louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02434419: Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis
Official title: Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Satisfaction
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 45
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A prospective randomized clinical trial of patients undergoing bariatric surgery.

Patients were randomly assigned into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).

The assigned treatment began 15 days after surgery and was maintained during 12 weeks.

Detailed description: A prospective randomized clinical trial of patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (RYGB) during 2014 was performed.

Patients were randomly assigned using a random-number table into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).

The assigned treatment began 15 days after surgery and was maintained during 12 weeks.

Eligibility criteria: Inclusion Criteria:

* patients with body mass index (BMI) \>40 Kg/m2 or BMI \> 35 Kg/m2 with the presence of comorbidities associated to obesity, undergoing a bariatric procedure.

Exclusion Criteria:

* all kind of previous breast surgery.

Primary outcomes:
measure: Satisfaction degree. 7-points Likert scale was used for the quantification.
timeFrame: 12 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital General Elche
name: Jaime Ruiz-Tovar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02535819: Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular
Official title: Endothelial Cell Loss After Phacoemulsification Intra and Supracapsular
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Keywords: Cataract surgery
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2015-08-31
Enrollment: 294
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: Cataract is the clouding of the lens of the eye, which initially prevents clear vision and eventually progresses to blindness if left untreated. Cataract remains the leading cause of blindness and an important cause of visual impairment across the globe. Cataract surgery by ultrasonic phacoemulsification is the most common surgery practiced in France (600 000/year)

Two sub-categories of phacoemulsification coexist :

Endocapsulars techniques represented by Divide-and-Conquer and Phaco-Chop ; and Supracapsular techniques mainly represented by Subluxation (similar to Tilt-and-Tumble) The corneal endothelium plays an important role in maintaining the dehydrated state and the transparency of the cornea. Some degree of endothelial cell loss invariably occurs in all types of cataract surgery but the amount of endothelial cell loss may varies with the type of surgical technique The aim of the study is to evaluate the density of the central corneal endothelial cells before and after cataract surgery comparing two phacoemulsification techniques (Divide-and-Conquer vs Subluxation)


Eligibility criteria: Inclusion Criteria:

* Male or female aged ≥ 18 years
* Patients undergoing cataract surgery
* Visual acuity Monoyer scale \<6/10e (\< +0.2 logMar)
* Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification

Exclusion Criteria:

* insulin-dependent diabetes and /or diabetic retinopathy
* corneal disease: keratitis, dystrophy, corneal degeneration
* Any disease of intraocular pressure
* Any disease of the anterior segment
* Low preoperative endothelial cell density \< 1500 c/mm²
* Combined surgery (cataract + corneal transplant, cataract + glaucoma surgery, cataract +vitrectomy ...)
* Risk factors for surgical per-operative complication
* Pregnancy, lactation
* Ward of court
* Patient not covered by the Social Security scheme

Primary outcomes:
measure: Main Outcome Measures: postoperative Endothelial cell loss of the central corneal
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Metz
country: France
facility: Chr Metz Thionville
Study officials:
affiliation: CHR Metz-Thionville
name: Jean-Marc PERONE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perone JM, Ghetemme C, Zevering Y, Zaidi M, Ouamara N, Goetz C, Lhuillier L. Corneal Endothelial Cell Loss After Endocapsular and Supracapsular Phacoemulsification: The PERCEPOLIS Randomized Clinical Trial. Cornea. 2022 Jun 1;41(6):714-721. doi: 10.1097/ICO.0000000000002822. Epub 2021 Nov 2.
Clinical trial NCT05143619: Impact of "Teaching the Teachers" Concept on Global Education and Application of Hepatocellular Carcinoma Diagnosis Guidelines
Official title: Impact of "Teaching the Teachers" Concept on Global Education and Application of Hepatocellular Carcinoma Diagnosis Guidelines
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-12-03
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Abdominal radiologists with expertise in liver imaging working in academic, community, and governmental practices in many centers around the world.

Brief summary: This study evaluates a concept called 'Teaching the Teachers' and whether it is helpful in disseminating guidelines on the national and international levels. "Teaching the Teachers" involves teaching the guidelines to experts who later teach the same guidelines to other radiologists, trainees, and physicians to assume the teacher's role and disseminate the guidelines and so on.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate the magnitude of teaching of hepatocellular carcinoma (HCC) diagnostic guidelines after applying "Teaching the Teachers" concept.

II. Assess the effect of "Teaching the Teachers" concept on application of guidelines in clinical practice.

OUTLINE:

Participants complete surveys immediately after completion of a HCC diagnostic guideline webinar, monthly thereafter, and again at 6 months.

Eligibility criteria: Inclusion Criteria:

* Physicians who finished radiology residency
* Radiologists with current or completed specialized training in abdominal imaging
* Radiologists with expertise in liver imaging with no minimum number of years of experience
* Radiologists working in academic, community, and governmental practices
* Radiologists with current practice in any country around the globe
* Radiologists with and without previous knowledge of HCC diagnosis guidelines (Liver Imaging Reporting and Data System \[LI-RADS\])
* Radiologists with interest in education and/or teaching

Exclusion Criteria:

* Physicians with no formal training in radiology
* Radiologists with no expertise in abdominal/liver imaging
* Current radiology residents
* Radiologists with no interest in education and/or teaching

Primary outcomes:
measure: Teaching rates of the hepatocellular carcinoma diagnosis guidelines
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Khaled M Elsayes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01629719: Study Phase III Comparison of Superiority, Open With Blind Appraiser, to Evaluate the Efficacy and Safety of Barium Sulphate 66.7% With V (OPTI-BAR) Compared to Proceedings in Inert Radiological Examinations for the Diagnosis of Diseases for Image the Tratogastrointstinal
Official title: STUDY PHASE III COMPARISON OF SUPERIORITY, OPEN WITH BLIND APPRAISER, TO EVALUATE THE EFFICACY AND SAFETY OF BARIUM SULPHATE 66.7% W / V (OPTI-BAR) COMPARED TO PROCEEDINGS IN INERT RADIOLOGICAL EXAMINATIONS FOR THE DIAGNOSIS OF DISEASES FOR IMAGE THE TRATOGASTROINTSTINAL.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: X-ray Examinations of the Gastrointestinal Tract
Lead sponsor: Alko Do Brasil Industria e Comercio Ltda
Sponsor class: INDUSTRY
First posted: 2012-06-28
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women over 18 years.

Brief summary: Phase III clinical study, two samples, with assessor blind for the purpose of evaluating the efficacy and safety of the superiority of the use of barium sulphate 66.7% w/v (Opti-bar) as a contrast X-ray (X-ray).


Eligibility criteria: Inclusion Criteria:

* Men and women over 18 who need x-rays gastrointestinal tract with contrast;
* Healthy patient, ambulatory;
* Willingness to comply with the requirements of the study after signing an informed consent and (hit).

Exclusion Criteria:

* Pregnant or lactating women;
* Patients allergic to barium sulfate, latex rubber or simethicone;
* Patients who have asthma, eczema, cystic fibrosis, heart disease, high blood pressure, rectal cancer, colostomy, obstruction in the stomach or intestines, pseudotumor cerebri, blocking stomach or intestinal disease, Hirsch or pseudotumor cerebri;
* Patients who have recently undergone a rectal biopsy or surgery or a recent history of drilling into your esophagus, stomach or intestines; Patients who have already participated in another clinical protocol in the last six months;
* Other clinical criteria that in the opinion of the study investigator could compromise the welfare of the patient or interfere with the results expected from the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06860919: Prospective Evaluation of the Results of Multidisciplinary Follow-up After a Transitional Consultation for Esophageal Atresia
Official title: Evaluation Prospective Des résultats du Suivi Pluridisciplinaire Mis en Place au décours d'Une Consultation de Transition Pour l'atrésie de l'œsophage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Atresia
Keywords: Esophageal Atresia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adults with esophageal atresia

Brief summary: A transition consultation for adult patients with esophageal atresia, involving medical and paramedical stakeholders, was set up at Hôpital Saint-Louis in 2020. The aim of this initiative is to: 1. initiate adult medical, psychological and social follow-up; 2. empower these adults in their future care; 3. establish a personalized follow-up schedule. This project is the first to focus on post-traumatic stress disorder (PTSD) in young adults with esophageal atresia. A 3-year analysis of the somatic and psychosocial variables analyzed will confirm the validity of this initiative, and define its optimal contours for improving these patients' quality of life as adults.


Eligibility criteria: Inclusion Criteria:

* Patients with esophageal atresia
* Aged 18 to 30
* Followed at Hôpital Saint Louis
* Informed and not opposed to the study
* Patients affiliated to a social security scheme

Exclusion Criteria:

* Inability to answer questionnaires
* Patients under guardianship
* Patients under AME (Aide Médicale d'Etat in France)

Primary outcomes:
measure: Prevalence of Post Traumatic Stress Disorder
timeFrame: At day 0
Secondary outcomes:
measure: Hospital Anxiety and Depression score
timeFrame: At day 0
measure: Hospital Anxiety and Depression score
timeFrame: At 3 years
measure: Quality of life evaluation
timeFrame: At day 0
measure: Quality of life evaluation
timeFrame: At 3 years
measure: Eating assessment
timeFrame: At day 0
measure: Eating assessment
timeFrame: At 3 years
measure: Quality of life assessment
timeFrame: At day 0
measure: Quality of life assessment
timeFrame: At 3 years
measure: Weight
timeFrame: At day 0
measure: Weight
timeFrame: At 3 years
measure: Height
timeFrame: At day 0
measure: Height
timeFrame: At 3 years
measure: Body Mass Index
timeFrame: At day 0
measure: Body Mass Index
timeFrame: At 3 years
measure: thoracic CT scan
timeFrame: At day 0
measure: thoracic CT scan
timeFrame: At 3 years
measure: respiratory function test
timeFrame: At day 0
measure: respiratory function test
timeFrame: At 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Saint Louis
Study officials:
References:
Clinical trial NCT04393519: Non-invasive Evaluation Program for TIPS and Follow Up Network 2 (NEPTUN2)
Official title: Non-invasive Evaluation of Prognostic Parameters for Patients With Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using a Structured Follow up Protocol 2
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Portal Hypertension
Keywords: transjugular intrahepatic portosystemic shunt (TIPS)
non-invasive assessments
Transthoracic echocardiography (TTE) with Speckle-tracking
Computer tomography scan (CT-scan)
Magnetic resonance imaging (MRI)
Circulating biomarkers
Electroencephalography (EEG)
Elastography
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 1000
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 patients receiving TIPS according to guidelines

Brief summary: Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.

Detailed description: NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.

Eligibility criteria: Inclusion Criteria:

* Insertion of TIPS according to guidelines

Exclusion Criteria:

* Contraindication for TIPS

Primary outcomes:
measure: Survival
timeFrame: up to 10 years
Secondary outcomes:
measure: Ascites
timeFrame: up to 10 years
measure: Hepatic Encephalopathy (HE)
timeFrame: up to 10 years
measure: Variceal Bleeding
timeFrame: up to 10 years
measure: Liver Failure
timeFrame: up to 10 years
measure: Acute-on-Chronic Liver Failure (ACLF)
timeFrame: up to 10 years
measure: Organ Failures
timeFrame: up to 10 years
measure: Kidney Failure
timeFrame: up to 10 years
measure: Sarcopenia
timeFrame: up to 10 years
measure: post-surgical survival
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
Study officials:
affiliation: University of Bonn
name: Michael Praktiknjo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05066919: Operative Versus Non-operative Treatment of Recalcitrant Plantar Fasciitis - A Randomized Study
Official title: Operative Versus Non-operative Treatment of Recalcitrant Plantar Fasciitis - A Randomized Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Plantar Fascitis
Surgical Treatment
Non-operative Treatment
Randomized Study
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 0
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 purpose of the study is to examine whether patients with heel spurs for more than 6 months, who have been treated conservatively, have better effect of surgery than further conservative treatment. The study is performed as a randomized trial with the inclusion of 32 patients divided between open plantar fasciectomy and conservative treatment.

The primary endpoint is Self-Reported-Foot-And-Ankle Score (SEFAS-score) after 24 months.

Secondary endpoints includes: Pain (Visual analogue score) at first step, rest and activity after 3, 6, 12 and 24 months, SEFAS-score after 3, 6 og 12 months, changes in gait after 6 months (measured with gait-analysis). All endpoints are measured at inclusion.

The power calculation is based on the assumption that surgical treatment gives an improvement in SEFAS-score of 10 points (SD 7.9) after 24 months when compared to conservative treatment together with an alpha-value of 5 % and a beta value of 90 %.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* Isolated plantar fasciitis through more than 6 months
* Ultrasonic verification of diagnosis (plantar fascia \>4 mm)
* Ability to follow the post-operative- and conservative plans
* Able to give informed consent.

Exclusion Criteria:

* Previous surgical treatment of plantar fasciitis or surgery around the heel
* Rheumatic disease
* Diabetes
* Dementia
* Neuropathy
* Known alcohol abuse
* Pareses/paralysis of the affected extremity.

Primary outcomes:
measure: Self-Reported-Foot-And-Ankle Score (SEFAS)
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital, Department of Ortopedic Surgery
Study officials:
References:
Clinical trial NCT00475319: Late Phase 2 Study of OPC-12759 Ophthalmic Suspension
Official title: Late Phase 2 Study of OPC-12759 Ophthalmic Suspension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndromes
Keywords: Dry Eye Syndromes
OPC-12759
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 308
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients


Eligibility criteria: Inclusion Criteria:

1. Outpatient
2. Subjective complaint of dry eye that has been present for minimum 20 months
3. Ocular discomfort severity is moderate to severe
4. Corneal - conjunctival damage is moderate to severe
5. Unanesthetized Schirmer's test score of 5mm/5minutes or less
6. Best corrected visual acuity of 0.2 or better in both eyes

Exclusion Criteria:

1. Presence of anterior segment disease or disorder other than that associated with keratoconjunctivitis sicca
2. Ocular hypertension patient or glaucoma patient with ophthalmic solution
3. Anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study
4. Anticipated use of contact lens during the study
5. Patient with punctal plug
6. Any history of ocular surgery within 12 months
7. Female patients who are pregnant, possibly pregnant or breast feeding
8. Known hypersensitivity to any component of the study drug or procedural medications
9. Receipt of any investigational product within 4 months

Primary outcomes:
measure: Change in Fluorescein Corneal Staining (FCS) Score From Baseline to Last Observation Carried Forward (LOCF)
timeFrame: Baseline, 4weeks
Secondary outcomes:
measure: Change in Lissamine Green Conjunctival Staining (LGCS) Score From Baseline to Last Observation Carried Forward (LOCF)
timeFrame: Baseline, 4weeks
Other outcomes:
Locations:
city: Chubu region
country: Japan
city: Kansai region
country: Japan
city: Kanto region
country: Japan
city: Kyushu region
country: Japan
city: Shikoku region
country: Japan
city: Tohoku region
country: Japan
Study officials:
affiliation: Division of dermatologicals and ophthalmologicals
name: Satoshi Oshima
role: STUDY_DIRECTOR
References:
citation: Kinoshita S, Awamura S, Oshiden K, Nakamichi N, Suzuki H, Yokoi N; Rebamipide Ophthalmic Suspension Phase II Study Group. Rebamipide (OPC-12759) in the treatment of dry eye: a randomized, double-masked, multicenter, placebo-controlled phase II study. Ophthalmology. 2012 Dec;119(12):2471-8. doi: 10.1016/j.ophtha.2012.06.052. Epub 2012 Sep 23.
Clinical trial NCT03413319: Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104
Official title: Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Progressive Supranuclear Palsy (PSP)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-01-29
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).


Eligibility criteria: Inclusion Criteria:

* Subject completed Study C2N-8E12-WW-104 (NCT02494024)
* Subject was not eligible to enroll in Study M15-562 (NCT02985879)

Exclusion Criteria:

* Subject weighs less than 35 kg at screening
* Subject has any contraindication or inability to tolerate brain MRI
* Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results

Primary outcomes:
measure: Adverse Events
timeFrame: From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San /ID# 170113
state: California
city: Dallas
country: United States
facility: Texas Health Physicians Group /ID# 170112
state: Texas
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: