louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04224844: Erector Spinae Plane Block for Carotid Endarterectomy
Official title: Ultrasound-Guided Spinae Plane Block for Perioperative Pain Control in Carotid Endarterectomy.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pain
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-13
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to test the hypothesis that erector spinae plane block will decrease intraoperative local anesthetic and postoperative analgesic consumption in patients undergoing carotid endarterectomy.

Detailed description: Patients who decided to participate in the study will be randomized into 2 groups: Erector Spinae Plane Block Group (Group E) and Control Group (Group C). Intraoperative local anesthetic consumption, postoperative tramadol consumption, intraoperative and pain scores, hemodynamic parameters and patient satisfaction will be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing carotid endarterectomy
* American Society of Anesthesiologists class 2 to 3
* Ability to consent

Exclusion Criteria:

* inability to communicate
* not understand the aim and objectives of the study
* not provide informed written consent
* contraindications for the block (local infection, coagulation disorders)
* hypersensitivity to the local anesthetics
* refusal of regional anesthesia

Primary outcomes:
measure: 24 hours tramadol consumption
timeFrame: 24 hours
measure: 6 hours tramadol consumption
timeFrame: 6 hours
measure: 12 hours tramadol consumption
timeFrame: 12 hours
measure: Assesment of postoperative analgesia
timeFrame: 24 hours
measure: Assesment of postoperative analgesia
timeFrame: 6 hours
measure: Assesment of postoperative analgesia
timeFrame: 12 hours
Secondary outcomes:
measure: Amount of use of intraoperative local anesthetic.
timeFrame: 1 hour
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Reseach Hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Ali Sait Kavakli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06927544: Intraocular Gas Tamponade for Treatment of Large Idiopathic Macular Holes
Official title: A Randomised Clinical Trial of Surgical Methods and Intraocular Gas Tamponade for Treatment of Large (410-1000 μm) Idiopathic Macular Holes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Idiopathic Macular Hole
Macular Hole
Macular Holes
Full Thickness Macular Hole
Keywords: macular hole
pars plana vitrectomy
perfluoropropane (C3F8)
sulfur hexafluoride (SF6)
Idiopathic Macular Hole
Full thickness macular hole
large macular hole
large macular holes
Lead sponsor: The Filatov Institute of Eye Diseases and Tissue Therapy
Sponsor class: OTHER
Collaborators: name: Ukrainian Vitreoretinal Society
First posted: 2025-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the visual and anatomical outcomes of large (410-1000 μm) full-thickness macular holes repair surgery using perfluoropropane (15% C3F8), sulfur hexafluoride (20% SF6) gas tamponade.

Detailed description: The project is a randomized clinical trial with a follow up time of 6 months comparing the effects of surgical treatment of large (410-1000 μm) idiopathic macular holes. Patients are randomized to vitrectomy surgery with internal limiting membrane peeling using perfluoropropane (15% C3F8), sulfur hexafluoride (20% SF6) gas tamponad. Intra- and postoperative complications are registered.

Eligibility criteria: Inclusion Criteria:

* Patient age 50 or above.
* Duration of Symptoms ≤ 12 months.
* Macular holes having a diameter 410-1000 μm.
* Informed consent.

Exclusion Criteria:

* Patients under 50 years of age.
* A patient who has already undergone treatment (surgery, laser etc.) for any disease of the retina.
* Traumatic or pediatric macular holes, and associated retinal detachment.
* History of any retinal disease such as high myopia, retinal dystrophies, central serous retinopathy, retinal vascular diseases, diabetic retinopathy, uveitis etc.
* Previous history of glaucoma or ocular hypertension.
* Failure to give informed consent.

Primary outcomes:
measure: Closure of macular holes
timeFrame: 6 months
measure: Type of macular hole closure
timeFrame: 6 months
Secondary outcomes:
measure: Best-corrected visual acuity
timeFrame: 6 months
Other outcomes:
Locations:
city: Odesa
country: Ukraine
facility: The Filatov Institute of Eye Diseases and Tissue Therapy
Study officials:
References:
Clinical trial NCT06824844: The Effect of 0.05% CsA Eye Drops on Diabetic Patients with Dry Eye Disease
Official title: The Effect of Topical 0.05% Cyclosporine Eye Drops on Diabetic Patients with Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Keywords: dry eye
0.05% cyclosporine
diabetes
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to observe the effects of 0.05% cyclosporine eye drops combined with artificial tears on patients with diabetes-associated dry eye, and to monitor changes in ocular surface characteristics and inflammatory cytokines in tears before and after treatment.


Eligibility criteria: Inclusion Criteria:

I. Age: 50 to 70 years old; II. Gender: No restriction; III. Meets the diagnostic criteria for dry eye: Refer to the 2020 Chinese Expert Consensus on Diagnostic Criteria for Dry Eye.

IV. Meets the diagnostic criteria for diabetes: History of type 2 diabetes with a course of ≥5 years; Diagnosis refers to the 1999 WHO Diagnostic Criteria for Diabetes.

V. Provision of written informed consent.

Exclusion Criteria:

I. active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin.

II. Uncontrolled systemic disease. III.Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.

-

Primary outcomes:
measure: ocular surface disease index (OSDI)
timeFrame: from baseline to 3 months after treatment
measure: Tear break-up time (TBUT)(s)
timeFrame: from baseline to 3 months after treatment
measure: Corneal fluorescein staining (CFS)
timeFrame: from baseline to 3 months after treatment
measure: Schirmer I test (SIt) (mm/5 minutes)
timeFrame: from baseline to 3 months after treatment
measure: Lissamine green staining
timeFrame: from baseline to 3 months after treatment
Secondary outcomes:
measure: corneal sensitivity (range, 60-0 mm)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of Interleukin-1β (IL-1β) (pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of Interleukin-6 (IL-6) (pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of Interleukin-10 (IL-10) (pg/ml)
timeFrame: from baseline to 3 months after treatment
measure: the concentration of Interleukin-17A (IL-17A) (pg/ml)
timeFrame: from baseline to 3 months after treatment
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Hong Qi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01828892: Glue Application in the Treatment of Low-Output Fistulas
Official title: A Randomized Controlled Trial to Evaluate Fibrin Glue Application in the Treatment of Low-Output Enterocutaneous Fistulas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low-output External Gastrointestinal Fistula
Keywords: Autologous platelet rich fibrin glue
Enterocutaneous fistulas
Single low output GI fistulas
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG), commercial fibrin glue, and control therapy in the management of patients with low-output volume ECFs.

Detailed description: * This is a prospective, randomized, multi-centered study clinical, safety and economic outcome of ECFs patients.
* Subjects are randomized to one of 3 groups:

  * Group 1: Autologous PRFG-treatment \[PRFG + Standard of care (SOC)\]
  * Group 2: Commercial FG-treatment \[FG + Standard of care (SOC)\]
  * Group 3: Control (SOC only)
* Study will include three phases:

  * Phase 1: Screening, consent and enrollment
  * Phase 2: Patients will receive either PRFG, commercial FG, or SOC only for 14 days
  * Phase 3: Follow up: for patients with closed fistula within 14 days, we will follow up them for 6 months. For patients whose fistulas were still open will be treated with other therapeutic option and follow up for 6 months after closure.

Eligibility criteria: Inclusion Criteria:

* Patients with a single tubular ECF
* Low output volume (\<200 ml/24h)
* Tract length \>2cm
* Tract diameter \< 1cm

Exclusion Criteria:

* Cancer-infiltrated fistula
* Abscess
* Foreign bodies
* Distal bowel obstruction
* Inflammatory Bowel Disease

Primary outcomes:
measure: Closure rates up to 14 days
timeFrame: 14 days
Secondary outcomes:
measure: Number of adverse events
timeFrame: Participants will be followed for at least 180 days
Other outcomes:
measure: Economic outcome
timeFrame: From fistula onset to the end of treatment, which is at least 180 days
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, China
name: Jianan Ren, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu X, Ren J, Wang G, Wang J, Wang F, Fan Y, Li Y, Han G, Zhou Y, Song X, Quan B, Yao M, Li J. Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial. Trials. 2015 Oct 7;16:445. doi: 10.1186/s13063-015-0966-9.
Clinical trial NCT05255692: Brain Activity During Bladder Filling: Pilot Study of an fMRI Protocol
Official title: Pilot Study: Apllicability of an fMRI Protocol for Incontinence Research
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: fMRI Research
Keywords: Bladder control
functional magnetic resonance imaging
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
name: University of Zurich
First posted: 2022-02-24
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016).

Higher brain centers responsible for bladder function may be related to the presence of incontinence.

The current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence.

Detailed description: Urinary incontinence is the most frequently observed lower urinary tract symptom (LUTS) in children with cerebral palsy (CP) (Samijn et al., 2016). Being more or completely dry could improve the quality of life and health status of the child and the social environment.

Higher brain centers responsible for bladder function may be related to the presence of incontinence. These higher brain centers could be correlated to the brain damage seen in children with CP.

The current pilot study is the first study of a research project focusing on correlations between brain damage and incontinence. The study wants to validate if the defined fMRI paradigm can provide correct information concerning brain activity during bladder filling, to ensure usable results and comply with ethical demands for testing in children, the protocol will be tested and results validated during the pilot study with healthy adults. During the fMRI study, the bladder will be filled until FSF and NDV. Functional MRI-data will be obtained during the filling and emptying phase of the bladder on both volumes

Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* lower or upper urinary tract dysfunction

Primary outcomes:
measure: Activated brain regions demonstrating brain activity
timeFrame: through study completion, an average of 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Bieke Samijn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04330092: Diagnosis of Cow's Milk Protein Allergy
Official title: Diagnosis of Cow's Milk Protein Allergy Among Infants and Children in Assiut University Children Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cow's Milk Allergy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the infant from 1st day to 2 years Exclusively breast feeding ,breast-fed infants with supplementary foods and non-breast fed infants with supplementary foods who complain from either frequent regurgitation, vomiting,diarrhea,constipation (with/without perianal rash) ,blood in stool or pallor.

Brief summary: The study will assess the diagnosis of cow's milk protein allergy (CMPA) among infant and children in assiut university children hospital using skin prick test and specific serum IgE as well as their management.

Detailed description: Food allergy is a reproducible specific immune response to exposure to a given food. Cow's milk protein allergy (CMPA) is clinically abnormal reaction to cow's milk protein (CMP) via immune mechanisms triggered by milk protein (Boyce etal.,2010).

According to European academy for allergy and clinical immunology (EAACI) and the world allergy organization (wao) , a hypersensitivity reaction to cow's milk involving the immune system can be called as CMPA. There is difference between CMPA and non-allergic cow's milk intolerance (e.g lactose intolerance) which occurs as a result of lactase deficiency without involvement of the immune system (Venter etal.,2013).

CMPA is categorized into immunoglobulin IgE mediated , non -IgE mediated ,or mixed CMPA (Sicherer etal.,2001).

1.9% to 4.9% prevalence of CMPA among children with a peak in prevalence (2-3%) in the first year of life and prevalence of \<1% in children aged \>=6 years (koletzko etal.,2012).

Eligibility criteria: Inclusion Criteria:

* - Exclusively breast feeding ,breast-fed infants with supplementary foods and non-breast fed infants with supplementary foods who complain from either frequent regurgitation, vomiting,diarrhea,constipation (with/without perianal rash) ,blood in stool or pallor.

Exclusion Criteria:

* : Infant and child with gastrointestinal symptoms due to specific etiology.

Primary outcomes:
measure: diagnosis of cow's protein allergy among infants and children from 1st day of life-2 years
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit University
Study officials:
References:
Clinical trial NCT06484192: Pain Control After Lumbar Spine Fusion
Official title: Randomized Controlled Trial of Postoperative Inpatient Ketorolac and Outpatient Naproxen Use Following Elective Lumbar Spine Fusion
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Spine Fusion
NSAID (Non-Steroidal Anti-Inflammatory Drug)
Postoperative Pain
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not receive NSAIDs.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age, ≥1-level planned lumbar spinal fusion
* Capacity to enroll
* English speaking

Exclusion Criteria:

* Chronic kidney disease (preoperative creatinine ≥1.4)
* History of gastrointestinal bleed or peptic ulcer disease
* History of spinal fusion nonunion
* Non-steroidal anti-inflammatory drug allergy
* Previously diagnosed coagulopathy
* Preoperative thrombocytopenia (platelets \<100,000)
* Connective tissue disease
* Operative indication due to infection, neoplasm, or trauma
* Currently pregnant

Primary outcomes:
measure: Fusion failure
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04322344: Escin in Patients With Covid-19 Infection
Official title: Efficacy and Safety of Escin as add-on Treatment in Covid-19 Infected Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Coronavirus Infections
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Pugliese Ciaccio
name: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
First posted: 2020-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In December 2019,a new type of pneumonia caused by the coronavirus (COVID-2019) broke out in Wuhan ,China, and spreads quickly to other Chinese cities and 28 countries. More than 70000 people were infected and over 2000 people died all over the world. There is no specific drug treatment for this disease. Considering that lung damage is related to both viral infection and burst of cytokines, our idea is to evaluate the efficacy and safety of escin as add-on treatment to conventional antiviral drugs in COVID-19 infected patients.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 75 years, extremes included, male or female
* Positivity to covid-19 screening test in molecular biology
* In escin group: Low response to standard treatment
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Female subjects who are pregnant or breastfeeding.
* patients with previous history to allergy
* patients meet the contraindications of escin
* Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
* patients can't take drugs orally

Primary outcomes:
measure: Mortality rate
timeFrame: up to 30 days
measure: Clinical status evaluated in agreement with guidelines
timeFrame: up to 30 days
Secondary outcomes:
measure: The differences in oxygen intake methods
timeFrame: up to 30 days
measure: Time of hospitalization (days)
timeFrame: up to 30 days
measure: Time of hospitalization in intensive care units
timeFrame: up to 30 days
measure: Pulmonary function
timeFrame: up to 3 months after discharge
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Luca Gallelli
Study officials:
References:
Clinical trial NCT04783844: Usefulness of 3D Digital Reconstruction in the Imaging Diagnosis of Pancreatic Tumors
Official title: Usefulness of 3D Digital Reconstruction in the Imaging Diagnosis of Pancreatic Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreas Neoplasm
Keywords: 3D virtual model
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 60
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 with suspected pancreatic tumor.

Brief summary: Reconstruction using 3D virtual models has brought about a revolution in diagnostic imaging and its use is increasingly widespread. The objective of this work is to determine the precision of the 3D model when establishing the characteristics of tumors and their relationship with other anatomical structures.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected pancreatic tumor.

Primary outcomes:
measure: Accuracy
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: David Ferreras
Study officials:
References:
Clinical trial NCT01860144: An Observational Study of Bevacizumab in Chinese Patients With Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Colorectal Cancer
Keywords: bevacizumab
overall survival
adverse events
tumor resection rate
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: metastatic colorectal cancer patients accept bevacizumab

Brief summary: This observational, multicenter, prospective study will evaluate the use of bevacizumab in real clinical practice in chinese patients with metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed metastatic colorectal cancer patients Having initiated treatment with bevacizumab

Exclusion Criteria:

* non-metastatic colorectal cancer patients not recieved bevacizumab

Primary outcomes:
measure: Objective response rate
timeFrame: 6 weeks
Secondary outcomes:
measure: overall survival
timeFrame: 3 months
measure: progression free survival
timeFrame: 6 weeks
measure: Proportion of patients with bevacizumab treatment discontinuation
timeFrame: 3 weeks
measure: resection rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Beijing Cancer Hopital
name: Lin Shen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: