louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04144049: A Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Ranging, Parallel, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Submental Fat
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 176
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, double-blind, placebo-controlled, dose-ranging, parallel, multi-center, phase II study to evaluate the efficacy and safety of MT921 in subjects with moderate to severe submental fat.


Eligibility criteria: Inclusion Criteria:

* Subjects over 19 and under 65 years old
* Subjects achieving CA-SMFRS and PA-SMFRS score of 2 or 3
* Subjects who voluntarily signed the Informed Consent

Exclusion Criteria:

* Subjects who had liposuction or other procedures on the treatment area that might affect the assessment.
* Subjects with BMI over 35.0kg/m\^2
* Subjects with dysphagia
* Subjects who are allergic or hypersensitive to the investigational product
* Subjects who are pregnant or lactating, or does not agree to use an accepatble form of contraception during the clinical trial.
* Subjects who are otherwise deemed uneligible by the investigator.

Primary outcomes:
measure: Responder rate of 2-grade improvement in CA-SMFRS
timeFrame: 4 weeks after the last treatment session
measure: Responder rate of 2-grade improvement in PA-SMFRS
timeFrame: 4 weeks after the last treatment session
measure: Responder rate of 1-grade improvement in CA-SMFRS
timeFrame: 4 weeks after the last treatment session
measure: Responder rate of 1-grade improvement in PA-SMFRS
timeFrame: 4 weeks after the last treatment session
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-ang University Hospital
Study officials:
References:
Clinical trial NCT06874049: Comparison Between Vaginal Misoprostol Gel and Oral Misoprostol Solution in Induction of Labor
Official title: Oral Versus Vaginal Misoprostol Solution Among Pregnant Women Undergoing Induction of Labor At Ain Shams University Maternity Hospital a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Cervical Ripening and Induction of Labor
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to study the efficacy of vaginal versus oral misoprostol solution in cervical ripening for induction of labor.

The main questions it aims to answer is : is Vaginal misoprostol solution as effective as oral misoprostol solution for induction of labor? Researchers will compare oral Misoprostol Solution and vaginal misoprostol solution prepared by KY gel Participants will then be randomized into two groups using a computer-generated randomization list , the first group will receive oral solution equal to 25 microgram misoprostol every 2 hours while the second group will receive 25 microgram vaginal misoprostol solution every 4 hours The cervix will be assessed and scored at each examination. They will be reviewed before the stipulated time if they were contracting. The administration of the drugs will be discontinued when a favorable cervix is diagnosed (modified Bishop score ≥6 ) or 24 hours of study drug had been given.


Eligibility criteria: Inclusion Criteria:

1. Women with a singleton pregnancy.
2. Cephalic presentation.
3. Age range: 18-40 years.
4. Gestational age between 36 and 42 weeks.
5. Intact fetal membranes.
6. Absence of spontaneous uterine contractions.
7. Non favorable cervix (Bishop score ≤ 5).
8. A reactive non stress test in case of positive fetal life.

Exclusion Criteria:

1. History of cesarean section or uterine scars
2. Grand Multipara P ≥5
3. Known fetal non-cephalic presentation
4. Any known allergy to misoprostol.
5. Multiple pregnancy
6. Contraindication to vaginal delivery.

Primary outcomes:
measure: The primary outcome measure is induction to cervical ripening (Bishop score ≥6) time interval.
timeFrame: 24 hours max
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university Maternity Hospital
Study officials:
References:
Clinical trial NCT01321749: The Neuroprotective Effect of Remote Ischemic Preconditioning on Ischemic Cerebral Vascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cerebrovascular Disease
Keywords: ischemic cerebral vascular disease
stroke secondary prevention
remote ischemic preconditioning
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2011-03-24
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a prospective, randomized, single-center trial, designed to observe the effect of remote limb ischemic preconditioning on ischemic cerebral vascular disease.


Eligibility criteria: Inclusion criteria:

1. Patients with stroke or transient ischemic attack (TIA) within 180 days and the neurologic deficits were well matched to the territory of the stenosed artery, with intracranial arterial stenosis of at least 50% by angiography, at least 70% by ultrasound, or at least 70% by computed tomographic angiography (CTA) or magnetic resonance angiography (MRA)
2. Age between 18 to 80 years old
3. Trial of Org 10172 in Acute Stroke Treatment-1 (TOAST-1) subtype
4. National Institutes of Health Stroke Scale (NIHSS) score 0-15, and Modified Rankin Scale (mRS) score 0-4.
5. ABCD2 score between 6 to 7
6. Stable vital signs, normal hepatic and renal functions,
7. No hemorrhagic tendencies.

Exclusion criteria:

1. Within 72 hrs of intra-artery or intravenous thrombolysis
2. Intracranial hemorrhage or large area of cerebral infarction (more than 1/3 middle cerebral artery perfusion territory)
3. Any soft tissue, orthopedic, or vascular injury, wounds or fractures in extremities which may pose a contraindication for application of the preconditioning cuffs
4. Acute myocardial infarction
5. Systolic blood pressure more than 200 mmHg after drug control
6. Peripheral blood vessel disease
7. Hematologic disease
8. Severe hepatic and renal dysfunction
9. Severe or unstable concomitant disease
10. Cannot tolerate BLIPC or without informed consent
11. Patients who did not complete the whole treatment procedure.

Primary outcomes:
measure: Blood Pressure and Heart Rates;
timeFrame: at the time points of baseline and 1, 15 and 30 days after BLIPC treatment
measure: Plasma Biomarkers of Coagulation and Fibrinolysis
timeFrame: the time points of baseline and 1, 15 and 30 days after BLIPC treatment
measure: Number of Patients Who Got New Brain Lesions
timeFrame: 300 days after treatment
Secondary outcomes:
measure: The Time Point Until the First Stroke Recurrence,
timeFrame: At the 300-day after the initial treatment
measure: Brain Perfusion Improvement Are Evaluated With SPECT and TCD
timeFrame: 300-day after treatment
Other outcomes:
Locations:
city: Xicheng District
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing P.R.
Study officials:
References:
Clinical trial NCT00284349: Study to Investigate the Added Value of a Rehabilitation Brace in the Treatment at Home After a Fracture of the Ankle
Official title: Study to Investigate the Added Value of a Rehabilitation Brace in the Treatment at Home After a Fracture of the Ankle
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fracture of the Ankle
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Comparison between immobilisation by a plaster and a rehabilitation brace for the treatment of a fracture of the ankle


Eligibility criteria: Inclusion Criteria:

* Fracture of the ankle

Exclusion Criteria:

-

Primary outcomes:
measure: Mobility of the ankle
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Ghent
name: Rene Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04326049: LLETZ With Videocolposcopy Versus LLETZ With Binocular Colposcopy
Official title: Performance of Large Loop Excision of the Transformation Zone Using Videocolposcopy Versus Binocular Colposcopy in Women With Cervical Dysplasia: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Dysplasia
Keywords: conization
LLETZ
randomized controlled trial
colposcopy
binocular colposcopy
intraoperative colposcopy
videocolposcopy
loop excision
Lead sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry
Sponsor class: OTHER
Collaborators: name: Ruhr University of Bochum
First posted: 2020-03-30
Enrollment: 227
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the benefits of performing large Loop excision of the transformation Zone (LLETZ) using videocolposcopy compared to binocular colposcopy.


Eligibility criteria: Inclusion Criteria:

* histologically proven cervical dysplasia
* colposcopy Prior to conization
* informed consent

Exclusion Criteria:

* significant language barrier
* a personal history of conization
* pregnancy
* the use of blood thinner
* unwillingness to participate

Primary outcomes:
measure: the resected cone mass
timeFrame: 10 minutes
Secondary outcomes:
measure: Margin status
timeFrame: 2 Days after conization
measure: Operation time
timeFrame: 20 minutes
measure: Operative complications
timeFrame: 14 days
measure: number of fragments of the surgical specimen
timeFrame: 10 minutes
measure: The circumference of the surgical specimens
timeFrame: 2 Days after conization
measure: the length of the surgical specimens
timeFrame: 2 Days after conization
measure: the thickness of the surgical specimens
timeFrame: 2 Days after conization
measure: handling of the device
timeFrame: 30 minutes
measure: satisfaction with the device
timeFrame: 30 minutes
measure: Time to complete intraoperative hemostasis
timeFrame: 120 seconds
measure: Intraoperative blood loss
timeFrame: 5 hours
Other outcomes:
Locations:
city: Herne
country: Germany
facility: Department of Obstetrics and Gynecology of the Ruhr University Bochum
state: NRW
Study officials:
affiliation: Zydolab - Institute of Cytology and Immune Cytochemistry
name: Ziad Hilal, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rezniczek GA, Neghabian N, Rehman S, Tempfer CB. Video colposcopy versus headlight for large loop excision of the transformation zone (LLETZ): a randomised trial. Arch Gynecol Obstet. 2022 Feb;305(2):415-423. doi: 10.1007/s00404-021-06331-0. Epub 2021 Nov 21.
Clinical trial NCT04344249: Cohort of Patients With Inflammatory Bowel Disease During COVID-19 Pandemic
Official title: Prospective Multicenter Cohort of Patients With Inflammatory Bowel Disease Treated by Infliximab or Vedolizumab During COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IBD
COVID
Keywords: IBD
Ulcerative colitis
SARS-CoV-2
infliximab
vedolizumab
Crohn's disease
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 1109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all adult patients with Crohn's disease or ulcerative colitis treated by infliximab or vedolizumab

Brief summary: Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cells

Detailed description: Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cellsNo data has been published concerning the incidence and prevalence of SARS-CoV-2 infection in patients with IBD and treated by IV infusion of infliximab or vedolizumab. It seems that biotherapies have a minimal impact on the severity of the viral infection but data are scarce. The objectives of the cohort are to quantify the incidence and the prevalence of SARS-CoV-2 in this population of patients, to determine clinical, demographic and biological factors associated with the risk of infection and the severity of the disease with a Multicenter cohort of patients followed for 6 months during the pandemic in France with biocollection of sera and peripheral blood mononuclear cells.

Eligibility criteria: Inclusion Criteria:

* adult patients (\>18 years), know Crohn's disease or ulcerative colitis, treated by infliximab or vedolizumab

Exclusion Criteria:

* not affiliated to a sanitary social insurance

Primary outcomes:
measure: IgG and IgM anti SARS-CoV-2
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Clinical factors and severity of COVID-19 infection
timeFrame: through study completion, an average of 2 year
measure: demographic factors and severity of COVID-19 infection
timeFrame: through study completion, an average of 2 year
measure: pharmacologic factors and severity of COVID-19 infection
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Nantes
country: France
facility: Chu Nantes
Study officials:
References:
Clinical trial NCT06413849: Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers
Official title: Telephone-coached "Graphic Narrative" Bibliotherapy for Informal Caregivers of People With Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia Caregiver
Depressive Symptoms
Caregiving Appraisal
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-05-14
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to assess the efficacy of telephone-coached graphic narrative bibliotherapy in improving dementia caregiver depressive symptoms compared with the booklet group.

Detailed description: This is a two-arm cluster randomized controlled trial using a repeated-measures design to examine the effects of telephone-coached graphic narrative bibliotherapy on 128 (64 per group) informal caregivers of people with dementia. Participants in the intervention group will receive eight weekly telephone-coached graphic narrative bibliotherapy sessions, plus two face-to-face booster sessions and two follow-up sessions. The control group will receive an education booklet and check-in calls. Caregiver depressive symptoms, stress and anxiety, caregiving appraisal, care-recipient neuropsychiatric symptoms, and quality of life will be measured to test the intervention's effects immediately after completion and at a 6-month follow-up.

Eligibility criteria: Inclusion Criteria:

* provide unpaid care to a person diagnosed with early to moderate stage dementia;
* provide at least 14 hours of care a week for at least 3 months
* aged 18 years or above
* able to read
* have depressive symptoms
* use a message application

Exclusion Criteria:

* with an unstable physical or mental condition
* with cognitive impairment
* receiving medical, psychological, or psychiatric treatment for depression
* have been included in another interventional study

Primary outcomes:
measure: Changes in depressive symptoms
timeFrame: Pre-intervention, immediately post-intervention, 6 months post-intervention
Secondary outcomes:
measure: Changes in caregiving appraisal
timeFrame: Pre-intervention, immediately post-intervention, 6 months post-intervention
measure: Changes in stress and anxiety
timeFrame: Pre-intervention, immediately post-intervention, 6 months post-intervention
measure: Changes in patient neuropsychiatric symptoms
timeFrame: Pre-intervention, immediately post-intervention, 6 months post-intervention
measure: Changes in quality of life
timeFrame: Pre-intervention, immediately post-intervention, 6 months post-intervention
Other outcomes:
Locations:
city: Hong Kong SAR
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References:
Clinical trial NCT06263049: Is Ejaculation Preservation TURis the Natural Evolution of the "Gold Standard".
Official title: Ejaculatory Preserving Transurethral Resection of the Prostate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: ejaculation, incontinence
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 106
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: evaluation of the impact of apical urethral mucosa sparring with the urethra around the verumontanum on the ejaculatory function and early postoperative urinary incontinence

Detailed description: Benign Prostatic Hyperplasia (BPH) is a common disease in elderly men and transurethral resection of the prostate (TURP) is still the gold standard for the treatment of BPH However, postoperative urinary incontinence (UI) and retrograde ejaculation are of the common complications and its incidence is nearly 2% of UI UI brings great suffering to patients and its unpredictability and uncertainty in the recovery period cause significant pressure to surgeons. External urethral sphincter damage is the main reason for UI after prostatectomy. The treatment of postoperative UI and post operative retrograde ejaculation has also become an important issue for many years. Along with the progress of technology, there have been various methods of transurethral resection of the prostate but no method has been found to adequately avoid the occurrence of UI and retrograde ejaculation

Eligibility criteria: Our inclusion criteria were preidentified to those who complained of voiding lower urinary tract symptoms (LUTS) and scheduled for TURP with prostate size less than 100 gm. This included patients with refractory retention, recurrent gross hematuria of prostatic origin, non-compliance to medical treatment, recurrent infection, and patients with bladder calculi secondary to obstruction. Exclusion criteria were: patients with neurogenic bladder, detrusor hypo-contractility, Diabetes more than 10 years, urethral stricture, or previous prostatic surgeries.

Primary outcomes:
measure: post operative antegrade ejaculation
timeFrame: within 1 month post operative
Secondary outcomes:
measure: post operative urine continence
timeFrame: within 1 month post operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
affiliation: Ain Shams University
name: mohamed essmat aboughareb, consultant
role: STUDY_DIRECTOR
References:
citation: Liang JQ, Ma WT, Lu BW, Dai L, Zhao YM, Zhang JD, Tian B, Liu QL. Clinical Study on the Application of Preserved Urethral Mucosa at the Prostatic Apex in Transurethral Plasmakinetic Resection of the Prostate. Front Surg. 2022 Jun 17;9:922479. doi: 10.3389/fsurg.2022.922479. eCollection 2022.
Clinical trial NCT04201249: Mesotherapy In Lateral Epicondylitis
Official title: MILES STUDY - Mesotherapy In Lateral Epicondylitis, a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Lateral Epicondylitis
Lead sponsor: Hospital de Santa Maria, Portugal
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Investigate the short- and long-term efficacy and safety of intradermal NSAIDs and lidocaine (delivered through mesotherapy) for the treatment of LE comparing it with empty intradermal injections.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis defined as pain over the lateral epicondyle provoked by palpation;
* A visual analogue scale (VAS) score for pain greater than 40mm;
* symptoms duration for more than 1 month.

Exclusion Criteria:

* other diseases that can alter clinical evaluation detected through history, clinical examination, ultrasound or other exams for comorbidities such as carpal tunnel syndrome, cervical radiculopathy, elbow arthritis, intra-articular loose bodies, previous elbow surgery or clinically significant or recent trauma, fibromyalgia and major psychiatric conditions;
* VAS score for pain less than 40mm;
* any of the following treatments during the previous 4 weeks before baseline visit: physical therapy, bandage, mesotherapy and local corticosteroid injection or a combination of these: NSAIDS taken during the week previous to inclusion;
* pregnancy;
* allergy to any of the study drugs;
* severely immunosuppressed patients;
* known coagulopathies. During the study period, enrolled patients are not allowed to take oral corticosteroids, NSAIDs or receive any other medical intervention during the treatment period (physical therapy, bandage, mesotherapy and local corticosteroid injection or a combination of these).

Primary outcomes:
measure: Pain intensity: visual analogue scale score
timeFrame: 3 months
Secondary outcomes:
measure: Clinical and functional evaluation
timeFrame: 0, 1, 2, 3 weeks and 6 months
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
Study officials:
References: