louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03479658: Dose-effect of HIIT on Cardiovascular Health of Children
Official title: Dose-effect of HIIT on Cardiovascular Health of Children Aged 9 to 10 Years Old Participating in a School Based Multidisciplinary Intervention Program: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases Risk
Adiposity
Keywords: HIIT
nutritional education
Dose-effect
school
children
cardiovascular
adiposity
blood pressure
fitness
Lead sponsor: Universidad Pública de Navarra
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 180
Sex: ALL
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: An adequate physical activity level has important effects on cardiovascular health of children. However, the scientific literature suggests that few children meet the physical activity recommendations to obtain these cardiovascular benefits which may have immediate and long term consequences in public health. High intensity interval training (HIIT) has emerged as an effective strategy for improving physical and mental health in children. To note that HIIT can be completed in a shorter period of time and its results in physical health seem to be equivalent to those obtained in longer sessions of traditional aerobic training. However, there is no information about the dose of HIIT needed to obtain significant effects on cardiovascular health of children.

The adoption of healthy dietary habits is also important in the prevention of obesity and cardiovascular diseases.

School-based programs including physical activity and nutritional education have been recommended as important components of programs aiming to prevent obesity and cardiovascular diseases.


Eligibility criteria: Inclusion Criteria:

All school children able to attend the physical education sessions of the school

-

Exclusion Criteria:

* Children with medical condition that limits physical activity

Primary outcomes:
measure: Change in cardiorespiratory fitness
timeFrame: Change from baseline cardiorespiratory fitness at eight weeks
Secondary outcomes:
measure: Change in Body fat
timeFrame: Change from baseline body fat at eight weeks
measure: Change in Ankle-brachial index
timeFrame: Change from baseline Ankle-brachial index at eight weeks
measure: Change in Dietary habits
timeFrame: Change from baseline Dietary habits at eight weeks
measure: Change in Muscular strength
timeFrame: Change from baseline Muscular strength at eight weeks
measure: Change in speed-agility
timeFrame: Change from baseline speed agility at eight weeks
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Department of Health Sciences, Universidad Pública de Navarra
state: Navarra
Study officials:
References:
Clinical trial NCT00788658: Cognitive Behaviour Therapy for Patients With IBS
Official title: Cognitive Behavior Therapy (CBT) as Compared With Standard Therapy for Patients With IBS and Other Functional Gastrointestinal Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Constipation
Abdominal Pain
Depression
Keywords: Obstructed constipation
Quality of life
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 100
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: Irritable bowel syndrome (IBS) affects approximately 10-15% of the adult population. This condition is characterized by abdominal pain, altered bowel habit, abdominal bloating and reduced quality of life. Options for treating IBS include pharmacotherapy, psychotherapy, hypnotherapy and cognitive behavior therapy (CBT). Available data on the effectiveness of CBT in IBS patients in Israel are scarce.

The aim of the present study is to assess effectiveness of CBT as compared with standard therapy for IBS patients in Israel The course of CBT consisted of up to six 40 min sessions, and included education about IBS and techniques to reduce focusing on symptoms and to manage stress.Standard therapy includs life style modifications.

The primary outcome measure was the score on a symptom-severity scale specific to IBS.

Detailed description: Symptomatic treatment of patients would not be modified

Eligibility criteria: Inclusion Criteria:

* Age 18-75
* IBS

Exclusion Criteria:

* Malignancy
* Known psychiatric disorders

Primary outcomes:
measure: Symptom score
timeFrame: 3 months
Secondary outcomes:
measure: Quality of life assessment
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: RMC
name: Ram Dickman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02911558: Implication of a Mobile Team of Palliative Care and Reality of the Palliative Approach in the Units
Official title: Implication of a Mobile Team of Palliative Care and Reality of the Palliative Approach in the Units
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Death
Palliative Care
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients died between July, 2013 and September, 2014 and for which at least one opinion of the EMSP was required

Brief summary: The aim of the study is to estimate the impact of the implication of a Mobile Team of Palliative Care (EMSP) on the palliative strategy in the units with concerned patients. The Mobile Team of Palliative of Foch hospital Care was created in March, 2011.


Eligibility criteria: Inclusion Criteria:

* Patients died between July, 2013 and September, 2014 and for which at least one opinion of the EMSP was required

Exclusion Criteria:

* None

Primary outcomes:
measure: Time between specific treatments discontinuation and patient death
timeFrame: 6 months maximum
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Edouard Ferrand
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02933658: Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension and Dyslipidemia
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-14
Enrollment: 71
Sex: MALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male who are ≥19, \<50 years old
* Man who weights over 55kg and whose BMI is 18\~30(kg/m2)
* Man who doesn't have any chronic disease or history of disease

Exclusion Criteria:

* man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry

Primary outcomes:
measure: AUC of Reference 1
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
measure: Cmax of Reference 1
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
measure: AUC of Reference 2
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
measure: Cmax of Reference 2
timeFrame: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02972996: Blueberry Consumption and Type 2 Diabetes
Official title: Effects of Blueberry Consumption on Cardiometabolic Parameters in Men With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: Albany Research Institute, Inc.
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 55
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lifestyle strategies that include dietary modification, such as consumption of a plant-based diet, are well recognized in disease prevention and may improve type 2 diabetes. Various components of a plant-based diet may contribute to its beneficial health effects, but there has been keen interest in the possibility that plant polyphenols may have a role. Blueberries are dietary sources of polyphenols, specifically anthocyanins. To date there are few human clinical trials evaluating the beneficial health effects of blueberries in populations with type 2 diabetes. The objective of the study is to determine if freeze-dried blueberries compared to a blueberry placebo will improve cardiometabolic parameters in men with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male
* Ages 45 to 75 years at beginning of study
* BMI \>25 kg/m2
* HbA1C \> 6.5 and \< 9
* Medical diagnosis of type 2 diabetes for at least 6 months

Exclusion Criteria:

* Use of insulin
* Presence of chronic kidney disease (GFR \< 45 mL/min), liver cirrhosis, gastrointestinal disease, pancreatic disease, or malabsorption syndromes
* Weight loss of \>10% of body weight over the last 6 months; routine participation in heavy exercise
* Heavy smokers (\>20 cigarettes per day)
* Unable or unwilling to give informed consent or communicate with study staff
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigators may interfere with study participation or the ability to follow the intervention protocol
* Allergies to blueberries or blueberry products

Primary outcomes:
measure: Blood Pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Albany
country: United States
facility: Stratton V.A. Medical Center
state: New York
Study officials:
affiliation: Stratton V.A. Medical Center
name: Margaret M. Wilson, MS, RD, CDE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stote KS, Wilson MM, Hallenbeck D, Thomas K, Rourke JM, Sweeney MI, Gottschall-Pass KT, Gosmanov AR. Effect of Blueberry Consumption on Cardiometabolic Health Parameters in Men with Type 2 Diabetes: An 8-Week, Double-Blind, Randomized, Placebo-Controlled Trial. Curr Dev Nutr. 2020 Mar 9;4(4):nzaa030. doi: 10.1093/cdn/nzaa030. eCollection 2020 Apr.
Clinical trial NCT05812196: Late Respiratory Consequences of SARS-CoV-2 Pneumonia
Official title: Changes in the Respiratory System in Post-COVID Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Function Tests
Long COVID
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients after COVID-19 infection. In the control group, healthy volunteers.

Brief summary: The goal of this observational study is to learn about the respiratory system in post-COVID syndrome. The main question aims to answer:

how the post-COVID syndrome alters the lung function Participants will be asked to perform lung function tests. Researchers will compare post-COVID group to matched control healthy individuals.


Eligibility criteria: Inclusion Criteria: COVID-19 infections in the post-COVID group. -

Exclusion Criteria:

-

Primary outcomes:
measure: Respiratory mechanics
timeFrame: 6-12 months after COVID-19 infections
Secondary outcomes:
measure: Spirometry
timeFrame: 6-12 months after COVID-19 infections
measure: Lung diffusion capacity
timeFrame: 6-12 months after COVID-19 infections
measure: Plethysmography
timeFrame: 6-12 months after COVID-19 infections
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Barna Babik
Study officials:
References:
Clinical trial NCT05687396: Virtual Reality in COPD Exacerbation
Official title: Virtual Reality in Chronic Obstructive Pulmonary Disease: Randomized Contolled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD Exacerbation
Pulmonary Rehabilitation
Keywords: COPD, pulmonary rehabilitation, virtual reality
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-01-18
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: In addition to conventional pulmonary rehabilitation, virtual reality will be applied during the hospitalization period of individuals hospitalized for COPD exacerbation. It is aimed to get more efficiency from the interventions in this short time.

Detailed description: Subjects with COPD exacerbation will be divided two groups. Group-1 will exercise with a bicycle ergometer until fatigue in addition to pulmonary rehabilitation. Group-2 will do the same exercises. Subjects in Group-2 will use virtual reality simulation, which is designed as cycling in the forest while cycling. Treatment will continue until discharge. CAT score, mMRC dyspnea score, hospital anxiety and depression score and London chest daily living activity score will be examined before and after treatment.

Eligibility criteria: Inclusion Criteria:

* Individuals who are in COPD exacerbation period, FEV1 \<70%, GOLD 2-3 spirometric stage, Hodkinson mental test score \> 6 and who want to participate in the study voluntarily will be included in the study.

Exclusion Criteria:

* If there is respiratory disease considered more significant than COPD (bronchiectasis, lung cancer requiring active therapy, or asthma), Heart failure New York Heart Association (NYHA) stage 3-4, Significant hemoptysis, surgical or non-surgical lung volume in the past 6 months Individuals with reduction procedures, Lung transplantation or pneumonectomy surgery in the last 6 months, pulmonary embolism or pulmonary edema, acute myocardial infarction, acute heart failure, vertigo, epilepsy and visual impairment will be excluded from the study.

Primary outcomes:
measure: 1 minute sit and stand test
timeFrame: 5 minutes
measure: Chronic Obstructive Pulmonary Disease Assessment Test
timeFrame: 3-7 days
measure: London chest activity of daily living
timeFrame: 3-7 days
measure: Hospital anxiety and depression scale
timeFrame: 3-7 days
measure: Modified Medical Research Council
timeFrame: 3-7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
state: Pamukkale
Study officials:
affiliation: Pamukkale University
name: Erhan Kızmaz, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Orçin Telli Atalay, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04956796: Effect of Airway Video Library on Intubation in Novices
Official title: Effect of Airway Video Library on Intubation in Novices
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Anesthesia
Anesthesia Intubation Complication
Keywords: Intubation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the anesthesia residents employed by the University of Minnesota (UMMC) and part of the Fairview system comprise the study population. The clinic/hospitals these residents (CA-1 year) are affiliated with include University of Minnesota Medical Center East and West Bank and VA Minneapolis.

Brief summary: Endotracheal intubation requires significant training and expertise. This experience can be quite stressful for novice users. To accelerate the learning curve of newly enrolled trainees to assess and secure airway, the investigators propose supplementing current training techniques with access to an airway video library consisting of real- life clinical videos of airway and endotracheal intubations.

Detailed description: Timely and correctly performed endotracheal intubation is important. It can be stressful especially among beginners and requires significant expertise. Studies suggest that endotracheal intubation success rates are below 50% for the first 10 intubations among novices and the learning curve of laryngoscopy does not plateau above a 90% success rate until a mean of 57 attempts. Although simulation, which is currently the mainstay of training for airway management help orient a novice user, it is siloed from the actual experience. Endotracheal intubation requires significant training and expertise. This experience can be quite stressful for novice users. To accelerate the learning curve of newly enrolled trainees to assess and secure airway, the investigators propose supplementing current training techniques with access to an airway video library consisting of real- life clinical videos of airway and endotracheal intubations.

Eligibility criteria: Inclusion Criteria:

* Incoming anesthesia resident (CA-1 year)

Exclusion Criteria:

* Participants with prior experience of more than 60 intubations

Primary outcomes:
measure: Number of Attempts to Successful Intubation
timeFrame: 2 months
measure: Time for Successful Intubation
timeFrame: 2 months
measure: Difficulty Level of Intubation as Assessed by Intubation Difficulty Scale
timeFrame: 2 months
Secondary outcomes:
measure: Stress Level as Assessed by Ottawa Mood Scales
timeFrame: 2 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Univeristy of Minnesota Medical School Department of Anesthesiology
name: Tjorvi Perry, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06895096: Comparison of Retention of Self-etch Sealants and Flowable Composite in Permanent Molars
Official title: Comparison of Retention of Self-etch Sealants and Flowable Composite in Permanent Molars
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pits and Fissures Sealant
Keywords: flowable composite
self-etch sealant
sealant retention
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 46
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients reporting to Paedodontics and Operative dentistry department of FUCD\&H will be selected according to inclusion criteria after history, clinical examination \& radiographic evaluation.

Brief summary: Comparison of Retention of Self-etch sealants and Flowable Composite in permanent Molars.


Eligibility criteria: Inclusion Criteria:

1. Patients aged between 8 to 18 years.
2. Patients with completely erupted maxillary and mandibular molars with deep pits and fissures having a score of 0 or 1 according to ICDAS classification -

Exclusion Criteria:

1. Patients with a history of any medical conditions such as Sjogren's syndrome , renal failure or have immunocompromised state (juvenile diabetes).
2. Patients with history of prolonged medication such as steroids, chemotherapy or TB medication.
3. Teeth with carious lesion extending to dentino-enamel junction/dentin.
4. Patients with poor oral hygiene.
5. Patients with bruxism or parafunctional habits.
6. Permanent molars with developmental defects or restorations.
7. Teeth with poor prognosis and having periodontal diseases.

Primary outcomes:
measure: sealant retention
timeFrame: from enrollment to end of treatment at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation university college of Dentistry and Hospital
state: Punjab
Study officials:
References:
citation: Singh C, Kaur K, Kapoor K. Retention of pit and fissure sealant versus flowable composite: An in vivo one-year comparative evaluation. J Indian Soc Pedod Prev Dent. 2019 Oct-Dec;37(4):372-377. doi: 10.4103/JISPPD.JISPPD_122_19.
Clinical trial NCT05374096: Study Exploring the Effect of Music on Pain After Ventral Hernia Surgery
Official title: The Effect of Music on Pain in Patients Undergoing Ventral Hernia Repair With Mesh: A Double-Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain, Acute
Ventral Hernia
Hernia Abdominal Wall
Surgery
Anxiety
Keywords: Music
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 321
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 purpose of this study is to assess whether listening to music during surgery has an effect on pain or anxiety after surgery.

Detailed description: After being informed about the study and potential risks and meeting eligibility criteria, all patients giving written informed consent will be scheduled for their hernia repair surgery. On the day of surgery, patients will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to listen to patient-chosen music during their surgery via headphones or just listen to silence via headphones. Pain and anxiety will then be assessed after surgery.

Eligibility criteria: Inclusion Criteria:

1. Adults having open retromuscular ventral hernia repair with mesh, with or without myofascial release for a hernia width ≤ 20 cm
2. Adults having open flank hernia repair that requires a myofascial release with mesh
3. Adults having parastomal hernia repair with mesh

Exclusion Criteria:

1. Primary language other than English, or lack of English language fluency
2. Hearing impairment, with or without use of hearing aids
3. Neurologic condition that, in the opinion of the investigators, may preclude accurate assessment of postoperative pain and anxiety
4. Patients who will remain intubated after surgery

Primary outcomes:
measure: Post operative Pain
timeFrame: At 24 hours (+- 3 hours) after surgery end time.
Secondary outcomes:
measure: Post operative Anxiety
timeFrame: At 24 hours (+- 3 hours) after surgery end time.
Other outcomes:
measure: Post operative Pain - 3 days
timeFrame: Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours)
measure: Post operative Pain - cumulative
timeFrame: Will be collected repeatedly by nursing staff per nursing protocol for the first 24 hours after surgery end time.
measure: Post operative Anxiety - 3 days
timeFrame: Collected at 3 time points after surgery end time - 24 hours (+- 3 hours), 48 hours (+-3 hours) and 72 hours (+-3 hours)
measure: Post operative opioid consumption
timeFrame: During the first 72 hours after surgery end time.
measure: Intraoperative sedative use
timeFrame: From induction of anesthesia to arrival in the post anesthesia care unit on the day of procedure
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ajita Prabhu, MD
role: PRINCIPAL_INVESTIGATOR
References: