louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03701165: The Effect of the DryMouth Shield on Snoring
Official title: The Effect of the DryMouth Shield on Snoring
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Snoring
Lead sponsor: VMS Medical Products, Inc
Sponsor class: INDUSTRY
First posted: 2018-10-09
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort non-randomized trial.
Primary purpose: TREATMENT

Brief summary: To measure the effect of the DryMouth Shield on snoring.

Detailed description: The primary outcome of this study is to aid in the final design of the DryMouth Shield and to assess the effect of the DryMouth Shield on snoring frequency. To accomplish this we will compare the frequency of snores during 1) overnight polysomnography without using the DryMouth Shield and 2) overnight polysomnography using the DryMouth Shield. Secondary outcomes of the study will include: 1) compare the difference in the volume of snores without and with the use of the DryMouth Shield; 2) estimate the changes in apnea hypopnea index without and with the use of the DryMouth Shield; 3) describe symptoms of dry mouth without and with the use of the DryMouth Shield 4) describe symptoms of bruxism without and with the use of the dry mouth shield and 5) gather patient feedback about the user experience with the dry mouth shield.

Eligibility criteria: Inclusion Criteria:

1. reports of snoring that disturbed a bed partner or housemate and
2. an objective measure of snoring such as a previous home sleep study, lab based polysomnography, or smart phone application with a snoring index of at least 20%

Exclusion Criteria:

1. Patient's with a body mass index of greater than 35 kilogram/meter squared.
2. A history of chronic lung disease with permanently impaired lung function testing.
3. A history of cardiovascular disease including but not limited to coronary artery disease or cerebrovascular disease.
4. Current smokers.
5. Patient's with a comorbid sleep disorder including but not limited to severe sleep apnea with an apnea hypopnea index of 30 events per hour, nocturnal hypoxia necessitating oxygen, current positive airway pressure use or restless legs syndrome
6. Poor nasal patency in the judgment of the investigator
7. Use of narcotics, benzodiazepines or other respiratory suppressing medication
8. Females who are pregnant.

Primary outcomes:
measure: Frequency of snoring
timeFrame: One night
Secondary outcomes:
measure: Volume of snoring
timeFrame: One night
Other outcomes:
Locations:
city: Huntersville
country: United States
facility: Thomas Stern, MD
state: North Carolina
Study officials:
References:
Clinical trial NCT06844565: Role of IL 12 and IL 23 as Potential Biomarkers in Diagnosis of Early Crohn's Disease
Official title: Role of IL 12 and IL 23 as Potential Biomarkers in Diagnosis of Early Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interleukin 12
Interleukin 23
Biomarker
Diagnosis
Crohn Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study will be carried out on 110 patients suspected of having Crohn's disease are present in Tanta University Hospitals in the period from January 2021 to December 2023 and the data will be collected in the duration from February 2025 to May 2025 that after approval from the institutional ethical committee.

Brief summary: This study aims to evaluate the role of Interleukin (IL)-12 and IL-23 as potential biomarkers in the diagnosis of early Crohn's disease.

Detailed description: Crohn's disease (CD) is characterized by periods of remission and relapse, with symptoms ranging from abdominal pain and diarrhea to severe complications such as fistulas and intestinal obstruction.

Interleukins (ILs) are known clusters of cytokines that regulate the proliferation, development, and activation of immune cells. IL-12 is predominantly a pro-inflammatory cytokine secreted by antigen-presenting cells (APC) in response to sensing of microbial components by Toll-like receptors. Another member of this family, IL-23 is also produced by DCs and macrophages after toll-like receptors (TLRs) engagement.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* Patients who are suspected of having Crohn's disease clinically and by colonoscopy (like ulcers, fistulas, or skip lesions).
* Non-specific ileitis by histopathology.

Exclusion Criteria:

* Patients with no pathological samples through colonoscopy.
* History of other significant gastrointestinal diseases (e.g., colon cancer, ischemic bowel disease).
* Immunosuppressive therapy or biologic agents at the time of study.
* Previous abdominal surgeries.

Primary outcomes:
measure: Sensitivity of IL-23 to predict Crohn's disease
timeFrame: 6 months after procedure
Secondary outcomes:
measure: Sensitivity of IL-12 to predict Crohn's disease
timeFrame: 6 months after procedure
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT01857765: Breast Augmentation Rehabilitation Program
Official title: How Rehabilitation Affects the Time to Pain-free Living After Endoscopic Transaxillary Subpectoral Breast Augmentation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Implants
Surgery, Plastic
Keywords: rehabilitation
reconstructive surgery
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether implementing a rehabilitation program can improve the post-operative time to pain free living after breast augmentation.


Eligibility criteria: Inclusion Criteria:

* women who undergo endoscopic transaxillary subpectoral breast augmentation
* women above the age of 18 years
* women with a BMI 18-27

Exclusion Criteria:

* women who underwent previous breast reconstruction (cosmetic or therapeutic)
* women who underwent previous chest surgery
* women with previous chest trauma
* women who underwent previous shoulder/arm surgery
* women with previous shoulder/arm injury
* women who smoke
* women who are Immunocompromised

Primary outcomes:
measure: Time to return to baseline as measured on Visual Analogue Scale for pain
timeFrame: Baseline, six months, and one year after surgery
Secondary outcomes:
measure: Time to return to bilateral shoulder baseline range of motion
timeFrame: Baseline, six months, and one year after surgery
measure: Change in psychosocial outcomes as measured by the BREAST-Q questionnaire
timeFrame: Baseline, six months, and one year after surgery
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Erin Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01658865: Assessment of Esophageal Motility With Transnasal Endoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Motility Disorder
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2012-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with esophageal motility disorder Healthy volunteer

Brief summary: The purpose of this study is to assese esophageal motor function by simplified transnasal endoscopy compared with esophageal manometry.

Detailed description: Esophageal manometry is a gold standard for diagnosis of esophageal motility disorder. However, esophageal manometry can not detect non-occulsive contraction. Endoscopic evaulation of esophageal motility is difficult becausea swallowing is nearly impossible during endoscopy. Simplified trans nasal endoscopy (E.G. ScanTM, IntroMedic Co.,Ltd.)composed with dysplay system,controller,and disposable probe with compact size.

The esophageal motor function will be assessed with both esophageal manometry and simplifed trnasnasal endoscopy in patients with esophageal motility disorder (such as achalasia) and healthy volunteer. The results of simplifed trnasnasal endoscopy is compared with the results of esophageal manometry.

Eligibility criteria: Inclusion Criteria:

* 1) Healthy volunteer without organic esophageal or gastric disorder 2) Patients knwon esophageal motility disorder (such as achalasia)

Exclusion Criteria:

* severe organic esophageal disorder including severe reflux esophagitis, stricture, and bleeding.
* previous opertion of esophagus or stomach
* GI bleeding, mechanical obstruction
* medication which can infulence GI motility

Primary outcomes:
measure: Agreement of endoscopic diagnosis of esophageal motor function with manometry
timeFrame: one day
Secondary outcomes:
measure: Discomfort of simplifed transnasal endoscopy compared with esophageal manomerty estimated by the patietns
timeFrame: one day
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
References:
Clinical trial NCT01602965: Effectiveness Between Nutritional Counseling Monthly Phone Call Versus Self Help Informative Booklet
Official title: Personalized Nutritional Program Plus a Nutritional Counseling Monthly Phone Call Versus a Personalized Nutritional Program With Self Help Informative Booklet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: obesity
counselling
weight loss
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2012-05-21
Enrollment: 40
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the most effectiveness between a personalized nutritional program with a counseling monthly phone call Versus personalized nutritional program with self help Informative Booklet in a group of obesity or overweight patients without counseling phone call.

Detailed description: Evaluate the best effectiveness between two methods applied in the Dietary Service of institute orthopedic Rizzoli for the achievement of the weight loss. Personalized nutritional program with counseling phone call versus personalized nutritional program with self help Informative Booklet in a controlled group.There will be compared two groups of patients: First group: patients subject to balanced personalized nutritional program associated to counseling monthly phone call ; compliance and loss of weight will be done monthly for one year. Second group: patients subject to balanced personalized nutritional program associated to self help informative Booklet; compliance and loss of weight will be done after six months and after one year from the first meeting.

Eligibility criteria: Inclusion Criteria:

* Female and male
* BMI \>25 and \<35
* Ages Eligible for Study: 18 years old to 75 years old
* Patients of the Institute Orthopedic Rizzoli subject to personalized nutritional program admitted to the wards and patients attending the clinic of Anaesthesiology, analgesic therapy, Rheumatology
* participants gave informed consent

Exclusion Criteria:

* Patients with psychiatric disorders (depression, bulimia, anorexia
* Concomitant use of medicines or food supplements that can alter the weight loss.
* Patients with inclusion criteria that have not signed the informative report and the declaration of consent.

Primary outcomes:
measure: Weight Loss
timeFrame: Percent Change in weight loss at one year
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT02731248: Pulse Oximeter Screening in Congenital Heart Disease
Official title: Pulse Oximeter Screening for Critical Congenital Heart Disease in Newborns
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
Lead sponsor: Dr. Sami Ulus Children's Hospital
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 50000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Babies within the first 24-72 hours followed up in well baby nurseries

Brief summary: Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey

Detailed description: The early detection of life-threatening, critical congenital heart defects in newborn babies still presents an important clinical challenge. Most defects are amenable to intervention but timely diagnosis (ie, before presentation with cardiovascular collapse or death) is crucial. In high-income countries, examination and, increasingly, antenatal ultrasound have formed the basis of screening, but test accuracy of these procedures is variable and many babies with critical congenital heart defects are discharged before diagnosis. Pulse oximetry screening of newborn infants increases early detection of critical congenital heart disease and minimises the risk of circulatory collapse before surgery. This study provides an update on the implementation of pulse oximetry screening in Turkey

Eligibility criteria: Inclusion Criteria:

* Babies within the first 24-72 hours followed up in well baby nurseries
* Babies prior to discharge, if discharged before 24 hours of age,
* Babies ≤5 days and still followed up in well baby nurseries
* Babies born ≥35 gestational weeks

Exclusion Criteria:

* Babies within the first 12 hours of life
* Babies \>5 days of life
* Babies with a gestational age of \>35 weeks
* Babies with major congenital anomaly except congenial heart disease
* Babies who had a prenatal diagnosis of congenital heart disease

Primary outcomes:
measure: pulse oximeter positivity
timeFrame: 6 months
Secondary outcomes:
measure: echocardiographic confirmation
timeFrame: 12 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr Sami Ulus Children Hospital
city: Bursa
country: Turkey
facility: Bursa Sevket Yılmaz Training and Research Hospital
city: Erzurum
country: Turkey
facility: Ataturk University Medical Faculty
city: Mersin
country: Turkey
facility: Mersin Maternity Hospital
city: Mugla
country: Turkey
facility: Mugla Sıtkı Koçman University Medical Faculty
city: Urfa
country: Turkey
facility: Urfa Maternity Hospital
Study officials:
affiliation: DR sami Ulus Training and Research Hospital
name: Dilek Dilli, Assoc Prof
role: STUDY_CHAIR
References:
Clinical trial NCT05224648: Comparison of Train of Four, Tetanus 50 and 100 Hz Recovery After Rocuronium Block Reversed by Neostigmine
Official title: Comparison of Train of Four, Tetanus 50 Hz and Tetanus 100 Hz Recovery Following Rocuronium Induced Neuromuscular Block Reversed by Neostigmine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Residual Curarization
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Despite neuromuscular transmission monitoring and pharmacological reversal allowing a train of four ratio recovery higher than 0.9, patients receiving neuromuscular blocking agent during general anesthesia have a high risk of postoperative pulmonary complications. While this train of four ratio threshold is considered as the gold standard to confirm the lack of residual paralysis, tetanus 100 Hz stimulation showed a marked fade. This result has been observed in absence of reversal agent administration.

Therefore, the present study has been designed to compare the recovery of train of four stimulation, tetanus 50 Hz and tetanus 100 Hz stimulation in patient receiving rocuronium during general anesthesia and reversed by an anticholinesterase agent (neostigmine). Neostigmine will be injected once four muscular contractions of the adductor pollicis muscle will be observed after a train of four stimulation, at a dose (40 µg/kg) in accordance with the clinical practice worldwide admitted.

Two questions have to be investigated. First, is this dose of neostigmine sufficient to allow a complete recovery of tetanus stimulations ? Second, due to the pharmacological properties of neostigmine, does a recurarisation phenomenon occur following repeated tetanus stimulations ? The attented results of this study will be to propose a new thinking on what we really need to make relevant progress in the safety aspects of residual paralysis outcome.


Eligibility criteria: Inclusion Criteria:

* ASA clinical status 1 to 3 informed consent obtained before anesthesia induction

Exclusion Criteria:

* ASA clinical status 4 emergency surgery scheduled surgery in prone position hepatic or renal disease BMI higher than 35 allergy to rocuronium or neostigmine

Primary outcomes:
measure: To determine the delay following neostigmine administration to obtain a train of four ratio higher than 0.9 and a tetanus 100 Hz ratio higher than 0.9
timeFrame: 30 minutes after neostigmine administration
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
affiliation: CHU de Poitiers FRANCE
name: Bertrand Debaene, MD phD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04146948: The Differences of Muscle Activity Between Patients With COPD and Healthy Adults
Official title: Comparing Activity of Accessory Inspiratory Muscles and Upper Limb Muscles During Performing Activities of Daily Living Between Patients With Chronic Obstructive Pulmonary Disease and Healthy Adults
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: activities of daily living
accessory inspiratory muscles
oxygen consumption
minute ventilation volume
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with COPD will be recruited from the Department of Internal Medicine in National Cheng Kung University Hospital

Brief summary: The purpose of this study attempts to investigate the differences and relationships of respiratory parameters, muscle activity, and dyspnea during ADL between patients with COPD and age-matched healthy participants.


Eligibility criteria: Inclusion Criteria:

* 40 years or older
* With the clinical diagnosis of COPD

Exclusion Criteria:

* With the clinical diagnosis of asthma or cancer
* With cardiovascular, musculoskeletal and neurological diseases limiting physical activities in daily life
* In the unstable medical state
* MMSE under 25
* Barthel index score under 61

Primary outcomes:
measure: Cardiopulmonary exercise testing device
timeFrame: baseline
measure: Surface electromyography device
timeFrame: baseline
measure: The clinical Chronic Obstructive Pulmonary Disease questionnaire
timeFrame: baseline
measure: Modified Borg Scale
timeFrame: baseline
measure: Modified Medical Research Council
timeFrame: baseline
Secondary outcomes:
measure: EQ-5D questionnaire
timeFrame: baseline
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University
Study officials:
References:
Clinical trial NCT01944748: Family Mediation Program For At-Risk Youth
Official title: Family Mediation Program For At-Risk Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Functioning
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 111
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this project is to conduct a pilot evaluation of a parent-child mediation program for at-risk youth. It is investigating whether families who receive parent-child mediation show greater improvement in family functioning, as well as adolescent substance use, academic performance, and delinquency, over a 6-week and 12-week period compared to a wait-list control sample.


Eligibility criteria: Inclusion Criteria:

1. Has a child referred to FARS due to having problems in any of the following areas: (a) poor grades; (b) truancy; (c) defiant behavior; (d) running away; (e) delinquency; (f) substance use
2. Agrees to participate in at least one FARS mediation session
3. Agrees to complete 3 surveys and be available over the next 3 months for follow-up
4. Fluent in English or Spanish

   -

   Exclusion Criteria: Families referred to FARS due to: (a) conflicts involving gang violence (e.g., shootings, killings); (b) conflicts involving weapons; (c) arson; (d) conflicts involving explicit sex activities; (e) conflicts involving domestic violence/child abuse; and (f) threats to harm self or others.

   -

Primary outcomes:
measure: Positive Family Relations
timeFrame: 6-week
measure: Family Conflict
timeFrame: 6-week
measure: Family Communication
timeFrame: 6-week
measure: Parent Support
timeFrame: 6-week
measure: Positive Family Relations
timeFrame: 12-week
measure: Family Conflict
timeFrame: 12-week
measure: Family Communication
timeFrame: 12-week
measure: Parent Support
timeFrame: 12-week
Secondary outcomes:
measure: Lifetime and Past Month Substance Use
timeFrame: 6-week
measure: Academic Performance
timeFrame: 6-week
measure: Delinquency
timeFrame: 6-weeks
measure: Lifetime and Past Month Substance Use
timeFrame: 12-week
measure: Academic Performance
timeFrame: 12-week
measure: Delinquency
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Centinela Youth Services
state: California
Study officials:
affiliation: RAND
name: Joan S. Tucker, PhD
role: PRINCIPAL_INVESTIGATOR
References: