louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02571751: Open-label, Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL®
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Augmentation
Lead sponsor: Sewoon Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Bundang Hospital
name: Samsung Medical Center
First posted: 2015-10-08
Enrollment: 69
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to Augmentation Mammaplasty for Purpose of Cosmetic Surgery.


Eligibility criteria: Inclusion Criteria:

* Has given written informed consent to entry
* Female, 22 years to 60 years
* Breast augmentation(cosmetic surgery) is for following subjects

  * Who is not content with breast size and shape
  * Who has congenital asymmetrical deformity
* subject who agree to MRI scan during the trial
* subject who agree to visit to hospital according to schedule specified in the protocol during the entire period of the trial

Exclusion Criteria:

* Pregnant or lactating women and women of childbearing age
* Subject who has operation history of breast augmentation or reconstruction
* Subject who has fibrocystic Breast Disease coming up for precancerous lesion not accompanied with subcutaneous mastectomy
* Subject who has breast cancer or prodromal phase and no proper treatment.
* Subject who is diagnosed with Breast Imaging-Reporting and Data System(BI-RADS) category 3 under breast ultrasonography.
* Subject who has uncontrolled active infectious disease or abscess
* Autoimmune disease
* Diabetes mellitus
* Keloidosis
* Subject who cannot take general anesthesia due to abnormal blood or ECG results.
* Subject who is not appropriate for breast augmentation due to damaged tissue or blood vessel or ulcer
* Subject who has metal materials in a body such as ventricular assist system or cerebral aneurysm clips, or has claustrophobia (not suitable for MRI SCAN)
* Physically/mentally disabled subject that may disturb understanding and cooperation for the trial.
* Any other conditions that may interfere with correct assessment of the trial.

Primary outcomes:
measure: a rate of rupture of 4%
timeFrame: 2 years
measure: a rate of capsular contracture of 10%
timeFrame: 2 years
Secondary outcomes:
measure: Kaplan-Meier Analysis of rupture or capsular contracture events
timeFrame: 2 years
measure: Change in nipple sensitivity
timeFrame: 2 years
measure: a rate of adverse evnets
timeFrame: 2 years
measure: Change in chest, bust and under bust circumference
timeFrame: 2 years
measure: SF-36(Short Form (36) Health Survey ), Evaluation of quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT03390751: Atropine Weight and Risk of Postoperative Confusion in the Elderly
Official title: Atropine Weight and Risk of Postoperative Confusion After Hip Fracture Surgery or Prosthetic Surgery of the Lower Limb, in the Elderly
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aging
Keywords: atropinic drugs
confusion
elderly patients
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 130
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The recruitment of patients will be ensured from the consultation of anesthesia or the entry into hospitalization by the anesthesia team of the orthopedic surgery department of the Hospital.

Brief summary: The identification of a high atropine load of treatment received during hospitalization as a predictor of postoperative confusion could have various benefits:

* Pharmacoepidemiological: identify factors associated with postoperative confusion
* Clinics: by favoring treatments with a low atropine load during anesthesia, the management of patients hospitalized in orthopedics. Similarly, stopping or re-evaluating treatments with a high atropine weight for scheduled surgery is an easy step to take.
* Socio-economic: by reducing the costs related to the occurrence of a confusional syndrome (over-treatment, prolonged hospital stay, loss of autonomy, institutionalization of patients...).

In total, the present study would improve the daily management of hospitalized patients and the practices of clinicians, by offering a decision-making aid.


Eligibility criteria: Inclusion Criteria:

* Admitted to the orthopedic department for surgical management of a fracture of the upper end of the femur in emergency or for the installation of a hip or knee prosthesis
* Patient able to understand and respond to the protocol
* No opposition to the collection of data of the patient or his / her designee

Exclusion Criteria:

* Pre-existing confusion to surgery, detected by the CAM scale
* Serious or moderate head trauma less than three months old
* Removing / installing prosthesis.

Primary outcomes:
measure: Association between atropine load of medications on the risk of postoperative confusion
timeFrame: up to 7 days
measure: Atropinic load of drugs
timeFrame: up to 7 days
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: Up to discharge, an average of ten days
measure: Autonomy
timeFrame: Month 3
measure: Cognitive dysfunction
timeFrame: baseline
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Pierre-Paul-Riquet University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Vincent Minville
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02693951: Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices
Official title: Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Varices
Cirrhosis
Keywords: gastric varices
endoscopic injection of tissue adhesive
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to assess the efficiency and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

Detailed description: At present, there is still a controversy about the application of antibiotics in the treatment of patients with non acute hemorrhage of esophageal varices. This study is a randomized controlled trial. Patients randomly enter two treatment groups:

1. the prophylactic use of antibiotics group

   and
2. the non-prophylactic use of antibiotics group

Treatment allocation is by block randomization with an equal number for both groups. The incidence of infection after endoscopic treatment will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
* age between 18-75 years old;
* Diagnosis of esophageal gastric varices by gastroscopy
* Preparation of endoscopic injection of tissue adhesive

Exclusion Criteria:

* No esophageal gastric varices bleeding history;
* Esophageal varices or gastric varices which temporarily won't be treated by endoscopic therapy;
* The cefotiam contraindications: such as allergies, pregnancy etc;
* Patients with the other malignant tumor except liver cancer;
* The preoperative diagnosis of infection;
* The large amount of ascites;
* The acute bleeding period (\< 5 days);
* Patients refused to participate in the study.

Primary outcomes:
measure: The incidence of infection after endoscopic treatment
timeFrame: 1 week
Secondary outcomes:
measure: Rebleeding rate
timeFrame: 2 months
measure: Mortality rate
timeFrame: 2 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Shiyao Chen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02436551: Gestational Diabetes in Central Asia: Prevalence and Management
Official title: Gestational Diabetes in Central Asia: Prevalence and Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes Mellitus
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
name: Helmholtz Zentrum München
First posted: 2015-05-07
Enrollment: 3200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women in rural setting; pregnant women in urban setting;

Brief summary: Evaluate prevalence and management of gestational diabetes in Tajikistan in two different settings (one rural and one urban).


Eligibility criteria: Inclusion Criteria:

* pregnancy

Exclusion Criteria:

* known diabetes mellitus

Primary outcomes:
measure: prevalence of gestational diabetes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Med. Dept. 2, University Munich
Study officials:
References:
Clinical trial NCT02037451: The Effects of Auditory Cueing on Rhythmic Movement and Cortical Excitability in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Auditory Cueing
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Parkinson's disease (PD) is a progressive degenerative disease of central nervous systems deficit. The clinical symptoms of Parkinson's disease include the following motor tasks: difficult in initiating movement, performing rhythmic movement or serial movement, the ability of learning motor movement is also affected. The primary treatment for Parkinson's disease is medical treatment; surgery is used if in need. Rehabilitation such as physical therapy, which aims to improve patient's quality of life and functions, is a non-invasive treatment and value for PD patients. Auditory cue is a technique that widely applied on training patients with Parkinson's disease, and some researches revealed that auditory cueing could improve motor performance. However, the mechanism under this treatment technique is still unknown.

This study is to investigate the effect of auditory cueing on rhythmic finger movement in patients with Parkinson's disease. To investigate the mechanism under auditory cueing, neurophysiological data such as motor cortex excitability and blood flow in cortical cortex will be obtained by using Transcranial magnetic stimulation (TMS) and near infrared spectroscopy (NIRS).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Parkinson disease

Exclusion Criteria:

* Clinical diagnosis of other neurological diseases
* Dementia
* Been diagnosed with any mental illness
* History of seizures
* Brain trauma
* Body with a pacemaker or other electrical stimulator
* Pregnancy

Primary outcomes:
measure: Finger Tapping
timeFrame: Baseline,45-60 minutes.
measure: Motor evoked potential
timeFrame: Baseline,45-60 minute
measure: Intracortical inhibition & Intracortical facilitation
timeFrame: Baseline,45-60 minutes
measure: Blood oxygen dependent level
timeFrame: Baseline, in experiment,45-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References:
Clinical trial NCT05633251: Using Reinforcement Schedules to Increase Fruit&Vegetable Intake, Reduce Waste, and Increase School Lunch Participation
Official title: Using Reinforcement Schedules to Improve Carotenoid Levels, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation in El Paso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Changes
Psychology, Social
Nutrition
Keywords: fruit, vegetable, food waste
Lead sponsor: New Mexico State University
Sponsor class: OTHER
Collaborators: name: Paso del Norte Health Foundation
name: University of Texas
name: Brigham Young University
name: Ysleta Independent School District, El Paso
First posted: 2022-12-01
Enrollment: 1626
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Number of participants below is best estimate of students exposed to the intervention based on school lunch participation rates.
Primary purpose: PREVENTION

Brief summary: Using small monetary rewards to reinforce healthy behaviors, such as the consumption of fruits and vegetables (F\&V), the investigators tested fixed and variable reinforcement schedules in three middle schools.

The investigators measured carotenoid levels, as a biomarker of F\&V intake, and F\&V waste over the intervention time frame. The investigators also tracked the school lunch participation rates over time.


Eligibility criteria: Inclusion Criteria:

* students attending three participating middle schools (Ysleta Independent School District)

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Change in food waste
timeFrame: 24 weeks
measure: Change in fruit and vegetable intake
timeFrame: 12 weeks
Secondary outcomes:
measure: School lunch participation rates
timeFrame: 32 weeks
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Ysleta Independent School District
state: Texas
Study officials:
affiliation: New Mexico State University
name: Mihai Niculescu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00396851: Double Blind Randomized Trial to Compare Gurmar (Gymnema Sylvestre) With Metformin in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
Collaborators: name: Indian Council of Medical Research
name: International Clinical Epidemiology Network (INCLEN) TRUST
First posted: 2006-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 25
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 plans to compare the glucose-lowering effect of gurmar, a herbal preparation, with metformin in patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Newly detected type 2 diabetes
* Fasting plasma glucose \>126mg/dl
* HbA1c \> 7%

Exclusion Criteria:

* Serious comorbid illnesss
* History of drug abuse
* History of recent weight loss

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
Study officials:
affiliation: PGIMER
name: Deepak Bhasin, MD,DM
role: STUDY_CHAIR
affiliation: PGIMER
name: Anil Bhansali
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
Clinical trial NCT02719951: Glutaminergic Transmission in Autism : Molecular Imaging Exploration
Official title: Glutaminergic Transmission in Autism : Molecular Imaging Exploration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autism
Fragile-X Syndrome (FXS)
Healthy Volunteers
Keywords: autism
fragile X syndrome (FXS)
PET (Positron Emission Tomography)
glutamate
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Glutamatergic transmission exploration using PET (Positron Emission Tomography) imaging in autism compared to Fragile-X Syndrome ( FXS) and Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

* Male
* Between 18 years-old and 45 years-old
* Informed, written consent obtained from patient or his representant
* Subject with an affiliation to French social security
* For autistic patient : patient with diagnosis of ASD (Autistic Spectrum Disorders) following DSM-IV or DSM-5 criteria with recommended tools (ADI-R and/or ADOS)
* For FXS patient : diagnosis of FXS and confirmation of total mutation of FMR1

Exclusion Criteria:

* Contraindications to MRI
* Excessive use of alcohol or drug, or addiction to alcohol or drug during last 6 months
* Any unstable or uncontrolled disease, clinically significant
* Participation to an other experimental protocol with drug or irradiant exam
* Person under exclusion period because of previous participation to an other experimental protocol
* Person under temporary guardianship
* Forbidden treatments : any psychotropic treatment for 4 last weeks before PET exam and changing durably glutaminergic transmission directly or undirectly
* For healthy subjects : adult under guardianship, medical history of central nervous system disease, medical history of attention deficit hyperactivity disorder, past or present psychiatric or neurologic disorder (MINI DSM-IV)

Primary outcomes:
measure: cerebral glutaminergic activity assessed by binding potential of [18F]FPEB
timeFrame: An average of 3 years
Secondary outcomes:
measure: distribution volume of [18F]FPEB
timeFrame: An average of 3 years
Other outcomes:
Locations:
city: Tours
country: France
facility: CHU Tours
Study officials:
References:
Clinical trial NCT04022551: Emergency Room Evaluation and Recommendations for Older Users of Emergency Departments
Official title: Emergency Room Evaluation and Recommendations for Older Users of Emergency Departments: a Cohort Study Database on the Effects of ER2 Recommendations on Length of Stay and Hospital Admission
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Elderly Care
Length of Hospital Stay
Multimorbidity
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 4724
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It will be enrolled participants who are 75 years and over, and who will be brought at Emergency on medical stretcher. At Emergency, nurses will carry out a test called: Emergency Room Evaluation and Recommendation.

Brief summary: The study evaluates if the Emergency Room Evaluation and Recommendation Tool (ER2) reduces the hospital admission rate and the length of stay in Emergency.

Detailed description: Regardless of the reason for ED visit and its care plan, there are simple interventions, which may be continued to prevent short-term ED adverse outcomes. Delirium, motor deconditioning, adverse drug reactions due to polypharmacy, and inappropriate home support are the main conditions to target when taking care of older ER users.

Evidence based medicine showed that simple and early intervention in the process of care may prevent delirium (e.g., hydration, avoid restraint, mobilize and satisfy basic needs, time and place reorientation) and motor deconditioning (e.g., encourage mobility, up to chair at meal time during day light hours, provide appropriate walking aid) in older patients. The medication reconciliation is also an efficient intervention for the prevention of adverse drug reactions. Furthermore, an early assessment of home support is a crucial step to adjust home services for an early discharge to home.

Eligibility criteria: Inclusion Criteria:

* Being 75 years old and over
* Being brought at Emergency on medical stretcher

Exclusion Criteria:

* Being less than 75 years old
* Never come at Emergency

Primary outcomes:
measure: Hospital admission rate by age
timeFrame: Around 10 months
Secondary outcomes:
measure: Length of stay at Emergency
timeFrame: Around 10 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06057051: Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma
Official title: A Prospective, Multicenter Study of the Glaukos® iStent Infinite Trabecular Micro-Bypass System Model iS3 in Subjects With Mild to Moderate Primary Open-angle Glaucoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 245
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma
* Phakic or pseudophakic
* Age 35 years or older

Exclusion Criteria:

* Traumatic, uveitic, neovascular, angle-closure glaucoma or
* glaucoma associated with vascular disorders
* Active corneal inflammation or edema
* Retinal disorders not associated with glaucoma

Primary outcomes:
measure: Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Glaukos Investigator Site
state: Ohio
Study officials:
References: