louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01155076: Effects of a Vitality Dietary Supplement on Physical and Mental Function in Middle-aged Adults
Official title: Effects of a Proprietary Ginseng, Cordyceps, and Pomegranate Supplement on Physical and Mental Function in Middle-aged Adults: a Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health-related Quality of Life
Lead sponsor: Pharmanex
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2010-07-01
Enrollment: 116
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to determine the effects of 8 weeks Vitality Product supplementation on physical and mental function in middle-aged adults


Eligibility criteria: Inclusion Criteria:

* Males and females aged 40-70 years
* Signed Informed Consent
* BMI between 19 and 30 kg/m2
* Normotensive, defined as systolic blood pressure 90-140 mmHg and diastolic blood pressure 50-90 mmHg

Exclusion Criteria:

* Regular dietary supplement use and unwilling to discontinue use at least 1 month prior to enrollment in the study
* Self-reported chronic condition that may affect subject safety (e.g. diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g. chronic fatigue)
* Pregnancy/suspected pregnancy, breastfeeding
* Antihypertensive medication use
* Allergies to any supplement ingredients
* Consumption of more than 600mg caffeine from any source per day
* Consumption of "energy drinks" (e.g. Red Bull, Monster) or any herbal supplement known to affect energy levels
* Known iron anemia
* Medically treated for insomnia
* Medically treated for depression
* Taking medications known to affect energy, e.g. thyroid medication
* Tobacco user
* Planned surgical procedure in next 2 months
* Participating in another clinical (medical or nutritional) study or likely to enroll in another medical or nutritional study

Primary outcomes:
measure: Health-related quality of life
timeFrame: 8 weeks
Secondary outcomes:
measure: Medical Outcomes Study (MOS) Sexual Function questionnaire
timeFrame: 8 weeks
measure: Adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Quality of Life Medical and Research Center
state: Arizona
city: Chaska
country: United States
facility: Ridgeview Chaska Medical Plaza
state: Minnesota
city: Houston
country: United States
facility: West Houston Clinical Research Services
state: Texas
Study officials:
affiliation: Quality of Life Medical & Research Center, LLC
name: John McGettigan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00865176: Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions
Official title: Comparative Bioavailability Study of Eplerenone 50 mg Tablets (Sandoz Inc., USA) and Inspra 50 mg Tablets (GD Searle LLC, USA) in Healthy Male and/or Female Volunteers Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-03-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg ER Tablets under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence according to US FDA guidelines
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Allied Research International Inc.
name: Deepen Patel, M.D., CCFP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03877276: Dietary Oxalate and Immune Cell Function
Official title: Dietary Oxalate and Immune Cell Function
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Stone
Keywords: dietary oxalate
diet therapy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate mitochondrial function in white blood cells and platelets from healthy individuals following dietary oxalate intake.

Detailed description: Inflammation and dietary oxalate have been shown to play an important role in the development of kidney stones. Oxalate is a small molecule found in plants and plant-derived food. Individuals that have high oxalate intake have an increased risk of developing kidney stones. The co-investigators have previously shown that healthy subjects that consume dietary oxalate have increased plasma and urine oxalate.

White blood cells are essential for the immune response and rely on the mitochondria to carry out important cell functions. The Principal Investigator's current research shows that patients with calcium oxalate kidney stones have decreased mitochondrial function in their immune cells. Using the expertise of the investigators, this study will test whether oxalate has a direct effect on mitochondrial function in immune cells from healthy subjects. This information could help us understand the role of oxalate on the immune system during kidney stone pathogenesis.

Eligibility criteria: Inclusion Criteria:

* Mentally competent adults who are able to read and comprehend the consent form, written in English
* Male or Female
* Age 18 to 70 years
* Non-tobacco users
* BMI between 19 and 27
* Willingness to abstain from vigorous exercise during study period
* Normal blood comprehensive metabolic panel

Exclusion Criteria:

* Mentally incompetent adults who are unable to read or comprehend the consent form, written in English
* Pregnant females
* Active medical problems
* History of kidney stones
* Any medical disorder that could influence absorption or excretion of oxalate
* BMI less than 19 or greater than 27
* Tobacco users
* Current use of medications or dietary supplements

Primary outcomes:
measure: Change in monocyte cellular energetics after 5 hours
timeFrame: 0 hours - 5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Tanecia Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumar P, Patel M, Oster RA, Yarlagadda V, Ambrosetti A, Assimos DG, Mitchell T. Dietary Oxalate Loading Impacts Monocyte Metabolism and Inflammatory Signaling in Humans. Front Immunol. 2021 Feb 25;12:617508. doi: 10.3389/fimmu.2021.617508. eCollection 2021.
Clinical trial NCT00674076: Clinical Application of Ultrasound in Obstructive Sleep Apnea
Official title: Clinical Application of Ultrasound in Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who are arranged to recived polysomography

Brief summary: We hypothesize the width air-colum of retropalatal region and tongue voulme by ultrsound through submental area is different between normal control with those with obstructive sleep apnea syndrome who was comfirmed by polysomography.

Detailed description: Patients with obstructive sleep apnea mainly due to upper airway narrowing are evaluated conventionaly by polysomography. Recently, the magnetic resonace imaging has been well established in evaluating upper airway and correlating with the severity by tongue mass and the area of retropalatal airway. However, some drawbacks of MRI includes expensiveness might lead its less use. As for ultrasound which is very popularly applied in medical illness, is more convenient and money saving than MRI. We propose that ultrsound measuring the tongue volume and width of upper airway through submental area may be a alternative image for a upper airway measuring.

Eligibility criteria: Inclusion Criteria:

* group of sleep apnea: patients who have been diagnosed as having obstructive sleep apnea
* control group: patients who have a negative polysomogrphy or a normal score of Pittsburg sleep questionaire

Exclusion Criteria:

* Less than 18-year-old
* un-willing
* not co-operated person

Primary outcomes:
measure: apnea-hypopnea index
timeFrame: less than one month apart from ultrasound
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital, Internal Medicine
name: Hao-Chien Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013.
Clinical trial NCT00915876: Vascular Reactivity in Chronic Kidney Disease (CKD) Patients Receiving Paricalcitol Versus Placebo
Official title: Effects of 19-nor-1α-dihydroxyvitamin D2 (Paricalcitol) Versus Placebo on Oxidative Stress and Vascular Reactivity in CKD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
Vitamin D
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Albany College of Pharmacy and Health Sciences
First posted: 2009-06-08
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This research is studying how Vitamin D may affect blood vessels reaction to stress and blood levels of substances that may increase blockages in the blood vessels in chronic kidney disease (CKD) patients. Blood vessel health is worsened in CKD and some studies have shown that Vitamin D improves blood vessel health. The type of Vitamin D being used in this study (paricalcitol) is Food and Drug Administration (FDA) approved to treat high parathyroid hormone levels. The purpose of this study is to find out if paricalcitol has other benefits beyond its ability to lower parathyroid hormone levels such as improving the blood vessels reaction to stress and decreasing blood levels of substances that may increase blockages in the blood vessels.


Eligibility criteria: Inclusion Criteria:

* Males or females ≥ 18 years of age at the start of screening
* CKD with eGFR 15-60 mL/min/1.73m2 by MDRD
* Not expected to start dialysis for 4 months
* Serum intact PTH 70-200 pg/mL during screening period
* On stable ACEI/ARB regimen for 30 days prior to screening

Exclusion Criteria:

* History of any of the following diseases:

  * congestive heart failure
  * MI within the last 6 months
  * history of cerebrovascular accident
  * significant valvular disease
  * malignancy
* Currently taking any vitamin D products
* Mean systolic blood pressure values \> 190 or diastolic blood pressure values \> 100 mm/Hg during the preceding 30 day period prior to screening
* Currently being titrated on therapy with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker
* Two consecutive serum calcium values greater than 10.2 mg/dL or Ca x P \> 55 mg2/dL2
* Currently receiving erythropoiesis stimulating agent or intravenous iron therapy
* Pregnant or breastfeeding

Primary outcomes:
measure: Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56
timeFrame: Day 28 and Day 56
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center South Clinical Campus
state: New York
Study officials:
affiliation: Albany College of Pharmacy and Health Sciences
name: Amy Pai, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Albany College of Pharmacy and Health Sciences
name: Amy Pai, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01829776: Pilot Study of Free From Falls Program in Multiple Sclerosis
Official title: Pilot Study on the Effect of the Free From Falls Program on Falls in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Accidental falls
Multiple Sclerosis
Education
Exercise
Postural balance
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This pilot study will compare how often people with multiple sclerosis (MS) fall before participating in the Free From Falls (FFF) educational program, during the program, and for 8 weeks after the program. The protocol will also evaluate the accuracy, efficiency and convenience of an email survey to count how often people fall.

Detailed description: This pilot study will recruit people with MS who report falling at least twice in the previous 2 months to participate in the FFF program. All subjects will record their falls and injurious falls on a daily basis for at least 3 weeks before the program, during the program and for 8 weeks after the program. The program will consist of a weekly 2 hour session. One hour of the session will be educational and one hour of the program will involve exercise. The outcome of this study will be change in fall rate between the periods before, during and after the program.

Eligibility criteria: Inclusion Criteria:

* MS of any type
* Age 18 years or older
* Able to walk at least 100 meters with intermittent or unilateral constant assistance (cane, crutch or braces) with or without resting
* Self-reported history of 2 or more falls in the previous 2 months
* Clinically stable MS with no relapses within 30 days
* Willing to provide informed consent
* Fluent in written and spoken English.
* Daily access to email and willing to respond to a daily email questionnaire

Exclusion Criteria:

* Serious psychiatric or medical conditions that would preclude reliable participation in the study.

Primary outcomes:
measure: Change in fall frequency per month (30 days)
timeFrame: difference between the wait period before the 8 week FFF program and the 8 weeks after the end of the 8 week FFF program
Secondary outcomes:
measure: Relationship between paper and electronic fall calendars
timeFrame: 5 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University and Portland VA Medical Center
state: Oregon
Study officials:
affiliation: Oregon Health & Science University, Portland VA Medical Center
name: Michelle H Cameron, MD, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05820776: Tele-rehabilitation in Chronic Respiratory Disease: an Observational Cohort Study
Official title: Remote Exercise-based Pulmonary Rehabilitation Telemedicine in Chronic Respiratory Disease: an Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Respiratory Disease
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults diagnosed with chronic respiratory disease affecting the airways and other structures of the lungs causing dyspnea including chronic obstructive pulmonary disease (COPD), occupational lung diseases and pulmonary hypertension.

Brief summary: Pulmonary rehabilitation is a program that helps people with lung disease improve their function. It uses exercise, education, and self-management strategies to improve physical ability and quality of life. Because some people are unable to visit West Park Healthcare Centre, we established a remote supervised pulmonary rehabilitation program that patients can access via an electronic device (computer, tablet or smart phone). Regular quality assurance is necessary to ensure that the program is effective. We plan to collect and summarize the program's results. The benefit of doing so is that it allows us to make any changes or improvements that may help patients with chronic respiratory conditions.


Eligibility criteria: Inclusion Criteria:

* stable chronic respiratory disease
* qualified candidates for pulmonary rehabilitation,
* current non-smoker;
* primary diagnosis chronic respiratory disease limited by dyspnea (mMRC≥2);
* free of exacerbation at the time of admission, and
* stable co-existing conditions

Exclusion Criteria:

* completed PR within the previous 12 months of the current admission and
* being unable to communicate with the treating team.

Primary outcomes:
measure: health-related quality of life Chronic Respiratory Questionnaire - dyspnea
timeFrame: 12 weeks
Secondary outcomes:
measure: 6-minute walk test distance
timeFrame: 12 weeks
measure: 30-second Chair Stand Test
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: West Park Healthcare Centre
name: Roger Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02401776: Effect of Caffeine on Heart Function
Official title: An Evaluation of the Heart Rate, Blood Pressure and Repolarization Effects of an Energy Drink as Compared to Coffee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Tachycardia
Keywords: heart rate
blood pressure
caffeine
energy drink
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: * The primary objective of this study is to assess the effect of an energy drink on ventricular repolarization as measured by the interval between the cardiac Q wave and the cardiac T wave (QT interval)obtained from the body surface ECG.
* The secondary objective is to assess the effects of an energy drink on heart rate and blood pressure (hemodynamic effects).

To place the observed changes in context, comparison will be made to a commonly consumed drink, coffee: Starbuck's K-cup Breakfast Blend.

Detailed description: This study will assess cardiac repolarization before and after three conditions each of which will involve the subject drinking beverages of varying caffeine content.

Eligibility criteria: Inclusion Criteria:

* Healthy
* BMI between 24 - 29

Exclusion Criteria:

* Resting heart rate below 60 bpm
* Resting heart rate above 88 bpm
* Cardiovascular or metabolic disease

Primary outcomes:
measure: QT interval will be measured in msec
timeFrame: 19 hrs
Secondary outcomes:
measure: Heart rate will be measured as beats per minute.
timeFrame: 19 hrs
measure: Blood Pressure will be measured in the brachial artery as mmHG
timeFrame: 19 hrs
Other outcomes:
Locations:
city: Austin
country: United States
facility: Environmental and Autonomic Physiology Laboratory; University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Robert M Brothers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01420276: Female Sexual Function and Back Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Female Sexual Function
Keywords: Female sexual function
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2011-08-19
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female with active sexual life

Brief summary: Back paın is a common hormonal disorder in women that may affect the phases of female sexual function (FSD). We investigated sexual function in patients with back paın A total of 54 women with back paın and 27 age matched voluntary healthy women who served as the as control group were evaluated with a detailed medical and sexual history, including a female sexual function index (FSFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.

Detailed description: A total of 54 women with back paın and 27 age matched voluntary healthy women who served as the as control group were evaluated with a detailed medical and sexual history, including a female sexual function index (FSFI) questionnaire and the Beck Depression Inventory. Serum prolactin, dehydroepiandrosterone sulfate, free testosterone, androstenedione, 17alpha-hydroxyprogesterone, estradiol, free thyroxin and thyrotropin were measured. These variables were compared statistically between the 2 groups.

Eligibility criteria: Inclusion Criteria:

* 20-45 year old
* Female
* Active sexual life

Exclusion Criteria:

* Younger than 20, older than 45 year old.
* Menopause

Primary outcomes:
measure: Female sexual function
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: