louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01517685: Hallelujah Acres Omega 3 Fat Study
Official title: Hallelujah Acres Omega 3 Fat Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Omega 3 Fat Status
Keywords: Eicosapentaenoic acid
EPA
Docosahexaenoic acid
DHA
Omega 3 fat
alpha-linoleic acid
ALA
fish oil
flax seed oil
Lead sponsor: Hallelujah Acres
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This research is being done to study the effect of taking flax seed oil and fish oil on blood lipids in vegetarians following the Hallelujah Diet. Omega 3 fats are important to our health and we want to see how effective both flax seed oil and fish oil are in raising your Omega 3 Score (higher is better). The Omega 3 Score is one of many indicators that may show your personal risk of dying suddenly from a heart attack.

Detailed description: This study is being conducted to compare the response of individuals to flax seed oil or fish oil, measured by blood lipids. Especially the amount of the long chain omega 3 polyunsaturated fats EPA and DHA will be tested. An omega 3 score for whole blood will be measured. The omega 3 score is the percent sum of omega 3 fats in the blood.

The hypothesis is that 5 grams of fish oil will increase the amount of EPA and DHA in a person's blood to a protective level, and that 30 grams (2 tablespoons) of flax oil will not change the blood levels of EPA significantly and not change the blood concentrations of DHA at all, even for a person consuming a low omega 6 oil diet and following a vegan diet high in fruits and vegetables.

Most of the testing of flax and fish oil has not been done in vegans. This trial will extend this testing to this subpopulation.

Eligibility criteria: Inclusion Criteria:

* Must have followed the Hallelujah Diet (or very similar diet) for at least the last two years,
* Must have stable body weight (not gained or lost more than 5 pounds of weight over the last three months)

Exclusion Criteria:

* Pregnancy (all pregnant women should take fish oil, not flax seed oil)
* Currently using fish oil, or flax seed oil,EPA, DHA, or flax seed oil with added DHA
* Eating more than 2 teaspoons of flax seed per day
* Diabetes (fish oil may affect blood sugar levels)
* Generally poor health

Primary outcomes:
measure: Omega 3 Score
timeFrame: 8 weeks of supplementation before testing
Secondary outcomes:
Other outcomes:
Locations:
city: Zillah
country: United States
facility: Hallelujah Acres Research Office / Laboratory
state: Washington
Study officials:
affiliation: Hallelujah Acres
name: Michael Donaldson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04194437: OCS Liver DCD Trial
Official title: Prospective Trial to Evaluate the Effectiveness of The Portable Organ Care System (OCS) Liver for Preserving, Optimizing and Assessing Currently Seldom Utilized DCD Donor Livers for Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Transplant
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2019-12-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and effectiveness of the OCS Liver System to preserve, optimize the condition, and assess levers from DCD donors.

Detailed description: To evaluate the safety and effectiveness of the OCS™ Liver to preserve, optimize the condition and assess livers from DCD donors that currently are seldom used for liver transplants due to limitations of cold static storage with extended warm ischemic time and older donors.

Eligibility criteria: Inclusion Criteria:

* Registered primary liver transplant candidate
* Age ≥ 18 years
* Obtained informed consent

Exclusion Criteria:

* Acute, fulminant liver failure
* Prior solid organ or bone marrow transplant
* Ventilator dependent on day of transplant/donor organ offer

Primary outcomes:
measure: Liver Graft Survival Through 6 Months Post-transplant
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps
state: California
city: La Jolla
country: United States
facility: University of San Diego
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Tampa
country: United States
facility: Tampa General
state: Florida
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Bronx
country: United States
facility: Montefiore
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwest
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: San Antonio
country: United States
facility: University of Texas San Antonio
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: TransMedics
name: Ahmed Elbetanony, MD
role: STUDY_DIRECTOR
References:
citation: Kubal C, Mihaylov P, Holden J. Oncologic indications of liver transplantation and deceased donor liver allocation in the United States. Curr Opin Organ Transplant. 2021 Apr 1;26(2):168-175. doi: 10.1097/MOT.0000000000000866.
Clinical trial NCT02742337: Identification of Epigenetic Biomarkers for Early Detection of Rheumatic Disease
Official title: Identification of Epigenetic Biomarkers for Early Detection of Rheumatic Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis, Rheumatoid
Keywords: Epigenetic
Lead sponsor: Arthritis Northwest PLLC
Sponsor class: INDUSTRY
Collaborators: name: Epigenesys LLC
First posted: 2016-04-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is at-risk patients for chronic auto-immune and rheumatic disease.

Brief summary: • Given the cost and risk associated with biologic disease modifying anti-rheumatic drugs (bDMARDs), selection of the optimal medication is imperative. Current attempts to identify genetic factors that predict bDMARD response and effectiveness in rheumatoid arthritis patients have been inconclusive. Furthermore the presence of epigenetic signatures in rheumatoid arthritis patients has not been established. This protocol is the first step to identifying the practicality and feasibility of epigenetic testing to aid in diagnosis and/or medication selection in rheumatoid arthritis patients. Subsequent research into such epigenetic changes may be indicative of bDMARD response and/or safety. If such epigenetic signatures (EGS) exist the business need for such tests will thus be supported.

Detailed description: Two groups of patients will be assessed for the presence unique epigenetic signatures. The test group, having a bonafide diagnosis of rheumatoid arthritis (RA) and a control group of subjects who does not fulfill the American College of Rheumatology's classification criteria for RA. A buccal cell sample and blood draw will be sequenced and analyzed from each subject in each group for the presence of epigenetic signatures.

Eligibility criteria: Test patient Inclusion Criteria:

* Must fulfill the 2010 ACR rheumatoid arthritis classification criteria.
* Must have at least moderate disease activity (CDAI) for most recent disease activity score
* Any history of NSAID or corticosteroid use is acceptable
* Weight at time of blood draw must be greater than 110 lbs.
* Must be RF+ or CCP+

Control patient Inclusion Criteria:

* Female (age: 18 - 80)
* Must not fulfill the 2010 ACR rheumatoid arthritis classification criteria.
* Weight at time of blood draw must be greater than 110 lbs.
* Age will be within 5 years of a test patient.

Exclusion Criteria:

* Male
* Age 17 or less
* History of Disease Modifying Anti-Rheumatic Drugs (DMARDs), or biologic DMARDs.
* History of malignancy, except non-melanoma skin cancer
* Previous treatment for malignancy with chemotherapy agents
* Patient reported history of HIV, HepB, HepC, or TB

Primary outcomes:
measure: Counts of patients with epigenetic signatures.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
Study officials:
References:
Clinical trial NCT03144115: Does Oxytocin Modulate Rewarding Effects in Women and Fluctuating Across the Menstrual Cycle
Official title: Does Oxytocin Modulate Rewarding Effect of Metaphorical Compliments Fluctuating With Women's Fertility and Luteal Phase in a Romantic Context
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: oxytocin
sex hormone
verbal reward
mate selection
metaphorical language
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to explore how the rewarding effect of men's verbal compliment is modulated by oxytocin and gonadal hormone in a romantic context.

Detailed description: To investigate whether oxytocin (24IU) might interact with female sex hormone in modulating the rewarding effect of compliment to women in a romantic context.

The study employs a double-blind, within-subject, placebo-control design. Women will be administered with the same drug twice (oxytocin or placebo) respectively the fertile and luteal phase followed by a MRI scanning. During fMRI participants will rate men's attraction based on their facial pictures of average attractiveness associated with compliments of different combination of form and topic. Each male face will be paired with two sentences of the same kind. After the fMRI participants will recall the judgment followed by a memory test during which they have to indicate whether the they have seen the face during scanning (old) or whether it is an unknown face (new).

Eligibility criteria: Inclusion Criteria:

* Single in the past 3 months
* Healthy subjects with regular menstrual cycle

Exclusion Criteria:

* Pregnant, menstruating, taking oral contraceptives
* metal implanted, with tatoo, or hair dyed within 6 months
* participated in another intranasal experiment within 6 months
* with a history of past or current psychiatric or neurological disorder

Primary outcomes:
measure: Oxytocin effect on neural activity as assessed via fMRI towards reward between fertility and luteal phases
timeFrame: 45min-120min after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of Chia
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith M Kendrick, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao Z, Ma X, Zhou X, Xin F, Gao S, Kou J, Becker B, Kendrick KM. Oxytocin Reduces the Attractiveness of Silver-Tongued Men for Women During Mid-Cycle. Front Neurosci. 2022 Apr 28;16:760695. doi: 10.3389/fnins.2022.760695. eCollection 2022.
Clinical trial NCT02204215: Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients
Official title: Phase 1 Study of Electric Acupuncture for ICU-acquired Weakness in Mechanical Ventilation Patients With Sepsis/Multiple Organ Dysfunction Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Sepsis
Multiple Organ Dysfunction Syndrome
Keywords: Weakness
Mechanical Ventilation
Acupuncture Therapy
Lead sponsor: Jiangsu Province Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intensive care unit acquired weakness (ICU-AW) is common and dramatically affect recovery. The purpose of this study is to determine whether electric acupuncture therapy is effective in the treatment of ICU-AW especially in the patients receiving mechanical ventilation with sepsis or multiorgan system failure.

Detailed description: The principle of acupuncture is to produce bioelectric current, as a consequence, to invigorate the circulation, promote tissue regeneration, relieve pain, enhance the immune function, etc. And electric acupuncture can stimulate bioelectricity activities at acupoints, out of reach for ordinary acupuncture effect, especially in the fields of nerve/muscle recovery and regeneration.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of sepsis or multiple organ dysfunction syndrome
* Within 48 hours from the initiation of mechanical ventilation

Exclusion Criteria:

* Pregnant patients
* Neuromuscular disease or cerebrovascular accident
* With temporary or permanent pacemaker
* Need to use neuromuscular blocking agents
* Inactivity for more than 5 days before ICU admission

Primary outcomes:
measure: strength related parameters
timeFrame: Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
Secondary outcomes:
measure: mechanical ventilation duration
timeFrame: Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
measure: 28-day mortality
timeFrame: Participants will be followed until the 28th day after mechanical ventilation
measure: number of participants with adverse events of electric acupuncture
timeFrame: Participants will be followed until the date of weaning from mechanical ventilation, an expected average of 8 weeks
measure: ICU duration
timeFrame: Participants will be followed until the date of discharge from the ICU, an expected average of 8 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Intensive Care Unit, Jiangsu Province Hospital of TCM
state: Jiangsu
Study officials:
affiliation: Director of Intensive Care Unit
name: Xing Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00990015: A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04308515 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Safety; tolerability; pharmacokinetics/pharmacodynamics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics (understanding how a drug is absorbed and moves through the body) and pharmacodynamics (understanding the effects of a drug on certain target sites of activity in the body).


Eligibility criteria: Inclusion Criteria:

* Healthy males between 18 and 55 years, inclusive
* Healthy females between 18 and 44 years, inclusive.
* Women need to be surgically sterile

Exclusion Criteria:

* Evidence or history of clinically significant disease
* Post-menopausal women
* History of intolerance or significant adverse effects with glucocorticoids

Primary outcomes:
measure: To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515
timeFrame: 1 day
measure: To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06440915: Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
Official title: Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aspergillosis Invasive
Mucormycosis
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn the plasma concentration of isavuconazole in pediatric patients. It will also learn about the relationship of isavuconazole plasma concentrations to efficacy and safety in pediatric patients. The main questions it aims to answer are:

What is the plasma concentration after using isavuconazole in pediatric patients? What is the effective range of plasma concentration of isavuconazole in pediatric patients? What is the safe range of plasma concentration of isavuconazole in pediatric patients? Researchers will measure the plasma concentration of isavuconazole to see whether it is appropriate.

Participants will:

Take drug isavuconazole as prescribed by the doctor;

1mL of blood is drawn 30min before the next dose.

Detailed description: Objectives of Study:

Main objective: To monitor the plasma concentration of isavuconazole in children, and to study the pharmacokinetic characteristics of isavuconazole in children, so as to provide basis for the optimization of individualized drug administration.

Secondary objective: To evaluate the relevance of isavuconazole plasma concentrations to efficacy and safety in pediatric patients.

Eligibility criteria: Inclusion Criteria:

* Patients who intend to take isavuconazole for the treatment of invasive mycosis;
* Aged 0-18 years, gender unlimited;
* The subject and his/her guardian are willing to comply with the procedures and operations specified in the study protocol;
* The guardian of the subject and the subject of independent informed age are willing and able to provide written informed consent to participate in the study.

Exclusion Criteria:

* The subject is known to be allergic to any azole antifungal therapy or other ingredients contained in the study drug;
* The researcher believes that the condition of the child may interfere with study participation or other inappropriate conditions.

Primary outcomes:
measure: Plasma concentrations of isavuconazole
timeFrame: 30 minutes before next dosing
Secondary outcomes:
measure: Treatment success rates for IMI
timeFrame: 6 months
measure: AE and SAE
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
Study officials:
affiliation: Shanghai Children's Medical Center
name: Juan Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02418715: Effects of Water-Based Exercise on Lipid Profile and Lipoprotein Lipase of Dyslipidemic Premenopausal Women
Official title: Effects of Water-Based Exercise on Lipid Profile and Lipoprotein Lipase of Dyslipidemic Premenopausal Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effects of water-based exercises on lipid profile (LP) and lipoprotein lipase (LPL) levels in premenopausal dyslipidemic women.

It was hypothesized that a water-based aerobic interval-training period would decrease plasma concentrations of atherogenic lipoproteins and concomitantly increase HDL and LPL levels, as well as maximal oxygen uptake (VO2max) values.


Eligibility criteria: Inclusion Criteria:

* Premenopausal
* Sedentary
* Dyslipidemic
* Aged between 40 and 50 years old

Exclusion Criteria:

* Smokers
* Hypolipemic drugs users

Primary outcomes:
measure: Lipid Profile Levels (total cholesterol, LDL, HDL, triglycerides)
timeFrame: 12 weeks
Secondary outcomes:
measure: Lipoprotein Lipase Levels
timeFrame: 12 weeks
Other outcomes:
measure: Maximal oxygen uptake (VO2max) values
timeFrame: 12 weeks
Locations:
Study officials:
References: