louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05371509: Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
Official title: Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Snoring
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Remastered Sleep LLC
First posted: 2022-05-12
Enrollment: 43
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: This research study is being done to determine whether the repetition and resistance from the daily use of the myofunctional therapy (MT) nozzle will improve obstructive sleep apnea and primary snoring.


Eligibility criteria: Inclusion Criteria:

* Patients with mild-moderate Obstructive Sleep Apnea and snoring.
* Diagnosis of mild to moderate obstructive sleep apnea with Apnea Hypopnea Index 5-29 events/hour confirmed within last 2 years with an in-lab diagnostic polysomnography or home sleep apnea test.
* Ownership of a smartphone and willingness to use a smartphone application to automatic log daily water intake.
* Willingness and ability to discontinue the currently prescribed OSA treatment for at least 3 days prior to testing.
* Age greater than or equal to 18 years

Exclusion Criteria:

* Individuals not diagnosed with Obstructive Sleep Apnea and snoring.
* Significant weight change (10% change in body weight in Kg) from the time of the OSA diagnosis until the study initiation.
* Persistent excessive daytime sleepiness (Epworth Sleepiness scale \> 10), despite treatment of OSA
* Significant medical comorbidities requiring restricted oral fluid intake - decompensated heart failure, end stage renal disease, end stage liver disease, hyponatremia (S. Na \<130 mg/dl), nocturia \> times/night.
* Unable or unwilling to participate in study procedures.
* Previous upper airway surgeries significantly modifying upper airway anatomy such as UPPP, apnea surgeries, oral and throat cancer surgeries or radiation.
* Known congenital or acquired diseases significantly affecting upper airway anatomy such as Down's Syndrome, oral and throat cancer.
* BMI \>40 kg/m\^2.
* Currently treating OSA with hypoglossal nerve stimulator.

Primary outcomes:
measure: Adherence to Therapy
timeFrame: 60 days
measure: Change in quality of life
timeFrame: Baseline, Day 60
Secondary outcomes:
measure: Change in Apnea Hypopnea Index
timeFrame: Baseline, Day 60
measure: Myofunction Assessment
timeFrame: Baseline, Day 60
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Umesh Goswami, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00607009: Project ALIVE (A Lifestyle Intervention Via Email)
Official title: Email-Based Diet and Activity Promotion in Worksites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inactivity
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2008-02-05
Enrollment: 797
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this study is to test the effectiveness of an email-based diet and physical activity intervention on increasing physical activity and fruit and vegetable consumption and decreasing intake of saturated and trans fats and added sugars.


Eligibility criteria: Inclusion Criteria:

* regional Northern California KP employees

Exclusion Criteria:

* none

Primary outcomes:
measure: change in physical activity
timeFrame: 4 months
Secondary outcomes:
measure: change in fruits and vegetables
timeFrame: 4 months
measure: health-related quality of life
timeFrame: 4 months
measure: presentism
timeFrame: 4 months
measure: stage of change
timeFrame: 4 months
measure: self efficacy
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: Barbara Sternfeld, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sternfeld B, Block C, Quesenberry CP Jr, Block TJ, Husson G, Norris JC, Nelson M, Block G. Improving diet and physical activity with ALIVE: a worksite randomized trial. Am J Prev Med. 2009 Jun;36(6):475-83. doi: 10.1016/j.amepre.2009.01.036.
citation: Block G, Sternfeld B, Block CH, Block TJ, Norris J, Hopkins D, Quesenberry CP Jr, Husson G, Clancy HA. Development of Alive! (A Lifestyle Intervention Via Email), and its effect on health-related quality of life, presenteeism, and other behavioral outcomes: randomized controlled trial. J Med Internet Res. 2008 Nov 19;10(4):e43. doi: 10.2196/jmir.1112.
Clinical trial NCT04423809: Impact of Burden in Caregivers of Patients Hospitalized for a Psychotic Episode: a Multicenter Study
Official title: Impact of Burden in Caregivers of Patients Hospitalized for a Psychotic Episode: a Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Objective of Our Study is to Assess and Take Into Account Early on the Suffering of Family Members
Keywords: Psychiatry Nurse Burden Caregiver
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: caregiver of patient hospitalised in psychiatry

Brief summary: Family support is a positive predictor for psychiatric patients. For example, since the 1980s, it has been shown that family psychoeducation improves patient adherence to care and statistically decreases patient relapse and hospitalization rates by half, resulting in lower care costs. Yet, the stress of hospitalizing a patient, seeing the feelings of shame or guilt of caregiver and the impact on their quality of life are rarely taken into account by caregivers during the first weeks hospitalization in a patient's psychiatry.

Barrelet emphasizes the importance of organizing the meeting in the first hours of hospitalization with the family in order to strengthen the alliance, to improve communication.


Eligibility criteria: Inclusion Criteria:

* Family members or relatives
* Over 18 years
* Having a relative

  * First hospitalized in psychiatry or hospitalized in psychiatry within 5 years
  * Over 18 years of age
  * Psychotic episode
  * Having been informed of their participation in this study
* In regular contact with the patient prior to hospitalization, at least 4 hours per week.
* French language
* Signed written informed consent.

Exclusion Criteria:

-Psychiatric pathology of another family member than the hospitalized.

Primary outcomes:
measure: Center for Epidemiologic Studies-Depression scale
timeFrame: at patient admission
Secondary outcomes:
measure: Zarit burden inventory
timeFrame: at patient admission
measure: Short form 36
timeFrame: at patient admission
measure: Semi-directional interview
timeFrame: At patient admission
Other outcomes:
Locations:
city: Neuilly Sur Marne
country: France
facility: Unité de recherche clinique
state: Île De France
Study officials:
References:
Clinical trial NCT06879509: Thromboelastography to Study Burn Coagulopathy
Official title: The Use of Thromboelastography in Burn Injury to Improve Burn Coagulopathy Evaluation and Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Burn
Coagulation, Blood
Keywords: burn
coagulation
Thromboelastography
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot study examines the use of thromboelastography (TEG), a specialized blood test, to evaluate clotting abnormalities in burn patients. The study aims to understand how burn injuries impact the body's ability to form and break down blood clots over time. Specifically, the investigators will research whether the percentage of total body surface area burned (%TBSA) is associated with changes in blood clotting, track the evolution of clotting patterns during the first four weeks following a burn injury, and explore whether these changes can predict recovery or complications. By providing new insights into clotting dynamics in burn patients, the study seeks to improve diagnostic methods, enhance monitoring strategies, and guide treatments to optimize patient care and outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients admitted with acute burn injuries
* Aged 18 years and older
* Provided consent to participate in the study

Exclusion Criteria:

* Patients with a history of venous thromboembolism or hyper/hypocoagulopathy

Primary outcomes:
measure: Thromboelastography
timeFrame: Duration of hospital length of stay, up to 28 days
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: Duration of hospital length of stay, up to 28 days
measure: Complications During Treatment
timeFrame: Duration of hospital length of stay, up to 28 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Department of Plastic Surgery, University of Pittsburgh Medical Center
name: Francesco M Egro, MD, MSc, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baumeister S, Koller M, Dragu A, Germann G, Sauerbier M. Principles of microvascular reconstruction in burn and electrical burn injuries. Burns. 2005 Feb;31(1):92-8. doi: 10.1016/j.burns.2004.07.014.
citation: Alessandri-Bonetti M, Kasmirski JA, Liu HY, Corcos AC, Ziembicki JA, Stofman GM, Egro FM. Impact of Microsurgical Reconstruction Timing on the Risk of Free Flap Loss in Acute Burns: Systematic Review and Meta-Analysis. Plast Reconstr Surg Glob Open. 2024 Aug 9;12(8):e6025. doi: 10.1097/GOX.0000000000006025. eCollection 2024 Aug.
Clinical trial NCT02798809: GENOA ORAL GROWTH LONGITUDINAL STUDY (GeOrGS)
Official title: GENOA ORAL GROWTH STUDY: Longitudinal Investigation of Preschool and Primary School Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malocclusion
Dental Caries
Lead sponsor: University of Genova
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 270
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children born in 2008 and 2009 in Chiavari District (Italy)

Brief summary: The aim of the study is to follow a group of preschool children from early permanent dentition to determine the prevalence and incidence of caries malocclusions and to investigated the related risk factors as age, gender, ethnic origin and non-nutritive sucking habits, breathing disturbances, allergies, Dietary habits, oral hygiene status and dental care.

Detailed description: Once a year a clinical examination were performed. Data were collected with a questionnaire, that was filled out by the parents before the clinical examination, which included questions on child's clinical history, the type of feeding, the use of baby-bottle, the history of non-nutritive sucking habits (dummy-sucking and digit sucking) and the consent to the clinical examination. Two World Health Organization (WHO) calibrated examiners carried out the clinical examinations. They were blinded to the information collected from the parental questionnaires. Dental examinations were performed in a classroom environment under natural light, using gloves and masks in compliance with the infection control protocol, mouth mirrors and disposable paper rulers to measure overjet and overbite (in millimeters). The occlusion was assessed in centric occlusion and was classified according to Foster and Hamilton criteria \[Foster and Hamilton, 1969\] Radiographic examination was not performed.

Eligibility criteria: Inclusion Criteria:

* children born in 2008 and 2009 in Chiavari District (Italy)

Exclusion Criteria:

* parents' lack of consent
* absence at the date of the visit; no compliance
* orthodontic treatment; marked occlusal wear or early
* loss of primary teeth
* alterations in the number, size and shape of teeth
* syndromes or systemic problems affecting craniofacial growth
* cleft palate.

Primary outcomes:
measure: Incidence (rate %) of Malocclusions and Caries
timeFrame: longitudinal 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Genova
country: Italy
facility: Ortohdontic Department - Univesity of Genoa
Study officials:
affiliation: University of Genova
name: Alessandro Ugolini, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04178109: Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach.
Official title: EVALUATION OF ORAL USE OF DEXKETOPROFEN/TRAMADOL IN ACUTE POSTOPERATIVE PAIN IN PATIENTS UNDERGOING TOTAL HIP REPLACEMENT WITH A MINIMALLY INVASIVE ANTERIOR APPROACH (AMIS).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Pain, Acute
Lead sponsor: KAT General Hospital
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 226
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions . When unrelieved or poorly controlled, it is associated with medical complications, poor patient satisfaction and increased risk of developing chronic pain. Dexketoprofen is a new NSAID treating acute postoperative pain and when it combined with tramadol may have a better effect. The purpose of this study is to evaluate the analgesic effect of the oral use of the combination of dexketoprofen/tramadole on the reduction of postoperative pain after total hip arthroplasty with minimal invasive anterior approach (AMIS).


Eligibility criteria: Inclusion Criteria:

* unilateral total hip arthroplasty with a direct anterior minimal invasive technique
* ASA score I or II
* signed written informed consent form
* 3 days hospitalization
* 45-80 years old
* primary Total hip arthroplasty

Exclusion Criteria:

* allergy to any given drugs
* contraindications for spinal anesthesia
* active bleeding
* renal failure ( gfr\< 90ml/h)
* hepatic failure ( abnormal sgot,sgpt,γgt)
* heart failure
* history of gastrointestinal bleeding

Primary outcomes:
measure: Pain score in 8hours
timeFrame: 8 hours
measure: Pain score in 24hours
timeFrame: 24 hours
measure: Pain score in 48 hours
timeFrame: 48 hours
measure: Pain score in 72 hours
timeFrame: 72 hours
measure: Total analgesic consumption
timeFrame: 24 houra
Secondary outcomes:
measure: Side effects
timeFrame: 72 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Elena Nikolakopoulou
state: Kifissia
Study officials:
References:
Clinical trial NCT00773409: Evaluation of the Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents (GBCA)
Official title: A Prospective Study Evaluating the Incidence of Nephrogenic Systemic Fibrosis in Patients With Stages 4 to 5 Chronic Kidney Disease Without Exposure to Gadolinium Based Contrast Agents Within the Past 10 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 405
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 400 patients will be enrolled into this study based on their renal function (eGFR) and the fact that they have been GBCA free for the past 10 years.

Brief summary: The objective of this long term study is to prospectively evaluate the incidence of NSF in patients with severe CKD or kidney failure including patients undergoing dialysis (stages 4 and 5 i.e., with an eGFR below 30)who have not had exposure to a GBCA within 10 years prior to enrollment.


Eligibility criteria: Inclusion Criteria:

* Has CKD with an eGFR below 30 mL/min/1.73m2 and/or undergoing dialysis as calculated from a serum creatinine (SCr) value obtained from the local laboratory within 24 hours prior to signing the informed consent;
* Provides written informed consent and is willing to comply with protocol requirements

Exclusion Criteria:

* Has received a GBCA within the past 10 years prior to inclusion in this study including the administration of a GBCA for something other than an MRI (e.g., CT or DSA);
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives;
* Has ever been suspected of, or diagnosed with, NSF;
* Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy and laboratory/other diagnostic evaluations should development of NSF be suspected.

Primary outcomes:
measure: To estimate the incidence of NSF in patients that have not been exposed to GBCA within the last 10 years with severe CKD including those undergoing dialysis observed during the follow-up time period over the total number of eligible patients.
timeFrame: 1,3,6,12,18,24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Bracco Diagnostics Inc.
state: New Jersey
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Gianpaolo Pirovano, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02659709: Interest in Electronic Applications for Patients With Glaucoma
Official title: Interest of Patients and Their Caregivers in A Smartphone- and Tablet-Based Application for Patients With Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Glaucoma
Smartphone
Tablet
Application
Eye Drops
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2016-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma patients or care givers

Brief summary: To evaluation interest in use of smartphone- and tablet-based application (app) for participants with glaucoma, ocular hypertension, those at risk and their caregivers.

Detailed description: This study is designed to determine the amount of interest in an educational application (app) on social media for glaucoma patients and their caregivers.

The purpose of this App is to enhance understanding of glaucoma by using short video tutorials. The App will include glaucoma eye drop medication reminders, a short video tutorial which aims to improve understanding of how visual field testing should be performed, how to administer eye drops and a feature that will enable participants to store and organize testing results using a mobile device.

Eligibility criteria: Inclusion Criteria:

* Anyone affected by glaucoma
* Family and friends of someone with glaucoma

Exclusion Criteria:

* unable to complete survey

Primary outcomes:
measure: Patients Owning Smartphone/Tablet Technology
timeFrame: 1 hour
measure: Patients Having Access to Social Media Via Smartphone or Tablet in the Home
timeFrame: 1 hour
Secondary outcomes:
measure: Glaucoma Medication Compliance
timeFrame: 1 hour
measure: Use of Medication Reminder
timeFrame: 1 hour
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Wills Eye Hospital
name: Jonathan S Myers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waisbourd M, Dhami H, Zhou C, Hsieh M, Abichandani P, Pro MJ, Moster MR, Katz LJ, Hark LA, Myers JS. The Wills Eye Glaucoma App: Interest of Patients and Their Caregivers in a Smartphone-based and Tablet-based Glaucoma Application. J Glaucoma. 2016 Sep;25(9):e787-91. doi: 10.1097/IJG.0000000000000504.
Clinical trial NCT01163409: Exercise, Acupuncture and Fibromyalgia
Official title: Acupuncture and Physical Activity in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Juvenile
Keywords: juvenile fibromyalgia
acupuncture
exercise training
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Set of real acupuncture treatment and supervised aerobic exercise have better efficacy in pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised aerobic exercise, as well as treatment versus combination with aerobic exercise and resistance exercise the major muscle groups, both supervised versus group control, who just get guidance for physical activity.

Detailed description: Fibromyalgia syndrome is a chronic musculoskeletal pain of unknown etiology. It is characterized by diffuse musculoskeletal pain or painful specific sites, usually accompanied by sleep disorders, fatigue, morning stiffness, chronic headaches, mental disorders and functional bowel. The diagnosis is essentially clinical, with no abnormal laboratory and radiological features Physical exercises are part of the treatment of fibromyalgia, but does not report studies in children. In general children with fibromyalgia are encouraged to a multidisciplinary treatment including medication, family education and child graduated aerobic exercise, psychotherapy, interventions to reduce pain, stress and improve sleep quality. To date no studies in medical literature with the use of acupuncture and supervised physical activity in juvenile fibromyalgia.

The significant sample of this disease, our recent publications in this research and the lack of systematic study of physical activity and acupuncture have stimulated this research. Assess pain reduction and improvement in quality of life in children and adolescents with juvenile fibromyalgia.

Eligibility criteria: Inclusion Criteria:

* Juvenile fibromyalgia diagnosis
* Age between ten to seventeen years and eleven months

Exclusion Criteria:

* Previous treatment with acupuncture;
* Treatment with psychotherapy, exercise training, use of antidepressant and anti-inflammatory drugs in the last month;
* Inflammatory diseases, hypothyroidism and hyperthyroidism

Primary outcomes:
measure: pain
timeFrame: 14 weeks
Secondary outcomes:
measure: quality of life
timeFrame: 14 weeks
measure: strength
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
city: São Paulo
country: Brazil
facility: Magda Maria Maia
Study officials:
affiliation: University of Sao Paulo
name: Clóvis AA Silva, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: