louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03076788: Intracardiac Flow Remodeling in Athletes
Official title: Intracardiac Flow Remodeling in Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Remodeling, Ventricular
Keywords: echocardiography
intraventricular pressure gradients
cardiac remodeling
athletes
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 100
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: Athletes

Brief summary: The uncertainty concerning the onset and the extent of cardiac remodeling in response to intensive training hinders medical evaluation by physician. A better knowledge of the physiology of cardiac adaptation to training will enable physicians to correctly determine whether observed patterns of cardiac remodeling are physiological or pathological. This prospective study proposes to assess in a trained-athlete population the cardiac remodeling in response to intensive exercise training. This study is observational, we do not interfere with athlete's training.


Eligibility criteria: Inclusion Criteria:

* Age \> 18yrs old
* Ability to give written consent for participating in the study

Exclusion Criteria:

* Age \< 18yrs old
* Cardiac diseases, arterial hypertension, cardiac devices, diabetes, renal, liver or pulmonary failure

Primary outcomes:
measure: Evaluation of ventricular response to exercise training by echocardiography.
timeFrame: Day 1
Secondary outcomes:
measure: Evaluation of ventricular response to exercise training by electrocardiogram
timeFrame: Day 1
measure: Sport and medical history questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de CAEN
state: Normandie
Study officials:
References:
Clinical trial NCT04579588: Understanding Immunity to the Flu Vaccine in COVID-19 Patients
Official title: Understanding Immunity to the Flu Vaccine in COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Corona Virus Infection
Flu Vaccine
Immunity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2020-10-08
Enrollment: 230
Sex: ALL
Minimum age (years): 13
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (18-64 years) and children (13-17 years) diagnosed and not diagnosed (controls) with COVID-19 and who may have other medical conditions including long term COVID-19 symptoms, chronic fatigue, type 2 diabetes, and obesity.

Brief summary: The purpose of this study is to measure immunity to the flu vaccine over time in patients who have had COVID-19 and may have other medical conditions including obesity, type 2 diabetes, chronic fatigue, or long-term COVID-19 symptoms. Adults and children (age 13 to 64) who had been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.


Eligibility criteria: Inclusion Criteria:

* Age 13 through 64 years
* Diagnosed with COVID-19 at least 2 months prior enrollment
* Patients with or without obesity, diabetes, chronic fatigue and/or long term COVID-19 symptoms
* Patients without COVID-19 diagnosis for controls

Exclusion Criteria:

* Received the influenza vaccine less than 4 months ago
* Pregnant or lactating
* Patients with special risks attendant to venipuncture
* Use of immunomodulatory medications
* Immunodeficiency or autoimmune disease

Primary outcomes:
measure: Testing immunity to the flu vaccine over time
timeFrame: 1 week
measure: Testing immunity to the flu vaccine over time
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Sayantani Sindher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03873688: Effects of Expiratory Muscle Training on Cough Efficacy in Children and Adolescents With Cystic Fibrosis
Official title: Effects of Expiratory Muscle Training on Cough Efficacy in Children and Adolescents With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: expiratory muscle training
cough
respiratory muscle strength
exercise capacity
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2019-03-13
Enrollment: 28
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cystic fibrosis (CF) is an autosomal recessive genetic disease characterized by recurrent airway infections, affecting many systems including lung, pancreas and sweat glands. Cough is an important defense mechanism for clearing the secretions that increase in respiratory diseases. There have been studies investigating the effect of expiratory muscle training on disease groups such as chronic obstructive pulmonary disease, multiple sclerosis, parkinson's disease, and the elderly and healthy individuals. Studies that evaluating effects of expiratory muscle training in cystic fibrosis are limited in the literature. The aim of this study was to evaluate the effect of cough strength in children and adolescents with CF and the effect of expiratory muscle training program on cough strength, exercise capacity, respiratory muscle strength and quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cystic fibrosis
* 8-18 years
* Clinically stable during last six weeks

Exclusion Criteria:

* hemoptysis
* low saturation (SpO2\<90%)
* acute lower respiratory tract infection
* cardiac problems (heart failure, arrhythmia, cardiomyopathy, etc.)
* cognitive problems
* pneumothorax

Primary outcomes:
measure: Cough capacity
timeFrame: 6 weeks
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: every two weeks
measure: Exercise capacity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty
Study officials:
References:
citation: Emirza C, Aslan GK, Kilinc AA, Cokugras H. Effect of expiratory muscle training on peak cough flow in children and adolescents with cystic fibrosis: A randomized controlled trial. Pediatr Pulmonol. 2021 May;56(5):939-947. doi: 10.1002/ppul.25259. Epub 2021 Jan 26.
citation: Stanford G, Ryan H, Solis-Moya A. Respiratory muscle training for cystic fibrosis. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD006112. doi: 10.1002/14651858.CD006112.pub5.
Clinical trial NCT00544388: Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects
Official title: Trial to Compare the Efficacy of Levocetirizine and Cetirizine in Reducing Symptoms of Seasonal Allergic Rhinitis in Ragweed Sensitive Subjects Exposed to Pollen Challenge in an Environmental Exposure Unit (EEU).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Keywords: Levocetirizine dihydrochloride
Xyzal tablet
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-10-16
Enrollment: 570
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Controlled conditions of the EEU allow a reliable assessment of the efficacy and a determination of the action onset, action intensity and duration of effect of levocetirizine and cetirizine in order to establish the relative efficacy of these two drugs available for the treatment of SAR.


Eligibility criteria: Inclusion Criteria:

* Male/Female, aged \>= 16 years
* seasonal allergic rhinitis that required pharmacologic therapy each year during the last 2 ragweed pollen seasons
* documented seasonal allergy to ragweed pollen
* total symptom score of at least 18 points.

Exclusion Criteria:

* nasal anatomic deformities ? 50% obstruction
* acute sinusitis within 30 days of Period 2
* initiated or advanced an immunotherapy regimen
* immunotherapy injections within 48 hours of pollen exposure
* impaired hepatic function
* history of malignancy
* intolerance to histamines
* asthma requiring medication more than occasionally

Primary outcomes:
measure: Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).
Secondary outcomes:
measure: Mean change from baseline in MSC score over each 2-hour interval.
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06224088: Neuro-cognitive Function 1 Year Post ICU Discharge Among VV ECMO Survivors
Official title: Neuro-cognitive Function 1 Year Post ICU Discharge Among VV ECMO Survivors: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurocognitive Dysfunction
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with VV ECMO who survived to hospital discharge between 2021-2023

Brief summary: In the past three years, in the general intensive care unit in Meir medical center, 25 patients were treated with ECMO, of which two patients were treated with VA ECMO and the rest with VV ECMO. 70% of the patients survived to hospital discharge.

ECMO is indicated as a rescue therapy for patients in critical condition suffering from severe cardiac and/or respiratory failure that does not respond to conservative treatment. It can be used as a bridge to recovery or to heart/lung transplantation. ECMO was introduced in the late seventies of the pervious century. Between the years 2006-2011, partly due to the outbreak of the flu epidemic (H1N1), a 433% increase was observed in the use of ECMO worldwide in adults. In light of the outbreak of the Covid-19 epidemic in recent years, another significant increase has been observed.

There are short-term and long-term complications of ECMO. Short-term complications include bleeding, thrombosis, hemolysis, HIT, renal and neurological injuries, associated infections, and technical-mechanical problems. Long-term complications include significant physical and psychological consequences that may adversely affect the patient's daily function, especially executive function.


Eligibility criteria: Inclusion Criteria: All patients treated with VV ECMO who survived to hospital discharge between 2021-2023 -

Exclusion Criteria:

-

Primary outcomes:
measure: Neurocognitive function in ECMO survivors as measured by SF-36 questionnaire
timeFrame: one year after hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT06970288: Effectiveness of Introducing Ultra-High B-Value Diffusion-Weighted Imaging as a Modified Abbreviated Protocol for Breast Cancer Detection
Official title: Effectiveness of Introducing Ultra-High B-Value Diffusion-Weighted Imaging as a Modified Abbreviated Protocol for Breast Cancer Detection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Carcinoma
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 85
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in childbearing age who have a suspicious breast lump

Brief summary: The aim of this study is to evaluate the added value of non-contrast abbreviated MRI protocol featuring ultra-high B value Diffusion Weighted Imaging to detect, characterize suspicious breast lesions and avoid using contrast.


Eligibility criteria: Inclusion Criteria:

* • Women with suspicious breast mass (BIRADS 4a)

  * High risk women (Positive family history)
  * Women with suspicious axillary lymph nodes by Ultrasound
  * Women with dense breasts coming for MRI imaging.

Exclusion Criteria:

* • Contraindications to MRI

  * Pacemaker, cochlear implant, claustrophobia, ocular implants
  * Contraindications to contrast administration:
  * Elevated kidney functions
  * Women who haven't undergone reliable Mammogram \& Ultrasound
  * Women with prior treatment or intervention (e.g. biopsy)
  * Patients' refusal.

Primary outcomes:
measure: To evaluate the capability of detecting suspicious breast lesions using non-contrast enhanced MRI protocol featuring ultra-high B-value
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbasia
Study officials:
References:
Clinical trial NCT00916188: Effects of Black Tea on Type 2 Diabetes
Official title: Effects of Black Tea Consumption on Oxidative Stress, Serum Lipid Profile and Insulin Sensitivity in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Black Tea
Oxidative Stress
Blood Lipids
Insulin Sensitivity
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2009-06-09
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary objective of this study is to evaluate the efficacy of different doses of black tea (150, 300, 450, 600 ml) in the test group compared to 150 ml in the control group, in improving oxidative stress, lipid profiles and insulin sensitivity.

Detailed description: A total of 45 patients of known T2DM (16 males and 29 females) were introduced into the controlled clinical trial and randomly assigned to either test (57.0 ± 7.9 yrs, n=23) or control (55.4 •± 8.3 yrs, n=22) group. Patients in control group were instructed to have only one cup (150 ml) of black tea/day, as a 2.5 g tea bag that had to be prepared in a standard way for one week (washout period). Patients in the test group were instructed to have 300, 450, and 600 ml (2, 3, and 4 cups, respectively) in weeks 2, 3 and 4 respectively. We assessed the change in serum glutathion, superoxidismutase, total antioxidant capacity, FBS, CRP, HbA1C, lipid profiles and fibrinogen during the end of each week.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes mellitus

Exclusion Criteria:

* Intake of antioxidant supplements during previous six months

Primary outcomes:
measure: Insulin Sensitivity, oxidative Stress, lipid Profile
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
Study officials:
affiliation: National Nutrition & Food technology Research institute, Shaheed Beheshti University (M.C.), Islamic Republic of Iran,
name: Tirang R. Neyestani, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06237088: Mother-infant Connection Strategy Program
Official title: Mother-infant Connection Strategy Program: Impact on Psychological Distress and Mother-infant Bonding in Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological
Mother-Infant Interaction
Keywords: Mindfulness, Anxiety, Depression, Mother-Infant Interaction
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluated the long-term effects of an online mindfulness-based program on the psychological distress and mother-infant bonding of women

Detailed description: The aim of this study was to test the efficacy of an online mindfulness program in reducing women's perceived stress, anxiety, depression, and in enhancing mindfulness and mother-infant bonding compared to a control group. The investigators hypothesize that the use of an online mindfulness program or an eight-week mindfulness program by the two experimental groups will lead to improved mood symptoms and mother-infant bonding compared with the control group.

A randomized controlled trial comparing three groups of healthy, singleton pregnant women was conducted using the Random Allocation Software (Saghaei, 2004). We used G-Power 3.1.9 for Windows to analyze the minimum effect size that would be statistically significant with an 80% probability, using an alpha error probability of 0.05 in the "ANOVA: Repeated measures, between factors" option. We inputted 3 for the number of groups, 4 for the number of measurements, 0.5 for the correlation between repeated measures, and factored in a 20% attrition rate. There are 41 women in each group.

Eligibility criteria: Inclusion Criteria:

* Subjects were at the age over 18
* Could speak and read Chinese fluently
* Willing and be ale to attend the education program

Exclusion Criteria:

* Taking medication for diagnosing mental illness
* With complicated or high-risk pregnancies

Primary outcomes:
measure: anxiety
timeFrame: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum
measure: depression
timeFrame: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum
measure: mindfulness
timeFrame: baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum
measure: mother-infant bonding
timeFrame: the follow-up at 2 , 4 months postpartum.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wan-Lin Pan
Study officials:
affiliation: assistant professor
name: Wan-Lin Pan, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00015288: Buprenorphine and Naloxone Combination Study - 10
Official title: PK0496 Pharmacokinetics of Buprenorphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heroin Dependence
Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: New York MDRU
First posted: 2001-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.

Detailed description: The objective of this study is to examine pharmacokinetics and dose proportionality of sublingual tablets containing varying doses of buprenorphine and naloxone.

Eligibility criteria: Inclusion Criteria:

Male/Female between the ages of 21 and 45. Within 15% of ideal body weight. No oral pathology that would interfere with the sublingual absorption of the medication. Experienced in the use of opiates but not dependent.

Exclusion Criteria:

LFT's exceeding than 3x's normal. History of seizure. Opiate dependent.

Primary outcomes:
measure: Physiological measures
measure: Measurements of buprenorphine and naloxone in plasma
measure: Subjective symptoms measures
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York MDRU
state: New York
Study officials:
affiliation: New York MDRU
name: John Rotrosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02611388: Neurohumoral Mechanism of Deferent Frequency Transcutaneous Electrical Acupoint Stimulation(TEAS)
Official title: Neurohumor Mechanism of Deferent Frequency Transcutaneous Electrical Acupoint Stimulation(TEAS): A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to explore the neurohumoral mechanism of deferent frequency TEAS pretreatment.

Detailed description: Patients were randomly assigned to three groups, receiving TEAS 30min before anesthesia. The frequency of high frequency group is set to 10/50HZ, low frequency group is 2/10HZ, and the fake stimulation group only attach electrodes without electric current. Acupoint selection is bilateral Neiguan points(PC6). Venous blood is collected 4ml before and immediately after TEAS respectively. Heart rate variability is monitored continuously during the 30min TEAS. The adverse events recorded.

Eligibility criteria: Inclusion Criteria:

* Age 18yrs-65yrs
* ASA 1-2
* Scheduled for elective operation under general anesthesia
* BMI 18-30kg/m2
* Informed consented

Exclusion Criteria:

* Contraindications to TEAS
* Communication difficulty with researchers
* Addicted to alcohol, analgesics or other drugs
* Cardiac insufficiency or high blood pressure without controlled
* Hepatic or renal dysfunction
* Participate in the other clinical trial 3 month before the enrollment

Primary outcomes:
measure: Plasma concentration of epinephrine(ng/L)
timeFrame: change of TEAS 0 and 30 minutes
measure: Plasma concentration of norepinephrine(ng/L)
timeFrame: change of TEAS 0 and 30 minutes
Secondary outcomes:
measure: Heart rate variability
timeFrame: During 30min TEAS
measure: plasma concentration of glucocorticoid(μg/L)
timeFrame: change of TEAS 0 and 30 minutes
measure: plasma concentration of aldosterone(ng/L)
timeFrame: change of TEAS 0 and 30 minutes
measure: plasma concentration of renin(ng/L)
timeFrame: change of TEAS 0 and 30 minutes
measure: plasma concentration of β-endorphin(ng/L)
timeFrame: change of TEAS 0 and 30 minutes
Other outcomes:
Locations:
Study officials:
References:
citation: Lu Z, Dong H, Wang Q, Xiong L. Perioperative acupuncture modulation: more than anaesthesia. Br J Anaesth. 2015 Aug;115(2):183-93. doi: 10.1093/bja/aev227.
Clinical trial NCT03965988: Docosahexaenoic Acid on Breath Holding Spells in Children
Official title: Effect of Docosahexaenoic Acid on Breath Holding Spells in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breath Holding Attack
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: DHA on Breath Holding Spells

Detailed description: Effect of DHA on Breath Holding Spells

Eligibility criteria: Inclusion Criteria:

* Children with newly diagnosed sprlls

Exclusion Criteria Other treatment as iron and piracetam

Primary outcomes:
measure: Frequency of the spells
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Tanta University - Faculty of Medicine
name: Amira Darwish, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University - Faculty of Medicine
name: Abeer Salamah, MD
role: STUDY_DIRECTOR
References: