louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06382740: Selection Protocol for Liver Transplantation in Patients Aged Over 70 Years
Official title: Prospective Evaluation of a Selection Protocol for Patients Over 70 Years Old for Liver Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End Stage Liver DIsease
Liver Transplantation
Old Age
Keywords: liver transplantation
old recipients
age>70 years
Lead sponsor: Azienda Ospedaliera di Padova
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 18
Sex: ALL
Minimum age (years): 71
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive candidates for liver transplant with age \>70 and ≤ 75 years

Brief summary: Increased life expectancy and aging population has led to a trend of increasing liver transplant (LT) volume in the elderly. Nowadays, advanced age is not considered an absolute contraindication for LT but elderly LT candidates typically have an age-associated burden of comorbid conditions that can pose several clinical challenges during the selection/evaluation process for LT. Specific algorithms for elderly patient selection for LT are not well established; however, consensus agreement is that elderly LT candidates need a more rigorous selection process.

This study proposes a "step by step" algorithm of selection for liver transplant candidates more than 70 years.


Eligibility criteria: Inclusion Criteria:

* Age \>70 years and ≤ 75 years
* Liver transplant from cadaveric donor
* First liver transplant
* End stage liver disease or liver tumor

Exclusion Criteria:

* Age ≤ 70 years
* Living donor liver transplant
* Previous liver transplant
* Liver transplant for acute liver failure

Primary outcomes:
measure: 1 year patient survival
timeFrame: 12 months
Secondary outcomes:
measure: 1 year graft survival
timeFrame: 12 months
measure: 3 months mortality and morbidity
timeFrame: 3 months
Other outcomes:
Locations:
city: Padova
country: Italy
facility: U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
Study officials:
affiliation: Azienda Ospedaliera di Padova
name: Umberto Cillo, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05363540: Optimal Timing of Parasternal Intercostal Nerve Block Application for Acute Pain Management in Cardiac Surgery
Official title: Optimal Timing of Parasternal Intercostal Nerve Block Application (Pre-incisional Versus Post-incisional) for Acute Pain Management in Cardiac Surgery; a Randomized Double Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions, and the inability to cough due to median sternotomy. Therefore, duration of mechanical ventilation, length of intensive care unit (ICU) stay, and length of hospital stay of these patients will increase significantly.

many facial plane blocks have been introduced as simple and safe intervention for thoracic wall anesthesia and analgesia. Parasternal intercostal nerve block (PSIB) is a "superficial block" which involves local anesthetic (LA) infiltration in the intercostal space around the sternum where the anterior branches of intercostal nerves exist.

Intraoperative LA administration under direct vision of the surgeon ensures adequate delivery of drugs and minimizes bleeding complication or inadvertent administration in blood vessels. Meanwhile, Preoperative administration of LA guided by ultrasound imaging has been used in variable surgical settings with noticeable success because of preemptive inhibition of noxious stimuli.


Eligibility criteria: Inclusion Criteria:

* Age from 20-70 years,
* Scheduled to undergo elective cardiac surgeries through median sternotomy involving cardiopulmonary bypass (CPB).

Exclusion Criteria:

* Patients requiring preoperative inotropes, mechanical ventilation or intra-aortic balloon pump,
* patients who have previous cardiac surgery,
* prolonged CPB time (CPB\>120 minutes),
* Intubation time more than 12hrs or planned for overnight ventilation.
* Allergy to any of used drugs,
* opioids addiction,
* Chronic liver disease, chronic renal disease, and cognitive impairment.

Primary outcomes:
measure: Amount of rescue analgesia
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Intraoperative total fentanyl requirements
timeFrame: during surgery
measure: intraoperative mean arterial blood pressure (MAP)
timeFrame: during surgery (baseline, at skin incision, at sternotomy, at sternal retraction)
measure: pain score (VAS)
timeFrame: at extubation, 12th, 16th, 20th, and 24th hour postoperative
measure: adverse effects
timeFrame: 24 hours postoperative
measure: patient satisfaction
timeFrame: 28 hours postoperative
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Samar Rafik Amin
state: Qalubia
Study officials:
References:
Clinical trial NCT02855840: Auto-immune Diseases and Quality of Life
Official title: Qualitative Study of the Consequences of Auto-immune Diseases on Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Auto-immune Diseases
Quality of Life
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM)

Brief summary: Systemic lupus erythematous (SLE), systemic sclerosis (Ssc) and inflammatory myopathy (IM) are rare diseases, whose prevalence is estimated at 43, 15 and 10 cases, respectively, for 100 000 inhabitants in France. These diseases belong to the group of auto-immune diseases and require specialized follow-up in an expert centre. The repercussions of SLE, Ssc and IM on the everyday life of patients are heavy, and notably linked to skin involvement, to diminished functional capacities and psychological problems. The vast majority of these diseases concern middle-aged, professionally-active individuals, for whom the socio-professional repercussions are major and too often neglected. The aim of this study is to analyse the consequences of auto-immune diseases on quality of life. Current quality of life questionnaires are not suitable, and do not reveal the reality of the situation and its different nuances. In this research, the quality of life of patients will be envisaged through their everyday lives. How do these patients construct the social reality of the disease? How do they perceive their health status and their social situation? How do they organize their everyday lives around the disease: work, leisure, relationships with their entourage... ?


Eligibility criteria: Inclusion Criteria:

* For all patients:
* Patients aged 18 to 75 years
* Patients able to understand written and spoken French
* Patients who have been given oral and written information about the research

For patients with SLE:

- SLE defined by American College of Rheumatology (ACR) 1997 criteria

For patients with systemic sclerosis:

- SSc according to the Leroy or American Rheumatism Association (ARA) criteria

For patients with IM:

- IM according to the Trojanov criteria

Exclusion Criteria:

* Refusal to take part in the study
* Cognitive/psychological status incompatible with interviews

Primary outcomes:
measure: semi-directive individual interviews in the 3 groups of patients
timeFrame: day one
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT02047240: Renal Function Determination in Patients With Liver Cirrhosis
Official title: Renal Function Determination With Creatinine and Cystatin C Dependent Formulas Compared to Gold Standard DTPA-TC-99 (Diethylene-triamine-pentaacetate- Technetium-99) in Mexican Cirrhotic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Keywords: liver cirrhosis
glomerular filtration
cystatin C
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be selected from the Liver Clinic from the Gastroenterology Department at a tertiary care center in Mexico

Brief summary: We have several ways to appropriately determine renal function in healthy patients and in several diseases, in cirrhotic population we dont have a precise tool that has sufficient precision that reflects glomerular function, although it has been reported that cystatin C, because of its nature could improve diagnostic accuracy to determinate the renal function in this population.

The investigators hypothesize that glomerular filtration obtained from cystatin-C-derived formulas are more accurate when compared to creatinine-derived formulas with DTPA-Tc99 (diethylene-triamine-pentaacetate- technetium-99) as gold standard.

Detailed description: The aim of the study is to determine if the formulas for glomerular filtration are close to the estimation of actual renal function in mexican cirrhotic patients of different etiologies.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis
* Stability in creatinine levels in the previous three months (variation \<0.3 mg/dL)
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Hepatocellular carcinoma
* Cerebrovascular events
* Decompensated heart failure
* Drugs that modify serum creatinine levels
* Renal replacement therapy

Primary outcomes:
measure: Levels of glomerular filtration through several formulas in cirrhotic patients
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
state: DF
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Aldo Torre, MD MSci
role: STUDY_DIRECTOR
References:
Clinical trial NCT04443140: Preeclampsia-like Syndrome Induced by COVID-19: Is it a Real Public Health Issue in Pregnancy During the Pandemic?
Official title: Evaluation of COVID-19 Incidence in Patients With Preeclampsia During Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Preeclampsia
Pregnancy Related
Keywords: covıd-19
pregnancy
preeclampsia
preeclampsia-like syndrome
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: First consecutive 100 preeclamptic pregnant women applied to our hospital during covid-19 pandemic

Brief summary: By applying polymerase chain reaction (PCR) test for Covid-19 to preeclampsia patients who applied to our hospital during the Covid-19 pandemic period, we investigated the frequency of Covid-19 related preeclampsia-like syndrome in this patient group.

Detailed description: The investigators studied the frequency of Covid-19 related preeclampsia-like syndrome by PCR test and lung ultrasound for Covid-19 to preeclampsia patients presenting to the instutution during the Covid-19 pandemic period. The first consecutive 100 preeclampsia patients presented to our hospital during the pandemic will be involved in our study. The primary outcome measure is to detect Covid-19 positivity among the preeclamptic pregnant women..

Eligibility criteria: Inclusion Criteria:

* First consecutive 100 pregnant women presenting with preeclamptic symptoms and signs between March 15, 2020 and June 1, 2020.

Exclusion Criteria:

* The pregnancies with known diagnosis of preeclampsia before Covid-19 pandemic
* Preeclamptic patient without a Covid-19 PCR test result
* Pregnant women who does not want to participate in study or does not want their personal informations to be shared
* Pregnant women less than 18 years old and more than 40 years old are excluded

Primary outcomes:
measure: PCR positivity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Zeynep Kamil Maternity and Childrens Training and Research Hospital
Study officials:
affiliation: Zeynep Kamil Maternity and Childrens Hospital Training and Research Hospital
name: Resul Karakus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mendoza M, Garcia-Ruiz I, Maiz N, Rodo C, Garcia-Manau P, Serrano B, Lopez-Martinez RM, Balcells J, Fernandez-Hidalgo N, Carreras E, Suy A. Pre-eclampsia-like syndrome induced by severe COVID-19: a prospective observational study. BJOG. 2020 Oct;127(11):1374-1380. doi: 10.1111/1471-0528.16339. Epub 2020 Jun 21.
Clinical trial NCT00116740: Safety and Efficacy of APD356 in the Treatment of Obesity
Official title: A 12-Week, Dose-Ranging, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of APD356 in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: Serotonin
5-HT2c
Satiety
Obesity
Appetite suppressant
Weight Loss
Overweight
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-07-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c receptor agonist, in clinical development as a potential treatment for obesity.

The purpose of this study is to obtain a preliminary assessment of the safety and efficacy of APD356, when administered daily for 12 weeks, in obese subjects who are otherwise healthy. Subjects who are on concomitant medications for control of hypertension or blood lipids may qualify.

Detailed description: This is a double-blind, placebo-controlled, randomized, parallel group study. Three different doses of APD356 or placebo will be administered daily for 12 weeks, to obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Healthy male or nonpregnant, nonlactating females aged 18-65 years (inclusive)
* Body mass index (BMI) of 30-45 kg/m2
* Non-smoker
* No concomitant medications other than hypertension medications (stable \> 90 days) and/or statins (stable \> 90 days)
* No past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency
* No more than mild mitral valve regurgitation and absence of aortic valve regurgitation upon screening echocardiogram

Primary outcomes:
measure: Change in body weight
Secondary outcomes:
measure: Safety
measure: Changes in waist circumference, hip circumference, and waist/hip ratio
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
citation: Smith SR, Prosser WA, Donahue DJ, Morgan ME, Anderson CM, Shanahan WR; APD356-004 Study Group. Lorcaserin (APD356), a selective 5-HT(2C) agonist, reduces body weight in obese men and women. Obesity (Silver Spring). 2009 Mar;17(3):494-503. doi: 10.1038/oby.2008.537. Epub 2008 Dec 4.
Clinical trial NCT02663401: Impact of a Front-of-pack Nutrition Label on the Nutritional Quality of Purchases in Campus Cafeterias
Official title: Impact of a Front-of-pack Nutrition Label on the Nutritional Quality of Purchases in Campus Cafeterias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Labelling
Lead sponsor: University of Paris 13
Sponsor class: OTHER
First posted: 2016-01-26
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates the impact of the introduction of a front-of-pack nutrition label on fods and beverages sold in a campus cafeteria in France on the nutritional quality of purchases. The design involves one site with the intervention and one control site with the same consumer and product characteristics.

Detailed description: The introduction of front-of-pack nutrition labelling is thought to help consumers making healthier choices at the point of purchase.

Recently, the French government is considering the introduction of the 5-Colour Nutrition Label as a front-of-pack nutrition label.

Evaluations of the 5-CNL suggest it is efficient in helping consumers making healthier choices. However, its impact in vulnerable populations has not yet been tested.

Students are thought to be a vulnerable population due to their limited resources and to their unhealthy food choices.

The objective of the present study is to investigate the impact of the introduction of the 5-CNL in campus cafeterias on the nutritional quality of food purchases.

The intervention is conducted during several months, with another similar cafeteria serving as control for the intervention.

Data on purchases is collected regularly, and the nutritional quality of purchases is evaluated over time between the intervention situation and the control situation

Eligibility criteria: Inclusion Criteria:

* All subjects purchasing foods or beverages in the selected campus cafeterias

Exclusion Criteria:

* None

No individual data is collected. Only purchases data is collected (cash register sales data)

Primary outcomes:
measure: Overall nutritional quality of purchases
timeFrame: Every 15 days, up to 6 months
Secondary outcomes:
measure: Energy content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Saturated fat content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Sugar content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Sodium content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Fibers content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Protein content of purchases
timeFrame: Every 15 days, up to 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CROUS Nice - Toulon
Study officials:
References:
Clinical trial NCT04588701: Long Term Outcomes After Surgery for Anal Fistula
Official title: Long Term Outcomes After Surgery for Anal Fistula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fistula in Ano
Keywords: anal fistula
fistulotomy
ano-rectal advancement flap
sphincter saving
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all persons with anal fistulas treated by a single surgeon at the University of Michigan Hospital from January 1996 through December 2018

Brief summary: Anal fistula is a common condition with a wide variety of clinical presentations, which can make evaluation and treatment challenging and surgical outcomes uncertain. This study was undertaken to identify lessons learned in the surgical treatment of 483 patients over a 20- year period leading to a pragmatic approach to treatment of this condition.

Detailed description: The wide array of variations of anal fistulas makes them challenging both to classify and to treat. The aim of the study is to determine if a systematic approach to their evaluation and surgical treatment, regardless of how one wishes to classify them, can be based on careful assessment of sphincter length and of the anatomical and etiological characteristics of the fistula.

Eligibility criteria: Inclusion Criteria:

* anal fistulas

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of patients who heal after simple or staged operations for fistula
timeFrame: typically 1 year, but up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Richard E Burney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02036801: The Specific Elastance in ARDS Patients: a Pediatric Study
Official title: The Specific Elastance in ARDS Patients. Connections Between Volutrauma and Barotrauma - A Pediatric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric ARDS
Keywords: ARDS
Lung
Specific Elastance
Pediatric patients
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ARDS pediatric patients in mechanical ventilation or patients with healthy lung treated with mechanical ventilation for clinical purposes

Brief summary: Aim of this study is to assess lung specific elastance in a population of pediatric patients with Acute Respiratory Distress Syndrome (ARDS) treated with mechanical ventilation, and in a pediatric population of ICU patients with healthy lung which are treated with mechanical ventilation for other clinical purposes.


Eligibility criteria: Inclusion Criteria:

* ARDS (Berlin Definition Criteria) or mechanical ventilation in healthy lungs

Exclusion Criteria:

* Hemodynamic instability
* Lung diseases other than ARDS
* Parental refuse

Primary outcomes:
measure: Specific elastance of the lung
timeFrame: 10 minutes from the start of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCC Ca' Granda - Ospedale Maggiore Policlinico
Study officials:
References:
citation: Chiumello D, Chidini G, Calderini E, Colombo A, Crimella F, Brioni M. Respiratory mechanics and lung stress/strain in children with acute respiratory distress syndrome. Ann Intensive Care. 2016 Dec;6(1):11. doi: 10.1186/s13613-016-0113-0. Epub 2016 Feb 5.