louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06316284: miRNA in Chronic Kidney Diseases
Official title: The Role of miRNAs in the Regulation of Oxidative Stress and Microvascular Reactivity in Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Kidney Diseases
Keywords: chronic kidney diseases
miRNA
oxidative stress
hypertension
Lead sponsor: Josip Juraj Strossmayer University of Osijek
Sponsor class: OTHER
Collaborators: name: University Hospital Center Osijek
First posted: 2024-03-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CKD and healthy controls, i.e. patients with hypertension without kidney damage (eGFR CKD-EPI \> 90 mL/min/1.73 m2). Subjects and controls will be age- and gender-matched. Inclusion criteria for patients with CKD: the study will include patients having chronic kidney disease of the 3rd - 5th degree (eGFR CKD-EPI\< 60 mL/min/1.73 m2).

Brief summary: Oxidative stress and endoplasmic reticulum (ER) stress play a key role in tubular damage in both acute kidney injury and chronic kidney disease (CKD). Oxidative stress in the kidneys promotes renal vascular remodeling and increases preglomerular resistance. These are key elements in hypertension, acute and chronic kidney injury, as well as diabetic nephropathy. Chronic renal hypoxia is highlighted as the final common pathway to end-stage renal disease (ESRD). MicroRNA molecules (miRNA) also play an important role in these processes. MicroRNAs (miRNAs) are regulators of gene expression and play a role in the progression of renal ischemia-reperfusion injury. Although the pathophysiological contribution of microRNAs (miRNAs) to kidney damage has also been highlighted, the effect of miRNAs on kidney damage under conditions of oxidative and ER stress remains understudied.


Eligibility criteria: Inclusion Criteria:

* healthy normotensive adults (eGFR CKD-EPI \>90 mL/min/1.73 m2, BP \<140/90 mmHg)
* hypertensive adults (eGFR CKD-EPI \>90 mL/min/1.73 m2, BP \>140/90 mmHg)
* patients with chronic kidney disease stage 3-5 (eGFR CKD-EPI\< 60 mL/min/1.73 m2)

Exclusion Criteria:

* cardiovascular diseases, but hypertension
* diabetes
* cerebrovascular diseases
* peripheral artery disease

Primary outcomes:
measure: Systemic microvascular function
timeFrame: Day 1
measure: Serum level of antixidant enzymesprotein concentration of SOD, CAT and glutathione-peroxidase
timeFrame: Day 1
measure: Detecton of miRNA of interest
timeFrame: Day 1
Secondary outcomes:
measure: Body fluid compartments
timeFrame: at one time point
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: Faculty of Medicine Osijek
Study officials:
References:
Clinical trial NCT05623202: Pilot Study of Capacity-oriented Intervention to Promote Food Security and Diet Quality Among Hispanics/Latinos
Official title: Pilot Intervention Study for Capacity-oriented Approaches to Food Security, Diet Quality, and Cardiovascular Disease Risk Among Hispanics/Latinos
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nutrition, Healthy
Knowledge, Attitudes, Practice
Self Efficacy
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Despite a large proportion exhibiting cardiovascular disease risk factors and experiencing food insecurity, U.S. Hispanics/Latinos demonstrate low cardiovascular mortality, which may indicate existing capital (e.g., assets) protecting health and diet. The goal of this study is to evaluate the feasibility and short-term efficacy of a pilot intervention aimed at improving diet quality through strengthening food- and diet-related capital and food security among low-income, Hispanic/Latino adults in San Diego, California. The pilot intervention will be integrated into an existing local health or nutrition program serving low-income Hispanic/Latino adults. Participants will be asked to:

* Complete questionnaires before and after the intervention
* Engage in nutrition education activities
* Engage in food access-related activities


Eligibility criteria: Inclusion Criteria:

* Self-identified Hispanic/Latino
* Living full-time in San Diego County with no plan to move in next 3 months
* At or below 200% of Federal Poverty Line

Exclusion Criteria:

* Not Hispanic/Latino
* Living outside San Diego County
* Living only part-time in San Diego County
* Planning to move out of San Diego County in next 3 months
* \>200% of Federal Poverty Line

Primary outcomes:
measure: Diet quality
timeFrame: 3 months
Secondary outcomes:
measure: Household food security status
timeFrame: 6 weeks, 3 months
measure: Self-efficacy for food security
timeFrame: 6 weeks, 3 months
measure: Food resource management knowledge
timeFrame: 6 weeks, 3 months
measure: Food resource management knowledge
timeFrame: 6 weeks, 3 months
measure: Food resource management skills
timeFrame: 6 weeks, 3 months
measure: Food resource management skills
timeFrame: 6 weeks, 3 months
measure: Material capital
timeFrame: 6 weeks, 3 months
measure: Human capital
timeFrame: 6 weeks, 3 months
measure: Social capital
timeFrame: 6 weeks, 3 months
measure: Social capital
timeFrame: 6 weeks, 3 months
measure: Cultural capital
timeFrame: 6 weeks, 3 months
measure: Cultural capital
timeFrame: 6 weeks, 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04869202: Covid-19 Infection in Pregnancy
Official title: Fetomaternal Outcomes of Pregnancies Complicated by COVID-19 Infection; Prospective Study in a Tertiary University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perinatology
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 224
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who contract COVID-19 virus infection during pregnancy

Brief summary: Prospective study of both maternal and fetal outcomes of those pregnancies that were complicated by COVID-19 infection at various gestational ages. The follow up will be from the time the diagnosis was made till discharge of the mother and her baby from the hospital.

Detailed description: Pregnancies that have a confirmed covid-19 infection by nasopharyngeal swab whether taken at our laboratory or confirmed at private or Ministry of health (MOH) laboratories will be followed up till delivery and discharge from the hospital.

They will be followed up for hospitalization, intensive care unit (ICU) admission, any complications (organ failure, DIC, renal failure, septic shock), intubation, mortality, miscarriage, congenital malformations, intra-uterine growth restriction (IUGR), oligohydramnios, spontaneous preterm birth, mode of delivery, birth weight, APGAR score at 1 and 5 minutes, neonatal infection with covid-19, neonatal ICU admission and breast feeding. Those patients will be followed up prospectively at our hospital and those with missed follow up and delivered outside our unit will be contacted to bring all the above-mentioned parameters. There will be no exclusion of cases.

Eligibility criteria: Inclusion Criteria:

* pregnant women

Exclusion Criteria:

* None

Primary outcomes:
measure: feto-maternal outcome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan University Hospital
Study officials:
affiliation: The University of Jordan
name: Asma Basha
role: STUDY_DIRECTOR
References:
Clinical trial NCT03466502: Oral Vancomycin to Prevent Recurrent C Difficile Infection With Antibiotics
Official title: Efficacy of Prophylactic Oral Vancomycin in Preventing Recurrent Clostridium Difficile Infection in Hospitalized Patients Requiring Antibiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Clostridium Difficile Infection
Keywords: vancomycin
Clostridium difficile
Clostridium difficile infection
Recurrent Clostridium difficile infection
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
Collaborators: name: Renown Regional Medical Center
First posted: 2018-03-15
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.

Detailed description: This study will assess the efficacy of oral vancomycin prophylaxis in preventing recurrent Clostridium difficile infection in hospitalized patients requiring oral or intravenous antibiotics for a suspected or confirmed bacterial infection.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Previous CDI diagnosis
3. Current admission with a suspected or a confirmed bacterial infection requiring antibiotics

Exclusion Criteria:

1. Active chronic diarrheal illness (eg, Crohn's disease, ulcerative colitis, short bowel syndrome)
2. Previous adverse reactions to oral vancomycin
3. Requiring metronidazole during hospitalization
4. Known pregnancy
5. Expected survival \<72 hours
6. Patients receiving antibiotics only for surgical prophylaxis
7. Patients who received prophylactic oral vancomycin for the current antibiotic course prior to enrollment in the study

Primary outcomes:
measure: Recurrent Clostridium difficile infection
timeFrame: During hospitalization or the 12 weeks after therapy
Secondary outcomes:
measure: Recurrence rate of CDI according to C diff inducing properties of the prescribed antibiotics
timeFrame: During hospitalization or the 12 weeks after therapy
measure: Time between recurrent CDI and the last C diff infection
timeFrame: During hospitalization or the 12 weeks after therapy
measure: Rate of recurrence of CDI in immunocompromised patients
timeFrame: During hospitalization or the 12 weeks after therapy
measure: Rate of recurrence of CDI in patients with a history of the NAP-1 strain
timeFrame: During hospitalization or the 12 weeks after therapy
measure: Rate of reported adverse events
timeFrame: During hospitalization or the 12 weeks after therapy
measure: Mortality rate
timeFrame: During hospitalization or the 12 weeks after therapy
Other outcomes:
Locations:
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
Study officials:
affiliation: Renown Regional Medical Center
name: Lauren Zion, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00324402: Plasma Brain Natriuretic Peptide Levels in Pregnancy
Official title: Plasma Brain Natriuretic Peptide Levels in Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathy
Pregnancy
Keywords: brain natriuretic peptide
pregnancy
biomarker
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
First posted: 2006-05-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant women, 18-40

Brief summary: To evaluate the maternal blood concentrations of brain natriuretic peptide (BNP) during the second and third trimesters of a normal pregnancy. We will attempt to define a normal range for pregnancy and any outliers that may serve as markers for abnormal cardiovascular physiology.

Detailed description: The brain natriuretic peptide (BNP) is a useful marker for volume overload, increased filling pressures and stretching of the myocardium. The current literature contains limited and unreliable information regarding normal BNP values in pregnancy. After baseline echocardiogram to detect individuals with asymptomatic structural defects, the participants will submit to 3 blood draws during the second and third trimester and at delivery to determine normal pregnancy values.

Eligibility criteria: Inclusion Criteria:

* women age 18 to 40
* second trimester of pregnancy

Exclusion Criteria:

* known cardiac or valvular disease,
* atrial fibrillation or other arrhythmia,
* pulmonary hypertension,
* chronic hypertension,
* hypertensive disorders of pregnancy,
* morbid obesity (BMI \> 40 kg/meter squared)
* history of sleep apnea
* multiple gestation
* known renal dysfunction
* medications known to affect cardiac function
* current or past abnormal echocardiogram

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Oklahoma State University Center for Health Sciences
state: Oklahoma
Study officials:
affiliation: Oklahoma State University Center for Health Sciences
name: Kimberly A Sorensen, DO
role: STUDY_CHAIR
affiliation: Oklahoma State University Center for Health Sciences
name: John M Beal, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05670002: Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of at Risk and Stunted Children
Official title: Nutrition Intervention of Complementary Milk Feeding to Improve Linear Growth of at Risk and Stunted Children Aged Between 12-36 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: At Risk or Stunted Children
Lead sponsor: FrieslandCampina
Sponsor class: INDUSTRY
Collaborators: name: Universiti Sains Malaysia
First posted: 2023-01-03
Enrollment: 118
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a non-randomized open label 6 months intervention study that aims to assess the effectiveness of consuming milk daily for 6 months will improve the linear growth rate of children aged 12-36 months.


Eligibility criteria: Inclusion Criteria:

1. Malaysian child
2. Boys and girls between the age of 12 and 36 months
3. Length-for-age z score (LAZ) \<-1.5 SD and \> -3 SD according to the WHO Growth standard
4. Weight-for-age z score WAZ \<1.0 SD and \> -3 SD
5. Parents and/or legal guardian who can speak and read Malay or English language
6. Written informed consent from parents and/or legal guardian
7. Child who are apparently healthy with no obvious on-going infection and no history of chronic illness.
8. Child with no physical and/or mental illness
9. Parents and/or legal guardian who owns a mobile phone or smart phone
10. Mothers who have ever received breastfeeding counselling from a qualified breastfeeding counsellor.

Exclusion Criteria:

1. Child with zinc protoporphyrin (ZnPP) value of \>65 (at either -T3 or T0)
2. Clinical symptoms of iron deficiency as examined by Doctor even with zinc protoporphyrin (ZnPP) value between 40-64
3. Child with severe acute malnutrition, other chronic diseases or any congenital disorder or deformity
4. Child with an ongoing episode of diarrhoea or a history of persistent diarrhoea in the past month
5. Child with history of cow's milk allergy/intolerance to milk
6. Child who is already taking multivitamins, including iron, before enrolled to the study
7. Child who is taking breastmilk as part of the diet

Primary outcomes:
measure: Linear growth
timeFrame: 6 months
Secondary outcomes:
measure: Growth velocity
timeFrame: 9 months
measure: Zinc Protoporphyrin (ZnPP) levels
timeFrame: 9 months
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: School of Health Sciences
state: Kelantan
Study officials:
affiliation: Universiti Sains Malaysia
name: Hamid Jan Jan Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00282802: Twins and the Risk of Parkinson's Disease: A Clinical and Imaging Study
Official title: Twins and the Risk of PD: A Clinical and Imaging Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
twins
SPECT
National Academy of Sciences/National Resource Council (NAS/NRC) World War II Veteran Twins Cohort Registry
NAS/NRC
World War II Veteran Twins
Lead sponsor: The Parkinson's Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2006-01-27
Enrollment: 250
Sex: MALE
Minimum age (years): 77
Maximum age (years): 88
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from a closed cohort-the National Academy of Sciences/National Resource Council (NAS/NRC) World War II Veteran Twins Cohort

Brief summary: The purpose of this study is to examine the role of genetic and environmental factors in the cause of Parkinson's disease.

Detailed description: Parkinson's disease (PD) is a growing health problem in the elderly, and genetic factors may provide substantial clues toward eventual treatment and/or prevention of the disorder. The National Academy of Sciences/National Resource Council (NAS/NRC) World War II (WWII) Veteran Twins Cohort Registry is one of the few population-based groups of elderly twins. Previous studies in this group indicated that genetic factors were involved only in early-onset PD, however there was no follow-up to these studies.

The purpose of the "Twins and the Risk of PD" study is to follow-up previous studies and confirm the initial findings. In this study, investigators will use the NAS/NRC WWII Veteran Twin Cohort Registry to compare the concordance rates for PD in monozygotic and dizygotic twins-at least one of whom has PD.

The overall goal of this research is determine the contributions of genetic and environmental factors in the cause of PD.

The study will involve traditional clinical research methods, such as a clinical examination, as well as innovative imaging techniques, such as single photon emission computed tomography (SPECT). SPECT-a nuclear imaging test involving blood flow to tissue-is used to evaluate certain brain functions.

Findings from this study may help to set research priorities in PD, and to develop tools for early detection of the disorder.

Eligibility criteria: Inclusion:

* Participants will be recruited from a closed cohort-the National Academy of Sciences/National Resource Council (NAS/NRC) World War II Veteran Twins Cohort

Primary outcomes:
measure: Onset of Parkinson's disease
timeFrame: duration of the project
Secondary outcomes:
measure: Age of Parkinson's disease onset
timeFrame: duration of the project
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: The Parkinson's Institute, 675 Almanor Avene
state: California
Study officials:
affiliation: The Parkinson's Institute
name: Caroline M. Tanner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02088502: Theophylline, N-acetylcysteine, and Theophylline Plus N-acetylcysteine in Preventing Contrast-induced Nephropathy
Official title: Comparative Evaluation of the Effect of Theophylline Plus N-acetylcysteine, Theophylline Alone, and N-acetylcysteine Alone in Preventing Contrast-induced Nephropathy in Patients With Moderate to High Risk Undergoing Coronary Angiographic Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Contrast-Induced Nephropathy
Keywords: Coronary Angiography
Side Effects
Contrast-Induced Nephropathy
Prevention
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the efficacy of Theophylline, N-Acetylcysteine and, and Theophylline plus N-acetylcysteine in the prevention of contrast-induced nephropathy. Investigators assume that Theophylline plus N-acetylcysteine is more effective than Theophylline alone and N-acetylcysteine alone. Investigators include patients referring for elective coronary angiography or angioplasty and allocate them to each of the mentioned treatments from 24 hours before to 48 hours after administration of contrast material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25% of the baseline value.


Eligibility criteria: Inclusion Criteria:

* adult patients
* candidate of elective coronary angiography or angioplasty
* at least moderate risk for contrast induced nephropathy

Exclusion Criteria:

* unstable angina or myocardial infarction, cardiac arrhythmia, seizures, acute renal failure, end-stage renal disease
* unstable serum creatinine
* unstable hemodynamic
* intravascular administration of contrast material in the past month
* using theophylline or N-acetylcysteine in the past month,
* known hypersensitivity to theophylline or N-acetylcysteine

Primary outcomes:
measure: Plasma creatinine level
timeFrame: up to 48h after contrast injection
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Chamran Hospital
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Mortaza Arabmomeni, M.D.
role: STUDY_DIRECTOR
References:
citation: Albabtain MA, Almasood A, Alshurafah H, Alamri H, Tamim H. Efficacy of ascorbic acid, N-acetylcysteine, or combination of both on top of saline hydration versus saline hydration alone on prevention of contrast-Induced nephropathy: a prospective randomized study. J Interv Cardiol. 2013 Feb;26(1):90-6. doi: 10.1111/j.1540-8183.2012.00767.x. Epub 2012 Sep 20.