louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05691075: Metatarsophalangeal Arthrodesis of the Hallux
Official title: Metatarsophalangeal Arthrodesis of the Hallux : Observational Study Evaluating the Efficacy and Tolerance of Synthetic Methods Using Dorsal Plate and Large-diameter Screws
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hallux Deformity
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-01-19
Enrollment: 3
Sex: ALL
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: Patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw.

Brief summary: The purpose of the study is to describe the rate of bone fusion (radiological consolidation) in the 2 groups (A and B) 4 months after the operation.

Detailed description: The main objective of the study is to describe the rate of bone fusion obtained with the different types of osteosynthesis material: dorsal plate, large-diameter compression screw.

Patients will be divided into two groups:

* patient undergoing arthrodesis of the hallux with a large diameter screw (group A)
* patient undergoing arthrodesis of the hallux by plate (group B)

This is a prospective, cross-sectional, open, comparative, non-randomized, non-interventional, monocentric study on two methods of synthesis (large-diameter plate or screw) of hallux metatarsophalangeal arthrodesis. Patients will be managed in accordance with current practice, the choice of surgical strategy (percutaneous / open) being left to the discretion of the investigators.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing isolated first ray surgery (M1 only) of hallux valgus, hallux varus or hallux rigidus by percutaneous or conventional approach;
* Patient who can benefit from first-line arthrodesis using a dorsal plate or large-diameter screw;
* Patient able to understand information related to the study and complete quality of life questionnaires;
* Patient accepting study follow-up visits;
* Patient having been informed and agreeing to participate in the study.

Exclusion Criteria:

* Pregnant or breastfeeding women;
* Patient undergoing lateral ray surgery;
* Patient undergoing revision arthrodesis;
* Patient with a loss of bone substance requiring a graft;
* Patient suffering from chronic inflammatory disease;
* Patient treated with long-term immunosuppressive or corticosteroid treatments;
* Patient under guardianship or curatorship, or under a regime of deprivation of liberty.

Primary outcomes:
measure: Rate of bone fusion obtained with different types of osteosynthesis material (dorsal plate and large-diameter compressive screw)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Blomet
Study officials:
References:
Clinical trial NCT05165875: Splint Versus Steroid Randomized Trial
Official title: Splint Versus Steroid Injection for DeQuervain's Tenosynovitis: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: De Quervain Syndrome
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial design is a multicentre, randomized controlled, assessor blinded, 2 arm 1:1 superiority trial.
Primary purpose: TREATMENT

Brief summary: The primary aim is to compare the effectiveness of splinting versus steroid injection in improving the DASH scores in participants diagnosed with De Quervain's tenosynovitis over a period of 6 months.

Detailed description: The primary hypothesis is that steroid injection into the first dorsal compartment is more effective compared with splinting at 3 months.

The secondary hypothesis is that steroid injection yields better clinical outcomes compared with splinting at 1 month, 3 months and 6 months.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of de Quervain's tenosynovitis based on the de Quervain's screening tool (DQST) with scores ≥ 5 (refer to table 1)
* No prior treatment
* Above 21 years of age

Exclusion Criteria:

* Allergy to steroid (triamcinolone acetate) or local anaesthetic (lignocaine)
* History of work related trauma

Primary outcomes:
measure: Quick Disability of Arm, Shoulder, Hand (QuickDASH)
timeFrame: 6 months
measure: Patients who have recovered from De Quervain's Tenosynovitis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National University Hospital, Singapore
name: Renita Sirisena
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02736175: OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Official title: A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3C Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Surgical Ocular Pain
Post-Surgical Ocular Inflammation
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-13
Enrollment: 438
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 the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation


Eligibility criteria: Inclusion Criteria:

* Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of posterior chamber lens
* Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

Exclusion Criteria:

* Any intraocular inflammation in the study eye present during the screening slit lamp examination
* Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
* Any intraocular inflammation in the study eye present during the screening slit lamp examination

Primary outcomes:
measure: Absence of Anterior Chamber Inflammation
timeFrame: Day 14
measure: Absence of Ocular Pain
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04963075: Multisensory Rehabilitation of Hemianopia
Official title: Non-Invasive Multisensory Rehabilitation of Hemianopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemianopia
Keywords: visual cortex injury
stroke
blindness
cortical damage
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Neuroscience Clinical Trial and Innovation Center (NCTIC)
First posted: 2021-07-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will participate in weekly sessions (1.5-2 hours) for three months which contain baseline testing, training, and repeated testing of visual recovery
Primary purpose: BASIC_SCIENCE

Brief summary: The current proposal is to generate "proof of concept" evidence that hemianopia can be successfully rehabilitated in humans when this multisensory rehabilitation paradigm is used.

Detailed description: The over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. The participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery.

Eligibility criteria: Inclusion Criteria:

* adults (\<85) of either sex
* diagnosis of a stable homonymous hemianopia (\>6 months) with absence of hemineglect
* lesion encompassing at least primary visual cortex but sparing parietal cortex
* normal auditory and cognitive function
* willingness to participate in the three month program
* ability to perform the visual discriminations in their intact field

Exclusion Criteria:

* adults (\>85)
* normal auditory and cognitive function
* unwilling to participate in the three month program
* inability to perform the visual discriminations in their intact field

Primary outcomes:
measure: Number of points detected
timeFrame: 3 months
measure: Reaction time
timeFrame: 3 months
measure: Distance between perceived and actual stimulus location
timeFrame: 3 months
measure: Low-vision visual functioning questionnaire (LV-VFQ-48)
timeFrame: Baseline
measure: Low-vision visual functioning questionnaire (LV-VFQ-48)
timeFrame: Month 3
measure: Humphrey visual field test
timeFrame: Baseline
measure: Humphrey visual field test
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Benjamin Rowland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04929275: Enhanced Recovery Programs and Small Bowel Obstruction
Official title: Feasability and Impact of Enhanced Recovery Programs After Surgery for Small Bowel Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Small Bowel Obstruction
Surgery
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-06-18
Enrollment: 50
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: Small bowel obstruction surgery is frequent and would benefit from enhanced recovery programs. While some studies advocate for their feasibility, it has never been proved and prospective studies are required to confirm the feasibility of such program and the impact on postoperative outcomes.


Eligibility criteria: Inclusion Criteria:

* Adhesionnal small bowel obstruction requiring surgical management

Exclusion Criteria:

* No surgery
* Patients disagreeing to participate

Primary outcomes:
measure: occurence rate of postoperative ileus
timeFrame: within 30 postoperative days
Secondary outcomes:
measure: Feasibility of the enhanced recovery program after small bowel obstruction surgery
timeFrame: within 30 postoperative days
measure: Postoperative morbidity
timeFrame: within 30 postoperative days
measure: length of stay
timeFrame: the day of discharge assessed up to 30 days
measure: Rate of nasogastric tube replacement
timeFrame: within 30 postoperative days
measure: Rate of tolerance to solid food
timeFrame: within 30 postoperative days
measure: Time to GI function recovery
timeFrame: within 30 postoperative days
measure: acceptability toward the enhanced recovery program
timeFrame: the day of discharge up to 30 days
Other outcomes:
Locations:
city: Angers
country: France
facility: UH Angers
Study officials:
affiliation: UH Angers
name: Aurélien Venara, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03067675: Triton Reference Database
Official title: Topcon DRI OCT Triton Reference Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Eyes
Keywords: no known ocular pathology
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2017-03-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population will consist of subjects without eye disease.

Brief summary: The objective of this study is to collect OCT measurement data on normal healthy eyes.

Detailed description: The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon DRI OCT Triton based on the percentile points for 1%, 5%, 95%, and 99%.

Eligibility criteria: Inclusion Criteria

1. Subjects 18 years of age or older on the date of informed consent
2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
3. Subjects presenting at the site with normal eyes bilaterally (cataracts are acceptable)
4. IOP ≤ 21 mmHg bilaterally
5. BCVA 20/40 or better bilaterally

Exclusion Criteria

1. Subjects unable to tolerate ophthalmic imaging
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images
3. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses \> 20% or false positives \> 33%, or false negatives \> 33%
4. Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings:

   1. On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
   2. Glaucoma hemi-field test "outside normal limits."
5. Narrow angle
6. History of leukemia, dementia or multiple sclerosis
7. Concomitant use of hydroxychloroquine and chloroquine

Primary outcomes:
measure: Retinal Thickness
timeFrame: 1 Minute
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Southern California College of Optometry
state: California
city: Pasadena
country: United States
facility: Accessoreyes Optometry
state: California
city: Chicago
country: United States
facility: Illinois College of Optometry
state: Illinois
city: Willmar
country: United States
facility: Fischer Laser Eye Center
state: Minnesota
city: Jamaica
country: United States
facility: New York VA
state: New York
city: New York
country: United States
facility: Stat University of New York College of Optometry
state: New York
Study officials:
affiliation: Topcon Corporation
name: Charles Riesman, MS
role: STUDY_CHAIR
References:
Clinical trial NCT05858775: Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation
Official title: MAPVIX: Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervix; Pregnancy
Keywords: Cervical Stiffness
Lead sponsor: Pregnolia AG
Sponsor class: INDUSTRY
First posted: 2023-05-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women at gestational ages between 16+0 - 22+6 weeks

Brief summary: The assessment of cervical stiffness plays a major role in obstetrics, for example to assess the risk of preterm birth.

The Pregnolia System is a CE-certified measuring device that objectively determines cervical stiffness using a slight negative pressure. The Pregnolia System was developed in Switzerland and resulted from a research project of the ETH and the University Hospital Zurich.

Until now, the stiffness of the cervix was examined and individually assessed by palpation (palpation with fingers). The Pregnolia System was developed to make this measurement objective and independent of the examining person.

The aim of the study is to measure cervical stiffness at different locations on the cervix to see if there are differences between the measurement locations.


Eligibility criteria: Inclusion Criteria:

* Informed Consent signed by the subject
* Pregnant woman at GA 16+0 - 22+6
* Singleton pregnancy
* 18 years or older
* Nulliparous cohort: nulliparous pregnant woman
* Multiparous cohort: multiparous pregnant woman

Exclusion Criteria:

* Lack of informed consent
* Placenta praevia
* Severe vaginal bleeding
* Rupture of membranes before 34 weeks (to be excluded with pH test)
* Visible tissue scarring at the measurement locations\* on cervix
* Light bleeding (if the bleeding can be stopped, it is no longer an exclusion criterion)
* Cervical dilation ≥ 3 cm
* Cerclage or pessary in place
* Vaginal or cervical infections (to be excluded with the Amsel criteria)

Primary outcomes:
measure: Cervical Stiffness Index at 16+0 - 22+6
timeFrame: 16+0 - 22+6 gestational weeks
Secondary outcomes:
measure: Cervical Stiffness Index (repetition)
timeFrame: 16+0 - 22+6 gestational weeks and optional follow-up visits
measure: Cervical Stiffness Index (cohort)
timeFrame: 16+0 - 22+6 gestational weeks and optional follow-up visits
measure: Delivery data
timeFrame: 1-4 weeks after delivery or termination of the pregnancy
Other outcomes:
Locations:
city: Uster
country: Switzerland
facility: gynosense AG
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT01416675: Delirium Assessment in the Pediatric Intensive Care Unit
Official title: Delirium Assessment in the Pediatric Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-08-15
Enrollment: 68
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric Intensive Care Unit Patients

Brief summary: Objective: Studies documenting the prevalence of delirium among critically ill children are still rare. Emerging literature from psychiatric specialists reports the prevalence of delirium to be approximately 10% in the pediatric intensive care unit (PICU). This is likely to be an underestimation of the true prevalence, as demonstrated in early adult delirium literature, especially given the absence of validated bedside tools to diagnose delirium in the PICU.

The primary aim of this study is to validate the German version of the Pediatric Confusion Assessment Method for the Intensive Care Unit (pCAM-ICU). The secondary aim of the study is to compare validity and reliability of the pCAM-ICU and the Pediatric Anesthesia Emergence Delirium (PAED) Scale.


Eligibility criteria: Inclusion Criteria:

* pediatric ICU patients

Exclusion Criteria:

* non-German-speaking
* inability to communicate due to severe hearing loss or brain injury
* preexisting psychosis
* mental retardation due to a specific diseases (e.g. M. Crouzon, Kabuki Syndrome, Z.n. Battered Child, Atrogryposes multiplex congenita)

Primary outcomes:
measure: Sensitivity of the pediatric confusing assessment method for the intensive care unit (pCAM-ICU)
timeFrame: The participants will be followed up in the sample period (1 to 21 days)
Secondary outcomes:
measure: Specifity of the pediatric confusing assessment method for the intensive care unit (pCAM-ICU)
timeFrame: The participants will be followed up in the sample period (1 to 21 days)
measure: Specifity of the Delirium Rating Scale (DRS)
timeFrame: The participants will be followed up in the sample period (1 to 21 days)
measure: Sensitivity of the Delirium Rating Scale (DRS)
timeFrame: The participants will be followed up in the sample period (1 to 21 days)
measure: Positive predictive value of the Delirium Rating Scale (DRS)
timeFrame: The participants will be followed up in the sample period (1 to 21 days)
measure: Prevalence of delirium
timeFrame: The participants will be followed up in the sample period (1 to 21 days)
measure: Depth of sedation
timeFrame: The participants will be followed up in the sample period (1 to 21 days)
measure: Quality of Analgesia
timeFrame: The participants will be followed up in the sample period (1 to 21 days)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum and Campus Charité mitte, Charité - Universitaetsmedizin Berlin
Study officials:
References:
Clinical trial NCT05524675: The Effect of Multiple Medications on the Incidence of Organic Dyspepsia
Official title: The Effect of Multiple Medications on the Incidence of Organic Dyspepsia：a Prospective Observational Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dyspepsia
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged ≥ 18 years old who met broad criteria of dyspepsia with upper endoscopy and abdominal ultrasonography within one year were eligible for our study.

Brief summary: Dyspepsia is a very common gastrointestinal disease, presented as predominant symptom of upper abdominal pain. Underlying causes for dyspepsia can classified as organic or functional dyspepsia. Some medications (eg. non-steroid anti-inflammatory drugs (NSAIDs)) were associated with higher frequent incidences of organic lesions. Multiple medications showed an increased trend with aging of the population and multimorbidity. Multiple medications were suggested to be strongly relate to adverse drug events (ADEs), adverse drug reactions (ADRs), drug-drug interactions, and drug-disease interactions, which had been reported to lead to higher incidences of some diseases, including fractures, cognitive impairment and malnutrition. However, it was unknown if multiple medications was associated with more incidences of organic dyspepsia.


Eligibility criteria: Inclusion Criteria:

1. aged ≥18 years old
2. patients who met broad criteria of dyspepsia
3. undergoing upper endoscopy and abdominal ultrasonography within one year.

Exclusion Criteria:

1. organ failure defined by Marshall standard
2. severe psychiatric illnesses
3. suspected or identified bowel obstruction
4. known malignancy
5. pregnancy or lactation
6. unable to provide consent

Primary outcomes:
measure: the rate of patients diagnosed with organic upper gastrointestinal (GI) diseases.
timeFrame: 1 day
Secondary outcomes:
measure: Functional dyspepsia
timeFrame: 6 months
measure: Number of participants with different subtypes of functional dyspepsia
timeFrame: 6 months
measure: Short Form of Nepean Dyspepsia Index (SF-NDI)
timeFrame: 1 day
measure: Hospital anxiety scale
timeFrame: 1 day
measure: Hospital depression scale
timeFrame: 1 day
measure: Quality of Life scores
timeFrame: 1 day
measure: Severity of functional dyspepsia judged by patients
timeFrame: 1 day
measure: Number of participants with other functional gastrointestinal diseases
timeFrame: 1 day
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Xijing 986 Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References: