louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02318641: Measurement of the Oxygen Saturation in the Retinal Vessels With Oxymap
Official title: Measurement of the Oxygen Saturation in the Retinal Vessels With Oxymap
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chorioretinal Disorders in Diseases Classified Elsewhere
Keywords: oxygen consumption
retinal oximetry
Lead sponsor: Kagawa University
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy eyes and eyes with various chorioretinal disease.

Brief summary: Retinal oximetry can be measured with newly developed Oxymap (Oxymap ehf, Reykjavik, Iceland). Briefly, the device simultaneously acquires digital images at two wavelengths and automatically tracks retinal vessels on both images. Retinal vessel oxygen saturation is estimated by spectrophotometric analysis of light reflected from retinal vessels and from the immediately surrounding retina. Oxygen saturation measurements are made on major temporal arteries and veins. Briefly, the first and second degree vessels are used, with the addition of third degree vessels in images where peripapillary haemorrhage prevented analysis close to the optic disc. Vessel segments chosen for analysis are used consistently for consecutive measurements in the same retina.

Detailed description: Retinal oximetry can be measured with newly developed Oxymap (Oxymap ehf, Reykjavik, Iceland). Briefly, the device simultaneously acquires digital images at two wavelengths and automatically tracks retinal vessels on both images. Retinal vessel oxygen saturation is estimated by spectrophotometric analysis of light reflected from retinal vessels and from the immediately surrounding retina. Oxygen saturation measurements are made on major temporal arteries and veins. Briefly, the first and second degree vessels are used, with the addition of third degree vessels in images where peripapillary haemorrhage prevented analysis close to the optic disc. Vessel segments chosen for analysis are used consistently for consecutive measurements in the same retina.

Retinal oximetry in various chorioretinal diseases will be measured with Oxymap.

Eligibility criteria: Inclusion Criteria:

* Healthy eyes and eyes with various chorioretinal diseases, including diabetic retinopathy, retinal vein occlusion, epiretinal membrane, macular hole, inherited chorioretinal diseases, glaucoma, retinal detachment, etc.

Exclusion Criteria:

* Eye with medial opacity.

Primary outcomes:
measure: Change of retinal oxygen saturation from baseline at 6 months
timeFrame: Six months.
Secondary outcomes:
Other outcomes:
Locations:
city: Miki
country: Japan
facility: Kagawa University Faculty of Medicine
state: Kagawa
Study officials:
affiliation: Kagawa Univerisity Faculty of Medicine
name: AKITAKA TSUJIKAWA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04184141: Preoperative Use of Alprazolam and Hydroxyzine in Anxiety
Official title: The Effect of Hydroxyzine and Alprazolam Premedication on Preoperative Anxiety and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Agitation on Recovery From Sedation
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be divided into three groups. Group H patients will be given 100 mg Hydroxyzine orally 1 hour before surgery while group A patients will receive 0.5 mg Alprazolam orally. group P will be placebo group. Amsterdam Preoperative Anxiety and Knowledge Scale (APAIS) anxiety scores will be evaluated and recorded 1 hour before surgery. APAIS score will be evaluated again in the the operation room before surgery started. After base measurements of patients are recorded with standard monitoring, spinal block will be performed with 15 mg Heavy Bupivacaine from the L2-L3 or L3-L4 levels of spinal cord in sting position. When T10 level sensory block and Bromage 0-1 neuromusculer block will be occured , surgery will be started. Heart rate, non-invasive arterial blood pressure and the degree of peripheral O2 saturation will be measured at 5 minutes interval throughout the operation. IOWA anesthesia satisfaction scale will also performed to the patients the day after the surgery.


Eligibility criteria: Inclusion Criteria:

* sacrococcygeal dermoid cyst patients
* Saceptance of spinal anaesthesia
* between 18-60 years old patients
* ASA I-II

Exclusion Criteria:

* drug allergy
* BMI\>35kg/m2
* psychiatric disorders
* serious renal and hepatic damage
* coagulation disorders
* serious cardiac and respiratory disorderders
* rejection of spinal anesthesia

Primary outcomes:
measure: preopartive anxiety
timeFrame: 1 hour later orally admition of drugs
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03817541: Expiratory and Plasma Propofol Concentration in Gastrological Surgery Patients
Official title: Expiratory and Plasma Propofol Concentration in Bariatric and Cholecystectomy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery Candidate
Cholecystectomy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One Group of morbidly obese patients for bariatric surgery One Group of normal weight cholecystectomy
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determination of accuracy With Edmond (reg) expiratory propofol measurement Device, compared With concommitant plasma samples of propofol

Detailed description: Edmon (trade mark) is a New Device from BBraun, measuring the expiratory concentration of propofol in anaesthetized patients.

The investigators will test the accuracy and stability of such measurements in comparison With plasma propofol Levels.

The investigators will test during target Control infusion (Marsh model) and assumed stable plasma Levels.

Plasma samples of propofol will be taken for comparison With exhaled propofol.

Eligibility criteria: Inclusion Criteria:

* • Patients admitted to Oslo University Hospital, scheduled for elective laparoscopic bariatric surgery or elective laparoscopic cholecystectomy.

  * Both genders.
  * Age 18-60 years, both inclusive.
  * BMI ≥ 20 kg/m2, 10 patients with BMI 20-30, and 10 patients with BMI \> 40
  * ASA classification I-III

Exclusion Criteria:

* • Known hypersensitivity or other contraindication to propofol administered as Target Controlled Infusion.

  * Patients which during a preoperative visit are deemed not to tolerate propofol bolus or infusion as administered by Target Controlled Infusion.
  * Ongoing neuroleptic medication.

Primary outcomes:
measure: exhaled propofol concentration
timeFrame: start of anaesthesia to end of anaesthesia, 2-3 hours in total
measure: propofol plasma concentration
timeFrame: 4-6 samples in the period between start and end of anaesthesia
Secondary outcomes:
measure: calculated plasma concentration
timeFrame: From start of anaesthesia until end of anaesthesia, 1-3 hrs in total
measure: BIS
timeFrame: from start of anaesthesia until end of anaestheisa, 1-3 hours in total
measure: calculated effect site concentration
timeFrame: from start of anaesthesia until end of anaesthesia, 1-3 hours in total
measure: EEG Power spectrum
timeFrame: f
measure: EEG Power distribution
timeFrame: from start of anaesthesia until end of anaesthesia, 1-3 hours in total
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Study officials:
References:
Clinical trial NCT04423341: Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm
Official title: Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm - a Prospective Double-masked Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Blepharospasm
Blepharospasm, Benign Essential
CBD
Keywords: Cannabidiol
Epidiolex
Botulinum Toxin
Eyeblink analysis
Videorecording
Blepharospasm
BEB
Lead sponsor: Silkiss Eye Surgery
Sponsor class: OTHER
Collaborators: name: Benign Essential Blepharospasm Research Foundation
name: GW Pharmaceuticals Ltd
name: Smith-Kettlewell Eye Research Institute
First posted: 2020-06-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.


Eligibility criteria: Inclusion Criteria:

* Patients in the private practice of the principal investigator with an ICD code of "blepharospasm" and:
* undergoing routine maximal botulinum therapy
* experiencing break through symptoms of spasm
* marijuana naïve

Exclusion Criteria:

* concomitant diagnosis of epilepsy
* patients whom are not marijuana naive
* patients on concurrent anti-epileptics
* patients who are pregnant or wishing to become pregnant
* patients not wishing to participate in the study.

Primary outcomes:
measure: Eyeblink analysis from high speed videocamera recordings - see separate outcome measures
timeFrame: 4 measurements over 6 months
measure: Median Blink Amplitude
timeFrame: 4 measurements over 6 months
Secondary outcomes:
measure: Median Blink Duration
timeFrame: 4 measurements over 6 months
measure: Median Max Blink Velocity
timeFrame: 4 measurements over 6 months
measure: Number of Blinks per 100ms
timeFrame: 4 measurements over 6 months
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Silkiss Eye Surgery
state: California
Study officials:
References:
Clinical trial NCT06957041: Intertransverse Process Block for Quality of Recovery Post-Open Hepatectomy
Official title: Effect of Intertransverse Process Block on the Quality of Recovery Post-Open Hepatectomy: A Pilot Non-Randomised Study of Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hepatectomy
Intertransverse Process Block
Quality of Recovery (QoR-15)
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims to assess the analgesic efficacy of the ITPB at the retro-SCTL space in patients undergoing major open hepatectomy surgery. This is assessed by:

Primary Objective:

Primary outcome measure:

● Assessing the quality of recovery 15 (QoR15) score at 24 and 48 hours

Secondary outcome measure:

* Number of anaesthetic and hypoesthetic dermatomes on the ventral and dorsal aspect of the thorax on both the sides at 30 minutes of block completion and during the post anaesthetic room (PACU) discharge
* Assessing the 24-hour area under the curve of postoperative pain numerical rating score (NRS, 0-10) at rest and deep breathing or upon use of triflow.
* Assessing the amount of postoperative morphine (mg) equivalent consumption at 24 and 48 hours
* Time to discharge from High dependency unit (HDU) or Intensive care unit (ICU)

Hypothesis:

The investigators hypothesize that the application of ITPB targeting the retro-SCTL space in patients undergoing open hepatectomy will improve overall quality of recovery and pain score.


Eligibility criteria: Inclusion Criteria:

- Adult patients aged 18-75 years of ASA I - III physical status classification undergoing open hepatectomy for benign or malignant liver lesion.

Exclusion Criteria:

* Patient refusal
* Patients who are unable to comprehend the QoR15 form
* Local or systemic infection
* Coagulopathy leading to absolute contraindication to regional anesthesia
* Contraindication to local anaesthetics (LA) such as LA allergy

Primary outcomes:
measure: Quality of Recovery (QOR-15)
timeFrame: 24 and 48 hours
Secondary outcomes:
measure: Dermatomal blockade on Thorax 30 minutes upon block completion
timeFrame: Up to 30 minutes after block completion
measure: 24 hours area under curve of postoperative pain score
timeFrame: Up to 24 hours
measure: Morphine consumption at 24 and 48 hours postoperatively
timeFrame: At 24 and 48 hours postoperatively
measure: Time to discharge from HDU / ICU
timeFrame: Up to 5 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03463941: Peer Support Dyads in Churches
Official title: Peer Support Dyads in a Health Promotion Program in African American Churches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peer Support and Chronic Disease
Obesity
Type II Diabetes
Cardiovascular Disease
Cancer
Keywords: African American
Faith institutions
Dyads
Health disparities
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-03-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to explore how working with a partner can influence participation in a church wellness program. There are many different types of church wellness programs. Church members are more likely to participate and achieve goals in these programs when they have peer support. The researcher would like to know what African American men and women think about working with a support partner. This information will help researchers design better church wellness programs. The participants are being asked to take part in this research because the investigators believe that it is helpful to share feelings and thoughts about experiences working with a partner to achieve health goals. This knowledge will be used to create church wellness programs that will help African American men and women prevent disease and live healthier lives.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria will be churches with mostly African American members.
* Participant criteria will be: ages \>=18 or older who identify as African American
* Attend church at least once per week
* Speak, read and write English
* Willing to complete study activities and assessments
* Able to engage in moderate physical activity. (e.g., walking - based on their own activity level and assessment).

Exclusion Criteria:

-

Primary outcomes:
measure: Feasibility as Measured by Retention
timeFrame: Baseline to week 18
measure: Number of Participants Who Agreed That Program Component Was Acceptable
timeFrame: Measured at Week 18
measure: Health Educators' Perceptions of Feasibility as Measured by Semi-structured Interviews
timeFrame: Measured at Week 18
Secondary outcomes:
measure: Goal Attainment as Measured by BMI (Body Mass Index)
timeFrame: Week 18
measure: Goal Attainment as Measured by Weight in Pounds
timeFrame: Week 18
measure: Goal Attainment as Measured by Number of Participants Consuming 7 or More Fruits and Vegetables Per Day
timeFrame: Week 18
measure: Goal Attainment as Measured by Days Per Week That Participants Exercised for 30 Minutes or More
timeFrame: Week 18
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Faithful Families Program
state: North Carolina
Study officials:
affiliation: Duke University
name: Isaac Lipkus
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04715841: Gait Analysis in Females Suffering From Patellofemoral Pain Syndrome (PFPS)
Official title: Gait Analysis in Females Suffering From Patellofemoral Pain Syndrome (PFPS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: Delta University for Science and Technology
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 female with patellofemoral pain syndrome aged from 18 to 35 years old free from any musculoskeletal problems in lower limb

Brief summary: The purpose of the study was to evaluate the spatial and temporal variables during walking cycle in adolescent females suffering from patellofemoral pain syndrome (PFPS) versus healthy adolescent females .


Eligibility criteria: Inclusion Criteria:

* peripatellar or retropatellar knee pain worsen with upstairs and walking

Exclusion Criteria:

* previous knee or patella surgeries

Primary outcomes:
measure: step length
timeFrame: 3 months
measure: stride length
timeFrame: 3 months
measure: speed
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gamasa
country: Egypt
facility: Delta University for Science and Technology
state: Dakahelia
city: Gamasa
country: Egypt
facility: Delta University For Science and Technology
Study officials:
References:
Clinical trial NCT01044641: Measurement of Colloid Osmotic Pressure in Plasma and Interstitial Fluid in Children
Official title: Measurement of Colloid Osmotic Pressure in Plasma and Interstitial Fluid in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colloid Osmotic Pressure
Keywords: Colloid Osmotic pressure in interstitial fluid
Colloid Osmotic pressure in plasma
Protein fractions in interstitial fluid
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2010-01-08
Enrollment: 99
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary care clinic (ENT)

Brief summary: The purpose of this study is to identify normal values of colloid osmotic pressure in interstitial fluid and plasma in healthy children between 2 and 10 years.

Detailed description: Measurements of colloid osmotic pressure (COP) by sampling of interstitial fluid from subcutaneous tissue and plasma are well documented in animal models and human adult studies. COP plays a major role in transcapillary fluid balance and is valuable in fluid therapy planning in critically ill patients. There are no data regarding interstitial fluid COP values in neither sick nor healthy children. Sampling of interstitial fluid by the wick method in children who is under general anaesthesia (ear-nose-throat operations) gives the opportunity to identify normal COP values in this age group.

Eligibility criteria: Inclusion Criteria:

* Children from 2 to 10 years

Exclusion Criteria:

* Medication
* Ongoing illness
* Syndromes

Primary outcomes:
measure: Colloid osmotic pressure
timeFrame: 60 minuttes after wick insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Hanukeland University Hospital
name: Hans Joergen T Guthe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guthe HJ, Indrebo M, Nedrebo T, Norgard G, Wiig H, Berg A. Interstitial fluid colloid osmotic pressure in healthy children. PLoS One. 2015 Apr 8;10(4):e0122779. doi: 10.1371/journal.pone.0122779. eCollection 2015.
Clinical trial NCT04223141: Single-stapled Double Purse-string Technique for Colorectal Anastomosis
Official title: Single-stapled Double Purse-string Anastomotic (SIA) Technique in Robotic Malignant Sigmoid Resections
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colo-rectal Cancer
Keywords: Robot
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single-arm, single-center prospective study of a novel double purse-string technique for constructing the colorectal anastomosis in robot-assisted laparoscopic resection of the sigmoid colon for cancer.

Detailed description: In all, 30 consecutive patients will be enrolled. The first 5 will be regarded as a pilot series for testing and aligning the study setup. The next 25 patients will form the study group. The clinical outcomes will be compared with historical control patients from our own department. Safety and feasibility will be assessed by short-term clinical outcomes.

Eligibility criteria: Inclusion Criteria (all must be fulfilled):

* Verified cancer of the sigmoid colon
* Planned elective robot-assisted laparoscopic resection of sigmoid colon with primary anastomosis
* Operation with curative intent

Exclusion Criteria:

* Not legally competent and/or \< 18 years old
* Not able to comprehend information and/or give written consent

Primary outcomes:
measure: Technical success
timeFrame: 30 days
measure: Complications
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: LOS
timeFrame: 90 days
measure: Readmissions
timeFrame: 30 days
measure: Operation time
timeFrame: 30 days
measure: Blood loss
timeFrame: 30 days
measure: Medical complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital, Department of Surgery
Study officials:
affiliation: Staff Surgeon
name: Helene J Würtz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consultant
name: Flemming H Dall, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department Head
name: Hans B Rahr, MD DMSc
role: STUDY_DIRECTOR
References: