louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03831581: Evaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block
Official title: Evaluation of Dermatomal Distribution in the Erector Spinae Plane (ESP) Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Pain, Postoperative
Keywords: Erector Spinae Plane
Erector Spinae Plane Block
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Assignment interventional
Primary purpose: TREATMENT

Brief summary: Interventional study that evaluate dermatomal distribution and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block

Detailed description: Interventional study that evaluate dermatomal distribution with pinprick and cold, and its demographic determinants in patients who underwent to Erector Spinae Plane (ESP) block with 20 ml of bupivacaine 0.5% at the thoracic level in patients with pain in the thorax and upper abdomen.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years, in the acute / chronic pain service that presents pain in the thoracic region and / or upper hemiabdomen.

Exclusion Criteria:

* Women in pregnancy
* Patients with less than 50 Kg of weight
* Dissent of informed consent

Primary outcomes:
measure: Dermatomes with sensitive block
timeFrame: 60 minutes
Secondary outcomes:
measure: weight
timeFrame: 60 minutes
measure: Adverse events
timeFrame: 60 minutes and 24 hours
measure: Success rate
timeFrame: 60 minutes and 24 hours
measure: Degree of satisfaction
timeFrame: 60 minutes and 24 hours
measure: Visual Analogue Scale (VAS)
timeFrame: 60 minutes and 24 hours
measure: Height
timeFrame: 60 minutes
measure: Age
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: hospital universitario San Vicente Fundacion
state: Antioquia
Study officials:
affiliation: Universidad de Antioquia
name: Adriana Cadavid
role: STUDY_CHAIR
References:
citation: Barrios A, Camelo J, Gomez J, Forero M, Peng PWH, Visbal K, Cadavid A. Evaluation of Sensory Mapping of Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E289-E296.
Clinical trial NCT05165381: Contactless Vital Signs Measurement
Official title: Video Plethysmography for Contactless Vital Signs Measurement: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure, Heart Rate, Respiratory Rate, Heart Rate Variability, Stress Index, Vital Signs Monitoring
Vital Signs Monitoring
Keywords: vital signs
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergoing elective inpatient surgery under general and/or regional anesthesia

Brief summary: This pilot study will determine the feasibility and effectiveness of implementing video plethysmography (PPG) for contactless vital signs and str5ess index measurements from surgical patients in preoperative care. Our primary objective is to determine the feasibility and validity of using video PPG to collect contactless BP, HR and RR measurements when compared medical-grade instruments. Our secondary objective is to validate the use of video PPG in measuring HRV and stress index when compared to a validated stress questionnaire.

Detailed description: The huge impact of the COVID-19 pandemic on global healthcare systems has given rise to an increased need for virtual care. This pilot study will determine the feasibility and effectiveness of implementing video plethysmography (PPG)for contactless vital signs measurements such as blood pressure (BP), heartrate (HR), respiratory rate (RR) and heart rate variability (HRV) from surgical patients in preoperative care. We also aim to validate the use of video PPG in measuring HRV and stress index when compared to a validated stress questionnaire.

This study aims to assess how video PPG technology can be implemented in a clinical and telemedicine. If proven to be effective, this technology can be integrated into any smartphone or tablet and will allow users to monitor their vital signs with just a 1.5-minute video.

Eligibility criteria: Inclusion Criteria:

* patients undergoing elective ambulatory surgery with general and/or regional anesthesia;
* 18 years or older;
* able to comprehend study instructions in English

Exclusion Criteria:

* refusal to consent for the study

Primary outcomes:
measure: Vital signs measurement
timeFrame: 24 hours
measure: Vital signs measurement
timeFrame: 24 hours
measure: Vital signs measurement
timeFrame: 24 hours
measure: HRV and stress index pressure
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: 399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto Western Hospital
name: Frances Chung, MBBS FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02372981: Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone
Official title: Doppler-guided Haemorrhoidal Artery Ligation With Suture Mucopexy vs. Suture Mucopexy Alone for the Treatment of Grade III Haemorrhoids: A Prospective-randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Third Degree Hemorrhoids
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 40
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: Novel minimally invasive techniques were established for prolapsing haemorrhoids to minimise the drawbacks of the golden standard of haemorrhoidal treatment, conventional haemorrhoidectomy techniques. Ligation techniques, such as Doppler-guided haemorrhoidal artery ligation (DG-HAL), were introduced to reduce the arterial inflow of the AVP and thus prevent the haemorrhoidal zone from being part of the continence system. Apart from inappropriate application of this surgical alternative for higher grade haemorrhoids, high recurrence rates of up to 38% after DG-HAL are due to technical failure of the ligation technique itself. This is a prospective randomised controlled trial to evaluate the efficacy of additional Doppler-guided ligation of submucosal haemorrhoidal arteries in patients with symptomatic grade III haemorrhoids.

Detailed description: All consecutive patients with symptomatic grade III haemorrhoids are randomly allocated to one of the two study arms: (A) DG-HAL with mucopexy or (B) mucopexy alone. Endpoints are pain, faecal incontinence, bleeding, residual prolapse and vascularisation of the anorectal vascular plexus. Vascularisation of the anorectal vascular plexus is assessed by transperineal contrast enhanced ultrasound.

Eligibility criteria: Inclusion Criteria:

* grade III haemorrhoids
* ≥18 years of age

Exclusion Criteria:

* malignant gastrointestinal disease
* inflammatory bowel disease
* any type of proctological intervention (i.e., fistula surgery)
* recurrent haemorrhoidal disease
* anorectal trauma in the history

Primary outcomes:
measure: pain assessment wit 1-month-pain diary
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Aigner F, Kronberger I, Oberwalder M, Loizides A, Ulmer H, Gruber L, Pratschke J, Peer S, Gruber H. Doppler-guided haemorrhoidal artery ligation with suture mucopexy compared with suture mucopexy alone for the treatment of Grade III haemorrhoids: a prospective randomized controlled trial. Colorectal Dis. 2016 Jul;18(7):710-6. doi: 10.1111/codi.13280.
Clinical trial NCT00805181: Kinetics of Biomarkers in Acute Pyelonephritis
Official title: Kinetics of Procalcitonin, C-reactive Protein and Pyuria in Uncomplicated Pyelonephritis in Women: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pyelonephritis
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2008-12-09
Enrollment: 30
Sex: FEMALE
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: 30 adult females with acute uncomplicated pyelonephritis

Brief summary: The objective of this study is to explore the kinetics of biomarkers in 30 adult female patients with uncomplicated acute pyelonephritis.

Detailed description: We will measure c-reactive protein, procalcitonin, pyuria and a new blood biomarker (Signature TM) everyday till normalization of these markers in 30 adult female patients with uncomplicated acute pyelonephritis.

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Flank/loin pain or tenderness, or both and fever \> 38°C during the last 48 hours and pyuria

Exclusion Criteria:

* Pregnancy
* Presence of indwelling catheters
* Known polycystic kidney disease or any malformation of the urinary tract, or single kidney; renal transplant recipients; acute or chronic renal failure requiring dialysis
* Recent discharge from hospital (during the last 10 days); ongoing antibiotic treatment
* Known severe immunosuppression: Receiver of solid-organ or hematopoietic stem cells transplants; neutropenia ( \< 1 G neutrophils / L); chronic (more than 14 days) use of systemic glucocorticoids (\>10 mg/d of prednisone); active use of immunosuppressive therapy for the treatment of auto-immune or inflammatory disease; HIV infection with \< 350 CD4+ cells / ml or unknown CD4+ status
* Pyelonephritis initially identified as complicated: obstruction of urinary tract, urinary stone; history of renal infection in the last 15 days
* Patient with severe sepsis or septic shock

Primary outcomes:
measure: Blood and urine biomarkers (procalcitonin, C-reactive protein, SIGNATURE(TM) test, pyuria
timeFrame: Daily till day 15.
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
affiliation: University Hospital, Geneva
name: Olivier T Rutschmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03402581: The Effect of Different Videolaryngoscopes on Intubation Success in Obese Patients
Official title: The Effect of Different Videolaryngoscopes on Intubation Success in Obese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult Airway, Videolaryngoscopes
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing elective surgery and have body mass index \> 35

Brief summary: Obese patients may have difficulty in airway management.Patients who have body mass index \> 35 are challenging patients for anesthesiologist. Short neck, more adipose tissue may be reasons for airway difficulty. Videolaryngoscopes are devices that ease the management of difficult airway.This study is designed to evaluate the differences and the effects of different laryngoscopes.


Eligibility criteria: Inclusion Criteria:

* body mass index\> 35

Exclusion Criteria:

* emergency airway

Primary outcomes:
measure: intubation difficulty
timeFrame: 1 minute
Secondary outcomes:
measure: airway assesment
timeFrame: 1 minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University
name: CIGDEM YILDIRIMGUCLU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00508781: Multiphoton Laser Scanning Microscopy in Cutaneous Optical Pathology
Official title: Multiphoton Laser Scanning Microscopy in Cutaneous Optical Pathology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Optical Biopsy
Cutaneous Pathology
Dermatopathology
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
name: National Health Research Institutes, Taiwan
First posted: 2007-07-30
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: We use multiphoton laser scanning microscopy to observe cutaneous anatomy and pathology. The study aims to compare surgical specimen by conventional pathology slice with the image by non-invasive multiphoton laser scanning microscopy.

Detailed description: For skin diseases, the most convincing method for diagnosis to date is surgical biopsy. However, a skin biopsy is an invasive procedure which carries the risk of tissue damage, wound infection and scar formation. To solve the inconvenience from surgical biopsy, multiphoton laser scanning microscopy is a developing, non-invasive method for observing the cutaneous anatomy and pathology. Multiphoton laser scanning microscopy is good in tissue penetration and resolution with less tissue damage. The study aims to compare surgical specimen by conventional pathology slice with the image by non-invasive multiphoton laser scanning microscopy. A good correlation in multiphoton image may serve as optical biopsy for cutaneous pathology and spare the invasive procedure of skin biopsy.

Eligibility criteria: Inclusion Criteria:

* Patients receiving cosmetic surgeries such as removal of moles

Exclusion Criteria:

* No special exclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Shiou-Hwa Jee, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01721681: A Study to Investigate Bio Product Laboratory Ltd (BPL's) Factor X in the Prophylaxis of Bleeding in Children <12 Years
Official title: A Phase III Open, Multicentre Study to Investigate the Safety, Pharmacokinetics and Efficacy of BPL's High Purity Factor X in the Prophylaxis of Bleeding in Factor X Deficient Children Under the Age of 12 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Factor X Deficiency
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2012-11-06
Enrollment: 9
Sex: ALL
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The primary objective of the study is to assess the efficacy of FACTOR X in the prevention of bleeding when given as routine prophylaxis over 12 months.

The secondary objectives of the study are:

1. To assess the pharmacokinetics of FACTOR X after a single dose of 50 IU/kg.
2. To assess the safety of FACTOR X when given as routine prophylaxis over 6 months (26 weeks).


Eligibility criteria: Inclusion Criteria

1. Children with hereditary severe or moderate FX deficiency (FX:C \<5 IU/dL), based on their lowest reliable FX:C recorded.
2. Children under 12 years old, whose parent/guardian has given informed consent.
3. Children with a history of severe bleeding e.g.: intracranial haemorrhage, before starting prophylactic therapy, OR a mutation in the F10 gene causing a documented severe bleeding phenotype.

Exclusion Criteria

1. Children must not suffer from clinically significant liver disease, renal disease, or other coagulopathy or thrombophilia
2. Children must have no history or suspicion of inhibitors to factor X.
3. Children who have known or suspected hypersensitivity to the investigational medicinal product or its excipients.
4. Children with a history of unreliability or non-cooperation.
5. Children who are participating or have taken part in another trial within the last 30 days.
6. Children planning more than 4 weeks' continuous absence from the locality of the investigational site, between the Screening Visit and the End of Study Visit at approximately 6 months (26 weeks) post-Baseline.

Primary outcomes:
measure: The Number of Participants With Excellent Reduction in Bleeding When Given FACTOR X as Routine Prophylaxis Over 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Safety of FACTOR X: Number of Participants Experiencing Adverse Events
timeFrame: 6 months
measure: Pharmacokinetics: FX:C Incremental Recovery
timeFrame: Baseline Visit and End of Study Visit, 30 minutes post-dose
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
Study officials:
affiliation: Great Ormond Street Hospital
name: Ri Liesner, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00825981: Primary and Secondary Hemostasis in Elective Coronary Artery Bypass Graft Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: coronary artery bypass graft

Brief summary: Patients undergoing elective coronary artery bypass graft surgery (CABG) are treated with platelet inhibitors to reduce myocardial infarction and mortality.However, this can increase perioperative bleeding. A retrospective analysis of the data in our institution has revealed a significant increase in transfusion requirements after elective CABG since 5 years. The aim of our study is to observe if this increase in transfusion requirements is due to platelet inhibitors or due to other coagulation abnormalities resulting from other anticoagulants.


Eligibility criteria: Inclusion Criteria:

* coronary artery bypass graft surgery with or without cardiopulmonary bypass

Exclusion Criteria:

* emergency; redo cardiac surgery; combined cardiac surgery; patients with renal insufficiency; patients with acquired coagulation abnormalities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
Study officials:
References:
citation: Hertfelder HJ, Bos M, Weber D, Winkler K, Hanfland P, Preusse CJ. Perioperative monitoring of primary and secondary hemostasis in coronary artery bypass grafting. Semin Thromb Hemost. 2005;31(4):426-40. doi: 10.1055/s-2005-916678.
Clinical trial NCT06696781: NOL Index in Response to Pacemaker Stimulation
Official title: NOL Index in Response to Pacemaker Stimulation in Open-heart Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nociceptive Pain
Keywords: cardiac surgery
nociception
NOL index
pacemaker
Lead sponsor: Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically ventilated postoperative adult patients, admitted to the ICU within 6 hours after elective cardiac surgery.

Brief summary: The Nociception Level Index (NOL Index) utilizes various signals to assess the balance of nociception and antinociception during anesthesia. Its correlation with nociceptive stimuli and opioids is known, but its response to isolated heart rate changes remains uncertain. The aim is to investigate how cardiac pacing affects the NOL Index.

Detailed description: The Nociception Level Index (NOL Index) represents an innovative approach to monitoring nociception during general anesthesia, utilizing a combination of signals from photoplethysmography, accelerometry, thermometry, and skin conductance to assess the balance between nociceptive and antinociceptive states. Research has already established how the NOL Index correlates with both nociceptive stimuli and opioid levels, providing valuable insights into patient responses. However, the impact of changes in heart rate, specifically through isolated cardiac pacing, on the NOL Index is not yet clear. The primary goal of this study is to explore and understand how cardiac pacing might influence the readings of the NOL Index, potentially offering a new dimension to managing anesthesia effectively.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Preoperative and postoperative sinus rhythm (50-80 bpm)
* Norepinephrine support \< 100 ng/kg/min

Exclusion Criteria:

* Redo or emergent surgery
* History of any cardiac arrhythmia
* Any cardiocirculatory support other than norepinephrine
* Perioperative treatment with beta-blockers, calcium-channel blockers or ivabradine

Primary outcomes:
measure: NOL index
timeFrame: Every minute during seven 5-minute intervals under various pacemaker settings, totaling 35 minutes of monitoring.
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: "Prof CC Iliescu" Emergency Institue for Cardiovascular Diseases
Study officials:
affiliation: CC Iliescu Cardiovascular Institute
name: Serban-Ion Bubenek-Turconi, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00767481: 1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Keywords: glaucoma
Patients with open-angle glaucoma or ocular hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2008-10-07
Enrollment: 6
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: Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* IOP at screening visit \<18mmHg in at least one eye Mean IOP in same eye (at both eligibility 1 \&2 visits)

  * 24 and ≤ 36 mmHg at 9:00
  * 21 and ≤ 36 mmHg at 11:00 and 16:00

Exclusion Criteria:

* Severe central visual field loss Angle Shaffer grade \< 2 C/D ratio \> 0.8 (horizontal or vertical measurement)

Primary outcomes:
measure: Mean IOP
timeFrame: 9:00,11:00, and 1600 time points at month 12
Secondary outcomes:
measure: Percent change in IOP, IOP change from baseline, patients with IOP <18mmHg. BSCVA, Ocular signs, Dilated fundus, perimetry, pachymetry, cardiovascular parameters(pulse, BP and AEs at W2, W3, M6, M9 and M12.
timeFrame: All on therapy time points not included in primary efficacy
Other outcomes:
Locations:
city: Mexico City
country: Mexico
Study officials:
References: