louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03057717: The Effect of Antenatal Corticosteroids on the Fetal Thymus - a Possible Role in Fetal Immune Programming
Official title: The Effect of Antenatal Corticosteroids on the Fetal Thymus - a Possible Role in Fetal Immune
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Labor
Fetal Glucocorticoid Exposure
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 86
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Administration of corticosteroids is standard practice for pregnant patients at risk of preterm labour to reduce the risk of neonatal respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis and neonatal mortality. However, there is an unknown effect of antenatal steroids on both fetal and neonatal immune function. The purpose of this study is to demonstrate the effect of antenatal steroids on the size of the fetal thymus gland.

Detailed description: Women with a singleton pregnancy in the twenty-forth to thirty-fourth week of gestation who are at risk for preterm labour, requiring the administration of Betamethasone twelve milligrams intramuscularly every twenty-four hours for two doses will be included in this study along with an equal number of gestational-age matched controls not at risk for preterm delivery and therefore not requiring the administration of Betamethasone. A 2-D ultrasound assessment of the fetal thymus size with measurements of the maximum transverse diameter and thymus perimeter in the three-vessel view will be performed as a baseline measurement within 36 hours of the administration of the first dose of corticosteroids. For each patient enrolled, a gestational-age matched control will have a similar ultrasound assessment. These measurements will be repeated 2 weeks after the first baseline ultrasound, and then only patients who received corticosteroids will have subsequent ultrasound measurements every 2 weeks until delivery.

Eligibility criteria: Inclusion Criteria:

* Women with a singleton pregnancy in the twenty-forth to thirty-fourth week of gestation who are at risk for preterm labour, requiring the administration of Betamethasone twelve milligrams intramuscularly every twenty-four hours for two doses will be included in this study along with an equal number of gestational-age matched controls not at risk for preterm delivery and therefore not requiring the administration of Betamethasone.

Exclusion Criteria:

* chronic use of steroids during pregnancy for other indications
* delivery less than 1 week from enrollment
* confirmed chorioamnionitis or preterm premature rupture of membranes.

Primary outcomes:
measure: Fetal Thymus Size
timeFrame: 24 weeks gestation to delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Unity Health Toronto
name: Howard Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05348317: Developing a Telehealth Model to Improve Treatment Access for Rural Veterans With Substance Use Disorders
Official title: Using Telehealth to Expand Treatment Access for Veterans With Opioid Use Disorder (CDA 18-008)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
Substance Use Disorders
Substance Dependence
Veterans
Keywords: Telehealth
Motivational Interviewing
Cognitive Behavioral Therapy
Rural Health
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Ann Arbor Healthcare System
First posted: 2022-04-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This project will pilot-test and obtain stakeholder input on a telehealth-delivered substance use disorder (SUD) care model (with initial engagement and ongoing MI-CBT treatment) with the goal of increasing treatment utilization and improving outcomes for rural and non-rural Veterans with SUDs.


Eligibility criteria: Inclusion Criteria:

* Veteran patients at the Ann Arbor VA Healthcare System
* Diagnostic and Statistical Manual of Mental Disorders (DSM-5) SUD diagnosis and/or substance use on average of 2 days a week over the past month
* Telephone access
* Able to provide informed consent

Exclusion Criteria:

* Receiving SUD psychotherapy
* Inability to speak or understand English
* Substantial mental health instability or conditions that preclude informed consent (e.g., acute psychosis, cognitive deficits) or understanding of assessment or program content
* Prior alcohol withdrawal seizures or delirium tremens

Primary outcomes:
measure: Feasibility of the intervention (engagement)
timeFrame: 8 weeks
measure: Acceptability of the telehealth intervention
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
measure: Change in substance consumption
timeFrame: baseline, 8 weeks post-baseline
measure: Change in frequency of substance use as reported on the Timeline Follow-Back (TLFB)
timeFrame: baseline, 8 weeks post-baseline
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Lewei Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04554017: Knowledge on Preventive Measures of Hypertension
Official title: Knowledge on Preventive Measures of Hypertension: An Interventional Study Among Senior High School Students, Kenyase - Ghana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Garden City University College
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 345
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Hypertension among children and adolescents is on the rise in both developed and developing countries. Childhood and adolescent obesity, a key factor for hypertension in this population results largely from unhealthy dietary and physical inactivity behaviours. Adequate knowledge, a component for behavior change, has been found to be crucial to improving one's confidence to tackle these improper behaviours. Despite this, there are gaps in knowledge on hypertension and its risks factors in Ghanaian adolescents. Using an educational intervention (health talk), the study therefore sought to improve knowledge on preventive measures of hypertension among senior high school students in Ghana.

Detailed description: A pre-post interventional study using health talks was carried out among 345 adolescents aged 13 to 20 years. Participants included both male and female students aged 13 to 20 years. Owing to the large number, the students were divided into two groups. The Pre-test was then administered. Following this, two health education sessions were delivered by two registered nurses for each session. A week after these health talks, the research team went back to the school to collect data for the post-intervention. Questionnaires used for both pre and post assessment collected data on demographic factors and knowledge on dietary and physical activity behaviours linked to hypertension.

Eligibility criteria: Inclusion Criteria:

* Participants who gave consent
* Minors with parental or guardian assent

Exclusion Criteria:

* Participants already living with hypertension

Primary outcomes:
measure: Change in participants knowledge on the preventives measures of hypertension using the mean scores
timeFrame: 1 week
Secondary outcomes:
measure: Association between the demographic characteristics and impact of the educational intervention on adolescents' knowledge on the preventive measures was measured using logistic regression analysis
timeFrame: 1 week
Other outcomes:
Locations:
city: Kumasi
country: Ghana
facility: Isaac Nkrumah
Study officials:
affiliation: Garden City University College
name: Isaac Nkrumah, Masters
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01432717: Study of ACE-536 in Healthy Postmenopausal Women
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ACE-536 in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia
Lead sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether ACE-536 can be safely given to patients. This study will also look to see if ACE-536 increases red blood cells, the cells that carry oxygen in the body.


Eligibility criteria: Key Inclusion Criteria:

* Postmenopausal women
* Body Mass Index (BMI) of 20 - 32 kg/m2.

Key Exclusion Criteria:

* History of hypertension
* Subject has received any erythropoiesis stimulating agents (e.g., Epogen, Procrit, Aranesp, etc.) within 6 months prior to Day 1
* History of clinically significant cardiac, endocrine, hematologic, hepatic, immune, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other disease
* Surgery within 3 months (other than minor cosmetic surgery or minor dental procedures)
* Subject has received treatment with another investigational drug, or approved therapy for investigational use within 1 month prior to Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Day 1, whichever is longer

Primary outcomes:
measure: Number of participants with Adverse Events as a measure of safety and tolerability.
timeFrame: 22 weeks
Secondary outcomes:
measure: ACE-536 serum concentration after single and multiple ascending doses.
timeFrame: 22 weeks
measure: Hemoglobin levels after single and multiple ascending doses.
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Acceleron Investigative Site
state: Arizona
Study officials:
References:
citation: Attie KM, Allison MJ, McClure T, Boyd IE, Wilson DM, Pearsall AE, Sherman ML. A phase 1 study of ACE-536, a regulator of erythroid differentiation, in healthy volunteers. Am J Hematol. 2014 Jul;89(7):766-70. doi: 10.1002/ajh.23732. Epub 2014 Apr 26.
Clinical trial NCT03135717: Wasting in Chronic Kidney Disease
Official title: Wasting in Chronic Kidney Disease: Refeeding Techniques and Artificial Nutrition Practices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Hospitalized
Keywords: Chronic kidney disease
Enteral nutrition
Oral nutritional supplements
Parenteral nutrition
Refeeding
Wasting
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 48
Sex: ALL
Minimum age (years): 44
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease

Brief summary: Protein energy wasting is an independent factor associated with morbi-mortality in chronic kidney disease. Wasting is particularly common in chronic diseases of organs such as kidney disease with a major impact at the stage of dialysis. It covers 20 to 70% of patients diagnosed with chronic kidney disease according to the degree of evolution of the disease and the diagnostic method.

Mechanisms of PEW are based mainly on anorexia and metabolic abnormalities caused by kidney disease. Nutritional treatment differs depending on the stage of the kidney disease acute or chronic treated whether or not by dialysis. Nutritional monitoring should be regular, individualized and collaborative to detect a risk of PEW or treat installed PEW. Refeeding techniques should allow all the nutritional needs. Their indications depend on the clinic, biochemical assessment and nutrient intake.


Eligibility criteria: Inclusion Criteria:

* Patients with kidney disease
* Patients hospitalized in a university hospital renal ward

Exclusion Criteria:

- Hospitalization less than two weeks

Primary outcomes:
measure: Nutritional care evaluated with questionnaire
timeFrame: Since admissions to hospital, up to 4 weeks
Secondary outcomes:
measure: body composition
timeFrame: Since admissions to hospital, up to 4 weeks
measure: physical activity
timeFrame: Since admissions to hospital, up to 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Denis Fouque, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03293017: Baclofen in Managing Acute Alcohol Withdrawal
Official title: Baclofen Bij de Behandeling Van Acute Alcoholontwenning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Alcohol Use Disorder
Alcohol Withdrawal
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal. The investigators will compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized controlled trial including patients receiving symptom triggered diazepam.

Detailed description: The conducted study will be randomized and single-blind (patients). After signing informed consent, the participants will be randomized in one of three groups: - placebo - baclofen 30 mg/day - baclofen 60 mg/day. The participants will be given a first administration after which the participant can receive Clinical Institute Withdrawal Assessment (CIWA-ar) score triggered diazepam, frequently assessed for at least 7 days. The primary outcome measure is the number of participants who received additional diazepam during these 7 days. The secondary outcome measure is the amount of diazepam received per group.

Eligibility criteria: Inclusion Criteria:

* Be an inpatient at the Psychiatry unit at UZBrussel at time of study enrollment.
* Be able to sign informed consent.
* Be male/female aged 18-60
* Primary diagnosis of alcohol use disorder.

Exclusion Criteria:

* Pregnancy and breastfeeding.
* Benzodiazepine use of more than the equivalent of diazepam 25 mg /day.
* Psychosis, confusion and acute mania.
* Parkinson's disease.
* Use of tricyclic antidepressants.
* Use of opioids.
* Known baclofen or benzodiazepine sensitivity or allergy.
* Unable to take oral medication.
* epidermal growth factor receptor (EGFR) \< 60 (blood samples are routinely performed at intake).
* Prior diagnosis of epilepsy.
* Lactose intolerance.

Primary outcomes:
measure: Need for additional diazepam
timeFrame: Measured 7 days after the start of alcohol withdrawal
Secondary outcomes:
measure: Dosage of additional diazepam needed
timeFrame: Measured 7 days after the start of alcohol withdrawal
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Frieda Matthys, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01055717: Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults
Official title: Bioavailability of Avenanthramide-Enriched Oats in Healthy Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: avenanthramide
enriched
oat
phytochemical
bioavailability
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Agriculture and Agri-Food Canada
First posted: 2010-01-26
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a placebo-controlled, crossover study investigating the pharmacokinetic bioavailability of avenanthramides from avenanthramide-enriched oats and their in vivo metabolites in a cohort of healthy, older adults.


Eligibility criteria: Inclusion Criteria:

* Men and postmenopausal women
* BMI 18.5-29.9 kg/m2

Exclusion Criteria:

* Cigarette smoking and/or nicotine replacement use
* Use of cholesterol-lowering medications
* Use of blood pressure-lowering medications
* Use of any stomach acid-lowering medications
* Cardiovascular (heart) disease
* Gastrointestinal disease
* Kidney disease
* Endocrine disease: including diabetes, untreated thyroid disease
* Rheumatoid arthritis
* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
* Systolic blood pressure \> 150 mm Hg and/or diastolic blood pressure \> 95 mm Hg
* Regular use of oral steroids
* Regular daily intake of 2 or more alcoholic drinks
* Illicit drug use
* No fish oil supplements (including cod liver oil) for one month prior to study admission
* No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) or homeopathic remedies, for one month prior to study admission

Primary outcomes:
measure: Levels of avenanthramides and their in vivo metabolites in blood, urine, and feces following the consumption of avenanthramide-enriched oats delivered in a baked muffin
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts Unversity
name: Jeffrey B Blumberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00443417: A Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease
Official title: Dose Finding Study to Assess the Efficacy and Safety of SK-PC-B70M in Patients With Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-03-06
Enrollment: 188
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find optimistic dose and to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.


Eligibility criteria: Inclusion Criteria:

* Age range : 50 \~ 85 years
* Clinical diagnosis of probable Alzheimer's disease (DSM-IV and NINCDS-ADRDA criteria)
* MRI within the last 12 months consistent with a diagnosis of AD
* MMSE score 10 to 26
* AChEI or memantine was discontinued at least 3 months prior to screening

Exclusion Criteria:

* Patient in mild cognitive impairment (MCI; CDR-SB \<2.5)
* Other central nervous disease
* hypothyroidism, Vitamin B12/ Folic acid deficiency, hypercalcemia, neurosyphilis, AIDS
* T.I.A or Major infarction within the last 12 months
* Any serious disorder that could limit the ability of the patient to participate in the study
* COPD or asthma
* Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study

Primary outcomes:
measure: ADAS-cog(Alzheimer's Disease Assessment Scale-Cognitive subscale)
timeFrame: 30 minutes
Secondary outcomes:
measure: MMSE(Mini Mental State Examination)
timeFrame: 10 minutes
measure: CDR-SB(Clinical Dementia Rating Sum of Box)
timeFrame: 20 minutes
measure: QOL-AD(Quality of Life in Alzheimer's Disease)
timeFrame: 10 minutes
measure: Delayed Word-Recall Task
timeFrame: 5 minute
measure: Symbol Digit Modalities Test
timeFrame: 5 minutes
measure: Digit Backward
timeFrame: 5 minutes
measure: Maze Task
timeFrame: 3 minutes
measure: Digit Cancellation Task
timeFrame: 5 minutes
measure: Verbal Fluency-Categories
timeFrame: 1 minutes
measure: Concentration / Distractibility
timeFrame: 1 minutes
measure: GDS
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SKchemicalsI nvestigational Site
Study officials:
affiliation: Konkuk University Hospital
name: Seol Heui Han, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06228417: A Mobile App for Medication Adherence in Persons With Hypertension: a Pilot Study
Official title: Adaptive Digital Interventions Through Mobile App for Medication Adherence Improvement in Persons With Hypertension: a Pilot Study for Usability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: artificial intelligence
focus group
adherence, medication
pilot study
Lead sponsor: Halmstad University
Sponsor class: OTHER
Collaborators: name: Vinnova
First posted: 2024-01-29
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with hypertension, more than one year, were enrolled. From primary care.

Brief summary: A development and pilot test of an app targeting persons with hypertension. Content in the app was based on persons with hypertensions experiences and a literature review. The participants experience of using the app as well as testing a instrument for medication adherence.


Eligibility criteria: Inclusion Criteria:

* 40-70 years of age,
* have hypertension (i.e., ICD 10 codes I10-I15 in the person's medical history) for ≥1 year
* have been prescribed medications to treat said hypertension
* speak and understand Swedish
* have a smartphone

Exclusion Criteria:

* having received medication with unit-dose packages (Apodos)
* previous stroke
* previous myocardial infarction
* psychological disorder or cognitive impairment (i.e. ICD 10 codes F01-F99)
* pregnancy-induced hypertension´
* insulin treatment
* kidney disease, defined as glomerulus filtration rate (GFR) \<60 ml/min.

Primary outcomes:
measure: Medication adherence
timeFrame: two weeks
measure: Adherence hypertension medication
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Halmstad University
Study officials:
affiliation: Halmstad University
name: Slawomir Nowaczyk, Professor
role: PRINCIPAL_INVESTIGATOR
References: