louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06721455: Modeling Blood Management and Hemolytic Risk in Pediatric Heart Surgery
Official title: Mathematical Modeling of Salvaged Red Blood Cells-based Blood Management Strategy and Their Hemolytic Risk in Pediatric Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Surgery
Blood Transfusion
Hemolysis
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients under 18 years of age undergoing cardiac surgery with clear prime on cardio-pulmonary bypass (CPB) at Boston Children's Hospital (BCH).

Brief summary: This study aims to learn more about blood management in children undergoing heart surgery, such as the right amounts, and the best blood products, to administer. It also aims to develop a mathematical model that may help researchers better predict and treat patients who need blood transfusions during heart surgery.


Eligibility criteria: Inclusion Criteria:

* pediatric patients under 18 years of age undergoing cardiac surgery with clear prime on cardio-pulmonary bypass (CPB) at Boston Children's Hospital (BCH).

Exclusion Criteria:

* patients with known hemolytic disorders, patients on nitric oxide preoperatively, and patients found to have abnormal coagulation on routine preoperative assessment. Patients receiving heparin, American Society of Anesthesia (ASA) status, apixaban, warfarin, or bivalirudin held appropriately (i.e. for elective surgery) will not be excluded

Primary outcomes:
measure: Intraoperative hemolysis during pediatric cardiac cardio-pulmonary bypass (CPB) cases as assessed using the plasma free hemoglobin assessment
timeFrame: 1 day (during cardio-pulmonary bypass)
Secondary outcomes:
measure: In vitro salvaged red blood cells (RBCs) co-incubation with patients' plasma for hemolysis assessment compared to patients' baseline RBCs
timeFrame: 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Koichi Yuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01049555: Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research
Official title: Contribution of Actigraphy and Recognition Video in Apathy Assessment of Alzheimer's Disease : Experimental Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: alzheimer
apathy
actigraphy
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Neuropsychiatric symptoms form part of the clinical picture of Alzheimer's disease (AD) and other dementias. Irrespective of the severity of the disease, the most frequently encountered symptom is apathy. Apathy is increasingly diagnosed in patients with neurological and psychiatric conditions. Apathy is a disorder of motivation, defined as "the direction, intensity and persistence of goal-directed behaviour". Most of the current descriptions acknowledge this point and consider apathy in terms of a lack of goal-directed behaviour, cognition or emotion. The classical neuropsychiatric symptom assessments are subjective structured interview-based, using input from the caregiver and/or the patient. New technologies are likely to provide us with a more objective measure. An example is ambulatory actigraphy, consisting of a piezoelectric accelerometer designed to record arm movement in three dimensions.

The aim of the present study is to assess using actigraphy and video recording signal, AD patients with (n = 15) and without (n = 15) apathy and control subjects (n = 5) during an activity of daily living scenario .


Eligibility criteria: Inclusion Criteria:

* male or female, \> 65 years ;
* Alzheimer's disease according to the NINCDS-ADRDA criteria (McKhann,Drachman et al. 1984) ;
* Mini Mental Test Examination (MMSE) \> 20 ;
* no motor anomaly according to UPDRS III (tremblements, rigidité musculaire) ;
* no depression criteria according to DSM IV-R criteria ;
* patient with a cholinergic treatment at dose stable since 3 months ;
* patient with social insurance ;
* signature of informed consent.

Exclusion Criteria:

* neuropsychologics assessment impossible due to sensorial and disrupt ;
* prescription of psychotrop treatment (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week previous actigraphy recording.

Primary outcomes:
measure: assessment of motricity
timeFrame: one time point - at the only visit of protocol
Secondary outcomes:
measure: video recording
timeFrame: one time point - at the only visit of the protocol
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
affiliation: Nice University Hospital
name: Philippe ROBERT, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00785655: Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower - Compatibility
Official title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To demonstrate the absence of irritation potential (primary dermical irritability and cumulated dermical irritability) and allergy (sensibilization) of the product Dermacyd PHDETINLYN Sweet Flower.


Eligibility criteria: Inclusion criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunossupression drugs
* Personnel history of atopy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

* History of sensitivity or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT02721355: Effect of Chicken Egg Antibody (IgY) on Patients With Chronic Gastritis
Official title: Evaluation of a Health Food Supplement Containing Anti-Helicobacter Pylori Urease IgY Antibody on Patients With Chronic Gastritis in Hanoi, Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Gastritis Caused by Helicobacter Pylori
Keywords: Chronic gastritis
Gastric ulcer
Helicobacter pylori
IgY
Lead sponsor: Immunology Research Institute in Gifu
Sponsor class: INDUSTRY
Collaborators: name: Dong Do Pharmaceutical Co.
First posted: 2016-03-29
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: H. pylori positive patient volunteers that passed the selection criteria are recruited and divided into a test and a control group. Both groups are treated with a current treatment regime (EAC: Esomeprazole 40 mg/day; Clarithromycin 1000 mg/day; Amoxicillin 2000 mg/day) but only the test group received IgY-containing food supplement as an adjunctive measure for 15 days. The subjects are examined before and 4 weeks after the treatment initiation by Urea Breath Test (UBT) and gastro-endoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients with gastritis or gastric ulcer who are positive to H. pylori

Exclusion Criteria:

* People allergic to egg proteins

Primary outcomes:
measure: UBT Values at Baseline and 8 Weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants With a Reduction in Severity of Abdominal Pain at 1 and 4 Weeks
timeFrame: 4 weeks
measure: Number of Participants With a Reduction in Gastrointestinal Symptom Rating Scale (GSRS) Scores at 1 and 4 Weeks
timeFrame: 4 weeks
Other outcomes:
measure: Number of Participants With Reduced Bloating After 1 Week
timeFrame: 1 week
Locations:
city: Hanoi
country: Vietnam
facility: 108 Military Central Hospital
Study officials:
affiliation: Dept. of Diagnostic Endoscopy, 108 Military Central Hospital, Hanoi, Vietnam
name: Khien V Vu, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01053455: Observational Crossover Study Comparing Oxygenation and Ventilation Using SiPAP Versus CPAP in LBW Infants
Official title: Observational Crossover Study Comparing Oxygenation and Ventilation Using Biphasic CPAP (SiPAP) Versus CPAP to Treat Respiratory Distress in Low Birth Weight Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilation
Respiratory Distress Syndrome
Keywords: Non-invasive ventilation
SiPAP
CPAP
low birth weight infants
respiratory distress syndrome
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: low birth weight infants

Brief summary: Investigation of effects of SiPAP versus NCPAP on oxygenation and ventilation in LBW infants with respiratory distress. Our hypothesis is that the LBW infants will achieve the same level of oxygenation and improved ventilation when being treated with SiPAP as compared to NCPAP.


Eligibility criteria: Inclusion Criteria:

1. LBW infant (birth weight \<2500 grams)
2. Currently on nasal CPAP
3. Use of nasal CPAP for \>24 hours prior to study initiation
4. If history of intubation with mechanical ventilation, patient will be extubated \>24 hours prior to study initiation
5. FiO2 requirement of 25-50%

Exclusion Criteria:

1. FiO2 requirement \>0.5
2. Congenital defects/deformities of the head, pulmonary or cardiovascular systems
3. Chromosomal abnormalities/genetic syndromes
4. Active medical treatment for symptomatic PDA
5. Active medical treatment for culture proven sepsis
6. Within 24 hours of invasive surgical procedure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Childrens Hospital and Clinics of MN - St. Paul
state: Minnesota
Study officials:
affiliation: Childrens Hospitals and Clinics of MN - St. Paul
name: Andrea Lampland, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lampland AL, Plumm B, Worwa C, Meyers P, Mammel MC. Bi-level CPAP does not improve gas exchange when compared with conventional CPAP for the treatment of neonates recovering from respiratory distress syndrome. Arch Dis Child Fetal Neonatal Ed. 2015 Jan;100(1):F31-4. doi: 10.1136/fetalneonatal-2013-305665. Epub 2014 Aug 1.
Clinical trial NCT02427555: Effects of Barley Based Food Products on Metabolism and Gut Microflora
Official title: Effects of Barley Based Food Products on Metabolism and Gut Microflora
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2015-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The main objective is to investigate gut microflora composition in relation to cardiometabolic risk markers, and to investigate the effects of 3 days intervention with a barley kernel based product on these variables.

Detailed description: 100 subjects were invited to deliver faecal samples. From this cohort 40 subjects were chosen based on their gut microflora composition to participate in the Barley intervention.

Eligibility criteria: Inclusion Criteria:

* healthy men and women between 50-79 years and
* BMI between 19-28.

Exclusion Criteria:

* fasting blood glucose concentrations \> 6,1 mmol/L,
* known metabolic disorders or gastrointestinal diseases or other disorders that can interfere with the results of the study.
* furthermore, the subjects should be non-smokers and
* consume a normal (non-vegetarian) diet as is recommended by the Nordic dietary guidelines.
* antibiotics or probiotics should not have been taken during four weeks prior to faeces donation.

Primary outcomes:
measure: Changes in glucose regulation
timeFrame: Changes in fasting and postprandial blood glucose concentrations after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread
measure: Changes in colonic microbiota composition after intervention with barley
timeFrame: Changes in colonic microbiota composition after 3 days intervention with a barley based bread in comparison to 3 days intervention with a white wheat based bread
measure: nucleotide polymorphisms (SNP in TCF7L2)
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Food for Health Science Centre, Medicon Village, Lund University
Study officials:
affiliation: Food for Health Science Centre, Medicon Village, Lund University
name: Anne Nilsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandberg J, Kovatcheva-Datchary P, Bjorck I, Backhed F, Nilsson A. Abundance of gut Prevotella at baseline and metabolic response to barley prebiotics. Eur J Nutr. 2019 Sep;58(6):2365-2376. doi: 10.1007/s00394-018-1788-9. Epub 2018 Jul 25.
Clinical trial NCT03490955: Effects of Black Pepper on the Absorption of Nutrients in Vegetables
Official title: Effects of Black Pepper on the Absorption of Nutrients in Vegetables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Black Pepper
Absorption
Carotenoid
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this project is to determine the extent to which eating black pepper together with vegetables increase the absorption of carotenoids (a class of important nutrients) in the vegetables such as beta-carotene.

Detailed description: Black pepper has multiple health-promoting effects, many of which are associated with the relatively high levels of piperine it contains. Piperine can enhance the oral bioavailability of nutraceuticals in foods due to its inhibitory activity on drug metabolizing enzymes such as cytochrome P450 and p-glycoprotein in the gastrointestinal mucosa. This decreases the first-pass metabolism of nutraceuticals thus increasing their levels in the systemic circulation. Numerous studies in both animals and humans have validated the efficacy of piperine in boosting nutraceutical bioavailability. However, most of these studies utilized highly purified sources of both piperine and nutraceuticals, and therefore do not provide direct evidence on the ability of black pepper (used as a spice) to enhance the bioavailability of nutraceuticals in real foods.

Eligibility criteria: Inclusion Criteria:

* 18-30 year old healthy adults

Exclusion Criteria:

* those who are \<18 or \>30 years old, have a BMI of \<20 or \>29 kg/m2, have a weight change \>4.5 kg (9.91 pounds) in the past 3 months, exceed exercise activities of a recreational level over the past 3 months, have any diseases, especially intestinal disorders including lipid malabsorption or lactose intolerance, had abnormal liver or kidney function tests.
* Those who smoke, consume more than two alcoholic drinks per day, use medication affecting lipid profiles or dietary supplements affecting plasma cholesterol (e.g., Benocol or fiber supplements) will also be excluded.
* Additionally, this study excludes menopausal women, those using hormone-based contraceptives, those with abnormal menstrual cycles, and those who are pregnant, lactating or planning to become pregnant.

Primary outcomes:
measure: Determine the level of carotenoids in blood
timeFrame: 12-16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amherst
country: United States
facility: Institute for Applied Life Sciences
state: Massachusetts
Study officials:
References:
Clinical trial NCT01608555: Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis
Official title: Tobramycin 300 mg o.d. Aerosol in in Adult Patients With Cystic Fibrosis: Pilot Study on Antimicrobial Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
bacterial load
inhaled tobramycin
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2012-05-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will include 10 adult patients with cystic fibrosis. The aim of the study is to evaluate whether Tobramycin 300 mg aerosol once-a-day for 28 days can reduce the bacterial load in the airways. Secondary end-point is the evaluation of variation in bacterial susceptibility during and at the end of study period.

Detailed description: Ten adult patients with cystic fibrosis will be enrolled in a stable phase and will received prophylaxis with aerosol of Tobramycin 300 mg once a day for 28 days.

Eligibility criteria: Inclusion Criteria:

* Outpatients, male and female, age range 18-45 years
* Diagnosis of cystic fibrosis
* FEV1 \>50% predicted.
* sputum samples available
* Chest x ray negative for pneumonia and tuberculosis
* Informed consent

Exclusion Criteria:

* Allergy to tobramycin
* Use of systemic steroids in the previous 2 weeks
* Pregnancy or breast feeding
* Treatment with other experimental drug in the previous 3 months

Primary outcomes:
measure: Evaluation of bacterial load decrease
timeFrame: day 7-9 vs day 1, day 14-16 vs day 7-9, day 28-30 vs day 14-26
Secondary outcomes:
measure: Evaluation of inflammatory serum biomarker
timeFrame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
measure: Evaluation of serum biomarker
timeFrame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
measure: Evaluation of serum biomarker
timeFrame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
measure: evaluation of serum biomarker
timeFrame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale Maggiore Policlinico via F. Sforza 35
Study officials:
affiliation: University of Milan Italy
name: Giovanna Pizzamiglio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01521455: Therapeutic Equivalence Study of HCP0910 250/50 Mcg to Seretide 250 Diskus in Asthmatic Patients
Official title: A Phase I, Randomized, Open, Multi-center, Cross Over Study to Evaluate the Therapeutic Equivalence of Repeated Dose of HCP0910 250/50 μg to SeretideTM 250 DiskusTM in Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide 250 Diskus when repeatedly dosed to Asthmatic patients.


Eligibility criteria: Inclusion Criteria:

* age 20 \~ 75 inclusive
* Asthmatic diagnosis in more than 12 weeks from screening day
* Shows more than 12 % increase, and 200mL increase in FEV1 measure on Visit 2

Exclusion Criteria:

* Maintain controlled asthma for more than 4 weeks before screening
* Diagnosed as a severe asthmatic patients

Primary outcomes:
measure: mean change of morning predose FEV1 from baseline
timeFrame: day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
state: Gyunggi -do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyunggi -do
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
city: Seoul
country: Korea, Republic of
facility: Seoul National University
Study officials:
affiliation: Hanmi Pharmaceutical Co.
name: Kyung-mi Park, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT02658955: Changing Technique of Abdominal Wall Closure (PHACPA)
Official title: Changing Technique of Abdominal Wall Closure According to European Hernia Society (EHS) Guidelines in a General Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Closure of Abdominal Wall
Keywords: Abdominal wall closure
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 1164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Implementing guidelines of EHS for abdominal wall closure in all specialities of a General Hospital. Migrating from large stitch technique to short stitch technique.

Detailed description: Surgeons will receive instruction about new techniques of closure of the abdomen and will practice in models and receive a certification previously to implement in their surgical practice the new technique.

Results will be monitorised and compared with previous cohort of patients. A protocol of closure will be implemented. Patients without risk factors will receive a laparotomy closure with "short stitch" technique and patients with risk factor for developing incisional hernia or burst abdomen and aditional profilactic suprafascial mesh.

Eligibility criteria: Inclusion Criteria:

* Patients operated on by laparotomy

Exclusion Criteria:

* Previous mesh
* Concomitant hernia repair

Primary outcomes:
measure: Incisional hernia and burst abdomen rate
timeFrame: One year
Secondary outcomes:
measure: Rate of fulfillment of the protocol
timeFrame: One year
measure: Complication rate
timeFrame: One month
measure: Mesh complications rate
timeFrame: One year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: José A. Pereira
Study officials:
affiliation: Surgeon
name: José A. Pereira, MD
role: PRINCIPAL_INVESTIGATOR
References: