louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06985030: Head Position Monitoring After Pars Planar Vitrectomy
Official title: Compliance of Head Positioning After Pars Planar Vitrectomy With Tamponade
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Retinal Detachment
Macular Hole
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who get vitrectomy with gas or silicone oil tamponade followed by positioning prescription

Brief summary: In ophthalmic surgical practice, particularly for treating retinal detachment and macular hole disorders, vitrectomy procedures are routinely performed to remove the vitreous body followed by the injection of tamponade agents such as gaseous compounds (e.g., C3F8 or SF6) or silicone oil. These tamponade materials function by creating internal pressure against the retinal surface to facilitate reattachment. A critical determinant of surgical success in these cases is postoperative head positioning (prone posturing), as improper alignment may compromise the tamponade effect.

At the investigators' institution, participants undergoing such procedures are prescribed a strict prone position regimen for 7 consecutive postoperative days. This facedown positioning protocol aims to optimize interfacial contact between the tamponade agent and retinal tissue. However, conventional clinical practice faces a significant limitation: the inability to objectively verify patient compliance with prescribed postural guidelines outside clinical settings. Subjective patient reporting and intermittent clinical observations prove insufficient for quantifying adherence levels.

To address this critical gap in postoperative monitoring, the investigators propose implementing a novel electronic monitoring system integrated into therapeutic eye patches. This advanced device incorporates a miniaturized triaxial gyroscopic sensor array capable of continuously tracking cephalo-cervical orientation with high angular resolution. The system features complete electrical isolation from ocular tissues while maintaining sterility. Data acquisition occurs through a microSD card (capacity: 16GB) that logs positional parameters at 0.2Hz sampling frequency, creating comprehensive temporal records of head movement patterns.


Eligibility criteria: Inclusion Criteria:

* Patients who get vitrectomy

Exclusion Criteria:

* Patients who cannot maintain positioning due to their physical disability

Primary outcomes:
measure: Compliance of head positioning
timeFrame: From enrollment to 7 days after surgery
Secondary outcomes:
measure: Baseline demographic and ocular characteristics
timeFrame: At enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, dep. of Ophthalmology
Study officials:
References:
Clinical trial NCT03871530: A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia
Official title: A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Analgesia
Epidural
Labor
Obstetric Analgesia
Obstetrical
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blind randomized trial
Primary purpose: TREATMENT

Brief summary: Programmed intermittent epidural bolus (PIEB) for labour analgesia allows an epidural pump to be programmed to deliver small amounts of the local anesthetic and opioid solution at regularly timed intervals. However, little evidence is available to guide optimal settings for PIEB. The gaps in evidence include: (1) programmed timing for the first PIEB bolus (referred to as the "NEXT bolus") (2) determination of PIEB bolus volume (3) the interval for subsequent doses (PIEB interval). Response Surface Methodology will be utilized to best estimate the optimal PIEB settings (NEXT bolus interval, PIEB interval time, PIEB volume) by using the following clinical primary outcome measures: maternal satisfaction score, need for a clinician administered rescue bolus, and the ratio of PCEA boluses requested/delivered.


Eligibility criteria: Inclusion Criteria:

* Nulliparous,
* English speaking
* 18-45 years
* single gestation ≥ 37 weeks
* vertex presentation
* American Society of Anesthesiologists (ASA) Physical Status II (mild and controlled systemic disease and/or pregnancy)
* requesting an epidural for labour analgesia
* cervical dilation ≤ 7 cm at the time of initiation of epidural analgesia.

Exclusion Criteria:

* Preeclampsia or HELLP syndrome
* maternal cardiac disease
* severe or uncontrolled maternal systemic disease
* contraindication to neuraxial analgesia (i.e. coagulopathy, infection, neuropathy)
* abnormal spinal anatomy (i.e. severe scoliosis, spina bifida, spinal instrumentation)
* chronic analgesic use
* a physical or psychiatric condition which may impair cooperation
* known fetal anomalies/intrauterine fetal demise
* height \< 5'0"
* Body Mass Index \> 45 kg/m2

Primary outcomes:
measure: Maternal satisfaction score
timeFrame: 24 hours following delivery
measure: Number of clinician administered rescue boluses
timeFrame: Start of labour epidural to delivery time
measure: Ratio of the number of PCEA boluses requested to the number of PCEA boluses delivered
timeFrame: Start of labour epidural to delivery time
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
References:
Clinical trial NCT04804930: Trichoscopy and Systemic Scleroderma
Official title: Prognostic Value of Trichoscopy in Patients With Systemic Scleroderma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scleroderma, Systemic
Keywords: Trichoscopy
Dermoscopy
Systemic Scleroderma
Scalp
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with systemic scleroderma

Brief summary: * Few data are available on scalp involvement in systemic scleroderma.
* Few data are available on the association between scalp abnormalities and features of systemic scleroderma
* Trichoscopy is a simple, reproducible, noninvasive examination that is part of the examination of hairy areas in routine dermatologic practice
* There is a lack of simple, noninvasive examinations to evaluate patients with systemic scleroderma

The objective will be to evaluate the contribution of trichoscopy in the evaluation of patients with systemic scleroderma


Eligibility criteria: Inclusion Criteria:

* Patient who fulfils the Systemic scleroderma ACR-EULAR 2013 criteria
* Signed informed consent
* Being social insured

Exclusion Criteria:

* Patients aged less than 18 years old
* patients under legal protection
* patients deprived of their liberty
* patients in emergency situations
* patients who refused or unable to give informed consent
* For the control group: sclap inflammatory disease active the day of the examination

Primary outcomes:
measure: Frequency of elementary lesions observed by trichoscopic assessment of the scalp
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between visceral damage of systemic scleroderma and trichoscopic features
timeFrame: Baseline
measure: Correlation between global severity of systemic scleroderma and trichoscopic features
timeFrame: Baseline
measure: Correlation between autoimmune profile of sclerodermic patients and trichoscopic features
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Vincent Sobanski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03217630: Ultrasound Evaluation of Gastric Emptying in Diabetic Patients: a Comparison With Non-diabetic Controls
Official title: A Cohort Study of Ultrasound Evaluation of Gastric Emptying in Diabetic Patients: a Comparison With Non-diabetic Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study participants will be diabetic and non-diabetic patients who are admitted to the surgical department and scheduled to undergo elective surgical procedures. 100 participants will be recruited in total.

Brief summary: This is a prospective cohort study. The main objective is to compare the prevalence of a "full stomach" using gastric ultrasound technique, in elective surgical patients with diabetes mellitus compared to non-diabetic controls following the present fasting guidelines (2 h after clear liquid and 6h after a light meal). For patients with a full stomach or intermediate stomach, an consecutive ultrasound scan is performed every 10 min,until empty stomachstomach contents are detected to determine the mean gastric emptying time for clear liquid and light meal, and to investigate the risk factors for delayed stomach emptying in diabetic patients by logistic regression analysis .


Eligibility criteria: Inclusion Criteria:

* diabetes (two fasting plasma glucose concentration≥7mmol/L or casual plasma glucose concentration≥11.1mmol/L);
* age≥18 yr; ASA physical status I-III;
* body mass index \<35kg/m2;
* who are admitted to the surgical department;
* who are able to understand the rationale of the study and provide informed consent.

Exclusion Criteria:

* pregnancy;
* a history of upper gastrointestinal disease or previous surgery on the oesophagus, stomach or upper abdomen;
* documented abnormalities of the upper gastrointestinal tract such as gastric tumors;
* recent upper gastrointestinal bleeding (within the preceding 1 month);
* taking medicines that may delay gastric emptying(e.g., anticholinergic agents).
* hypothyroidism.

Primary outcomes:
measure: Prevalence of full stomach
timeFrame: one day
Secondary outcomes:
measure: Mean gastric emptying time of clear liquid and light meal
timeFrame: one day
Other outcomes:
measure: Risk factors of delayed stomach empty in diabetic patients
timeFrame: one day
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: Chunling Jiang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou L, Yang Y, Yang L, Cao W, Jing H, Xu Y, Jiang X, Xu D, Xiao Q, Jiang C, Bo L. Point-of-care ultrasound defines gastric content in elective surgical patients with type 2 diabetes mellitus: a prospective cohort study. BMC Anesthesiol. 2019 Oct 10;19(1):179. doi: 10.1186/s12871-019-0848-x.
Clinical trial NCT07008430: Angle Specific Torque Profiles After Distal Radius Fracture
Official title: Angle-Specific Torque Profiles of Wrist, Forearm and Elbow Movements After Distal Radius Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radius Distal Fracture
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with distal radius fracture

Brief summary: Distal radius fracture (DRF) is one of the most common upper extremity injuries and can lead to long-term kinesiological and anatomical alterations despite proper surgical fixation and rehabilitation. This retrospective cohort study aims to analyze the angle-specific torque characteristics of wrist (flexion/extension), forearm (supination/pronation), and elbow (flexion/extension) movements in patients with a history of DRF treated by volar plate fixation.

The study will utilize archived raw data of 37 eligible patients who underwent isokinetic strength testing during the post-rehabilitation period. Data will be extracted from Cybex NORM® and Humac isokinetic dynamometer systems and analyzed using Statistical Parametric Mapping (SPM) with the open-source spm1d package in MATLAB. This analysis will generate 101-point angle-dependent torque curves for each joint movement and will be used to evaluate interlimb asymmetry, angle of peak torque production, and unilateral agonist/antagonist torque ratios.

Additionally, radiographic images archived during the treatment period will be analyzed to measure radial inclination, palmar tilt, and ulnar variance using the Dresdner scoring system. The torque profiles and radiological parameters will be statistically analyzed with SPSS. Between-limb comparisons and symmetry indices will be calculated using repeated-measures ANOVA, t-tests or non-parametric alternatives, depending on data distribution.

This research is expected to provide new insights into the kinesiological consequences of DRF by presenting detailed angle-specific torque characteristics, going beyond conventional peak torque and range of motion assessments commonly seen in the literature.


Eligibility criteria: Inclusion Criteria:

* Patients with distal radius fractures reduced with a volar plate will be included.

Exclusion Criteria:

* Patients with bilateral injuries, fractures in bones other than the radius, stabilization methods other than volar plate, and any other neurological or orthopedic condition that may affect the evaluation will be excluded from the study.

Primary outcomes:
measure: Angle Specific Torque Profiles
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İzmir Katip Çelebi University
state: Çiğli
Study officials:
References:
Clinical trial NCT01781130: Effect of Steroid Injection Which is Added to Percutaneous Trigger Finger Release: a Double-blinded Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Finger
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background

Present treatment strategies for trigger finger when conservative management including steroid injection was failed include percutaneous or open A1 pulley release, but some people showed prolonged swelling and delay of complete healing.

We aimed to test the hypothesis that an improved outcome can be achieved by employing steroid injection simultaneously with percutaneous release compared with conventional percutaneous release alone

Methods

We designed a double-blind, randomized controlled trial.

Inclusion criteria is the patient who has symptom of trigger finger warranted surgical release after sufficient time of conservative treatment.

Exclusion criteria are as follow: 1) multiple fingers at presentation; 2) Rheumatoid arthritis patients; 3) Pregnant or lactating patients; 4) Younger than 18 years old; 5) Previous surgery history of finger 6); the patients who got steroid injection more than 4 time previously; 7) coagulation abnormality including usage of anti-thrombotic agent.

After power analysis by a statistician, total 40 patients would be required for each group (percutaneous alone group versus percutaneous alone + steroid injection group).

The surgery will be performed by outpatients clinic basis with local injection. Additional steroid injection will be given to half of patients after allocation with randomized selection by permutaed block randomization.

Primary outcome measure is mean fall in pain visual analogue scale (pVAS) and secondary outcome will be proportion of patients with good response (defined as "Perfect" or "much better" as reported by patients).

Follow-up will be conducted 3 weeks and 3 month after index procedure


Eligibility criteria: Inclusion Criteria:

* Trigger finger patients who require surgical intervention due to failuer of sufficient time of conservative treatment

Exclusion Criteria:

* Age under 18 years old
* Rheumatoid arthritis patients
* Patients who got steroid injection more than 4 times previously
* Multiple finger affected at presentation
* Previous surgery history
* Any recent trauma history of affected hand

Primary outcomes:
measure: pain VAS
timeFrame: 3 month after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Patel MR, Moradia VJ. Percutaneous release of trigger digit with and without cortisone injection. J Hand Surg Am. 1997 Jan;22(1):150-5. doi: 10.1016/S0363-5023(05)80196-0.
Clinical trial NCT03306030: Comparison of Two Methods for Bowel Preparation in Patients With Constipation
Official title: Comparison of Two Split-dose Regimes for Bowel Preparation in Patients With Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Keywords: PEG
Bowel preparation
Colonoscopy
split-does
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Constipation is a common high risk factor for inadequate bowel preparation. The bowel cleansing efficacy of the standard split-does of 4L seems to be suboptimal in constipated patients. The investigator hypothesized that compared with the standard preparation regime, the split-dose with three times of 4L PEG may be superior in BP quality.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-80 with constipation.

Exclusion Criteria:

* History of colorectal surgery BMI\>30 Suspected colonic stricture or bowel obstruction Use of purgatives within 3 days Pregnancy or lactation Unable to give informed consent Haemodynamically unstable

Primary outcomes:
measure: Rate of adequate bowel preparation
timeFrame: 1 year
Secondary outcomes:
measure: Adverse event rate
timeFrame: 1 year
measure: Cecal intubation rate
timeFrame: 1 year
measure: Cecal intubation time
timeFrame: 1 year
measure: Withdrawal time
timeFrame: 1 year
measure: Polyps detection rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
Study officials:
References:
Clinical trial NCT05721430: Urdu Translation and Cross Cultural Validation of PedsQL Inventory Infant Scale Parent Report 1 to 12 Months
Official title: Urdu Translation and Cross Cultural Validation of PedsQL Inventory Infant Scale Parent Report Ages 1 to 12 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Development
Keywords: Health related quality of life of Infants
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 43
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The sample size was 43. Sample size was calculated by raosoft online software. Margin of error 5% Confidence level 95% Population size 20000 Response distribution 50% Sample Selection Criteria

Brief summary: The current study aimed to translate and validate Urdu version of that module from PedsQL, to measure the "quality of life" outcomes for Pakistan and Urdu speaking people.

Detailed description: Data will be collected by PedQL Infants Scale Parent report A mix method approach will be applied Forward translation Backward translation Review of forward and backward translation The process of translation will be followed the guidelines in the translation manual. Translators will translate the PedsQL Inventory Infants Scale Parent Report independently from each other in Urdu language following the proper forward and backward translation procedure.

Data Analysis Quality of life pediatric population will assess through Urdu translated version of PedsQL Inventory Infants Scale Parent report. Data will be analyzed through SPSS.

Eligibility criteria: Inclusion Criteria:

* Parents of both genders included
* Parents of infant age 1 to 12 months were included.

Exclusion Criteria:

* Parents suffering from psychological disorders
* Parents with severe behavior issue
* Parents who cannot understand Urdu

Primary outcomes:
measure: Quality of Life of Infants age 1 to 12 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah international university
state: Punjab
city: Lahore
country: Pakistan
facility: Rising Sun Institute
state: Punjab
Study officials:
affiliation: Riphah International University
name: Saiqa Tabassum, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varni JW, Limbers CA, Neighbors K, Schulz K, Lieu JE, Heffer RW, Tuzinkiewicz K, Mangione-Smith R, Zimmerman JJ, Alonso EM. The PedsQL Infant Scales: feasibility, internal consistency reliability, and validity in healthy and ill infants. Qual Life Res. 2011 Feb;20(1):45-55. doi: 10.1007/s11136-010-9730-5. Epub 2010 Aug 22.