louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05795166: A Study to Understand the Distribution of Obesity Classes and Obesity Related Diseases in People With Obesity Across Countries in Czech Republic, Hungary and Poland
Official title: A Multicentre, Observational Study to Understand the Distribution of Obesity Classes and Obesity Related Comorbidities (ORCs) in People With Obesity Within a Real World Population in Czech Republic, Hungary and Poland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-04-03
Enrollment: 1241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with obesity coming into the clinic as part of routine visit to their treating physician/general practitioner

Brief summary: The study is intended to understand the distribution of different obesity classes and obesity related diseases (diseases that present along with obesity) in patients with body mass index (BMI) ≥ 30 kg/m\^2.

Participants will be asked to give information about their health. They will continue their normal way of life and will not get any medication or additional medical test other than those prescribed to you by their doctor. Participation in the study will last for about 1 day.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age greater than or equal to 18 years at the time of inclusion/enrolment in the study.
3. BMI greater than or equal to 30 Kg/m\^2 as measured at the inclusion in the study

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study.
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation as judged by physician.

Primary outcomes:
measure: Percentage of patients with at least one obesity related comorbidity of interest for obesity classes I, II and III pooled across all countries
timeFrame: At the time of enrolment (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04196166: Routine Preoperative Evaluation in Surgical Patient
Official title: Does More Testing in Routine Preoperative Evaluation Benefit the Surgical Patient? Matched Case Control Study From a Resource-constrained Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic Disorder
Keywords: preoperative evaluation
orthopedic surgery
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients irrespective of age and gender who were classified as ASA-1 and ASA-2 by the anesthesia team and who underwent minor, intermediate and major primary elective orthopedic procedures

Brief summary: The "routine" pre-operative tests in healthy orthopaedic patients undergoing intermediate/ major surgery are not justified. In this study of 670 healthy orthopedic patients with 7610 preoperative tests, investigators found that surgical plan was influenced in \<1% of patients. Surgeons should be sensitized to reconsider this practice particularly with limited resources.

Detailed description: Background: Routine preoperative tests in healthy patients not only cause extra anxiety, but may delay treatment without influencing surgical plan. This has worse impact in resource-constrained settings where fee for service rather than health insurance is the usual norm. Investigators aim to determine if "routine" pre-operative tests are justified in healthy orthopedic patients.

Methods: Investigators conducted a non-commercialized, non-funded matched case control study in tertiary care university hospital and a level-1 trauma centre for healthy patients (ASA-1\&2) admitted from January 2014-December 2016 for elective orthopedic intermediate and major procedures. Cases (patient who had a change in his/her surgical plan after admission) and controls were selected independently of the exposure of interest then matched randomly to cases on age, gender and procedure type. Primary exposure was the routine preoperative lab tests, as defined by the American Society of Anesthesiologist, which included 13 blood tests. Analysis was done using Principle Component Analysis and Conditional logistic regression at univariate and multivariable levels reporting matched adjusted Odds Ratios. The data will bereported in line with STROBE criteria.

.

Eligibility criteria: Inclusion Criteria:

* Participants irrespective of age and gender.
* ASA-1 and ASA-2 status.
* Primary elective orthopedic procedures.
* Blood lab tests done at the institution only.

Exclusion Criteria:

* Ambulatory care procedures
* Revision surgery.
* Participants admitted to other services, high care or intensive care units.

Primary outcomes:
measure: preoperative blood tests compliance rate with institutional guidelines
timeFrame: 2014-2019
Secondary outcomes:
measure: Cost difference in local currency
timeFrame: 2014-2019
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04380766: Covid-19 Pandemic and Pancreatic Surgery in Italy
Official title: Effects of Covid-19 Pandemic on Pancreatic Surgery in Italy. A Multicenter Observational Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Pancreatic surgery
COVID-19
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with diagnosis of pancreatic cancer

Brief summary: Pancreatic cancer (PC) is recognized as one of the most challenging tumors to deal with and it is still characterized by a poor long-term prognosis. However, treatment of PC in high-volume centers with the support of a multidisciplinary approach has widely demonstrated improvement both in terms of short- and long-term outcomes. The recent worldwide spread of Covid-19 pandemic significantly affected the healthcare systems of most countries in the world, particularly in red areas such as Italy, with more than 100.000 cases in a two-month time lapse. This inevitably reflected in a reorganization of hospital activities, including the diagnostic and therapeutic pathways for PC treatment. With the aim of giving an objective and real representation of the impact of Covid-19 on PC treatment, the investigator here propose a multicenter Italian observational study comparing a 6-month period before and during the Covid-19 pandemic. Only high-volume centers will be involved in the study. A comparison between the general, clinical, endoscopic and surgical outcomes will be performed by means of a global and month-by-month analysis between the two study periods.


Eligibility criteria: Inclusion Criteria:

all patients with a diagnosis of pancreatic cancer referred to one of the centers involved in the study during the two study periods

Exclusion Criteria:

* patients under the age of 18
* inability to give informed consent

Primary outcomes:
measure: Changes in pancreatic cancer management during the COVID-19 pandemic
timeFrame: From admission to discharge/last outpatient visit, whichever comes first, assessed up to the 30th of June 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS di Roma
state: Lazio
Study officials:
References:
citation: Quero G, Pecorelli N, Paiella S, Fiorillo C, Petrone MC, Rosa F, Capretti G, Laterza V, Kauffmann E, Nobile S, Butturini G, Ferrari G, Coratti A, Casadei R, Mazzaferro V, Boggi U, Zerbi A, Salvia R, Falconi M, Alfieri S. Quantitative assessment of the impact of COVID-19 pandemic on pancreatic surgery: an Italian multicenter analysis of 1423 cases from 10 tertiary referral centers. Updates Surg. 2022 Feb;74(1):255-266. doi: 10.1007/s13304-021-01171-8. Epub 2021 Nov 24.
Clinical trial NCT05533866: Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
Official title: Characterization of the Microbiome in Colonized Dystrophic and Junctional Epidermolysis Bullosa Wounds Before and After Use of APR-TD011 ® Spray Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Epidermolysis Bullosa
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this pilot study, APR-TD011 antimicrobial wound cleansing spray will be given to all enrolled patients with junctional EB (JEB) or dystrophic epidermolysis bullosa (DEB) with Staphylococcus aureus or Pseudomonas aeruginosa culture-positive wounds. The primary aim will be to evaluate the change in skin microbiome (S. aureus, P. aeruginosa, commensal organisms) before, during, after treatment. Subjects who are colonized by S. aureus or pseudomonas will be treated for 8 weeks, will stop the spray and return at 12 weeks (4 weeks without the spray), and then will be able to use the spray as desired in a 6-month period of open-label use, with further feedback collected.


Eligibility criteria: Inclusion Criteria:

* Patients 6 months of age or above with junctional or dystrophic epidermolysis bullosa
* Target wound that has been present for at least 3 weeks and is at least 10 cm2
* Target wound that is colonized with Staphylococcus aureus and/or Pseudomonas aeruginosa

Exclusion Criteria:

* Patients currently or recently (within past 4 weeks) on topical or systemic antibiotics
* Do not agree to avoid bathing or topical application at the target starting the night before the visit.
* Do not agree to avoid dilute bleach or vinegar baths, or other antiseptic use, at the target site starting at screening throughout the study.

Primary outcomes:
measure: Change in microbiome species
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT06787066: Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms
Official title: Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Menopause
Keywords: Menopause
Sympathetic nerve activity
Sympathetic transduction
Blood flow
Women&#39;s health
Blood pressure
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators aim to assess the interactions between the sympathetic nervous system and the vasculature in women across the menopause transition to better understand why aging women have a higher risk of cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* Assigned female at birth
* 18-70 years of age
* Body mass index (BMI) \<30 kg/m2

Exclusion Criteria:

* Assigned male at birth
* Pregnancy, breastfeeding
* Body mass index ≥30 kg/m2
* Oral hormonal contraception in last 6 months, history of hormone replacement therapy, oophorectomy
* Current smoking/nicotine use
* Increased risk of bleeding, pro-coagulant disorders, clotting disorders, anticoagulation therapy
* Nerve/neurologic disease
* Cardiovascular, hepatic, renal, respiratory disease
* Blood pressure ≥140/90 mmHg
* Diabetes, Polycystic ovarian syndrome
* Communication barriers
* Prescription medications

Primary outcomes:
measure: Sympathetic transduction
timeFrame: 1 day (single study visit)
Secondary outcomes:
measure: Blood flow
timeFrame: 1 day (single study visit)
measure: Muscle sympathetic nerve activity
timeFrame: 1 day (single study visit)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04144166: Evaluation of Capillary Refill Index
Official title: Evaluation of Capillary Refill Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perfusion; Complications
Keywords: capillary refill time
peripheral perfusion
Lead sponsor: Nihon Kohden
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults in ED or admitted to ICU

Brief summary: Comparison of a peripheral perfusion assessment method using a pulse oximeter to the conventional capillary refill time visually assessed by a clinician.

Detailed description: A new technology, capillary refill index (CRI), to assess peripheral perfusion status quantitatively using pulse oximeter waveforms is being developed. The conventional capillary refill time (CRT) is widely used in clinical settings as a gold standard to assess peripheral perfusion.

The objective of this study is to evaluate the capability of CRI to predict altered peripheral perfusion determined with the conventional CRT test. Predictive capability of CRI needs to be assessed to achieve a goal to provide clinicians with an alternative method to the conventional CRT.

Eligibility criteria: Inclusion Criteria:

1. Individuals 18 years of age or older
2. Patients who present to the ED or who are admitted to the ICU of North Shore University Hospital (NSUH)

Exclusion Criteria:

1. Pregnant
2. Prisoners
3. Finger, hand or forearm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor
4. Patients' deemed clinically unstable by the clinical team

Primary outcomes:
measure: Predictive Capability of the Altered Peripheral Perfusion
timeFrame: < 30 min *right after enrollment
Secondary outcomes:
measure: Correlation of Device CRI to Conventional (Visual) CRT
timeFrame: < 30 min *right after enrollment
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
affiliation: Admin Dir Clinical Research Emergency Medicine, Northwell Health
name: Timmy Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05150366: Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler (ACTIFER)
Official title: Impact of Percutaneous Closure of the Left Atrial on the Maximum Proto-diastolic Speed of the Mitral Ring Measured by Tissue Doppler
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tissue Doppler
Left Atrial Closure
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2021-12-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main objective is to demonstrate the equivalence, before and after the percutaneous closure of the left atrial procedure, of the maximum proto-diastolic velocity of the lateral mitral annulus (e 'lat) measured by tissue Doppler. Patients with AF at high embolic risk and presenting a formal and definitive contraindication to anticoagulants having been operated on for percutaneous closure of the left atrial by St Jude AMULET device, considering an equivalence margin of 1 cm / sec.


Eligibility criteria: Inclusion Criteria:

* Man or woman over 18 years-old
* Patient with paroxysmal AF at high embolic risk (CHA2DS2Vasc score ≥ 4) and presenting a formal and definitive contraindication to anticoagulants
* Patient scheduled for percutaneous closure of the left auricle by St Jude AMULET device
* Patient in sinus rhythm
* Subject affiliated or beneficiary of a social security scheme
* Patient having signed the informed consent

Exclusion Criteria:

* Patient participating in another clinical study
* Patient in permanent ACFA
* Patient with a mitral prosthesis (biological or mechanical),
* Patient with a history of mitral annuloplasty
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
* Pregnant, breastfeeding or parturient woman;
* Patient hospitalized without consent.

Primary outcomes:
measure: lateral e' speed
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Privé Le Bois
Study officials:
References:
Clinical trial NCT05245266: Cell-Based Noninvasive Prenatal Testing
Official title: Improving Methods for Cell-Based Noninvasive Prenatal Testing (NIPT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Related
Keywords: prenatal
genetic testing
noninvasive
diagnostic
Lead sponsor: Luna Genetics
Sponsor class: INDUSTRY
First posted: 2022-02-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the overall study is to develop improved methods for recovery and analysis of fetal cells from the mother's blood in order to develop clinically useful forms of cell-based, diagnostic, noninvasive prenatal testing (NIPT). Luna genetics will obtain and analyze research blood samples from healthy pregnant women. A phlebotomist will be sent to any location in the United States to collect the blood samples. Sample identifiers will be removed as the first step so that laboratory personnel will not see or have access to identifiers.


Eligibility criteria: Inclusion Criteria for healthy pregnant subjects:

* Pregnant
* 18 years or older
* 65 or younger

Exclusion Criteria for healthy pregnant subjects:

* Acute illness
* Unavailability of maternal blood sample of at least 30 ml
* Language barrier (non-English speaking )
* Maternal age of less than 18 years, or over 65
* Higher order multiple pregnancy (triplet or greater)

Primary outcomes:
measure: Number of fetal cells recovered and quality of DNA data on each cell
timeFrame: 3 years
measure: Number of fetal cells recovered and quality of DNA data on each cell
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Luna Genetics
state: Texas
Study officials:
affiliation: Luna Genetics
name: Arthur Beaudet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02094066: The Effect of Tranexamic Acid for Total Hip Arthroplasty
Official title: The Effects of High Doze Tranexamic Acid Application on Hemorrhage, Blood Transfusion, Fibrin Degradation Products, and Kidney Functions for Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemorrhage
Keywords: tranexamic acid
total hip arthroplasty
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2014-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.

Detailed description: Orthopedic surgery may be associated with substantial blood loss requiring transfusion of erythrocytes.Transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, and transfusion related acute lung injury. Measures taken to allay concerns about the safety of blood transfusions have translated into the increasing cost of allogeneic blood units. Blood banks regularly undergo blood shortages. For these reasons, there is a need to reduce allogeneic blood transfusions. A number of effective interventions have been developed, such as preoperative autologous donation, cell salvage, or the use of erythropoietin. Pharmacologic agents such as aprotinin, tranexamic acid, or epsilon-aminocaproic acid (EACA) could reduce perioperative blood loss by interfering with fibrinolysis.

Eligibility criteria: Inclusion Criteria:

* ASA 2-3
* 18-75 age
* total hip arthroplasty surgery
* regional anesthesia

Exclusion Criteria:

* allergies to drug
* liver and kidney failure
* ischemic heart disease
* coagulopathy

Primary outcomes:
measure: hemorrhage
timeFrame: intraoperative
Secondary outcomes:
measure: erythrocyte transfusion
timeFrame: intraoperative and postoperative 3 days
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes univercity medicine faculty
Study officials:
affiliation: Erciyes university medicine faculty
name: seher orbay yasli, resident
role: PRINCIPAL_INVESTIGATOR
References: