louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06094387: The Use of Thrombin Generation Assay in Detection of Central Line Related Thrombosis (CRT) in Critically Ill Patients
Official title: The Use of Thrombin Generation Assay in Detection of Central Line Related Thrombosis (CRT) in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Line Complication
Thrombosis, Venous
Keywords: Thrombin generation
Central line related thrombosis
Lead sponsor: Queen Mary Hospital, Hong Kong
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring central catheter insertion in the ICU

Brief summary: To study thrombin generation parameters in critically ill patients with and without central line related thrombosis (CRT).


Eligibility criteria: Inclusion Criteria:

* Age ≧ 18; AND
* Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital in Hong Kong; AND
* Clinically indicated for central catheter insertion, which includes central venous catheters and dialysis catheters; AND
* Expected to have the central catheter in place for at least 5 days in their ICU stay.

Exclusion Criteria:

* Patients known to have active venous thromboembolism including deep venous thrombosis or pulmonary embolism;
* Patients known to have hypercoagulable states, e.g., hereditary thrombophilia, antiphospholipid syndrome; OR
* Patients with active solid organ or hematological malignancies; OR
* Patients already receiving therapeutic anticoagulation prior to study recruitment; OR
* Patients with thrombosis detected in the insertion site before central catheter insertion; OR
* Patients with a central venous catheter already in place prior to ICU admission; OR
* Patients admitted to the ICU for post-operative care; OR
* Patients admitted to the ICU for trauma care; OR
* Patients requiring extra-corporeal life support (ECLS); OR
* Patients with poor window or inaccessible for ultrasonographic examination; OR
* Pregnancy/post-partum within 6 weeks

Primary outcomes:
measure: Difference in peak thrombin generation (nM) between patients with and without central line related thrombosis
timeFrame: From the time of CVC insertion to the time of CVC removal
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
References:
Clinical trial NCT06472687: Efects of FIFA 11+Warm-Up Program on Agilitiy, Balance And Proprioception Parameters in The Professional Football Players
Official title: Efects of FIFA 11+Warm-Up Program on Agilitiy, Balance And Proprioception Parameters in The Professional Football Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial.
Primary purpose: PREVENTION

Brief summary: This study aimed to compare the effects of the FIFA 11+ warm-up program with a traditional warm-up on agility, balance, and proprioception in professional football players aged 18-30. Forty-four players were randomly assigned to either the FIFA 11+ group, which performed the program for 10 weeks, or the control group, which continued their usual warm-up routine.


Eligibility criteria: Inclusion Criteria:

* being 18-30 years, individuals who currently play professional football and actively participate in training and matches,
* participants with at least two years of professional football coaching experience,
* no history of any medical conditions that would hinder their ability to perform the required exercises.

Exclusion Criteria:

* a history of musculoskeletal surgery and fractures in the lower extremities,
* a history of acute injury to the musculoskeletal structures of other lower extremity joints in the last three months, affecting joint integrity and function and causing interruption of the desired physical activity for at least one day
* having a history of balance and vestibular disorders were excluded from the study.

Primary outcomes:
measure: Agility
timeFrame: Baseline assesment (Begining of the warm-up program), 10th week assessment (through FIFA 11+ program is completed.)
Secondary outcomes:
measure: Balance
timeFrame: Baseline assesment (Begining of the warm-up program), 10th week assessment (through FIFA 11+ program is completed.)
measure: Proprioception
timeFrame: Baseline assesment (Begining of the warm-up program), 10th week assessment (through FIFA 11+ program is completed.)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Elif Tuğçe
state: Maltepe
Study officials:
References:
Clinical trial NCT06876987: The Mobile-based Training System in Peritoneal Dialysis Patients
Official title: The Development and Evidence Effect of a Mobile-based Situational Simulation Peritoneal Dialysis Training System in the Retraining Program of Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peritoneal Dialysis
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The peritoneal dialysis patients participating in the study were divided into an experimental group and a control group.
Primary purpose: OTHER

Brief summary: The mobile-based training system can effectively improve the knowledge and technical correctness of peritoneal dialysis patients.

Detailed description: Use mobile-based training system in peritoneal dialysis patients' retraining programs and continuously monitor the effectiveness.

Eligibility criteria: Inclusion Criteria:

* Patients who have received peritoneal dialysis for more than 3 months; patients who have received peritoneal dialysis for less than 3 months but have recovered from peritonitis or catheter-related infection; patients who are conscious and have no mental illness.

Exclusion Criteria:

* Patients who are unable to perform peritoneal dialysis independently; illiterate; suffering from peritonitis or catheter exit site infection.

Primary outcomes:
measure: Peritoneal Dialysis Knowledge Scale
timeFrame: Immediately after recruitment, 1 month and 2 months after intervention
measure: Peritoneal Dialysis Procedure Checklist
timeFrame: Immediately after recruitment, 1 month and 2 months after intervention
Secondary outcomes:
measure: Infection event rate
timeFrame: 6 months after recruitment
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
References:
Clinical trial NCT05275387: AQP-1 Polymorphism on Fluid Status in Hemodialysis Patients
Official title: the Effect of AQP-1 Polymorphism on Fluid Status of Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Disease on Dialysis
Keywords: AQP1
fluid status
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ESRD patients on maintained hemodialysis.

Brief summary: It is a cross sectional observational study. It is to investigate whether AQP-1 polymorphism has any impact on fluid status in hemodialysis patients. The long term stable HD patients in the current center will be enrolled to the study after informed consent. Blood samples will be collected for gene-typing. Fluid status including blood pressure, weekly UF and intra-dialysis body weight change will be collected through their clinical records.


Eligibility criteria: Inclusion Criteria:

* age 18-70
* ESRD
* maintained HD
* no target weight change during the last week of entering the study and achieve target weight at the end of HD section
* informed consented

Exclusion Criteria:

* expected survival time less than 3 months

Primary outcomes:
measure: The total ultrafiltration volume in mls from hemodialysis for the whole week of the recruitment
timeFrame: up to 12 weeks
Secondary outcomes:
measure: The total weight gain in kgs of each HD section of the enrollment
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Zanzhe Yu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00431587: Changes in Different Fat Compartments and Their Effect on Particular Manifestations of Metabolic Syndrome After Bariatric Procedures.
Official title: Changes in Different Fat Compartments During Weight Loss and Their Effect on Particular Manifestations of Metabolic Syndrome After Bariatric Procedures.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morbid Obesity
Metabolic Syndrome
Visceral Obesity
Keywords: morbid obesity
metabolic syndrome
visceral fat
peripheral fat
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-02-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The metabolic risks associated with obesity are closely correlated with central (abdominal), rather than a peripheral (gluteofemoral) fat pattern It has been shown that weight loss after bariatric surgery is followed by metabolic improvements.

The amount of fat lost from each site may be independently regulated. Very scant information is found in the literature regarding the relative changes in different fat body compartments, and their effect on the improvement of the metabolic profile.

In this study we define the absolute and relative changes in the different adipose tissue compartment after weight loss surgery

Detailed description: The metabolic risks associated with obesity are closely correlated with central (abdominal), rather than a peripheral (gluteofemoral) fat pattern.

The amount of fat lost from each site may be independently regulated. Very scant information is found in the literature regarding the relative changes in different fat body compartments.

Rapid and preferential reduction of visceral fat mass could occur in morbid obese with visceral obesity. It has been previously shown, and it was also partially confirmed in this study, that a reduction in visceral fat was associated with metabolic improvements that included improved glucose tolerance and reduced plasma insulin and lipid levels.

This again suggests a threshold of proportional visceral fat loss, above which there is an improvement in insulin sensitivity and other component of metabolic syndrom.

We will quantify the different fat compartments changes after bariatric surgery by means of CT scan.

Eligibility criteria: Inclusion Criteria:

* Morbid obesity,
* Metabolic syndrome

Exclusion Criteria:

* Previous abdominoplasty surgery,
* Previous major abdominal surgey

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization,
Study officials:
affiliation: Hadassah Medical Organization
name: Andrei Keidar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weiss R, Appelbaum L, Schweiger C, Matot I, Constantini N, Idan A, Shussman N, Sosna J, Keidar A. Short-term dynamics and metabolic impact of abdominal fat depots after bariatric surgery. Diabetes Care. 2009 Oct;32(10):1910-5. doi: 10.2337/dc09-0943. Epub 2009 Jul 8.
Clinical trial NCT01357187: An Evaluation of the Effect of the AmnioFix Amniotic Membrane Allograft in Patients Undergoing Posterior Instrumentation Removal
Official title: An Evaluation of the Effect of the AmnioFix™ Amniotic Membrane Allograft on Scar Tissue and Adhesions in Patients Undergoing Posterior Instrumentation Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesions of Soft Tissue
Keywords: Lumbar pathology
requiring elective lumbar interbody fusion
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the clinical effectiveness of AmnioFix™ in the reduction of the tenacity and frequency of soft tissue adhesions during the removal of segmental posterior lumbar instrumentation.


Eligibility criteria: Inclusion Criteria:

* Adults (18 years or older)
* Diagnosed with lumbar pathology requiring elective lumbar interbody fusion
* Willingness to comply to follow-up examinations and diagnostic imaging procedures
* Ability to give full written informed consent

Exclusion Criteria:

* Previous surgical procedure performed at same site
* Sign or symptoms of other disease which could result in allograft failure
* Require a corpectomy
* Participating in another drug or device clinical trial
* Pregnant or may become pregnant during the study
* Prisoner
* Involved in workmen's compensation or other litigation relative to a spine injury
* Past medical history of allograft implantation which resulted in graft failure
* Any condition requiring treatment above the normal standard of care
* Currently taking medications which could affect graft incorporation (supervising physicians discretion)
* Auto-Immune disease
* Renal failure
* Failure to sign or understand informed consent information
* History of drug and/or alcohol abuse
* Allergic to aminoglycosides

Primary outcomes:
measure: Tenacity and frequency of soft tissue adhesion
timeFrame: At the time of removal of segmental posterior lumbar instrumentation
Secondary outcomes:
measure: Presence and extent of scar tissue using histological analysis of the lumbar tissue adjacent to the surgical site
timeFrame: At the time of removal of segmental posterior lumbar instrumentation
measure: Number of intra-operative complications
timeFrame: At the time of removal of segmental posterior lumbar instrumentation
Other outcomes:
Locations:
city: Reston
country: United States
facility: Virginia Spine Institute
state: Virginia
Study officials:
affiliation: Virginia Spine Institute
name: Brian Subach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03415087: Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine
Official title: Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine at Different Rates; Does it Make Difference?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Caesarean Section
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 56 Parturients, aged 18-40 year, undergoing elective CS were randomly assigned to receive sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at the same rate (normal sequential) NS or a rapid intrathecal injection of fentanyl followed by slow injection of hyperbaric bupivacaine (rapid sequential) RS. Time of first rescue analgesia, Dose of rescue analgesics, degree of postoperative pain, incidence of hypotension, hypotension duration, ephedrine dose, spinal anaesthesia related complications and failed block were recorded.

Detailed description: 56 ASA physical status I, II Parturients, aged 18-40 year, undergoing elective CS were randomly assigned to receive sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at the same rate through a 5ml syringe each (NS (normal sequential), n 28) or a rapid intrathecal injection of fentanyl through an insuline syringe followed by slow injection of hyperbaric bupivacaine through a 5ml syringe RS (rapid sequential), n 28). Onset of sensory block (T6 level), highest level of sensory block, time of first rescue analgesia, Dose of rescue analgesics, degree of postoperative pain by VAS 6H postoperative, Onset of motor block (Bromage scale0\>3), duration of motor block (return to Bromage 0), incidence of hypotension, hypotension duration, ephedrine dose, spinal anaesthesia related complications as nausea, vomiting, pruritis, shivering and failed block were recorded.

Eligibility criteria: Inclusion Criteria:

* ASA I, II
* Parturients aged from 18-40 years old
* scheduled for elective CS

Exclusion Criteria:

* parturients with complicated pregnancy as (preeclampsia, pregnancy induced HTN, gestational Diabetes, abnormal placenta (placenta previa), multiple gestation),
* BMI greater than 35 or less than 22,
* major systemic disease (cardiac, renal, liver),
* need for emergency CS,
* having allergy to drugs used in the study,
* having contraindication for spinal anaesthesia or
* refused regional anaesthesia

Primary outcomes:
measure: Duration of postoperative analgesia
timeFrame: 2-5 hours
Secondary outcomes:
measure: incidence of hypotension
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06195787: Improving Emergency Department Testing for Deep Vein Thrombosis
Official title: Assessing the Safety and Efficiency of a Simplified Diagnostic Approach for Deep Vein Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis (DVT)
Keywords: deep vein thrombosis
venous thromboembolism
emergency medical services
diagnosis
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
First posted: 2024-01-08
Enrollment: 458
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: Study participants will be enrolled after a visit to the Kingston Health Sciences emergency department and urgent care centre in Kingston, Ontario.

Brief summary: This observational study will use a new way to test for deep vein thrombosis (DVT) of the leg. A DVT is a blood clot in the leg and is a medical problem that can cause swelling, pain, and redness. If the blood clot is not treated, it can cause more serious, long-term effects, and occasionally lead to death.

The main questions the study aims to answer are:

1. How safe is our new blood clot testing method?
2. How efficient is our new blood clot testing method?

The study will be run in the emergency department and urgent care centre in Kingston, Ontario. Patients who are tested for a DVT in the leg can be included in the study. Researchers follow the patient through chart review to make sure the new system is safe and efficient.


Eligibility criteria: Inclusion Criteria:

- emergency physician decides to test for DVT of the lower limb.

Exclusion Criteria:

* \<18 years of age;
* tested for DVT without using the ToDay algorithm at the index visit;
* D-dimer level is known before ToDay item assessment;
* a new indication for anticoagulation at the emergency department assessment (other than DVT) in a patient not previously prescribed an anticoagulant;
* a history of prior lower limb DVT, where there is no access to baseline ultrasound imaging;
* suspected of having a pulmonary embolism;
* has previously participated in this study;
* has previously opted out of all research at hospital site;
* left the emergency department or urgent care centre against medical advice;
* D-dimer was ordered prior to initial physician assessment;
* imaging for DVT or pulmonary embolism within the previous 30 days;
* transferred from another hospital organization.

Primary outcomes:
measure: False negative rate of the new DVT testing
timeFrame: This will be measured at 30-days after the patient's index emergency department visit.
Secondary outcomes:
measure: Efficiency of the new DVT testing
timeFrame: At the index emergency department visit.
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT06980987: The PAINN Study - a Pilot Cross Sectional Study
Official title: Pain Prevalence and Management in Neurological and Neurosurgical in Patients- the PAINN Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospitalized Patient
Home Mechanical Ventilation
Pain
Pain Management
Keywords: Pilot cross sectional study
Neurological patients
Home mechanical ventilation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital admitted patients, needing home mechanical ventilation for neurological disease or trauma,

Brief summary: Pain prevalence in hospitalized patients has been reported between 65% and 75%, indicating poor and/or insufficient management. In addition, pain prevalence has been estimated for separate groups of individuals with specific neurological/neurosurgical conditions (25% - 84%) and the overall prevalence was calculated as 36% (95% CI: 31% - 42%). However, investigations on prevalence of pain in Danish neurologic inpatients is scarce, which may indicate an overlooked symptom in local neurologic settings.

This project was a cross-sectional investigation to identify pain prevalence, intensity and interference in admitted patients needing home menicahal ventilation (HMV) and we conducted as an exploratory investigation to collect data from the patients by pain questionnaires/instruments, observation of patients' pain behavior and physiologic parameters. The main patients' diagnoses were spinal cord injury, amyotrophic lateral sclerosis, cerebral palsy, spinal muscular atrophy, and defects from birth such as tracheomalacia. The study included 40 participants, all recruited from Respiratory Center East, University of Copenhagen, Rigshospitalet


Eligibility criteria: Inclusion Criteria: persons hospital admitted, minimum 18 years old, provided informed consent (provided by the patient or patient's relative).

Exclusion Criteria: persons who did not understand written and spoken Danish or denied participating in the study.

Primary outcomes:
measure: Brief Pain Inventory
timeFrame: 24 hours
Secondary outcomes:
measure: GAD-7
timeFrame: 24 hours
measure: PHQ-9
timeFrame: 24 hours
measure: The Barthel Index
timeFrame: 24 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Respirations center east
Study officials:
References: