louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04920799: Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function
Official title: Effect of Beet Juice Supplementation on Vascular and Inspiratory Muscle Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 24
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Older adults with coronary artery disease (CAD) have impaired vascular and inspiratory muscle function. The objective of this study is to examine the effect of beet juice supplementation on vascular and inspiratory muscle function in older adults with CAD.


Eligibility criteria: Inclusion Criteria:

* Adults with coronary artery disease (CAD) based on an angiogram \>50% stenosis in any major epicardial vessel or history of myocardial infarction or history of coronary revascularization.
* Considered to have stable CAD on optimal medical therapy
* 60 to 85 years of age
* Men and women (women must be postmenopausal either natural or surgical)
* Able to give consent

Exclusion Criteria:

* Ejection fraction \<50%, unstable angina, recent myocardial infarction within 6 months
* Coronary revascularization, including percutaneous coronary intervention and coronary artery bypass graft or thoracic surgery within 6 months.
* Stroke, obstructive pulmonary disease, hepatitis B, C, HIV, seizures, or other relevant on-going or recurrent illness
* Individuals that have participated in respiratory training within the last 12 months or cardiac rehabilitation within the last 6 months
* Uncontrolled hypertension
* Use of tobacco products including smoking traditional or e-cigarettes
* Use of hormone replacement therapy in women or men (e.g., estrogen, progesterone or testosterone)
* Regular aerobic exercise training
* Unwilling to stop using mouthwash at least 1 week before the start of the study and during study participation
* Unwilling to remain weight stable during study participation

Primary outcomes:
measure: Change in endothelial function
timeFrame: Baseline up to following 2 weeks of experimental condition
measure: Change in inspiratory muscle function
timeFrame: Baseline up to following 2 weeks of experimental condition
Secondary outcomes:
measure: Change in microvascular function
timeFrame: Baseline up to following 2 weeks of experimental condition
measure: Change in central arterial stiffness
timeFrame: Baseline up to following 2 weeks of experimental condition
measure: Change in central arterial hemodynamics
timeFrame: Baseline up to following 2 weeks of experimental condition
measure: Change in functional capacity
timeFrame: Baseline up to following 2 weeks of experimental condition
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Integrative Cardiovascular Physiology Laboratory, University of Florida
state: Florida
Study officials:
References:
Clinical trial NCT06383299: The Validity and Reliability Study of Turkish Version of Calgary Sleep Apnea Quality of Life Index
Official title: Turkish Validity and Reliability of Calgary Sleep Apnea Quality of Life Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstruvtive Sleep Apnea Syndrome (OSAS)
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Obstructive sleep apnea syndrome

Brief summary: The aim of this study is to investigate its validity and reliability of the questionarre whose original English name was "Calgary Sleep Apnea Quality of Life Index" which we plan to translate into Turkish as Sleep Apnea Quality of Life Index.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Apnea hypopnea index (AHI) of ≥5

Exclusion Criteria:

* Presence of sleep disturbances other than OSAS
* Presence of active alcohol or drug addiction
* Psychiatric impairment
* Cognitive impairment
* Recent acute illness (such as myocardial infarction) that may adversely affect their quality of life
* Difficulty in communicating

Primary outcomes:
measure: Calgary Sleep Apnea Quality of Life İndex (C-SAQLI)
timeFrame: time 0 and two week later
measure: Short Form 36
timeFrame: time 0 and two week later
measure: Epworth Sleepiness Scale
timeFrame: time 0 and two week later
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazıt University
Study officials:
References:
Clinical trial NCT03844399: (3D) Ultrasound Imaging Liver and Kidney
Official title: Use of 3-Dimensional (3D) Ultrasound Imaging to Guide the Treatment of Abdominal Tumours Using Focal Ablation or Biopsies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cancer
Kidney Cancer
Keywords: Diagnostic
Intervention
3D Ultrasound
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who meet the inclusion / exclusion criteria, who are already scheduled for a liver or kidney tumour ablation or biopsy will be selected for the study.

Brief summary: This study is to assess the addition of 3D ultrasound guidance during standard care ablation or biopsies of liver or kidney tumours. 3D ultrasound only differs from conventional 2D ultrasound in that the ultrasound transducer is mounted on a special assembly that moves the transducer in precise, stepped movements while a succession of 2D images are collected by the computer. Special software written specifically for 3D ultrasound precisely aligns these 2D images into a 3-demensional volume , allowing area in question to be viewed in many different planes. 3D ultrasound is a safe, fast, non-invasive imaging procedure. Ultrasound images will be checked against the pre- and post- procedure CT images to make sure the tumours were completely removed or properly targeted during biopsy.

Detailed description: Images will be acquired by a physician on patients who are undergoing a liver or kidney ablation or biopsy procedure who are well enough to provide consent. Patients will be imaged during the ablation procedure according to the standard of care, and subsequent analysis will commence following the acquisition. The devices being used are all property of the LHSC health network that have been licensed for clinical use through Health Canada. In addition, 3D ultrasound only differs from conventional 2D ultrasound in that the ultrasound transducer is mounted on a special assembly that moves the transducer in precise, stepped movements while a succession of 2D images are collected by the computer. Special software written specifically for 3D ultrasound precisely aligns these 2D images into a 3-dimensional volume, allowing the area in question to be viewed in different planes. The clinical 2D an d3D ultrasound images will be checked against the pre- and post- procedure CT images to make sure the tumours were completely removed.

Eligibility criteria: Inclusion Criteria:

* • Patients who are scheduled for standard care liver or kidney ablation or biopsy

Exclusion Criteria:

* None

Primary outcomes:
measure: Needle Guidance Intervention
timeFrame: April 2020
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT06710899: Vitamin C and Hiprex in rUTI
Official title: Does Vitamin C Improve the Efficacy of Methenamine Hippurate (Hiprex®) in Prophylaxis of Recurrent Urinary Tract Infections? A Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Urinary Tract Infections
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A single centre proof of concept study to assess whether Vitamin C improves the efficacy of Methenamine Hippurate (Hiprex®) in the prophylaxis of recurrent urinary tract infections (rUTIs) in women


Eligibility criteria: Inclusion Criteria:

* Female
* Age ≥18 years
* Recurrent proven UTI, defined as "two or more proven infections in six months or three or more infections in six months"
* Willing and able to give fully informed consent
* Patients suitable for prophylaxis following discussion with their clinician.
* No contra-indications to treatment with methenamine hippurate or Vitamin C
* All women will have undergone standard diagnostic work-up and have followed routine conservative UTI prevention measures.
* A working email address to be used to submit urine pH results
* Willing and able to comply with the study procedures
* Females of childbearing potential must be willing to use a highly effective method of contraception (hormonal or barrier method of birth control; abstinence; sterilisation or vasectomised partner)

Exclusion Criteria:

* Males
* Women who are pregnant or breast-feeding
* Contraindications to methenamine hippurate as described in BNF: known allergy, gout, severe metabolic acidosis, severe dehydration, eGFR less than 10 ml/min, severe hepatic impairment
* Currently using vitamin C containing supplement or cranberry extract tablets
* Women using urinary alkalinisation agents, e.g potassium citrate, sodium bicarbonate
* Currently receiving any form of bladder instillation or intradetrusor Onabotulinum Toxin A injections
* Patients already on low-dose antibiotics or methenamine hippurate (due to delay that will be incurred by 3-month washout period)
* Indwelling urinary catheter in situ or performing clean intermittent self-catheterisation
* Correctable urinary tract abnormalities, e.g., urinary tract calculi, urinary retention
* Formation of ileal conduit or augmented bladder
* Neurogenic bladder dysfunction
* Hyperoxaluria

Primary outcomes:
measure: Frequency of UTIs
timeFrame: 24 months
Secondary outcomes:
measure: Urine pH
timeFrame: 24 months
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
state: Staffordshire
Study officials:
References:
Clinical trial NCT00006499: Genetics of Hypertension and Its Intermediate Phenotypes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Hypertension
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-11-17
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To define the underlying genetics of hypertension in an Asian population by studying intermediate phenotypes.

Detailed description: BACKGROUND:

Hypertension, an exceedingly common trait in most developed countries, imparts an increased risk of cardiovascular, cerebrovascular and renal diseases. Nevertheless, the primary determinants of elevated blood pressure in most patients are unknown. Recognizing that a sizable portion of variation in blood pressure is genetically determined, one line of research has focused on identifying genetic variants that contribute to the pathogenesis of hypertension. However, standard genetic linkage analysis using "hypertension" as a phenotype may lack power due to the multifactorial nature of the disorder. A way to overcome this challenge is to subdivide hypertensive subjects into more homogenous subgroups.

DESIGN NARRATIVE:

The overall goal, which is to define the underlying genetics of hypertension in an Asian population by studying intermediate phenotypes, can be divided into three parts. First, the rural Chinese population will be characterized by the collection of intermediate phenotype data on 600 unrelated individuals with high diastolic blood pressure and on 100 normotensive controls. Intermediate phenotypes include: 1) non-modulation of adrenal and renal vascular responses to angiotensin II with changes in sodium intake; 2) altered urinary kallikrein excretion; 3) low plasma renin activity response to volume depletion; 4) increased free cortisol excretion; and 5) insulin resistance. Second, candidate genes will be chosen according to the underlying physiology of the intermediate phenotypes, and variations in the coding sequences of these potentially relevant genes will be identified. Finally, polymorphisms identified in the candidate genes will be tested through case-control analyses defined by the intermediate phenotypes.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Harvard University School of Public Health
name: Xiping Xu
References:
Clinical trial NCT00606099: Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B
Official title: A 26 Week Randomized, Open Label, Multi-center Study of the Efficacy and Safety of Telbivudine 600 mg Once Daily Versus Adefovir Dipivoxil 10mg Once Daily in Subjects With Compensated Chronic Hepatitis B and Sub-optimal Response to at Least 48 Weeks of Adefovir Dipivoxil 10 mg
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Keywords: Adults
compensated chronic hepatitis B
telbivudin
aedevofir dipivoxil
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-01
Enrollment: 0
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 study is designed to evaluate the efficacy and safety of telbivudine 600mg versus adefovir dipivoxil 10mg in patients with compensated chronic hepatitis B.


Eligibility criteria: Inclusion Criteria:

* Male or female, at least 18 years of age.
* Patients with compensated chronic hepatitis B who are currently receiving adefovir 10mg once daily.
* Patients must have received adefovir 10mg once daily for at least 48 weeks continuously and have a sub-optimal response to adefovir therapy (≥4log10 copies of HBV DNA/mL).
* Patient is willing to comply with all study requirements.
* Patient is willing and able to provide written informed consent.

Exclusion Criteria:

* Pregnant or nursing (lactating) women. All women must have a negative pregnancy test at the screening visit.
* Female patients of reproductive potential is unwilling to use double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide).
* Patient is co-infected with hepatitis C virus or HIV.
* Patient has previously taken lamivudine.
* Patient is currently abusing illicit drugs or alcohol.
* Patient is using any investigational drugs or with in the last 30 days.
* Patient is enrolled or plans to enroll in a clinical study involving investigational drug.
* Patient has a history of pancreatitis, hepatic decompsensation, Hepatocellular Carcinoma, or a history of hypersensitivity to telbivudine or adfovir.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Efficacy at 24 weeks of treatment.
timeFrame: 1 yr
Secondary outcomes:
measure: To compare biochemical response at week 24 of treatment. To compare changes in viral load at week 24 of treatment. To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.
timeFrame: 1yr
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Novartis
state: Georgia
city: Flushing
country: United States
facility: Novartis
state: New York
city: Sterling
country: United States
facility: Novartis
state: Virginia
Study officials:
References:
Clinical trial NCT04355299: A Short-term Mixed Exercise for Sarcopenic Hospitalized Aged 80+ Years
Official title: Effectiveness of a Short-term Mixed Exercise Program for Treating Sarcopenia in Hospitalized Patients Aged 80 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 121
Sex: ALL
Minimum age (years): 80
Maximum age (years): 102
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most previous clinical trials that addressed exercise for sarcopenic elderly subjects focused on community-dwelling older adults who were relatively healthy. There is a notable paucity of high-quality research investigating the effects and feasibility of exercise for hospitalized or institutionalized older people, who are generally frailer and more severe in functional impairment than those living in the community. Moreover, most reported exercise programs were of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term exercise would be effective for treating sarcopenia. Therefore, the investigators aimed to assess the effectiveness of short-term exercise for treating sarcopenia in hospitalized older patients aged 80 years and over.


Eligibility criteria: Inclusion Criteria:

1. aged ≥80 years;
2. being able to ambulate (assistance was acceptable);
3. being able to communicate and collaborate with the physiotherapist;
4. with sarcopenia defined by the AWGS criteria ;

Exclusion Criteria:

1. terminal illness;
2. uncontrolled heart failure;
3. myocardial infarction within the past three months;
4. uncontrolled respiratory failure;
5. bone fractures within the past three months;
6. acute pulmonary embolism;
7. major surgery within the past three months;
8. uncontrolled arrhythmia;
9. refusal to participate in this study.

Primary outcomes:
measure: The change of activities of daily living from the baseline to the end of the 2-week intervention
timeFrame: 2 weeks
Secondary outcomes:
measure: The change of gait speed
timeFrame: 2 weeks
measure: The change of handgrip strength
timeFrame: 2 weeks
measure: The change of the score of Short Physical Performance Battery
timeFrame: 2 weeks
measure: The change of the score of Timed Up and Go test
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Jiaojiao Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Ming Yang
role: STUDY_DIRECTOR
References:
Clinical trial NCT06440499: Screening of Congenital Anomalies of Kidney
Official title: Prenatal Ultrasonographic Screening of Congenital Anomalies of Kidney and Urinary Tract During the Third Trimester of Pregnancy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Kidney Congenital Anomalies
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 250
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant

Brief summary: To evaluate the role of ultrasound in prenatal diagnosis of congenital anomalies of kidney and urinary system in third trimester of pregnancy.

Primay outcomes:

To determine incidence of congenital anomalies in kidney and urinary system in Third Timerter by ultrasound.


Eligibility criteria: Inclusion Criteria:

* • Singleton pregnancy.

  * Healthy women Aged between 20 to 40 years old.
  * Third trimester

Exclusion Criteria:

* • Multiples pregnancies.

  * Maternal D.M or HTN
  * Patients\&#39; refusal to participate.

Primary outcomes:
measure: To determine sensitivity, spacificy, the +ve PP &-ve P.P of ultrsound screening for renal anomalies.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Al-Hamed MH, Sayer JA, Alsahan N, Tulbah M, Kurdi W, Ambusaidi Q, Ali W, Imtiaz F. Novel loss of function variants in FRAS1 AND FREM2 underlie renal agenesis in consanguineous families. J Nephrol. 2021 Jun;34(3):893-900. doi: 10.1007/s40620-020-00795-0. Epub 2020 Jul 8.
Clinical trial NCT06165549: Light Therapy for Internet Gaming Disorder
Official title: A Randomized Controlled Double-Blind Trial of Light Therapy for Internet Gaming Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Internet Gaming Disorder
Light Therapy
Lead sponsor: Jinan University Guangzhou
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims to investigate (1) the efficacy of light therapy on internet gaming disorder (IGD); (2) the underlying neural mechanisms of such efficacy


Eligibility criteria: Inclusion Criteria:

1. the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5 ) recommended diagnosis of Internet gaming disorder;
2. the scores of the Young-Internet addiction Test ≥ 50;
3. playing internet games ≥15 h/week for ≥1 year

Exclusion Criteria:

1. current or history of psychiatric or neurological illness;
2. current or history of use of illegal substances and other addictions;
3. current use of psychotropic medications ;
4. any history of head trauma, presence of metal in the body or other contraindication to functional MRI scanning;
5. photosensitivity disorders, such as systemic lupus erythematosus and chronic actinic dermatitis.

Primary outcomes:
measure: changes in IGD severity
timeFrame: baseline , within one day after intervention, and 4-week after intervention
measure: changes in weekly gaming time
timeFrame: baseline and within 1 day after intervention
measure: changes in withdrawal symptoms
timeFrame: baseline and within 1 day after intervention
measure: change of BOLD signals
timeFrame: baseline and within 1 day after intervention
measure: changes in craving
timeFrame: baseline and within 1 day after intervention
Secondary outcomes:
measure: changes in gaming-related compulsive behaviors
timeFrame: baseline and within 1 day after intervention
measure: changes in gaming-related compulsive thoughts
timeFrame: baseline and within 1 day after intervention
measure: changes in the quality and patterns of sleep
timeFrame: baseline and within 1 day after intervention
measure: changes in the severity of depression
timeFrame: baseline and within 1 day after intervention
measure: changes in the severity of anxiety
timeFrame: baseline and within 1 day after intervention
measure: changes in the severity of two emotion regulation strategies, cognitive reappraisal and expressive suppression
timeFrame: baseline and within 1 day after intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: South China Normal University
state: Guangdong
city: Guangdong
country: China
facility: Jinan University
state: Guangzhou
Study officials:
References: