louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01768390: Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients
Official title: Caries-preventive Effectiveness of a Dentifrice Containing 5.000 Ppm Fluoride - a Randomized Controlled Trial in Adolescents With Fixed Orthodontic Appliances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Keywords: caries
prevention
orthodontics
fixed appliances
adolescents
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 500
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: AIM: To evaluate the efficacy of daily tooth brushing with high concentrated fluoride dentifrice on white spot lesion (WSL) formation in adolescents during treatment with fixed orthodontic appliances (FOA).

The null hypothesis is that neither incidence nor severity of lesions would differ from a control group using standard fluoride dentifrice.

SUBJECTS AND METHODS: 420 healthy consecutive 11-16 year-old patients referred to 4 Orthodontic Specialist Clinics are randomized to use either a dentifrice containing 5.000 ppm fluoride or a regular dentifrice with 1.450 ppm sodium fluoride. To be eligible for inclusion, the patients are scheduled for bimaxillary treatment with FOA for an expected duration of at least 1 year. All are instructed to use 0.25 gram dentifrice and brush their teeth during 2 minutes twice daily during the entire period of treatment. Before bonding, and after polishing with a rubber cup and non-fluoride pumice paste, 3 digital photos of the maxillary incisors, canines and premolars are taken. At debonding, remaining composite material on the surfaces is removed with a slow rotating carbide bur followed by polishing with a rubber cup and pumice paste. A new series of frontal and lateral digital photos is thereafter exposed.

The primary outcome measure is the incidence and severity of WSL as registered separately by two blinded experienced and calibrated clinicians according to a validated index. A random sample of 50 cases is re-assessed to check intra- and inter-examiner reliability. The intervention is indended run throughout the full duration of the orthodontic treatment, varying between 18 and 24 months.

Detailed description: not desired

Eligibility criteria: Inclusion Criteria:

* healthy
* bi-maxillary treatment with fixed orthodontic appliances for at least 1 year

Exclusion Criteria:

* poor oral hygiene (not being able to brush their teeth)
* recent high caries activity

Primary outcomes:
measure: White spot lesion incidence
timeFrame: up to 24 months (at debonding of ortodontic appliances)
Secondary outcomes:
measure: white spot lesion severity
timeFrame: up to 24 months (at debonding of orthodontic brackets)
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Halland Hospital
Study officials:
affiliation: University of Copenhagen
name: Svante HA Twetman, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04731090: Standard Antibiotic Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy
Official title: Effect of Standard Antibiotic Prophylaxis Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Lead sponsor: Egyptian Biomedical Research Network
Sponsor class: NETWORK
First posted: 2021-01-29
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background and aim: Urinary tract infections (UTIs) are commonly seen after flexible ureteroscopy. Prevention of UTIs remains controversial. The present randomized study aimed to compare the rate of post-procedural UTI in patients subjected to the standard antibiotic prophylaxis alone versus enhanced prophylactic measures.

Patients and methods: The study included 100 patients subjected to fURS for management of ureteral and/or renal stones. Patients were equally and randomly allocated into one of the two treatment groups using randomly computer-generated allocation tables and concealed envelope technique. Treatment groups included standard antibiotic prophylaxis group and enhanced prophylaxis group. Patients in the standard antibiotic prophylaxis group IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively. In the enhanced prophylaxis group, patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.


Eligibility criteria: Inclusion Criteria:

* All patients subjected to flexible ureteroscopy for management of ureteral and/or renal stones.

Exclusion Criteria:

* Symptomatic urinary tract infection.
* Use of rigid ureteroscopy and antegrade ureteroscopy.

Primary outcomes:
measure: Urinary tract infection
timeFrame: 30-day postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Armed forced Hospital
Study officials:
affiliation: Al-Azhar Universiy
name: Mohamed Elhelaly
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01726790: Effect of Intravitreal Bevacizumab on Corneal Endothelium
Official title: Effect of Intravitreal Bevacizumab on Corneal Endothelium
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corneal Endothelial Cell Loss
Keywords: corneal endothelium
Bevacizumab
Intravitreal injection
Confoscan
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient in retinalvascular clinic with diagnosis of retinal vein occlusion with macular edema, diabetic macular edema, wet aged related macular degeneration and submacular hemorrhage)treated with intravitreal Bevacizumab

Brief summary: To evaluate corneal endothelium cell change after intravitreal Bevacizumab injection

Detailed description: Intravitreal Bevacizumab has been used by retinal specialist in treatment many retinal diseases. Although it not approved by FDA for treatment. In many In vitro studies, its showed saftey in the eyes especially for corneal endothelium cells, that important cells to keep cornea clear. This study use Confoscan-Corneal confocal microsope to evaluate corneal endothelium before and after intravitreal Bevacizumab injection in routine retinal disease at 6 month follow up.

Eligibility criteria: Inclusion Criteria:

* aged between 20 and 80 years old
* can come to regular follow up at 6 month
* signed written consent forms
* not have corneal scar, or glaucoma
* history of treatment with laser or anti-VEGF therapy in 3 month prior to recruit
* high risk in cerebrovascular and cardiovascular diseases
* Pregnancy and breastfeeding
* can undergo confocal microspopy

Exclusion Criteria:

* History of intraocular surgery or ocular trauma during study

Primary outcomes:
measure: Corneal endothelium cell change after intravitreal Bevacizumab injection
timeFrame: 6 months
Secondary outcomes:
measure: Assess the complication after intravitreal Bevacizumab injection
timeFrame: 6 month
Other outcomes:
Locations:
city: Khon kaen
country: Thailand
facility: KKU eye center, department of Ophthalmolgy, faculty of medicine, khon kaen university
Study officials:
References:
Clinical trial NCT02505490: The Effect of Television Watching on Liking of Food
Official title: The Effect of Television Watching on Liking of Food in Normal Weight Adults 18-35
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hunger
Keywords: Lunch
Television
Macaroni and Cheese
Salad tossed in dressing
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The purpose of the study is to investigate the effect of television viewing on liking of food.

Detailed description: The objective of this investigation is to determine whether participants will have a change of liking of food based on television viewing. The specific aims of the study are:

1. Determine the effect of television on liking of food.
2. Determine the effect of no television on liking of food.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 35 years
* Body mass index (BMI) between 18.5 kg/m2 and 24.9 kg/m2
* Unrestrained eater (≤ 12 on the Three Factor Eating Questionnaire \[TFEQ-R\])
* Report a favorable preference for foods served in the meal including: macaroni and cheese and salad (dressing will be chosen by the participant via initial phone screen), participants must rate each food item ≥ 3 during phone screen and ≥ 50 on a visual analogue scale (VAS) during the initial screening session
* Regularly eat a meal before 10:00 am
* Are able to complete all sessions within eight weeks of the screening session
* Report being a non-smoker
* Are not taking medications that affect appetite or food intake
* Are not pregnant or breastfeeding
* Are not on a dietary plan or have dietary restrictions that prevent consumption of certain types and/or amounts of food

Exclusion Criteria:

* Binge eating; and/or
* Athletes in training

Primary outcomes:
measure: The Effect of Television Watching on Liking of Food via Visual Analog Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
Study officials:
affiliation: The University of Tennessee, Knoxville
name: Rachel Rosenthal, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06047990: Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction
Official title: Endobiliary Percutaneous Cryobiopsy in Malignant Biliary Obstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Biliary Tract Carcinoma
Biliary Obstruction
Keywords: cryobiopsy
biliary obstruction
percutaneous transhepatic drainage
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The rationale of the study is to explore the safety and efficacy of percutaneously performed endobiliary cryobiopsy in patiens with histologically unverified biliary stenosis.

Detailed description: In patients with malignant biliary stenosis in whom endoscopic retrograde cholangiography (ERCP) is not feasible , percutaneous transhepatic drainage (PTD) is indicated. Biopsy is required for further management of the patient. In patients unsuitable for biopsy under CT or endoscopic guidance, samples can be collected endobiliary by PTD. The biopsy vie PTD can be sampled either at the initial drainage using disposable 5.2F forceps or delayed after 2 or more days using 7.5F endobiliary forceps. An alternative to this procedure is endobiliary sampling by cryobiopsy using 1.1mm, 1.7mm or 2.4mm catheters. To minimize bias, each patient will be sampled both by cryobiopsy and forceps biopsy. The order of cryobiopsy and forceps biopsy will be randomized.

Eligibility criteria: Inclusion Criteria:

* biliary stenosis of unknown etiology
* unsuccessful or unfeasable ERCP
* indicated percutaneous transhepatic drainage

Exclusion Criteria:

* histologically verified biliary stenosis
* INR ≥ 1,5

Primary outcomes:
measure: Sensitivity of biopsy sampling to detect malignancy
timeFrame: up to month 12 or death of the patient
measure: Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - weight
timeFrame: up to month 12 or death of the patient
measure: Quality of samples collected by endobiliary cryobiopsy and forceps biopsy - size
timeFrame: up to month 12 or death of the patient
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
Study officials:
References:
Clinical trial NCT01327690: Mental Health in Veterans and Families After Group Therapies
Official title: Mental Health in Veterans and Families After Group Therapies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Post-Traumatic Stress Disorders
Lead sponsor: Soul Medicine Institute
Sponsor class: OTHER
First posted: 2011-04-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: PTSD (posttraumatic stress disorder) and associated mental health conditions affect both veterans and their family members. This study investigates whether group therapy using EFT (Emotional Freedom Techniques) and CBT (Cognitive Behavior Therapy) produce reductions in PTSD and comorbid symptoms.


Eligibility criteria: Inclusion Criteria:

* The ability to follow instructions, complete written forms, and provide informed consent. Subjects are required to be literate and understand English.
* Physically healthy.
* Active duty military service, veterans, and their family members.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change from Baseline PTSD (posttraumatic stress disorder) Symptom Levels
timeFrame: Pre-Intervention, Post-Intervention, with one, three, six, and twelve month follow-ups
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Rosa
country: United States
facility: Soul Medicine Institute
state: California
Study officials:
affiliation: Soul Medicine Institute
name: Dawson Church, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02866890: The New Laryngeal Tube Suction-Disposable for Childrens
Official title: The New Laryngeal Tube Suction-Disposable for Childrens. An Observational Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adverse Anesthesia Outcome
Keywords: Laryngeal Tube Suction
seal pressure
mechanical ventilation
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-08-15
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Laryngeal Tube Suction Disposable( LTS-D) has recently undergone considerable structural changes in design. As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version The investigator hypothesized that the LTS-D perform clinically well during general anesthesia with controlled ventilation.

Detailed description: The LTS-D, is a second generation supraglottic airway device, made from the medical polyvinyl chloride introduce in 2005. It is used for maintaining the airway during spontaneous and controlled ventilation during general anesthesia . It has been advocated for prehospital emergency airway management and serves as a useful tool during failed intubations The LTS-D has recently undergone considerable changes in design based on clinical studies and investigators feedback. The new LTS-D is available to adult and pediatric sizes.For childrens the devices is presented in the size 3 for patients of \< 155 cm (\> 30 Kg.), the size 2.5 for patients 125-150cm. (20-30 Kg.), the size 2 for patients of 12-25 Kg, the size 1 for patients of 5-12 Kg and the size 0 for patients \< 5 Kg.

As these changes may influence the performance of the LTS-D relative to the old LTS-D version the investigator decided to check the new LTS-D in the pediatric version.

The investigator hypothesized that the LTS-D perform clinically well during general anesthesia with controlled ventilation.

Eligibility criteria: Inclusion Criteria:Pediatric patients, ASA I and II, normal airway, for minor elective surgery

Exclusion Criteria: Weigth \<10Kg or \> 30 Kg, known difficult airway, active esophagial reflux

Primary outcomes:
measure: Seal pressure in cm H2O
timeFrame: one minute
Secondary outcomes:
measure: Time of insertion in seconds
timeFrame: one minute
Other outcomes:
measure: Easy of insertion using a five-point Likert Scale
timeFrame: One minute
Locations:
Study officials:
affiliation: Bnai Zion Medical Center
name: Luis A Gaitini, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06421090: Transauricular Vagal Nerve Stimulation Improves Postoperative Delirium in Elderly Patients
Official title: Safety and Feasibility of Transauricular Vagus Nerve Stimulation in Improving Postoperative Delirium in Elderly Patients: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vagus Nerve Stimulation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the efficacy and safety of perioperative Transauricular vagal nerve stimulation in improving Postoperative Delirium in elderly patients undergoing elective surgery Lay the groundwork for a Phase III study.

Detailed description: This study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of Transauricular vagal nerve stimulation(taVNS) to improve the incidence of Postoperative Delirium(POD) in elderly patients undergoing anesthesia surgery. The intervention group will receive taVNS, while the control group will only wear a taVNS stimulator without current stimulation.

Eligibility criteria: Inclusion Criteria:

* Age≥65 years
* Expected operation time≥ 2 hours
* Postoperative hospital stay≥ 4 days
* Sign the informed consent form

Exclusion Criteria:

* Neurosurgery or cardiac surgery
* Emergency surgery within 6 hours of admission
* End-stage disease with an expected survival of \< 3 months
* Preoperative severe cognitive dysfunction affected perioperative cognitive function assessment
* Severe sinus bradycardia, AVB of degree II and above, pacemaker placement

Primary outcomes:
measure: TaVNS tolerance
timeFrame: 1-5 days after surgery
measure: Incidence of adverse events
timeFrame: At discharge，an average of 2 weeks
Secondary outcomes:
measure: Incidence of POD at discharge or within 5 days postoperatively
timeFrame: At discharge or within 5 days postoperatively
measure: Incidence of cognitive decline
timeFrame: Day 1 before surgery, day 5 after surgery, day 90 after surgery
measure: All-cause mortality
timeFrame: on the 90 days
measure: Postoperative pain
timeFrame: 1-5 days after surgery
measure: Time of anesthesia recovery
timeFrame: Within 2 hours after the end of the surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT06697990: Cerebrospinal Fluid Immune Microenvironment Mechanism in Anaplastic Lymphoma Kinase Positive Lung Cancer Patients
Official title: Exploring the Mechanism of Cerebrospinal Fluid Immune Microenvironment in Patients With Advanced Anaplastic Lymphoma Kinase (ALK)-Positive Lung Cancer With Brain Metastases Treated With Iruplinalib: an Interventional Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an an interventional study to explore the mechanism of cerebrospinal fluid immune microenvironment in patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer with brain metastases treated with Iruplinalib.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced non-small cell lung cancer(NSCLC) that is anaplastic lymphoma kinase (ALK)-postive as assessed by the next-generation sequencing (NGS) test.
* Confirmed diagnosis of brain metastases or suspected brain metastases
* Iruplinalib is proposed for treatment
* Eastern Cooperative Oncology Group(ECOG) Performance Status of 0-1
* Adequate organ and marrow function

Exclusion Criteria:

* Have serious gastrointestinal disease or other uncontrolled internal diseases and infections
* The presence of mental illness or substance abuse at the time of screening that may have affected compliance with the trial
* The presence of pleural fluid or ascites that requires treatment or is judged by the investigator to be uncontrollable at the time of screening
* Arterial/venous thrombosis events occurred within 6 months prior to administration, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism

Primary outcomes:
measure: Cerebrospinal fluid levels of Immune cells,inflammatory cytokines,immunoglobulins and cell adhesion molecules
timeFrame: 28 days
Secondary outcomes:
measure: Iruplinalib concentration in cerebrospinal fluid
timeFrame: Day 28
measure: Objective response rate
timeFrame: 16 weeks
measure: Disease control rate
timeFrame: 16 weeks
measure: Intracranial objective response rate
timeFrame: 16 weeks
measure: Intracranial disease control rate
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05552690: Thalassemia Screening by Third Generation Sequencing
Official title: Thalassemia Screening by Third Generation Sequencing (TGS): Pilot Study in Thai Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thalassemia Trait
Thalassemia; Mixed
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Test globin gene in participants

Detailed description: Recruit individuals who documented as thalassemia carrier or disease and who positive thalassemia screening but unknown mutation.

Blood will be sent for third generation sequencing to review alpha and beta globin gene mutation.

Eligibility criteria: Inclusion Criteria:

1. Thalassemia carriers or disease individuals with documented as known globin gene mutation.
2. Thalassemia carriers or disease individuals whose mutation did not retrieve from conventional technique and were assigned as no known mutation

Exclusion Criteria:

-incomplete medical data

Primary outcomes:
measure: Validate accuracy of TGS to provide globin gene mutation compared with conventional testing
timeFrame: 6 months after blood test
Secondary outcomes:
measure: Additional mutation added by TGS
timeFrame: 6 months after blood test
Other outcomes:
Locations:
city: ChiangMai
country: Thailand
facility: Maharaj Nakorn ChiangMai Hospital
Study officials:
References: