louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04962464: The Impact of a Fast Diet and Calorie Mimetic Supplements on Epigenetic Aging
Official title: The Impact of Fasting Mimicking Diet Program and Calorie Mimetic Supplements on Epigenetic Aging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Aging
Lead sponsor: TruDiagnostic
Sponsor class: INDUSTRY
Collaborators: name: L-Nutra Inc
name: Peak Human Labs
First posted: 2021-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective, randomized trial
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized clinical study of 50 patients to evaluate the fasting mimicking diet program by Prolon with a calorie mimetic supplement from Peak Human Labs. This study will be evaluating the effectiveness of the combined intervention over a three month program.

The study will assess the effects that the program has on the participants' biological aging.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals
* Age \> 16 years

Primary outcomes:
measure: Epigenetic Age Biomarkers
timeFrame: Change from baseline to 3 months
measure: Epigenetic Age Biomarkers
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: Change from baseline to 6 months
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Peak Human Labs
state: Ontario
Study officials:
References:
citation: Amano H, Chaudhury A, Rodriguez-Aguayo C, Lu L, Akhanov V, Catic A, Popov YV, Verdin E, Johnson H, Stossi F, Sinclair DA, Nakamaru-Ogiso E, Lopez-Berestein G, Chang JT, Neilson JR, Meeker A, Finegold M, Baur JA, Sahin E. Telomere Dysfunction Induces Sirtuin Repression that Drives Telomere-Dependent Disease. Cell Metab. 2019 Jun 4;29(6):1274-1290.e9. doi: 10.1016/j.cmet.2019.03.001. Epub 2019 Mar 28.
citation: Brandhorst S, Choi IY, Wei M, Cheng CW, Sedrakyan S, Navarrete G, Dubeau L, Yap LP, Park R, Vinciguerra M, Di Biase S, Mirzaei H, Mirisola MG, Childress P, Ji L, Groshen S, Penna F, Odetti P, Perin L, Conti PS, Ikeno Y, Kennedy BK, Cohen P, Morgan TE, Dorff TB, Longo VD. A Periodic Diet that Mimics Fasting Promotes Multi-System Regeneration, Enhanced Cognitive Performance, and Healthspan. Cell Metab. 2015 Jul 7;22(1):86-99. doi: 10.1016/j.cmet.2015.05.012. Epub 2015 Jun 18.
citation: Chen J, Li Y, Zhu Q, Li T, Lu H, Wei N, Huang Y, Shi R, Ma X, Wang X, Sheng J. Anti-skin-aging effect of epigallocatechin gallate by regulating epidermal growth factor receptor pathway on aging mouse model induced by d-Galactose. Mech Ageing Dev. 2017 Jun;164:1-7. doi: 10.1016/j.mad.2017.03.007. Epub 2017 Mar 24.
Clinical trial NCT02297464: Eggs as Part of a Healthy Breakfast
Official title: Eggs as Part of a Healthy Breakfast: Lack of Association With Heart Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Risk
Lead sponsor: University of Connecticut
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Contrary to popular belief, previous studies have demonstrated beneficial effects of whole egg consumption in modifying biomarkers indicative of a greater risk of coronary heart disease (CHD), chronic inflammation, and insulin resistance. The following study is designed to conduct a comprehensive evaluation of consuming an egg-based breakfast compared to an oatmeal-based breakfast on lipid biomarkers, oxidative stress, inflammation, insulin sensitivity, and satiety in young, healthy men and women. The investigators hypothesize that the consumption of 2 eggs per day will not negatively impact plasma lipids in a young, healthy population.


Eligibility criteria: Inclusion Criteria:

* BMI 18.5-30, willing to consume eggs and oatmeal daily, proficient in English, and with a healthy lipid profile.

Exclusion Criteria:

* Currently have liver disease, renal disease, diabetes, cancer, history of stroke or heart disease
* Currently taking glucose lowering drugs or supplements
* Plasma triglycerides \>500 mg/dL, glucose \>126, total cholesterol \>240
* Pregnant, lactating, or have endocrine or metabolic disorders
* BMI ≥ 30
* Blood pressure \> 140/90 (average of 3 readings)
* Allergies to eggs
* Celiac disease or gluten sensitivity

Primary outcomes:
measure: Spectrophotometry, NMR and ELISA will assess plasma lipids.
timeFrame: 1 year
Secondary outcomes:
measure: Visual analog scales (VAS) and ELISA assays will assess satiety.
timeFrame: 1 year
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
References:
Clinical trial NCT05572164: Comparison Of Epidural Analgesia Techniques In Percutaneous Nephrolithotomy With Surgical Pleth Index
Official title: Comparison On Efficiency Of Surgical Pleth Index-Guided Traditional Epidural And Dural Puncture Epidural Analgesia Techniques In Percutaneous Nephrolithotomy: A Randomised Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesia
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary aim of this study is to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia. Secondary aims are defining time interval between LA administration and SPI value dropping under 50 and hemodynamy. Tertiary results are total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI\>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis)


Eligibility criteria: Inclusion Criteria:

* aged 18-60
* ASA I-III
* grade I unilateral PNL

Exclusion Criteria:

* BMI \> 40 kg/m2
* drug or alcohol abuse history in the last 6 mounts
* chronic opoid usage or had chronic pain longer than 6 weeks
* peripheral and central neurological disorders
* preoperative hemodynamic disorders
* irregular sinus rhythm and pace makers
* diabetes, severe lung and major liver diseases with increasing biluribin
* use of anti-muscarinics, α2-adrenergic agonists, β1-adrenergic agonists, anti arrhythmic; who used chronic psychoactive drugs in last 90 days
* who are pregnant and breast feeding
* not willing to participate
* allergic or intolerant to any of the drugs in the study
* procedures that take less than 2 hours

Primary outcomes:
measure: consumption of local aneshesics
timeFrame: intraoperative
Secondary outcomes:
measure: time interval and SPI value dropping
timeFrame: intraoperative
measure: local anesthesic consumption
timeFrame: during the procedure/surgery and during 30 minutes of PACU stay
Other outcomes:
Locations:
Study officials:
affiliation: Ataturk University
name: Ayşenur Dostbil
role: STUDY_DIRECTOR
References:
Clinical trial NCT02571764: Supplementary Food for Moderate Acute Malnutrition in Children
Official title: The Effect of Supplementary Food on Recovery From Moderate Acute Malnutrition in Pre-school Children in Rural Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate Acute Malnutrition
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2015-10-08
Enrollment: 248
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Children with moderate acute malnutrition will be recruited in order to receive an intervention which consists in the consumption of a single serving of SF-cookies daily, 7-days a week for 12 months and 12 educational sessions on health and nutrition.


Eligibility criteria: Inclusion Criteria:

* Children (2-5 years old), who are from low socioeconomic classes (E and D classes),
* reside in rural areas, and with WHZ- between \> -3 and ≤ -2, and
* informed consent given by the subject's mother or caregiver

Exclusion Criteria:

* Severe acute malnutrition (HAZ, WAZ and WHZ-scores ≤-3) based on the 2006 World Health Organization (WHO) reference values (24)
* Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter)
* (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours).
* Current consumption of other supplementary foods.
* Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled.

Primary outcomes:
measure: Weight (kg) for height (cm) Z-score
timeFrame: 12 months
Secondary outcomes:
measure: Weight (kg) gains
timeFrame: 12 months
measure: height (cm) for age (months) Z-score
timeFrame: 12 months
measure: weight (kg) for age (months) Z-score
timeFrame: 12 months
measure: Mid-upper arm circumference (cm) (MUAC)
timeFrame: 12 hours
measure: height (cm) gain
timeFrame: 12 months
Other outcomes:
Locations:
city: Colonia Lomas De Chapultepec
country: Mexico
facility: Un Kilo de Ayuda
state: Distrito Federal
Study officials:
affiliation: Universidad Autónoma del Estado de México
name: Juan Osvaldo Talavera Piña, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02589964: Probiotics in the Reduction of Antibiotic Associated Diarrhea
Official title: Probiotics in the Reduction of Antibiotic Associated Diarrhea and Clostridium Difficile in Pneumonia Patients Within a Community Teaching Hospital
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Clostridium Difficile
Keywords: probiotics
antibiotic associated diarrhea
clostridium difficile
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in pneumonia patients.

Detailed description: The study will include patients admitted to Good Samariatan Hospital and placed on the pneumonia order set. After obtaining consent, subjects will be randomized to the proboiotic or placebo group. Subjects will be followed for 21 days after starting the study treatment to determine critical outcomes such as incidence of antibiotic-associated diarrhea and C-Diff. Other outcomes include length of stay, healthcare costs, and death.

Eligibility criteria: Inclusion Criteria:

* Admitted to Good Samaritan Hospital
* Placed on pneumonia order set
* Age 18+

Exclusion Criteria:

* Patient with inadequate coherency to understand consent
* Active Diarrhea at admission
* Non-controlled intestinal disease
* Documented positive C. difficile infection within the 3 months before enrollment
* Antibiotic use at hospital admission
* Immunosuppressive therapy
* Pregnancy
* Allergic to ingredients in Florajen-3
* Allergic to ingredients in placebo
* Immunocompromised state including:
* HIV with a low CD4 count
* Active malignancy receiving chemotherapy
* Medications including long-term steroids (\>2 weeks), and disease modifying biologic agents
* Acquired immune deficiency
* Unable to take oral medication
* Less than 4 doses of probiotic or placebo
* Taking probiotic in the past 30 days

Primary outcomes:
measure: Antibiotic Associated Diarrhea
timeFrame: 21 days after starting study treatment
Secondary outcomes:
measure: Length of stay
timeFrame: during hospitalization up to 4 weeks
measure: Mortality
timeFrame: During hospitalization up to 4 weeks
measure: Healthcare costs
timeFrame: During hospitalization up to 4 weeks
measure: Clostridium difficile
timeFrame: 21 days after initiating study treatment
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: TriHealth
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Amita Buddhdev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03173664: Post-Approval Study With the KAMRA Inlay
Official title: Post-Approval Study of Clinical Outcomes and Visual Symptoms With the KAMRA Inlay
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Presbyopia
Lead sponsor: AcuFocus, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-02
Enrollment: 529
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0.50 diopters to -0.75 diopters with less than or equal to 0.75 diopters of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.00 to +2.50 diopters of reading add.

Brief summary: KAMRA inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye. The inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser.

Detailed description: This is a post-approval study of the KAMRA inlay performance and potential device-related issues in a broader population over an extended period of time after pre-market establishment of reasonable safety and effectiveness.

Study objectives include:

* Evaluate the long-term performance (effectiveness) and safety of the device;
* Evaluate real-world performance of the device in subjects treated by refractive surgeons with a range of experience levels;
* Evaluate the performance of the device in racial/ethnic subgroups representative of the population for which the device is intended.

In addition, the data from a subset of the first 105 subjects who have been enrolled in this study will be used to validate the KAMRA Inlay Patient Questionnaire (KIPQ) for the assessment of patients who have received the KAMRA inlay for the treatment of presbyopia.

Eligibility criteria: Inclusion Criteria:

1. Meet the indications for use for this device;
2. Do not have any of the conditions described in the contraindications in the labeling of the device;
3. Are willing and able to provide informed consent;
4. Are not participating in any other clinical studies during the course of the study.

Exclusion Criteria:

1. Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help; or
2. Subject is not a fluent speaker of U.S. English.

Primary outcomes:
measure: Monocular Near Visual Acuity
timeFrame: Five years
Secondary outcomes:
measure: Best-corrected distance visual acuity
timeFrame: Five years
Other outcomes:
Locations:
Study officials:
name: TBD TBD, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04897464: Validation Study of a New Digital Treatment Test
Official title: Validation Study of a New Digital Treatment Test Based on Interactive Video Games for Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
MCI
Lead sponsor: Braingaze
Sponsor class: INDUSTRY
First posted: 2021-05-21
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Oculomotor behavior and cognitive processing of visual information are intimately connected. AD patients show ocular movement problems. Oculomotor deficits are broad consisting mainly of different saccade metrics, altered pupil responses. and smaller and irregular eye vergence movements. Here we test an interactive eye-tracking game to improve eye motion control and thereby training cognitive behavior


Eligibility criteria: Inclusion Criteria:

1) Clinical diagnosis of MCI or AD

Exclusion Criteria:

1. Severe cognitive deterioration
2. History of neurological disease with clinically relevant impact on cognition
3. Severe psychiatric disorder
4. Incidental structural brain findings with impact on cognitive impairment
5. Presence of relevant visual problems

Primary outcomes:
measure: MoCA
timeFrame: immediately after the intervention
measure: MMSE
timeFrame: immediately after the intervention
Secondary outcomes:
measure: CANTAB
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Braingaze
state: Barcelona
Study officials:
References:
Clinical trial NCT02709564: Sublingual Misoprostol in Decreasing Blood Loss Prior to Myomectomy
Official title: Single Dose Versus Two Doses of Sublingual Misoprostol in Decreasing Blood Loss Prior to Abdominal Myomectomy: A Randomized Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Loss in Myomectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to compare the effectiveness of sublingual administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram versus placebo before myomectomy to decrease blood loss during and after the operation.


Eligibility criteria: Inclusion Criteria:

* Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
* Age ≥ 18 years and ≤ 50 years
* Pre-operative hemoglobin \>8 g/dl
* Ability to understand and the willingness to sign a written informed consent.
* Admissible medical/surgical history
* Five or less symptomatic uterine myomas
* All myomas are subserous or intramural.
* Uterine size less than 24 weeks pregnancy

Exclusion Criteria:

* Patients who have had a prior abdominal myomectomy
* Post-menopausal women
* Patients with known bleeding/clotting disorders
* Patients with a history of gynecologic malignancy
* Hypertension.
* Cardiac and Pulmonary diseases.
* Obesity (body mass index \> 30 kg/m2).
* History of allergic reactions attributed to misoprostol
* Cases that will require intraoperative conversion of myomectomy to hysterectomy.

Primary outcomes:
measure: Mean amount of intraoperative blood loss
timeFrame: intraoperative
Secondary outcomes:
measure: Change of hemoglobin after surgery
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT03767764: Yliver as a Test to Early Diagnose HCC
Official title: Yliver as a Test to Early Diagnose Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Tumor associated antigen
Early diagnosis
Autoantibodies
Alpha fetoprotein
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: HCC: patients with HCC diagnosis Cirrhosis: patients with liver cirrhosis diagnosis Chronic liver disease: patients with chronic liver diasease without cirrhosis Control: normal human serum from donors without liver disease

Brief summary: Liver cancer (HCC) is the second cause of death related to cancer worldwide, with about 750,000 deaths from this cause in 2012. Although the early diagnosis of liver cancer increases the available treatment options, the methods currently used for screening are not sufficiently sensitive for this purpose.

The investigators provide a high-performance and highly reliable in vitro platform that allows the identification and quantification of autoantibodies in serum for use as biomarkers of liver cancer, using an ELISA test (Yliver).

The aim of the study is to demonstrate whether the Yliver test can be used as a biomarker for the early diagnosis of hepatocellular carcinoma with a collection of samples from 58 patients diagnosed with HCC, 42 cirrhosis, 40 normal controls and the inclusion of 25-50 patients with chronic liver disease without cirrhosis.


Eligibility criteria: Inclusion Criteria:

EASL Clinical Practice Guidelines \& Practice Guidance by the American Association for the Study of Liver Diseases for diagnosis of HCC, liver cirrhosis, chronic hepatitis without cirrhosis

Exclusion Criteria:

* Age under 18 years
* Very advanced disease (patient in a terminal state that is not indicated analytical determinations).
* Hepatic encephalopathy that prevents the correct understanding of informed consent.
* Refusal to carry out the determination or to sign the informed consent.
* Patients affected by another neoplastic disease

Primary outcomes:
measure: Yliver
timeFrame: October 2018-February 2019
Secondary outcomes:
measure: AFP
timeFrame: October 2018-February 2019
measure: Ultrasound
timeFrame: October 2018-February 2019
measure: AAb AFP
timeFrame: October 2018-February 2019
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacion Parc Taulí
state: Barcelona
Study officials:
References: