louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02563652: Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery?
Official title: Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery? A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Inflammatory Response Syndrome
Keywords: Abdomen/surgery
Biological markers
Length of stay
Postoperative care
Anesthesia recovery period
Prognosis
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: University of Parma
name: Study in Multidisciplinary Pain Research Group, Italy
name: Fondazione IRCCS Policlinico San Matteo di Pavia
First posted: 2015-09-30
Enrollment: 101
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: Patients eligible for major abdominal surgery in St Olavs Hospital, Trondheim, Norway

Brief summary: Patients undergoing major surgery are exposed to extensive damage of tissues, which induces widespread activation of the inflammatory system, called 'systemic inflammatory response syndrome' (SIRS).This activation of the inflammatory system may induce instability of the heart and respiration in the postoperative period. The degree of physiologic response to postoperative SIRS as well as the degree of postoperative pain differ between patients. Therefore, patients undergoing anesthesia and major surgery are treated in a 'post anesthesia care unit' (PACU) after end of surgery.Admittance to a PACU is expensive. The time patients need to stay in a PACU after major surgery has not been extensively studied, and more appropriate tools for prediction of length of stay are needed.

The main aim of this study is to assess whether clinical observations, inflammatory biomarkers or genetic markers may aid in the prediction of physiological instability and/or pain after major surgery. Such predictors would help clinicians planning the length of PACU-stays.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing major abdominal surgery (e.g. Whipple's operation, liver resection, abdominoperineal resection, vascular abdominal surgery etc.)
* Scheduled for PACU stay first 24 hours

Exclusion Criteria:

* Pregnancy
* Jehovah's witness
* Dementia

Primary outcomes:
measure: Time to established circulatory stability for > 2 hours [Time to event outcome]
timeFrame: 48 hours
measure: Time to reaching a state of no or mild pain problem for > 2 hours [Time to event outcome]
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University of Parma
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Erik Solligård, phd md
role: STUDY_DIRECTOR
References:
Clinical trial NCT03589352: Women's Knowledges About Gynaecological Aftercare
Official title: Women's Knowledges About Gynaecological Aftercare, Hospitalized in Maternity Service, or Consulting in Policlinic, in University Hospitals of Strasbourg
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gynecology
Keywords: gynaecological aftercare
contraception
breast cancer
cervix cancer
cervical screening
breast self examination
mammography
midwife
body knowledge
prevention
self care
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - women who are able to read and write French

Brief summary: The hypothesis of the investigators is that women don't have all the needfull knowledge to understand the importance of a regular gynaecological aftercare.

The main objective is to assess women's knowledge's about gynaecological aftercare.

The second objective is to identify barriers that prevent women of a regular gynaecological aftercare


Eligibility criteria: Inclusion Criteria:

* women aged over eighteen years old
* women who are able to read and write French

Exclusion Criteria:

* women aged under eighteen years old
* women who aren't able to read or write French

Primary outcomes:
measure: questionnaire
timeFrame: 24 hours before the discharge of patients from the gynecology department
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologie (CMCO)
Study officials:
References:
Clinical trial NCT02687152: Arginase Inhibition and Microvascular Endothelial Function in Type 2 Diabetes
Official title: Effect of Arginase Inhibition on Microvascular Endothelial Function in Patients With Type 2 Diabetes and Microvascular Dysfunction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 24
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: BASIC_SCIENCE

Brief summary: The present project is designed to test the hypothesis that arginase contributes to microvascular endothelial dysfunction in patients with type 2 diabetes and microvascular complications.

Detailed description: Background

The development of microvascular complications in diabetes is a complex process, in which endothelial dysfunction is of importance. Emerging evidence suggests that arginase is a key mediator of endothelial dysfunction in type 2 diabetes mellitus (T2DM) by reciprocally regulating nitric oxide bioavailability. The aim of this study was to test the hypothesis that arginase activity is increased and that arginase contributes to microvascular endothelial function in patients with T2DM and microvascular dysfunction.

Method

Microvascular endothelium-dependent and -independent vasodilatation are investigated in patients with T2DM (n =12) and healthy age-matched control subjects (n =12) with laser-Doppler flowmetry during iontophoretic application of acetylcholine and sodium nitroprusside, respectively, before and after intra-arterial administration of the arginase inhibitor N-hydroxy-nor-L-arginine (0.1 mg/min) for 120 min.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus and microvascular dysfunction defined as microalbuminuria \> 3.0 mg/mmol or presence of retinopathy.

Exclusion Criteria:

* Myocardial infarction or unstable angina within the last three months,
* Changed dose of any vasodilator drug during the preceding six weeks,
* Ongoing treatment with warfarin
* Concomitant disease that may have interfered with the possibility for the patients to comply with or complete the study protocol

Primary outcomes:
measure: Change in cutaneous microvascular endothelial function
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: John Pernow, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04318652: OCT Guided Punctal Stenosis Management
Official title: The Role of Anterior Segment Optical Coherence Tomography in Management of Acquired Punctal Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epiphora Due to Insufficient Drainage
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical trial study that was conducted on patients with punctal stenosis.We studied the diameter of stenosed puncta before and after treatment with preserved free steroid eye drops using AS-OCT.

Detailed description: The study was conducted on 40 eyes of 24 patients have acquired inflammatory punctal stenosis and 20 eyes of 10 patients of normal asymptomatic subjects as control group. We studied the external punctal diameter, visibility of the internal punctum and punctal depth before treatment using AS-OCT, and then patients were re-evaluated after one month of treatment with preservative free methylprednisolone 5% eye drops.

Eligibility criteria: Inclusion Criteria:

* Patients have acquired inflammatory punctum stenosis complaining of epiphora of different etiologies.

Exclusion Criteria:

* Previous lacrimal surgery.
* Lid margin malposition such as ectropion, entropion or lid retraction.
* Medial lid masses obscuring punctum.
* History of ocular trauma involving lid margin or punctum.

Primary outcomes:
measure: punctal opening
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Amr Awara
state: Gharbeyia
Study officials:
References:
Clinical trial NCT05393752: Malnutrition Assessment Tools in Surgery
Official title: Evaluation of Malnutrition Risk Assessment Tools in General Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Surgery--Complications
Keywords: nutrition
malnutrition
malnutrition risk tools
nutritional assessment
surgery
Lead sponsor: University Hospital of Crete
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 1650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 108
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective observational study including patients admitted in a surgical department during a 1-year study period, from January 2022 until January 2023 (TBReviewed)

Brief summary: The purpose of this study is to evaluate the main malnutrition risk assessment tools in patients undergoing operations of general surgery.

Detailed description: This is a multi centre prospective observational study including patients undergoing major/major+ operation of general surgery. Patients will be interviewed by surgical trainees and their malnutrition risk will be assessed with the use of SGA, MUST, NRS, MNA-SF etc. Clinical variables and demographics will also be recorded in order to enable meaningful comparisons of malnutrition risk assessment tools in terms of serious postoperative complications.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Patients undergoing elective or emergency surgery. Urgency of emergent operations is classified as follows, according to the clinical judgment of the surgeon, regarding the maximum time a patient could wait for surgery:

  * 3.Expedited (\>18 hours)
  * 2B. Urgent (6-18 hours)
  * 2A. Urgent (2-6 hours)
  * 1. Immediate (\<2 hours)
* Operations involving the gastrointestinal tract
* Magnitude of operation graded by POSSUM \[17,18\]:

  * Major+ (examples include colonic resection abdominoperineal resection of the rectum, radical total gastrectomy, intestinal bypass, whipple resection)
  * Major (examples include adhesiolysis, stoma formation, small bowel resection, anterior resection, cholecystectomy and exploration of the bile duct)

Exclusion Criteria:

* Age \<18 years
* Magnitude of operation graded by POSSUM:

  * Minor
  * Intermediate
* Inability to perform nutritional assessment
* Inability to provide informed consent

Primary outcomes:
measure: serious postoperative complications
timeFrame: 30 days after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Department of Surgery, General Hospital of Nicosia, School of Medicine, University of Cyprus
city: Heraklion
country: Greece
facility: Department of Surgery, University Hospital of Heraklion
Study officials:
affiliation: University Hospital of Heraklion, Crete, Greece
name: Konstantinos Lasithiotakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02779452: Gestational Diabetes Mellitus and Neurodevelopment in Newborns
Official title: Does Brain Functions Depend on Omega 3 Transferred to the Fetus During the Intra Uterine Life ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes, Gestational
Glucose Metabolism Disorders
Keywords: neurodevelopment
electroencephalography
gestational diabetes mellitus
omega 3 polyunsaturated fatty acids
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with singleton pregnancy were recruited in the Centre Hospitalier Universitaire de Sherbrooke (CHUS) at 24 - 28 weeks of gestation.

Brief summary: The purpose of this study is to evaluate the feasibility of using a quantitative EEG method to evaluate neurodevelopment in newborns and to evaluate whether subtle neurodevelopmental deficits can be detected in newborns from mothers with gestational diabetes mellitus (GDM) compared to control newborns.

The second purpose of this study is to determine whether cord blood concentration in docosahexaenoic acid (DHA), an omega-3 fatty acid, is similar in neonates of well-controlled mothers with gestational diabetes mellitus (GDM) compared to control mothers, and to evaluate whether this contributes to neonates neurodevelopment status.

Detailed description: Maternal weight is measured close to delivery and BMI is calculated. Birth weight, length, head circumference, Apgar score and glycaemia are recorded at birth. An EEG are performed on the newborn within 48 hrs after birth.A maternal blood sample is collected at admission to measure maternal glycated hemoglobin (A1C). Cord blood samples are collected in the umbilical vein after delivery.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* aged between 18 and 40 years

Exclusion Criteria:

* smoking,
* illicit drug consumption,
* omega-3/6 consumption,
* liver or renal disease,
* cancer
* any medical conditions affecting glucose/lipid metabolism.

Primary outcomes:
measure: Change in neurodevelopment
timeFrame: At birth
Secondary outcomes:
measure: Change in DHA level in cord blood
timeFrame: At birth
Other outcomes:
Locations:
Study officials:
affiliation: Université de Sherbrooke
name: Mélanie Plourde, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06107452: Customization of Cardiac Readaptation Based on Force-velocity Profile and Heart Rate Variability
Official title: Customization of Cardiac Readaptation Based on Force-velocity Profile and Heart Rate Variability: A Controlled and Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Cardiac rehabilitation
Physical activity
Force-velocity profile
Autonomic nervous system
Coronary artery disease
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Cardiac readaptation aims to mitigate cardiovascular risks and enhance the quality of life among coronary patients. Our research laboratory has an international expertise in training optimization in top-athletes and a previous study has demonstrated the efficacy of optimizing cardiac rehabilitation through the power-force-velocity profile (PFVP). The findings exhibited significant improvements in aerobic capacity, muscular strength, and cardiovascular parameters among patients who were trained based on their PFVP. Guided training utilizing heart rate variability (HRV) is also garnering increasing interest as a means to optimize training load and promote recovery

Detailed description: Our study aims to evaluate the application of HRV in regulating training load based on fatigue levels in cardiac rehabilitation patients utilizing the PFVP framework.

Eligibility criteria: Inclusion Criteria:

* \>18
* Acute Coronary Syndrome treated in the last 6 months
* Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
* Initial CPETt: MPA ≥ 60w in women and ≥80w in men
* French
* Informed consent

Exclusion Criteria:

- Significant co-morbidities limited practice of physical activity

Primary outcomes:
measure: The root mean square of successive differences in heart rate or RMSSD
timeFrame: Baseline to 2 months
Secondary outcomes:
measure: Value of maximum oxygen consumption
timeFrame: Baseline to 2 months
measure: Assessment of the ANS sympathetic branch
timeFrame: Baseline to 2 months
measure: Assessment of the ANS parasympathetic branch
timeFrame: Baseline to 2 months
measure: non-invasive measurement of arterial stiffness
timeFrame: Baseline to 2 months
measure: measurement of upper and lower limb muscle strength
timeFrame: Baseline to 2 months
measure: assessment of PFVP evolution
timeFrame: Baseline to 2 months
measure: assessment of physical a activity and sedentary behavior
timeFrame: Baseline to 2 months
measure: quality of life assessment
timeFrame: Baseline to 2 months
measure: assessment of subjective fatigue
timeFrame: Baseline to 2 months
measure: biological data
timeFrame: Baseline to 2 months
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: David HUPIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02990052: Conservative Treatment vs. Volar Plating of Distal Radius Fractures
Official title: Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fractures
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomized controlled single-center trial with 80 patients aged 50 years and above to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture

Detailed description: Volar plating has became as a standard approach for treating unstable distal radius fractures. The incidence of surgically treated patients with distal radius fractures has increased many fold from the beginning of this millennium, owing mostly to increased number of volar platings. The most striking increase of plate fixations has occurred in older patient groups, especially in females. With volar fixed-angle plate, very near-anatomic, stable fixation with relatively low complication rate, can be achieved even in osteoporotic bone. There are only few randomized, prospective studies comparing results of volar plating and conservative treatment, comparing patients aged over 65 years. Quite little is known of the results comparing conservative treatment and volar plating in patients aged below 65 years.

Main goal of our study was to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture in patients aged over 50 years an older.

Eligibility criteria: Inclusion Criteria:

* patients over 50 years-old
* primary dislocated distal radius fracture (AO/OTA 23 type A2-3 and C1-2)
* primary reduction of fracture is acceptable considering primary conservative treatment

Exclusion Criteria:

* bilateral and open fractures and fractures with neurovascular compromise
* other major concurrent fracture necessitating treatment of any kind
* patients under 50 years of age
* previous ipsilateral distal radius fracture
* inflammatory joint disease
* significant radiocarpal-joint degeneration
* patient's bad co-operation or major co-morbidity making an operation contraindicated

Primary outcomes:
measure: Difference of DASH-score between two study groups
timeFrame: 2 year observation
Secondary outcomes:
measure: Difference of radiological parameters between two study groups
timeFrame: 2 year observation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03261752: New Genes in the Carcinogenesis of Colorectal Cancer
Official title: Investigating the Role of SPG20,STK31 Genes in the Carcinogenesis of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colo-rectal Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 62
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient between 35-65 who are newly diagnosed with colorectal cancer

Brief summary: Colo rectal cancer is one of the greatest ,mutual malignancies worldwide ,accounting for an estimated 1.3 million new cases and \>500,000 mortality ⁄ year . is the fourth leading cause of cancer-associated mortality worldwide with speedily ,cumulative ,occurrence rate in the worldwide

Detailed description: colo rectal cancer represents a global and local problem, as it is one of the commonest types of cancer all over the world. Globally, Colo rectal cancer in women (9.2% of diagnoses) it is the second most common cause of cancer . it is the third most common in men (10.0%). After lung, stomach, and liver cancer it is the fourth most common cause of cancer death.

Cancer is a multistep procedure resulting from an ongoing accretion of genetic and epigenetic fluctuations to the genome.

Spartin is a protein that in humans is encoded by the SPG20 gene. This protein may be involved in endosomal trafficking, microtubule dynamics, or both functions. Aberrant promoter methylation of genes is a common epigenetic alteration in colo rectal cancer .

This has stimulated the prospect to implement a dependable, reasonable and simple approach for Colo rectal detection . The SPG20 gene is situated in chromosome band 13q13.3; the SPG20 gene converts the spartin protein, which is a multi functional protein that has formerly been recognized to be complicated in intra cellular epidermal growth factor receptor trading , The serine-threonine kinase 31 (STK31) gene was initially identified through cDNA subtraction as a testis-specific protein kinase gene expressed in mouse spermatogonia . Recently, STK31 has been described as a novel cancer testis (CT) antigen, highly expressed in Gastrointestinal cancer cells (colo rectal, gastric and esophageal cancer), while restricted to testis and fetal brain in normal tissues .

It was found that SPG20 is mutated in Troy er syndrome, an hereditary spastic paraplegia

Eligibility criteria: Inclusion Criteria:

* age between 35-65
* patient with colorectal cancer (at any stage)
* both sex included

Exclusion Criteria:

* pediatric patients
* patient with insufficient data
* cardiac patient
* pregnant women

Primary outcomes:
measure: detection of SPG20&STK31 genes
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: