louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03009383: A Bedside Portable Endoscopy for the Esophageal Foreign Body
Official title: Efficacy of a Bedside Portable Endoscopy on Identifying the Esophageal Foreign Body
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Foreign Body
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether a bedside portable endoscopy is effective in identifying the esophageal foreign body in the emergency room.


Eligibility criteria: Inclusion Criteria:

* Patients who visit the emergency room due to apparent foreign body in esophagus

Exclusion Criteria:

* Patients unable to insert a portable endoscopy through the nasal cavity
* Patients unable to undergo conventional esophagogastroduodenoscopy for a gold standard examination

Primary outcomes:
measure: Sensitivity, specificity, positive predictive value and negative predictive value of the bedside portable endoscopy to identify esophageal foreign body defined by comparison with conventional esophagogastroduodenoscopy as a gold standard method
timeFrame: Within 1 hr after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
References:
citation: Choi JH, Choi JH, Lee YJ, Lee HK, Choi WY, Kim ES, Park KS, Cho KB, Jang BK, Chung WJ, Hwang JS. Comparison of a novel bedside portable endoscopy device with nasogastric aspiration for identifying upper gastrointestinal bleeding. World J Gastroenterol. 2014 Jul 7;20(25):8221-8. doi: 10.3748/wjg.v20.i25.8221.
Clinical trial NCT05418283: Effects of 12-week Exercise Program on Sleep Quality and Fear of Death in Geriatric Individuals
Official title: Effects of 12-week Exercise Program on Sleep Quality and Fear of Death in Geriatric Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disorder
Depressive Disorder
Death
Physical Inactivity
Keywords: sleep disorder
fear of death
exercise
Elderly
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the effect of regular aerobic exercise program on tanatophobia and sleep quality in elderly individuals, and to evaluate the relationship between sleep disorder and fear of death.

Detailed description: The effect of regular exercise programs on fear of death in elderly individuals is unknown. The aim of this study is to determine the effect of regular aerobic exercise program on tanatophobia and sleep quality in elderly individuals, and to evaluate the relationship between sleep disorder and fear of death.

Eligibility criteria: Inclusion Criteria:

* Individuals aged 65 and over who volunteered to participate in the study,
* Conscious and without communication problems,
* No orthopedic injury that prevents walking
* Those who are physically inactive according to the International Physical Activity Assessment Questionnaire
* Those who have sufficient motivation to participate in the exercise program (will be evaluated by a one-on-one interview by the researchers)
* Being eligible to participate in an exercise program after a cardiac examination by a cardiologist (resting ECG and questioning of cardiac symptoms, further examinations such as exercise ECG test if necessary)

Exclusion Criteria:

* Having a history of neuromuscular disease
* Serious medical condition (eg advanced malignancy or major neurological, psychiatric or endocrine disease, respiratory failure, etc.) that would prevent the person from participating in exercise training.
* Less than 1 year life expectancy
* Having an orthopedic injury that prevents walking
* Presence of advanced sensory deficit
* Having visual and hearing problems
* Not having sufficient communication skills (Mini Mental Test score below 24 points)
* Not having agreed to participate in the study
* Uncontrolled hypertension
* Not being found suitable for exercise in the examination performed by physicians and physiotherapists

Primary outcomes:
measure: thanatophobia
timeFrame: 1 week
Secondary outcomes:
measure: sleep quality
timeFrame: 1 week
Other outcomes:
Locations:
city: Üsküdar
country: Turkey
facility: Sultan Abdülhamid Training and Research Hospital
state: İstanbul
Study officials:
affiliation: Sultan Abdülhamid Training And Research Hospital
name: Elif Yıldırım Ayaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01423383: Epidemiology Study of Keloid
Official title: Epidemiology Study of Keloid
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Keloid
Keywords: Keloid
Lead sponsor: Tirgan, Michael H., M.D.
Sponsor class: INDIV
First posted: 2011-08-25
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: General population will be sampled randomly

Brief summary: Although keloid is a very common condition; there are no statistics as to its true incidence and prevalence, neither in United States, nor elsewhere in the world. This trial intends to capture epidemiological data about this disease in a large population sample.

Detailed description: The purpose of current trial is to establish a robust database of incidence and prevalence of keloid, as well as prevalence of familial keloid, in various ethnic groups. Study sample size is 100,000 random individuals who will fill out either a web survery or a paper questionnaire.

Eligibility criteria: Inclusion Criteria:

1. Informed consent
2. Age above 18 to answer the survey questions
3. Parents shall respond on behalf of their minor children

Exclusion Criteria:

* None

Primary outcomes:
measure: Prevalence of various clinical findings will be determined at the end of Survey.
timeFrame: Two Years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Michael H. Tirgan, MD
state: New York
Study officials:
affiliation: St. Luke's-Roosevelt Hospital Center
name: Michael H. Tirgan, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05717283: Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology.
Official title: Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology in the University Hospital of Caen, France : Metatranscriptomics Approach by Next Generation Sequencing From Nasal Swabs.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbial Colonization
Viral Infection
Neonatal Infection
Keywords: Metatranscriptomics
Microbiome
Newborn
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 38
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this interventional study is to learn about nasal microbiome and viral infections in newborns hospitalised in neonatology.

The main questions it aims to answer are :

* how often are newborns infected by viruses in neonatology ?
* how does the microbiome develop during first weeks of life ?
* how does microbiome and viruses interacts together ?
* is there a link between viral infection, microbiome, and medical complications during hospitalisation in neonatology ? Participants will have a nasal swab taken each week during their hospitalisation in neonatology, and researchers will take medical data from the medical chart.


Eligibility criteria: Inclusion Criteria:

* newborn hospitalised in neonatal intensive care unit during the inclusion period
* parents have been informed about the study (speaking french) and have signed the informed consent.
* affiliated to the social security system.

Exclusion Criteria:

* parental refusal
* minor parents or under judicial protection
* newborn who already have been discharded home before inclusion
* hospitalisation after the first 48 hours of life
* only palliative care

Primary outcomes:
measure: Change in microbiome diversity
timeFrame: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
measure: Change in microbiome abundance
timeFrame: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
measure: Virus presence
timeFrame: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Secondary outcomes:
measure: Occurence of bronchopulmonary dysplasia
timeFrame: At discharge from neonatology.
measure: Change in expression of local innate immunity markers
timeFrame: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Other outcomes:
Locations:
city: Caen
country: France
facility: CAEN University Hospital
Study officials:
References:
Clinical trial NCT02965183: The Correlation Between Adenoid Hypertrophy and Body Temperature in Children Before and After Adenoidectomy
Official title: The Correlation Between Adenoid Hypertrophy and Body Temperature in Children Before and After Adenoidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Otolaryngological Diseases
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-11-16
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Examination of the correlation between adenoid hypertrophy and body temperature in candidate children for adenoidectomy after exercise

Detailed description: Examination of the correlation between adenoid hypertrophy and body temperature in candidate children for adenoidectomy after exercise.

Adenoid hypertrophy and adenoiditis are accompanied by chronic rhinitis with or without otitis media. It is very common phenomena at ages 2-6 years and those children are symptomatic with snoring, rhinitis, nasal obstruction.

In healthy children with nasal obstruction, body temperature can be elevated following exercise.

As adenoiditis and chronic rhinitis are accompanied by inflammatory process, we would like to examine body temperature of children with adenoid hypertrophy before after exercise.

Eligibility criteria: Inclusion Criteria:

* Healthy children with adenoid hypertrophy with or without OSA, SOM Parental concent. No other diseases

Exclusion Criteria:

* Syndromatic children Other diseases If getting antibiotics or other medications

Primary outcomes:
measure: Changes in temperature
timeFrame: one week before the surgery and one week after the surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00825383: Effect of Dietary Fiber on Glucose & Lipids in Non Insulin Dependent Diabetes Mellitus (NIDDM)
Official title: Effect of Dietary Fiber on Glucose, Lipid, and Mineral Metabolism in Patients With Non Insulin Dependent Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Insulin-Dependent Diabetes Mellitus
Keywords: Diabetes
lipids
fiber
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-01-21
Enrollment: 13
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Effect of Dietary Fiber on glucose, lipid, and mineral metabolism in patients with non insulin dependent diabetes mellitus.

Detailed description: Two diets will be compared,a low fiber diet and a high fiber diet. These two diets will differ only in the content of total dietray fiber derived from natural food products. The diets will be identical in terms of total energy, percentage of total energy as proteins, fat and carbohydrates.

Eligibility criteria: Inclusion Criteria:

* NIDDM
* age 35 to 80 years
* stable oral hypoglycemic treatment for at least one month
* fasting triglycerides \< 500 mg/dl

Exclusion Criteria:

* insulin dependent NIDDM
* insulin dependent diabetes
* hepatic disease
* significant hepatic dysfunction
* signifiacnt renal dysfunction
* presence of significant hematological, neurological, cardiovascular or gastrointestinal disorder, unless stable for past 6 months,
* serious intercurrent illness or anticipated major surgery
* female pregnant or likely to become pregnant
* chronic drug abuse, alcoholism or psychaitric disorder within the past 2 years
* treated with beta adrenergic blockers
* on lipid lowering drugs

Primary outcomes:
measure: glucose and lipid metabolism
timeFrame: Baseline and during the last 5 days of each 6 week dietary phase
Secondary outcomes:
measure: calcium isotope absorption in the gastrointestinal tract, stool mineral content, 24 h urinary mineral concentration, and serum chemistry including mineral concentration.
timeFrame: Baseline and during the last 5 days of each 6 week dietary phase
Other outcomes:
Locations:
Study officials:
affiliation: UT Southwestern Medical Center at Dallas
name: Abhimanyu Garg
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shah M, Chandalia M, Adams-Huet B, Brinkley LJ, Sakhaee K, Grundy SM, Garg A. Effect of a high-fiber diet compared with a moderate-fiber diet on calcium and other mineral balances in subjects with type 2 diabetes. Diabetes Care. 2009 Jun;32(6):990-5. doi: 10.2337/dc09-0126. Epub 2009 Mar 11.
Clinical trial NCT00075283: Walking Therapy In Hemiparetic Stroke Patients Using Robotic-Assisted Treadmill Training
Official title: Gait Restoration In Hemiparetic Stroke Patients Using Goal-Directed, Robotic-Assisted, Treadmill Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hemiparesis
Stroke
Keywords: Physical Therapy
Locomotion therapy
Gait training
Stroke
Robotics
Rehabilitation
Treadmill
Hemiparetic stroke
Unilateral brain lesion
Lead sponsor: U.S. Department of Education
Sponsor class: FED
First posted: 2004-01-09
Enrollment: 50
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 overall goal of this study is to determine whether robotic-assisted gait training is better than standard physical therapy treatments for improving walking ability in hemiparetic stroke patients.

Detailed description: Subjects enrolled into the study will be randomly assigned to one of 2 groups. The first group will receive one hour of conventional gait training, consisting of lower extremity strengthening exercises, stretching, and full weight bearing walking as tolerated, with appropriate physical assistance from a therapist. The second group will receive walking therapy using a Lokomat, which is a special treadmill that works in conjunction with 2 light-weight robotic arms that assists the subject to move their legs while they try to walk on the treadmill. Some of the subject's body-weight will be supported using a harness. During Lokomat training sessions, subjects will receive feedback of their walking performance on a computer monitor to help them walk. Both groups will be trained for 8-10 weeks, 3 times per week, for 1 hour training sessions (24 total sessions). Resources for transportation to the National Rehabilitation Hospital will be provided to all study participants.

Eligibility criteria: Inclusion:

* Unilateral brain lesion.
* Within 6 months post-stroke.
* Receiving no other therapy targeting function of lower limb.
* Demonstration of hemiparesis (motor dysfunction in lower limb).
* Able to walk 5 meters without therapist assistance (walking device only).
* Able to follow commands and protocol.

Exclusion:

* Significant cognitive or communication impairments.
* Uncontrolled hypertension.
* Uncontrolled diabetes.
* Clinical depression.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: National Rehabilitation Hospital
state: District of Columbia
Study officials:
affiliation: The Catholic University of America
name: Dr. Joseph M Hidler, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02195583: The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ
Official title: The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Fluoride uptake during the remineralization phase will also be measured.


Eligibility criteria: Inclusion Criteria:

* Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
* Participants with maxillary dental arch suitable for the retention of the palatal appliance

Exclusion Criteria:

* Participants taking fluoride supplement
* Pregnant or breast-feeding women

Primary outcomes:
measure: Percentage Surface Microhardness Recovery (% SMHR)
timeFrame: Baseline to 4 hours
Secondary outcomes:
measure: Enamel Fluoride Uptake
timeFrame: Baseline to 4 hours
measure: Percentage Net Acid Resistance (% NAR)
timeFrame: Baseline to 4 hours
measure: Percentage Comparative Acid Resistance (% CAR)
timeFrame: Baseline to 4 hours
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02092883: Evaluation of Neuroinflammation in Children With Infantile Spasms
Official title: Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infantile Spasms
Keywords: Infantile Spasms
Neuroinflammation
PK11195
PET
ACTH
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study was to investigate the presence of neuroinflammation in children with infantile spasms using 11C-PK11195 positron emission tomography (PK PET) scan, and its response to ACTH treatment by repeating the PK PET scan after treatment.


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of 'cryptogenic IS'
* Normal MRI
* No other neurological disorder

Exclusion Criteria:

* Abnormal MRI
* No anti-inflammatory medication 48 hrs prior to PK PET scans
* Parent/guardian unable to give written consent

Primary outcomes:
measure: Neuroinflammation in cortical and/or subcortical structures
timeFrame: up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
Study officials:
References:
citation: Ajay Kumar, Vijay N. Tiwari, Otto Muzik, Pulak K. Chakraborty, Harry T Chugani. In-Vivo Measurement of Brain Inflammation with [11C]-[R]-PK-11195 Positron Emission Tomography in Children with Epileptic Disorders. Epilepsy Currents 2014;14:330 (abs)
Clinical trial NCT06441383: Assessment of Sleep Disordersin People Living With HIV in the Era of New Antiretroviral Therapies in North of France
Official title: Assessment of Sleep Disordersin People Living With HIV in the Era of New Antiretroviral Therapies in North of France
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV Infections
Sleep Disorder
Lead sponsor: Tourcoing Hospital
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population is all adults living with HIV. The study will be offered to all PLHIV at the time of their annual specialist consultation with their infectiologist in the referring hospital centers in northern France.

Brief summary: People living with HIV (PLHIV) appear to present with sleep-related complaints more frequently than the general population, with a prevalence of 50-70%. The latest French multi-center epidemiological data are dated. The prevalence of the different types of sleep disorders, however, is poorly documented, with the literature focusing mainly on insomnia and neuropsychological disorders that can lead to sleep disorder-like symptoms, and on the impact of antiretroviral drugs in particular. However, there are other sleep disorders such as sleep apnea syndrome (SAHOS) or restless legs syndrome. SAHOS has been studied in small series of patients.

This multicenter, cross-sectional study will identify and update the functional complaints presented by PLHIV, estimate the prevalence of people at high risk of sleep apnea syndrome, and study the associated socio-demographic factors, in relation to HIV infection and antiretrovirals. This study could open up avenues for new management approaches and earlier detection of sleep disorders.


Eligibility criteria: Inclusion Criteria:

* PLHIV usually treated at referral centers in northern France.

Exclusion Criteria:

* Minor patient;
* Patient with insufficient understanding of the French language, as judged by the investigator;
* Patient unable to give free and informed consent;
* Refusal to participate;
* Patient under legal protection, guardianship or curatorship;
* Pregnant and breast-feeding women.

Primary outcomes:
measure: Prevalence of sleep disorders
timeFrame: at baseline
Secondary outcomes:
measure: Prevalence of Obstructive Sleep Apnea-Hypopnea Syndrome
timeFrame: at baseline
measure: Prevalence of Restless Legs Syndrome
timeFrame: at baseline
Other outcomes:
Locations:
city: Tourcoing
country: France
facility: CH Tourcoing
Study officials:
References: