm, Germany
name: Anne K Ebert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: