louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06611176: Local LevoBupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions
Official title: Local Levobupivacaine for Pain Relief After Endoscopic Submucosal Dissection for Esophageal Lesions: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endoscopic Submucosal Dissection
Levobupivacaine
Keywords: endoscopic submucosal dissection
ESD
esophagus
analgesic
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 88
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: Endoscopic submucosal dissection (ESD) is commonly performed for (pre)cancerous lesions in the esophagus. Following ESD, post-procedural chest pain is seen in many patients. Studies have shown that local bupivacaine (BP) into the residual submucosal layer of the resection wound after gastric ESD could reduce post-procedural pain rates effectively. Levobupivacaine (LB) is equipotent to BP regarding analgesic effects, but has a better safety profile. No studies have been performed to evaluate the efficacy of LB after esophageal ESD to reduce pain. Therefore, we want to evaluate the effect on post-procedural pain of local application of LB during esophageal ESD.


Eligibility criteria: Inclusion Criteria:

* Patients age ≥18 years at time of consent
* Visible lesion in the esophagus, minimum diameter of the lesion ≥20 mm
* Scheduled for esophageal ESD
* Informed consent

Exclusion Criteria:

* Presence of multiple lesions requiring two or more separate endoscopic resections
* History of esophageal surgery other than fundoplications
* History of esophageal ablation therapy
* History of radiotherapy of the esophagus
* Esophageal varices
* Prior endoscopic resection in the same area
* Uncontrolled coagulopathy
* Severe medical comorbidities precluding endoscopy
* Allergy to LB or other amide-type local anaesthesia
* Current regular use of opioids
* Other aetiology causing pain similar to post-ESD pain
* Inability to assess pain due to severe psychiatric or neurological disease
* Insufficient command of Dutch language
* Brugada syndrome
* Incapacitated patients

Primary outcomes:
measure: Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial
timeFrame: 90min
Secondary outcomes:
measure: Local levobupivacaine for pain relief after Endoscopic Submucosal Dissection for esophageal lesions: a Randomized Controlled Trial
timeFrame: 14 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
city: Utrecht
country: Netherlands
facility: UMCU
Study officials:
References:
Clinical trial NCT04181476: Efficacy Evaluation of Products Against Long Wavelength Ultraviolet A1 and Visible Light Induced Biological Effects
Official title: Efficacy Evaluation of Products Against Long Wavelength Ultraviolet A1 and Visible Light Induced Biological Effects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Sun Damaged Skin
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: L'Oreal
First posted: 2019-11-29
Enrollment: 12
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 evaluate the efficacy of topical products in providing protection against the visible light and ultraviolet A1 (UVA1) part of sunlight. Ultraviolet radiation and visible light are both components of sunlight that reach the earth. It is important to test these topical products against visible light and UVA1 because our current sunscreens may not protect against these very well.


Eligibility criteria: Inclusion Criteria:

* Patient age 18 and older
* Patients Fitzpatrick skin phototype (SPT) III-IV with normal skin health
* Patient able to understand requirements of the study and risks involved

Exclusion Criteria:

* A recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation
* A history of a relevant skin condition on any part of the patient's body (e.g. atopic dermatitis, eczema, vitiligo, sun burn, etc.
* A known history of photodermatoses
* A known history of photosensitivity disorders
* A known history of melanoma or non-melanoma skin cancers

Primary outcomes:
measure: Change in Investigator's Global Assessment (IGA)
timeFrame: through study completion, an average of 1 week
measure: Change in Colorimetry
timeFrame: through study completion, an average of 1 week
measure: Change in Diffuse Reflectance Spectroscopy
timeFrame: through study completion, an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
state: Michigan
Study officials:
affiliation: Henry Ford HS
name: Iltefat Hamzavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05017376: Evaluating the Effect of Optical Zones on Correction for SMILE: Vector Analysis
Official title: Evaluating the Effect of Optical Zones on Myopia and Astigmatism Correction in SMILE: Vector Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Keywords: small incision lenticule extraction
vector analysis
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: age of patients between 18-45 years; spherical refraction of -3.00 to -6.00 diopters (D) with or without astigmatism (\<-3.00 D); spherical equivalent, -3.00 to -6.00 D; corrected distant visual acuity (CDVA), \>20/25

Brief summary: Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in small incision lenticular extraction.

Detailed description: To retrospectively study whether different surgical optical zone sizes affect the correction of diopter and astigmatism in myopia patients. Divided into 2 groups according to the diameter of the optical zone. The vector analysis method was used to analyze the changes and errors of astigmatism in TR and SIR after operation. Generalized Estimation Equation (GEE) model is used for multiple regression analysis to evaluate the potential factors related to the error value.

Eligibility criteria: Inclusion Criteria:

* no ocular conditions
* normal topography
* central corneal thickness, \>500µm
* residual stromal thickness, \>280 µm
* pupil diameter, 2.78-4.9 mm (average, 3.76±0.43 mm);

Exclusion Criteria:

* history of intraocular surgery
* pupil diameter, \>4.9 mm or \<2.78mm
* keratoconus or corneal ectasia

Primary outcomes:
measure: astigmatic changes
timeFrame: 2021.03
measure: error value
timeFrame: 2021.04
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Eye Hospital
Study officials:
affiliation: Tianjin Eye Hospital
name: Yan Wang
role: STUDY_CHAIR
References:
citation: Moshirfar M, Thomson AC, West WB Jr, Hall MN, McCabe SE, Thomson RJ, Ronquillo YC, Hoopes PC. Initial Single-Site Experience Using SMILE for the Treatment of Astigmatism in Myopic Eyes and Comparison of Astigmatic Outcomes with Existing Literature. Clin Ophthalmol. 2020 Oct 29;14:3551-3562. doi: 10.2147/OPTH.S276899. eCollection 2020.
citation: Dishler JG, Slade S, Seifert S, Schallhorn SC. Small-Incision Lenticule Extraction (SMILE) for the Correction of Myopia with Astigmatism: Outcomes of the United States Food and Drug Administration Premarket Approval Clinical Trial. Ophthalmology. 2020 Aug;127(8):1020-1034. doi: 10.1016/j.ophtha.2020.01.010. Epub 2020 Jan 15.
Clinical trial NCT01030276: Bright Light Therapy in Seasonal Affective Disorder (SAD)
Official title: Placebo-controlled, Double Blind RCT on the Efficacy of Bright Light Therapy in SAD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Seasonal Affective Disorder
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: ODL Terveys Oy
name: Valkee Oy
name: University of Eastern Finland
First posted: 2009-12-11
Enrollment: 60
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 aim of this study is to investigate the efficacy of bright light therapy in SAD. This is a placebo-controlled, double-blind randomized controlled trial (RCT).


Eligibility criteria: Inclusion Criteria:

* a patient has, according to the DSM-IV-TR, a Major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)
* HAMD-21 (included in the SIGH-SAD) sum score is ≥ 22
* patient is over 18 years
* patient can read and understand the subject information sheet
* patient has signed the informed consent form
* patient is not pregnant

Exclusion Criteria:

* patient has a lifetime psychotic disorder
* patient has a DSM-IV Axis I disorder other than some anxiety disorder evaluated by MINI
* patient has some DSM-IV-TR Axis II disorder, which is likely to interfere with the study treatment according to the investigator
* patient has alcohol or some other substance use dependence or misuse
* life-time suicide attempt, or any thought of suicide during the last month
* patients has some unstable somatic disorder
* patient uses some medication on regular basis
* patient uses some herbal psychotropic agencies
* patient is, in the opinion of the investigator, unsuitable for any reason
* patient is a member of the site personnel or their immediate families
* patient has had bright light therapy during the current episode
* patient has some eye disease (patient can, however, be myopic or hyperopic)

Primary outcomes:
measure: Remission as defined by the SIGH-SAD
timeFrame: 28 (visit window from 26 to 30 days) days after the inclusion day
Secondary outcomes:
measure: Decrease of the severity of symptoms as assessed by SIGH-SAD, Hamilton anxiety scale, and Beck depression inventory-21
timeFrame: 28 (visit window from 26 to 30 days) days
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Research unit, ODL Terveys Oy, Albertinkatu 18 A
Study officials:
References:
Clinical trial NCT00290576: Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns
Official title: Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duration of Parenteral Nutrition
Keywords: Digestive and Nutritional Effects
Safety and Growth
Feeding Tolerance
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2006-02-13
Enrollment: 127
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Symbiotic interaction between probiotics ("Living alimentary microbials supplemental, affecting positively host by improving intestinal microbial equilibrium" (Fuller, 1989)) and human digestive tract was amply experimented and seems to be an interesting solution to orientate neonates digestive flora. Many studies showed a probant efficiency of probiotic supplementation in neonates on ECUN, despite abnormally high ECUN incidence in control group. Nevertheless, our aim is to test clinical efficiency of two new probiotics strains. Bifidobacterium Longum and Lactobacillus GG on Oral Nutrition (volume at Day 14 and Day 21) and safety (Adverse Events) in very premature babies.


Eligibility criteria: Inclusion Criteria:

1. newborns (\< 2 weeks of life)
2. 32 Weeks of Gestation,
3. weight \< 1500g,
4. Enteral nutrition begun,
5. Clinical stability,
6. Signed consent form from both parents.

Exclusion Criteria:

1. newborns (\>= 2 weeks of life),
2. weight \>= 1500g,
3. pathology avoiding the start of the enteral nutrition,
4. other pathologies of those due to premature and its complications,
5. No signed consent form.

Primary outcomes:
measure: Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition
timeFrame: at D14 and D21.
Secondary outcomes:
measure: Age when Enteral Nutrition reaches 50% of Nutritional needs.
measure: Incidence of Nosocomial Infections.
measure: Composition of Colic Flora.
measure: Fecal Calprotectin as Index of Inflammation
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes UH
name: Dominique Darmaun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bourdon A, Rouge C, Legrand A, Des Robert C, Piloquet H, Vodovar M, Voyer M, Roze JC, Darmaun D. Urinary citrulline in very low birth weight preterm infants receiving intravenous nutrition. Br J Nutr. 2012 Oct;108(7):1150-4. doi: 10.1017/S0007114511006660. Epub 2011 Dec 12.
citation: Rouge C, Piloquet H, Butel MJ, Berger B, Rochat F, Ferraris L, Des Robert C, Legrand A, de la Cochetiere MF, N'Guyen JM, Vodovar M, Voyer M, Darmaun D, Roze JC. Oral supplementation with probiotics in very-low-birth-weight preterm infants: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2009 Jun;89(6):1828-35. doi: 10.3945/ajcn.2008.26919. Epub 2009 Apr 15.
Clinical trial NCT01084460: Follow-up of the Natural Course of the Small EUS-suspected Gastric Gastointestinal Stromal Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tumor
Keywords: Gastrointestinal stromal tumor,endoscopic ultrasound,submucosal tumor
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-03-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This was a retrospective study. We reviewed 256 consecutive patients with the diagnosis of suspected gastric GISTs by EUS, from January 1997 to December 2008 at the National Taiwan University Hospital, Yuan's General Hospital and En Chu Kong Hospital.

Brief summary: Gastric gastrointestinal stromal tumors (GISTs) less than 2 cm are usually followed up conservatively. However, little is known about the natural course of small GISTs. The goal of this study was to evaluate the clinical course of the small EUS-suspected gastric GISTs and to determine the size predicting subsequent progression with increased malignant potential.


Eligibility criteria: Inclusion Criteria:

* (1) a small tumor size, less than 3 cm;
* (2) patients declined surgical intervention at initial identification of the lesion;
* (3) at least two EUS follow-up procedures were recorded;
* (4) the EUS follow-up period was more than 24 months.

Exclusion Criteria:

* (1) a tumor size, larger than 3 cm;
* (2) less two EUS follow-up procedures were recorded;
* (3) the EUS follow-up period was less 24 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Internal Medicine, National Taiwan University Hospital
name: Hsiu Po Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05587660: Early Functional Outcomes in Unisplaced Neck of Femur Fracture Treated With Partially Threaded and Fully Threaded Cannulated Screw Fixation in Patients of Age 60 and Above
Official title: Early Functional Outcomes in Unisplaced Neck of Femur Fracture Treated With Partially Threaded and Fully Threaded Cannulated Screw Fixation in Patients of Age 60 and Above
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck of Femur Fracture
Keywords: Cannulated screw
fracture
Hip Harris score
Lead sponsor: Nishtar Medical University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 82
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomization to be done through lottery method and then the allocation to be made in both study groups.
Primary purpose: TREATMENT

Brief summary: This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. A total of 82 (41 in each group) patients of both genders, aged 60 or above. The Radiographic Union Scale for Hip (RUSH) and Harris Hip score to be used to evaluate fracture healing.

Detailed description: This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. This is a randomized controlled trial where a total of 82 (41 in each group) patients of both genders, aged 60 or above. All these patients had garden type I or II and were mobile before femoral neck fracture were included. In Group-A patients cannulated screw fixation was done using partially threaded screws and in Group-B patients were treated with fully threaded screws were used. Patients were treated according to following schedule and were followed up at 6 weeks, 3 months and 6 months interval. The Radiographic Union Scale for Hip (RUSH) and Harris Hip score were used to evaluate fracture healing.

Eligibility criteria: Inclusion Criteria:

* Patients of garden type I or II fractures.
* All patients to be mobile before femoral neck fracture.

Exclusion Criteria:

* Patients having open fracture.
* Patients with present or past history of chronic kidney disorder.
* Patients presenting with hemorrhage.
* Patient with nervous stroke
* Patients unwilling to be part of this study.

Primary outcomes:
measure: Harris Hip Score (RUSH SCORE)
timeFrame: 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Multān
country: Pakistan
facility: Nishtar Medical University Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT04987060: Intrastromal Fresh Human Corneal Lenticule Implantation Using Smile Surgery for Treatment of Irregular Corneal Astigmatism After Penetrating Keratoplasty (new Approach)
Official title: Intrastromal Fresh Human Corneal Lenticule Implantation Using Smile Surgery for Treatment of Irregular Corneal Astigmatism After Penetrating Keratoplasty (new Approach)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Irregular Astigmatism
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Irregular astigmatism group
Primary purpose: TREATMENT

Brief summary: The aim of the study is to present the effect of implanting intrastromal fresh corneal lenticule by SMILE surgery as a new method-approach to correct the corneal shape on purpose to reduce irregular astigmatism and increasing visual acuity after penetrating keratoplasty.

Detailed description: Irregular astigmatism occurs when the curvature of the eye is pronounced in any direction, not just the center. The curve could be steeper towards the bottom than on top, or it could be any configuration in which the eye's surface area is uneven.

Irregular astigmatism usually can result from corneal degenerations(keratoconus,pellucid marginal degeneration,keratoglobus), corneal surgery or trauma.

Irregular astigmatism is still the main cause of decreased visual acuity after penetrating keratoplasty.

Our study present new therapeutic method and new technology to manage irregular astigmatism after PK. Knowing that the incidence of high and irregular astigmatism after PK is still a frequent complication and source of frustration for patients and corneal surgeons our study present an adequate surgical technique implanting intrastromal human corneal lenticule using SMILE for treatment of corneal irregular astigmatism after PK trying satisfy patients visual expectations.

Eligibility criteria: Inclusion Criteria:

* patients with irregular astigmatism
* low visual acuity

Exclusion Criteria:

* history of glaucoma
* retinal detachment
* history of ocular inflamation

Primary outcomes:
measure: Increase of visual acuity
timeFrame: 12 months
Secondary outcomes:
measure: Decrease of irregular astigmatism
timeFrame: 12 months
Other outcomes:
Locations:
city: Pristina
country: Kosovo
facility: Eye Hospital Pristina
Study officials:
References:
Clinical trial NCT02355860: Female Sexual Function and Socioeconomic Status
Official title: Female Sexual Function and Socioeconomic Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Dysfunction
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 268
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 238 sexually-active, non-pregnant women reporting to two urban gynecology clinics, representing patients with publicly funded (n=70) or privately funded health insurance (n=168).

Brief summary: In an urban gynecology practice serving patients with publicly and privately funded insurance, female sexual dysfunction was associated with low income, depression, urinary incontinence, and sexual inactivity.

Detailed description: Introduction: Female sexual dysfunction is common, and the effect of socioeconomic status in an urban population is unknown. The objective is to determine socioeconomic and clinical factors associated with female sexual dysfunction for patients with publicly and privately funded health insurance in an urban outpatient gynecology clinic.

Methods: We performed an observational, IRB approved, cross-sectional study of 238 sexually-active, non-pregnant women reporting to two urban gynecology clinics, representing patients with publicly funded (n=70) or privately funded health insurance (n=168). The participants completed validated questionnaires measuring sexual function (Female Sexual Function Index or FSFI), depression (Center for Epidemiologic Studies Depression Scale), urinary incontinence (Questionnaire for Urinary Incontinence Diagnosis), and demographic variables. Data was analyzed with non-parametric t-tests, chi-squared tests, and linear regression models.

Eligibility criteria: Inclusion Criteria:

* women age 18 or older, presenting for an annual routine gynecology appointment, and were sexually active in the past six months

Exclusion Criteria:

* pregnant women, women who were less than six weeks post-partum, women reporting for a gynecologic problem visit, non-English speakers, incomplete survey questionnaires, or refusal to consent to participate in the study.

Primary outcomes:
measure: FSF Index
timeFrame: Day 1
Secondary outcomes:
measure: Health Information Assessment
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References: