louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04201236: Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea
Official title: Comparison of the Effectiveness of Inspiratory Muscle Training and Oropharyngeal Exercises in Patients With Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
oropharyngeal exercises
inspiratory muscle training
sleep quality
Lead sponsor: Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 41
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effects of orofarangeal exercises (OE) and inspiratory muscle training (IMT) on sleep quality, disease severity, and airway muscle tone have been investigated in several studies. IMT and OE exercise modalities for patients and practitioners have advantages and disadvantages. It is recommended to compare exercise modalities in the studies. Whether OE or IMT exercise type is more effective on disease severity, sleep quality and snoring has not been investigated. The aim of this study was to compare the effectiveness of inspiratory muscle training and oropharyngeal exercises in patients with OSAS in terms of disease severity, snoring, daytime sleepiness, respiratory muscle strength and sleep quality.


Eligibility criteria: Inclusion Criteria:

\*To be diagnosed with mild, moderate and severe OSAS.

Exclusion Criteria:

* Patients with a history of stroke,
* neurological disease,
* severe obstructive nasal disease,
* and infection in the last month,
* BMI being 40 kg /m2 or more.

Primary outcomes:
measure: Polysomnography
timeFrame: 2 day
Secondary outcomes:
measure: Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device
timeFrame: 6 day
measure: 6 minute walk test
timeFrame: 2 day
measure: Epworth Sleepiness Scale
timeFrame: 2 day
measure: Berlin Questionnaire
timeFrame: 2 day
measure: Functional Outcomes of Sleep Questionnaire
timeFrame: 2 day
measure: The Pittsburgh Sleep Quality Index
timeFrame: 2 day
measure: Fatigue Severity Scale
timeFrame: 2 day
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
Study officials:
affiliation: Ahi Evren Thoracic and Cardiovascular Surgery Hospital
name: Adem Celik, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06991036: Validation of Plant-Based Vegan Meal for Gastric Emptying Testing in 10 Healthy Subjects
Official title: Validation of Plant-Based Vegan Meal for Gastric Emptying Testing in 10 Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Emptying
Gastroparesis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research study is to compare the stomach emptying function using a current standard meal which includes eggs and our new vegan meal alternatives for patients who are not able to eat eggs.

Detailed description: 10 healthy participants underwent randomized crossover (with concealed allocation) GE scintigraphy with standard and vegan meals, spaced ≥3 days apart to measure GE% at 2h, 4h, and GE T1/2. Group comparisons and variance analysis included Rank Sum tests and Bland-Altman plots.

Eligibility criteria: Inclusion Criteria:

* No history of diabetes
* Not on medications that affect gastric emptying without diagnosis of active gastrointestinal disease
* No history of prior gastrointestinal surgery that would interfere with testing
* No recent (within last 10 years) gastritis, gastrointestinal infections, COVID-19 (within last 2 years), H pylori, peptic ulcer disease
* Not pregnant,
* Not actively breast-feeding
* No history of stomach cancers
* No history of neurodegenerative disorder
* Able to sign informed consent and take part in study
* BMI \<35

Exclusion Criteria:

* History of diabetes
* Taking medications that affect gastric emptying (e.g., GLP-1 agonists, opioids, calcium channel blockers, pramlintide, tricyclic antidepressants, buspirone)
* Active gastrointestinal symptoms or disease
* Prior gastrointestinal surgery that could interfere with conduct or interpretation of the studies (gastric bypass, gastric sleeves, esophagectomy, vagal nerve stimulators, etc)
* Pregnancy or breast-feeding
* History of neurodegenerative disorders (Parkinson's disease, multiple sclerosis, dementia, documented autonomic dysfunction, amyotrophic lateral sclerosis, etc)
* Vulnerable population (dementia, severe intellectual disability etc)
* Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol which could interfere with the study assessments
* Allergy to eggs, allergy to soy, allergy to oats, or other study products

Primary outcomes:
measure: Gastric emptying T half
timeFrame: Baseline, 1 week
Secondary outcomes:
measure: Proportion emptied using the standard egg diet
timeFrame: 2 hours, 4 hours
measure: Proportion emptied using the vegan diet alternative
timeFrame: 2 hours, 4 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03815136: The Effectiveness of Chewing Gum in Influencing Capsule Endoscopy Transit Time
Official title: The Effectiveness of Improved Use of Chewing Gum in Influencing Capsule Endoscopy Transit Time: A Prospective Randomized, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Transit Time
Small-bowel Transit Time
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 250
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients aged 16-80 years who were scheduled to undergo the small bowel capsule endoscopy(SBCE).
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the effect of chewing gum, during the first one hour of examination in patients undergoing CE for GTT and SBTT time and the proportion of cases with complete small bowel examination and gastroscopy intervention.

Detailed description: The participants will include patients who need to a capsule endoscopy (CE) in this unit. The investigators will include 200 participants who had a CE at our centre based on the gastric transit times. These will be randomly divided into two groups. The participants (chew chewing gum) and the controls (do not chew chewing gum).

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years and \<80 years old presenting for capsule endoscopy. Obtained of written informed consent before the procedure.

Exclusion Criteria:

* Patients on motility enhancing and/or slowing drugs(narcotics/prokinetics) should stop these at least 7 days prior to the procedure.
* Patients, who have proven or suspected obstruction of the bowel.
* Patients, who have had prior small bowel and/or gastric surgery.
* Patients, who have a dysphagia prohibiting.
* Patients with diabetes mellitus and/or hypo-/hyper-thyroidism.

Primary outcomes:
measure: gastric transit time
timeFrame: 1 hour
measure: small bowel transit time
timeFrame: 8 hour
Secondary outcomes:
measure: Completion rate
timeFrame: 9 hours
measure: Diagnostic yield
timeFrame: 9 hours
measure: Intervention rate
timeFrame: 1 hours
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang Chinese Medical University
name: Bin Lv, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang L, Hu Y, Chen F, Liu S, Lu B. Effectiveness of Improved Use of Chewing Gum During Capsule Endoscopy in Decreasing Gastric Transit Time: A Prospective Randomized Controlled Study. Front Med (Lausanne). 2021 Feb 15;8:605393. doi: 10.3389/fmed.2021.605393. eCollection 2021.
Clinical trial NCT01351636: Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients
Official title: Effect of Arotinolol Hydrochloride on Cardiovascular Events in Hypertensive Haemodialysis Patients: An Open Labelled, Randomized, Multicentered, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
hypertension
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-05-11
Enrollment: 300
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 ascertain whether Arotinolol Hydrochloride reduces mortality and cardiovascular events in chronic kidney disease stage 5 patients with hypertension.


Eligibility criteria: Inclusion Criteria:

* Aged between 18-75 years-old;
* Chronic kidney disease stage 5 with haemodialysis treatment for 2 months;
* Patients with blood pressure≥140/90 mmHg after receiving 2 or 3 antihypertensive medications for 2 weeks;
* Patients who receiving alfa or beta blockers will be washed out for 2 weeks;
* Written informed consent

Exclusion Criteria:

* Unstable angina, myocardial infarction, symptomatic or continuous arrhythmia, cardiosurgery in the last 2 months;
* Patients who taking class I antiarrhythmic drugs;
* Resting heart rate less than 60;
* Patients with systolic pressure less than 90 mmHg;
* Patients with chronic obstructive pulmonary disease and asthma;
* Patients with cerebral infarction in the last 2 weeks;
* Severe disorders of liver function;
* Allergy to the arotinolol;
* Patients who planning to have kidney transplantation in the near future;
* Pregnancy and breast-feeding;
* Malignant tumor

Primary outcomes:
measure: Composite endpoints
timeFrame: 18 months
Secondary outcomes:
measure: Changes for metabolism related index
timeFrame: 18 months
measure: Blood pressure control in hypertensive haemodialysis patients
timeFrame: 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Nan Chen
state: Shanghai
Study officials:
affiliation: Shanghai Jiaotong University Medical School Affiliated Ruijin Hospital
name: Nan Chen, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00367536: Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution
Official title: An Open-label, Single-dose, Randomized-to-sequence, 4-period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopause
Keywords: Health
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-23
Enrollment: 24
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA).

About 24 subjects will take part in this study. Each subject's participation in this study will last for about 10 weeks. During this study, each subject will receive 3 different types of BZA/CE tablets plus an oral solution containing only BZA. The purpose of this study is to learn how the tablet dosage forms dissolve and are absorbed by the body compared to the BZA oral solution. In addition, information will also be learned about the safety and tolerability of these dosage forms given to healthy postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Generally healthy, nonsmoking (or smoker of less than 10 cigarettes/day)
* Postmenopausal women aged 35 to 70 years
* At least 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels at least 38 mIU/mL
* Women 55 years of older must have at least 12 months of amenorrhea
* Body mass index in the range of 18.0 to 35.0, with a minimum body weight of 50 kg

Exclusion Criteria:

* A history or active presence of clinically important medical disease.
* History or alcoholism or drug abuse within 1 year before study start.
* Use of estrogen-, androgen-, or progestin-containing medication by a non-oral route of administration within 6 months before study day 1 must be approved by Wyeth Research

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02729636: Multi-pad FES System for Drop Foot Treatment
Official title: Multi-pad Functional Electrical Stimulation for Droop Foot Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Drop
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Functional electrical stimulation (FES) is multi-pad system that allows fast optimization of stimulation patterns for achieving strong dorsiflexion/plantar flexion and automatic real-time control of ankle joint during FES assisted walking. The main aim of the present study is to compare the effects of functional electrical stimulation gait training after stroke and overground conventional physical therapy. With the assumption that the advanced method of functional electrical stimulation will improve gait parameters and functionality in patients with foot drop before and after FES treatment the objectives of this study are to examine the effects of functional electrical stimulation using FES:a method on indicators of walk and function in patients with foot drop before and after FES treatment.


Eligibility criteria: Inclusion Criteria:

* hemiplegia caused by stroke
* inadequate ankle dorsiflexion
* passive ankle range of motion to neutral position
* adequate cognitive and communication function to give informed consent
* sufficient motor ability and endurance to ambulate at least 6 minutes of walking independently with or without an assistive device
* calf muscle spasticity not higher than grade 3 according to the Modified Ashworth Scale

Exclusion Criteria:

* lower motor neuron injury with inadequate response to stimulation
* skin rupture in the area of the electrodes
* history of falls greater than once a week
* multiple or infratentorial cerebrovascular lesions
* severe cardiovascular disease, severe auditory and visual impairments
* inadequate response to stimulation (range of motion elicit by maximal pleasant stimulation lower than active range in first 5 days of the therapy).

Primary outcomes:
measure: gait speed by 10m walking test
timeFrame: 4 weeks
Secondary outcomes:
measure: motor arm impairment by Fugl Mayer assessment
timeFrame: 4 weeks
measure: Activities of daily living by Barthel index
timeFrame: 4 weeks
measure: postural stability by Berg Balance scale
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinic for rehabilitation dr Miroslav Zotovic Faculty of Medicine University of Belgrade
Study officials:
References:
citation: Malesevic J, Dedijer Dujovic S, Savic AM, Konstantinovic L, Vidakovic A, Bijelic G, Malesevic N, Keller T. A decision support system for electrode shaping in multi-pad FES foot drop correction. J Neuroeng Rehabil. 2017 Jul 3;14(1):66. doi: 10.1186/s12984-017-0275-5.
Clinical trial NCT04974736: eCEASE to Support Treatment for Parental Tobacco Use
Official title: Electronic Pediatric Office Systems to Support Treatment for Parental Tobacco Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Second Hand Tobacco Smoke
Smoking Cessation
Keywords: Family tobacco screening
Tobacco cessation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Children's Hospital of Philadelphia
First posted: 2021-07-23
Enrollment: 817
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm Randomized Control Trial with a stratified cluster randomization
Primary purpose: TREATMENT

Brief summary: The proposed project aims to develop an innovative and disseminable electronic health record (iEHR)-based approach that supports optimal primary care workflows to routinely screen families for tobacco and e-cigarette use, address household smoking behavior and promote smoke-free and e-cigarette free home and car rules in a routine and effective manner in the pediatric setting. Additionally, parents enrolled in the study will be offered assistance by a community health navigator (CHN). This study aims to examine how effective the iEHR + Navigator strategy is compared to usual care control.


Eligibility criteria: Inclusion Criteria:

* Parents or legal guardians who smoke, are present at the visit, and whose child is seen by a child healthcare clinician in a participating practice. "Smoker" will be defined as answering "yes" to either of the screening questions: "Have you smoked a cigarette, even a puff, in the past 7 days?" and "Have you smoked any other tobacco product (cigars like black and mild, hookah), even a puff, in the past 7 days?"

Exclusion Criteria:

1. Parent/legal guardian does not speak English;
2. No telephone; and
3. Prior enrollment in the study during a previous visit.

Primary outcomes:
measure: Parental Combusted Tobacco Quit Rate at 12 Months
timeFrame: 12-months
Secondary outcomes:
measure: Rates of Parental Quit Attempts
timeFrame: 12-months
measure: Rates of Parental Use of Pharmacotherapy or Services
timeFrame: 12-months
measure: Rates of Parental Institution of Smoking and Vaping Bans in Their Homes and Cars
timeFrame: 12-months
measure: Incremental Cost Per Quit of the Intervention
timeFrame: 12-months
measure: Rates of Tobacco Use Treatment Delivery
timeFrame: 36 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00556036: Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea
Official title: Hormone Dynamics and Bone Mineral Density in Anorexia Nervosa v. Hypothalamic Amenorrhea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anorexia Nervosa
Hypothalamic Amenorrhea
Obesity
Keywords: healthy
overweight
obese
anorexia nervosa
weight
cortisol
hormone
bone density
bone
osteopenia
osteoporosis
amenorrhea
menses
irregular
stress
depression
exercise
diet
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Bioenvision
First posted: 2007-11-09
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample and referrals by specialists

Brief summary: The purpose of this study is to determine whether the hormone dynamics in women with anorexia nervosa and hypothalamic amenorrhea is related to bone loss in those populations.


Eligibility criteria: Inclusion Criteria:

* Amenorrhea for at least three months (unless participating as healthy control)
* Normal TSH or free thyroxine (free T4).

Exclusion Criteria:

* A condition known to affect bone metabolism, including Cushing's syndrome or renal failure, with the exception of bone fracture.
* Any medication known to affect bone metabolism within 3 months of the study, including estrogen and progestins. Patients receiving depot medroxyprogesterone (Depo-Provera) will be excluded from participating for 6 months after their last injection.
* Pregnant and/or breastfeeding.
* Diabetes mellitus.
* Active substance abuse, including alcohol.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anne A Klibanski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Karen K Miller, MD
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: Erinne M Meenaghan, NP
role: STUDY_CHAIR
affiliation: Massachusetts General Hospital
name: Elizabeth A Lawson, MD
role: STUDY_DIRECTOR
affiliation: Massachusetts General Hospital
name: David B Herzog, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03123536: Use of Point-of-care Ultrasound in High Risk Surgical Patients
Official title: Effects of Perioperative Point-of-care Ultrasound Assessment on Postoperative Outcomes in High Risk Surgical Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ultrasonography
Outcomes
Cardiopulmonary
Keywords: high risk
complication
Ultrasonography
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: More and more high risk patients undergo surgery,which is associated with increased morbidity and mortality. The aim of the present study was to investigate the value of point-of-care ultrasound for assessment of postoperative outcomes in high risk surgical patients.

Brief summary: There is currently a lack of evidence to support the use of perioperative point-of-care ultrasound to assess the outcomes in high risk surgical patients. Thus, the purposes of this study were to evaluate whether perioperative use of point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical patients.

Detailed description: Point-of-care ultrasound is increasingly established as a useful bedside tool when performed by the anesthesiologist for evaluation of cardiopulmonary dysfunction and other emergent situations. However, it remains unclear whether use of perioperative point-of-care ultrasound can reduce the worse postoperative outcomes in high surgical risk patients.

Patients were randomly allocated to two groups. In the point-of-care ultrasound group, treatment was oriented by the findings of point-of-care ultrasound, while in the control group the decisions about the management of patients were made by the experience of the clinical team. The primary outcome measures were hospital mortality and 28-day mortality, and the secondary outcome measures were the complications and length of hospital stay.

Eligibility criteria: Inclusion Criteria:

* Patients who have comprised cardiovascular，respiratory diseases，or other critical illness.

Exclusion Criteria:

* Patients who decline to participate.

Primary outcomes:
measure: Hypotension
timeFrame: Within 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
References: