louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02861391: Evaluation of the Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Urinary Stress Incontinence.
Official title: Evaluation of the Safety and Efficacy of CO2 Acupulse Laser Treatment on Women With Urinary Stress Incontinence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exposure Laser
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in patients with stress urinary incontinence (SUI). Eligible subjects will either receive 3 laser or sham treatment sessions, 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.

Detailed description: Following a screening visit, eligible subjects will be enrolled into the study. Eligibility will be decided depending on the level of SUI the patient has. Each subject will receive either 3 laser or sham treatments 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12 months following the last treatment.

Further demographic information and patient history will be obtained from the subjects' electronical files.

Eligibility criteria: Inclusion Criteria:

* Negative urine culture.
* Positive cough test.
* Normal Papanicolaou (PAP) test from the past 3 years.

Exclusion Criteria:

* signs, symptoms or validated test results indicating possible urgency urinary incontinence or mixed urinary incontinence.
* Overactive bladder.
* Previous bulking injections.
* Previous transvaginal mesh implant.
* Previous surgery for stress urinary incontinence.
* Presence of pelvic organ prolapse.
* Presence of an active or recurring genital infection or urinary tract infection.
* Previous laser-based or other energy-based treatments for gynecological indications.
* Vaginal bleeding of unknown reason.
* Pregnancy.
* Current pelvic floor physiotherapy.
* Current treatment with local or systemic hormone replacement therapy.

Primary outcomes:
measure: Pad weight test.
timeFrame: 15 months from recruitment.
Secondary outcomes:
measure: Urinary distress index 6 questionnaire.
timeFrame: 15 months from recruitment.
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual questionnaire.
timeFrame: 15 months from recruitment.
measure: International Consultation of Incontinence questionnaire.
timeFrame: 15 months from recruitment.
measure: Cough test
timeFrame: 15 months from recruitment.
measure: Visual analogue scale.
timeFrame: 15 months from recruitment.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Lior Lowenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04687891: Transabdominal Versus Transvaginal Ultrasound to Assess the Thickness of the Lower Uterine Segment.
Official title: Transabdominal Versus Transvaginal Ultrasound to Assess the Thickness of the Lower Uterine Segment at Term in Women With Previous One Cesarean Section.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trans Abdominal Ultrasound
Transvaginal Ultrasound
Lower Uterine Segment Thickness
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 130
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 130 pregnant women at term with a previous one cesarean section admitted for an elective cesarean delivery will be enrolled. LUS thickness will be measured using both TVS and TAS prior to the cesarean. The actual thickness of the LUS will be measured using a sterile metal ruler before the neonate had been delivered.

Brief summary: aims to determine the accuracy of measurement of the LUS thickness by trans-abdominal and transvaginal ultrasound at term pregnancy in comparison to the actual thickness of LUS measured with manual caliper measurement during cesarean delivery.

Study hypothesis: In women with previous cesarean delivery, determination of the LUS thickness can be done by trans-abdominal and transvaginal ultrasound at term pregnancy and compared to the actual thickness of LUS measured with a manual caliper at cesarean delivery.

Study question: considering transabdominal \& transvaginal ultrasound, which of them would be more accurate in the assessment of LUS thickness?


Eligibility criteria: Inclusion Criteria:

* Age (20:40 years old).
* Women at term (37:40 weeks).
* With singleton pregnancy.
* Presenting by vertex (cephalic presentation).
* Having adequate liquor.
* Previous delivered by cesarean delivery one time.

Exclusion Criteria:

* Fetal malformations, e.g fetal hydrops.
* Uterine malformations, e.g bicornuate uterus.
* Placental malformations, e.g placenta praevia, placenta accrete.
* Uterine surgery is other than a cesarean, e.g myomectomy.
* Women in labor (painful, regular uterine contractions, cervical dilatation, tender scar, and discomfort is not stopped by sedation).
* Obese patients (BMI \>30 kg/m2)

Primary outcomes:
measure: accuracy test for measuring
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine - Cairo university
state: Kasr El Ainy
Study officials:
affiliation: Cairo University
name: Mohammed A Taymour, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagy Afifi A, Ahmed Taymour M, Mamdouh El-Khayat W. Transabdominal versus transvaginal ultrasound to assess the thickness of lower uterine segment at term in women with previous cesarean section. Eur J Obstet Gynecol Reprod Biol. 2022 Apr;271:145-151. doi: 10.1016/j.ejogrb.2022.01.027. Epub 2022 Feb 7.
Clinical trial NCT03026491: Chewing in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula
Official title: Chewing Function in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chewing Problem
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 35
Sex: ALL
Minimum age (years): 24
Maximum age (years): 192
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with repaired esophageal atresia-tracheoesophageal fistula

Brief summary: The investigators aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of atresia. Each child will be required to bite and chew a standardized biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the tolerated food texture of children.

Detailed description: The diet of children with normal feeding skills includes a combination of liquid, semisolid and/or solid foods. Chewing dysfunction (CD) in children may cause restrictions in solid food intake, thereby may result in insufficient food intake and delay in growth. It is aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of atresia. Each child will be required to bite and chew a standardized biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the tolerated food texture of children.

Eligibility criteria: Inclusion Criteria:

* Children with repaired esophageal atresia-tracheoesophageal fistula, without airway aspiration, intact airway closure

Exclusion Criteria:

* Children without repaired esophageal atresia-tracheoesophageal fistula, with airway aspiration, insufficient airway closure

Primary outcomes:
measure: Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS)
timeFrame: 10 minutes
Secondary outcomes:
measure: Observational oral motor assessment will be performed
timeFrame: 15 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: SELEN SEREL ARSLAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05938491: OCT and OCT-A Afer Diabetic Vitrectomy in PDR
Official title: OCT and OCT Angiography After Diabetic Vitrectomy With or Without Internal Limiting Membrane Peeling for Patients With PDR
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Proliferative Diabetic Retinopathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with complicated proliferative diabetic retinopathy underwent pars plana vitrectomy

Brief summary: Detection of any structural or vascular changes at the macula after Pars Plana Vitrectomy ( PPV ) in cases with complicated proliferative diabetic retinopathy ( PDR )


Eligibility criteria: Inclusion Criteria:

* Cases with complicated PDR as persistant vitreous hemorrhage or tractional retinal detachment involving or threatening the macula underwent PPV with or without ILM peeling

Exclusion Criteria:

* eyes with media opacity after PPV not allowing imaging of the macula

Primary outcomes:
measure: OCT and OCT angiography to assess the macular thickness , outline and vascularity
timeFrame: 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06393491: Equine-assisted Therapy and Anorexia Nervosa
Official title: Equine-assisted Therapy in the Management of Adolescent Patients With Severe Anorexia Nervosa: a Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Equine-Assisted Therapy
Keywords: Anorexia Nervosa
Equine-Assisted therapy
Animal-assisted therapy
Complementary therapy
Health Care
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 9
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female participants who were between 13 and 25 years old and had completed at least 2 sessions of equine-assisted therapy during a hospitalization for anorexia nervosa between 2016 and 2022 in the psychiatric hospitalisation unit of the Institut Mutualiste Montsouris (Paris)

Brief summary: Background: Severe anorexia nervosa is a complex psychiatric pathology with limited therapeutic tools to reduce morbidity and mortality. Equine-assisted therapy could provide additional therapeutic benefits.

Objectives : The investigators aimed to explore the effects of equine assisted therapy on the experience of adolescents with severe anorexia nervosa.

Méthods : Using a qualitative approach based on Interpretative Phenomenological Analysis, the investigators conducted semi-structured interviews with nine participants who had taken part in equine-assisted therapy sessions.


Eligibility criteria: Inclusion Criteria:

* having participated in at least 2 equine-assisted therapy sessions
* being or having been hospitalised between 2016 and 2022 in the psychiatric hospitalisation unit of the Institut Mutualiste Montsouris (Paris)
* ICD 10 diagnosis F50.0/ F.50.1
* female gender
* age between 13 and 25
* fluent French
* consent (including parents if minor participant)

Exclusion Criteria:

* having been under the care of C. Lepy (resident) during hospitalisation at the Institut Mutualiste Montsouris (Paris)
* refusal to participate on the part of the participant or the holder of parental authority.

Primary outcomes:
measure: Semi-structured face-to-face interviews of patients was carried out using the Interpretative Phenomenological Analysis (IPA) method.
timeFrame: Between November 2020 and May 2022, when participants had completed at least 2 sessions of equine-assisted therapy during a hospitalization for anorexia nervosa
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Mutualiste Montsouris
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Aurélie LETRANCHANT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04828291: Optimizing Daily Mindfulness Interventions Using Peer Support to Increase Well-Being in First-Year Students
Official title: Optimizing Daily Mindfulness Interventions Using Peer Support to Increase Well-Being in First-Year Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: OMI, OMI+, Control Group
Lead sponsor: Pitzer College
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project aims to examine the effect of a self-guided, evidence-based, online mindfulness intervention on well-being among first-year undergraduates at the 5 Claremont Colleges (5C's) and graduate students in the community. Additionally, it explores the feasibility and efficacy of peer support (pairs) as an adjunctive treatment component to enhance engagement and treatment effects, including social-connectedness, well- being, academic outcomes, and anxiety. Findings will provide insight into effective ways to (1) support students at The Claremont Colleges, and (2) leverage technology and peer support to implement mental health initiatives that are cost-effective, easily transportable, and scalable in low-resource settings.


Eligibility criteria: Inclusion Criteria:

* all participants must be either a first-year undergraduate student or a graduate student. Participants must be 18 years or older.

Exclusion Criteria:

* all participants must be either a first-year undergraduate student or a graduate student. Participants must be 18 years or older.

Primary outcomes:
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline to Day 46
Secondary outcomes:
measure: Sample Attrition
timeFrame: Baseline to Day 46
measure: PERMA (Overall Well Being)
timeFrame: Day 0-46
Other outcomes:
measure: Self-Report Health (SF-36)
timeFrame: Baseline
measure: Academic Motivation Scale
timeFrame: Day 38
Locations:
city: Claremont
country: United States
facility: Claremont Graduate University
state: California
Study officials:
References:
Clinical trial NCT00754091: Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy
Official title: Retention of an Orally Administered Investigational Device in the Oropharynx of Healthy Human Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2008-09-17
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single usage, open label study in 16 adult healthy males. Eligible subjects will receive a single usage of the investigational device. Retention of the radiolabeled device will be monitored using gamma scintigraphy.


Eligibility criteria: Inclusion Criteria:

* Refrain from nasal, throat, or lung inhalants and exercise for 24 hour prior to the test
* Are able to tolerate the procedure and
* Be generally healthy

Exclusion Criteria:

* Have history of allergy or hypersensitivity to the study ingredients
* Major diseases
* Taking medication regularly
* Radiation exposure recently

Primary outcomes:
measure: Area under the curve for the percent of the mucoadhesive liquid retained in the oropharynx
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Walter J Doll, PhD, RPh
state: Kentucky
Study officials:
affiliation: Scintipharma, Inc
name: Walter J Doll, PhD, RPh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03976791: A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
Official title: A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 294
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision.

The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification.

Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification.

Study Design: A prospective randomized controlled study


Eligibility criteria: Inclusion Criteria:

* Age-related cataract patients
* Age from 65 to 90
* The diameter of pupil after mydriasis is more than 6 mm
* LOCS III nuclear grade ≥4
* Corneal endothelial cell count \> 1500 cells/mm2
* Phacoemulsification and intraocular lens implantation are planned
* Agree to participate in this study and sign informed consent

Exclusion Criteria:

* History of ocular trauma
* Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
* Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
* History of Ophthalmic Surgery
* Intraoperative and Postoperative Complications

Primary outcomes:
measure: descemet membrane detachment(DMD)
timeFrame: postoperative 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02302391: Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation
Official title: Pharmacokinetic Analysis of Midazolam and Fentanyl in Pediatric Patients With Long-term Analgosedation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Sedation
Intensive Care Pediatric
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 25
Sex: ALL
Minimum age (years): 28
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients with long-term analgosedation at the Pediatric Intensive Care Unit of the University Medical Center Hamburg-Eppendorf.

Brief summary: Pharmacokinetic monitoring of midazolam, it's active metabolite and fentanyl in pediatric patients with long-term analgosedation will be performed. Especially, the chronologic sequence of the quantified plasma levels during sedation and during wake-up as well as the correlation to dose and sedation depth will be focused.

Detailed description: At pre-defined timepoints (see below) serum Levels of the above mentioned drugs and metabolites will be determined and pharmakokinetic (PK) modeling will be performed. PK data will be correlated to sedation depth, as assessed using a validated score.

Three Age Groups (infants, children and adolescents) will be evaluated considering the physiologic properties during pediatric development.

Eligibility criteria: Inclusion Criteria:

* pediatric patients between 28 days and 17 years of age
* mechanical ventilation more than 3 days
* analgosedation with midazolam and fentanyl

Exclusion Criteria:

* missing informed consent

Primary outcomes:
measure: Plasma levels of midazolam, 1'-Hydroxymidazolam and fentanyl and resulting pharmacokinetic parameters
timeFrame: Once daily during analgosedation [expected average of 10 days) and 0, 1, 2, and 4h after stopping of midazolam
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
measure: Sedation depth
timeFrame: Participants will be followed for the duration of mechanical ventilation, an expected average of 10 days
measure: Length of stay at the intensive care unit (ICU)
timeFrame: Participants will be followed for the duration of stay at the ICU, an expected average of 3 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Department of Pediatrics
name: Dominique Singer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: