louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00136266: Adherence With Iron Sprinkles Among High-Risk Infants
Official title: Adherence With Iron Sprinkles Among High-Risk Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Iron Deficiency
Keywords: Adherence
Supplements
Iron
Iron deficiency
Anemia
Vitamins
Minerals
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-08-29
Enrollment: 128
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.

Detailed description: Iron deficiency is the most common known nutrient deficiency and cause of anemia in childhood. It is associated with numerous adverse health effects, particularly delayed mental and motor development, that may be irreversible. Despite advances of iron nutrition, the prevalence of iron deficiency remains high among low-income infants and toddlers. Previous studies suggest adherence with iron containing drops is low. Adherence to iron sprinkles among children as tested in studies in less developed countries appears high.

Comparison: Children randomized to ferrous sulfate drops will be compared with children randomized to ferrous fumarate sprinkles.

Eligibility criteria: Inclusion Criteria:

* Healthy infants
* Age 5-7 months
* Presenting for 6 months well-child care
* Caregiver speaks English or Spanish

Exclusion Criteria:

* Pre-existing medical conditions with potential relation to iron deficiency or anemia (e.g., hemoglobinopathies, gastrointestinal disorders resulting in malabsorption, chronic renal disease, gestational age at birth of less than 36 weeks, and HIV infection)
* Inability to speak English or Spanish
* Use of vitamin or iron supplements in the previous three months

Primary outcomes:
measure: full adherence, use of iron supplements 6-7 days/week for 3 months
Secondary outcomes:
measure: iron deficiency at 9 months of age
measure: anemia at 9 months of age
Other outcomes:
Locations:
city: Boston
country: United States
facility: Whittier Street Health Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center Pediatric Primary Care Clinic
state: Massachusetts
Study officials:
affiliation: Boston University
name: Paul L. Geltman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geltman PL, Hironaka LK, Mehta SD, Padilla P, Rodrigues P, Meyers AF, Bauchner H. Iron supplementation of low-income infants: a randomized clinical trial of adherence with ferrous fumarate sprinkles versus ferrous sulfate drops. J Pediatr. 2009 May;154(5):738-43. doi: 10.1016/j.jpeds.2008.11.003. Epub 2008 Dec 25.
Clinical trial NCT01191866: Psychosocial Interventions in the Treatment of Youth With Type 1 Diabetes Mellitus
Official title: Intensive Individual and Familial Psychosocial Interventions in the Treatment of Children and Adolescents With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
psychosocial
metabolic control
quality of life questionnaires
children
adolescents
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-08-31
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic will be eligible for inclusion in the study.

Brief summary: Primary Objective is to evaluate the influence of psychosocial interventions in the treatment of children and adolescents with type 1 diabetes mellitus by measuring the connection between these interventions to quality of life and to metabolic control. Secondary Objective is to provide an opportunity, through quality of life (QOL) questionnaires, for enhanced communication between the patient, family and diabetes care team and also an opportunity to resolve negative issues.


Eligibility criteria: Inclusion Criteria:

* All children and adolescents with type 1 diabetes mellitus attending Assaf Harofeh Pediatric Diabetes Clinic will be eligible for inclusion in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Pediatric Diabetes Clinic
Study officials:
References:
Clinical trial NCT00323466: A Study of the Effect on Oro-dental Complications of Intensity Modulated Radiotherapy (IMRT) Versus Conventional Radiotherapy in Patients With Cancer of the Head or Neck
Official title: A Study of the Effect on Oro-dental Complications of Intensity Modulated Radiotherapy (IMRT) Versus Conventional Radiotherapy in Patients With Cancer of the Head or Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer: Head or Neck
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2006-05-09
Enrollment: 43
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: Study to investigate the effect of two types of radiotherapy on saliva: IMRT versus conventional radiotherapy.

In each group, one part will receive normal dental preventive treatment. The other part will use products for treatment of dry mouth (Biotene gamma).

Both anorganic and organic components of the saliva will be studied at different time points, combined with bacterial swabs.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Cancer of head or neck

Exclusion Criteria:

-

Primary outcomes:
measure: Volume of saliva
timeFrame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
measure: Quality of saliva
timeFrame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
measure: Oral flora
timeFrame: Before, during (week 4) and after radiation (week 2, 3, 6 and 12)
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Roeland De Moor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04288466: Gastric Emptying of Maltodextrin Solution in Elderly and in Adults
Official title: Gastric Emptying of Maltodextrin Solution in Elderly and in Adults: Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aspiration; Liquids
Fasting
Perioperative Pulmonary Aspiration
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Gastric volume will be measured before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly.

Detailed description: Gastric volume will be estimated before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly using antral ultrasound.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II;
* No known risk factor for slow or fast gastric emptying.

Exclusion Criteria:

* Vomiting the study solution before completion.
* Wrong timing of assessment.
* Protocol violation.

Primary outcomes:
measure: Antral Volume change
timeFrame: Just before and 5, 30, 60, 90 and 120 minutes after drinking the study solution (repeated measures)
Secondary outcomes:
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital das Forças armadas
state: Distrito Federal
Study officials:
affiliation: Professor
name: Gabriel MN Guimaraes, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05367466: Risk Factors of Neonatal Thrombosis
Official title: Evaluation of Acquired and Hereditary Risk Factors of Neonatal Thrombosis: Single-centre Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombosis
Keywords: newborn, hereditary risk factors
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 11
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newborns in NICU during 5 year period

Brief summary: The incidence of symptomatic thrombosis is between 2.4 and 6.8 per 1000 neonatal intensive care unit admission while it is 5.1 per 100 000 live births. Compared to adults, the anticoagulant and fibrinolytic system of newborns is significantly different.

In this study, the aim is to evaluate infants with neonatal thrombosis in our unit to characterize acquired and genetic risk factors, the laboratory work-up parameters and the diagnosis approach.

Detailed description: All newborn patients diagnosed with neonatal thrombosis in our NICU between 2014 and 2019; were included in the study.

Patients' data: maternal and neonatal characteristics, consanguinity, need for resuscitation, Apgar scores, diagnoses, need for mechanical ventilation, sepsis, catheter placement, treatment regimens and hospital outcomes; Laboratory findings: CBC; D-dimer levels and the performed genetic test Thrombosis diagnosis was confirmed by imaging techniques such as ultrasonography (USG), echocardiography, and magnetic resonance imaging (MRI).

The genotypes: Factor V (Leiden) G1691A, prothrombin G20210A, MTHFRC677T, MTHFRA1298C, PAI-SERPINE1, Factor XIII V34L mutations

Eligibility criteria: Inclusion Criteria:

* All newborn accepted at NICU

Exclusion Criteria:

* No

Primary outcomes:
measure: Thrombosis in the neonatal period is multifactorial
timeFrame: January 2022
measure: Hereditary thrombophilia factors also should be thought
timeFrame: January 2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06761066: Efficacy and Safety of NVP-NK4146 in Patients with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Official title: 36-week, Single-center, Randomized, Double-blind, Parallel-design, Placebo-controlled Trial to Determine the Safety and Efficacy of NVP-NK4146 in Patients with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2025-01-07
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to exploratively evaluate the efficacy and safety of NVP -NK4146 in improving mild cognitive impairment (MCI) in patients with due to Alzheimer's disease (AD) compared to placebo

Detailed description: 36-week, single-center, randomized, double-blind, parallel-design, placebo-controlled trial

Eligibility criteria: Inclusion Criteria:

1. Male and female adults aged 60 or older
2. Subject who meet the National Institute of Aging and Alzheimer's Associations (NIA-AA) core clinical criteria for MCI and have positive readings from amyloid PET
3. Subject who can read and understand the Informed Consent Form and legends and who voluntarily decided to participate in current clinical trial and have signed the Informed Consent Form

Exclusion Criteria:

1. Subject diagnosed with dementia according to the criteria of DSM-5 or ICD-10
2. Subject currently receiving treatment for malignant tumors (except those who have fully recovered from cancer for more than 5 years or those with basal cell carcinoma, squamous cell carcinoma, or prostate cancer may participate at the investigator's discretion)
3. Subject who are illiterate and/or without any education
4. Any other factors deemed by the investigator to be likely to ineligible for the study

Primary outcomes:
measure: amyloid PET scan
timeFrame: baseline and 36 weeks
Secondary outcomes:
measure: ADAS-Cog(Alzheimer's Disease Assessment Scale-Cognitive Subscale)13
timeFrame: baseline and 36 weeks
measure: CDR-SB(Clinical Dementia Rating-Sum of Boxes)
timeFrame: baseline and 36 weeks
measure: GDS (Global Deterioration Scale)
timeFrame: baseline and 36 weeks
measure: K-MMSE (the Korean Mini-Mental State Examination)
timeFrame: baseline and 36 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00125866: The Effect of Cocoa Flavonoids on Blood Pressure
Official title: The Effect of Cocoa Polyphenols on Various Cardiovascular Measurements Including Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: randomised double blind trial
blood pressure
cocoa flavonoids
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: MasterFoods
First posted: 2005-08-02
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects on blood pressure of a daily intake of a flavonoid-rich cocoa drink with that of the same drink from which the flavonoids have been largely extracted.

Detailed description: Flavonoids are natural substances found in fruits and vegetables, tea and red wine. The investigators know that people who eat a diet rich in these foods are less likely to have heart disease. This, in part, may be due to the blood pressure lowering effect of flavonoids. Cocoa beans are a rich natural source of flavonoids. Unfortunately when cocoa is made into chocolate most of the flavonoids are destroyed. The aim of this study is to find out the effect of cocoa flavonoids on blood pressure after 12 weeks of daily consumption of a specially prepared chocolate drink that is rich in flavonoids.

Eligibility criteria: Inclusion Criteria:

* Males or females of any age.
* Diagnosis of hypertension and on antihypertensive treatment.
* Stable blood pressure that has reached the British Hypertension Society (BHS) audit standard (\<150/90mmHg).

Exclusion Criteria:

* Participation in another clinical trial.
* Any reason to suspect that the patient will not comply with drinking a chocolate beverage every day for the trial duration.

Primary outcomes:
measure: Difference in mean 24 hour ambulatory blood pressure
Secondary outcomes:
measure: Difference in cholesterol
measure: Difference in glucose
measure: Difference in insulin
measure: Difference in echocardiogram
measure: Difference in pulse wave velocity
Other outcomes:
Locations:
city: Paddington
country: United Kingdom
facility: Imperial College London
state: London
Study officials:
affiliation: Imperial College London
name: Neil R Poulter
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05908266: Flexible Reaching Control in Parkinson Disease
Official title: Behavioural Study of Reaching Control in Healthy Volunteers and Volunteers With Parkinson Disease in Dynamical Context
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 100
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: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be based on two populations: on population of volunteers with Parkinson disease, and one population of age and sex matched healthy individuals.

Brief summary: Current research and theories have highlighted that the parameters linked to movement planning, e.g. the decision to select a movement goal, and adaptation, e.g. the ability to update control dependent on a novel dynamical context, are update quickly and within an ongoing movement in the general population. In parallel, it has been suggested that the evaluation of movement costs is a function of the basal ganglia, and it is impaired in Parkinson disease (PD). Here the investigators want to test whether these mechanisms also alter the ability of patients to update control during an ongoing action. A positive result would confirm that movement-related costs and dynamical representations depend on the integrity of the basal ganglia, in contrast a negative result would indicate that the deficit in PD is more specifically related to movement initiation, which would invite one to reconsider the cause of bradykinesia in this population.


Eligibility criteria: Inclusion Criteria:

* Ability to perform the task (assessed during the experiment)

Exclusion Criteria:

* Inability to perform the task (motor) or to understand the task requirements (cognitive)

Primary outcomes:
measure: Kinematics
timeFrame: Measured during the entire experiment (an average of 4.5 years)
measure: Surface Electromyogram
timeFrame: Measured during the entire experiment (an average of 4.5 years)
measure: Applied forces
timeFrame: Measured during the entire experiment (an average of 4.5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: Université catholique de Louvain
Study officials:
affiliation: Université Catholique de Louvain
name: Frédéric Crevecoeur, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00437866: Hepcidin in Anemic Chronic Heart Failure (CHF) Patients
Official title: Hepcidin in the Pathogenesis of Anemia in Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Chronic Heart Failure
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Heart failure outpatients

Brief summary: Background: Anemia in chronic heart failure (CHF) is directly linked to increased mortality and reduced exercise capacity. The pathomechanism for the development of anemia in CHF is not well understood. Impairment of iron homeostasis is discussed to be one of the major triggers in anemia of chronic disease. Hepcidin was recently described as the central regulator of iron homeostasis.

Main hypothesis: Plasma hepcidin levels are altered in anemic CHF patients compared to non anemic controls and might be a main contributing factor of anemia in CHF.

Iron regulator-hypothesis High levels of cytokines in CHF patients cause up-regulation of hepcidin, which in turn leads to low iron uptake causing anemia. In this case venous hepcidin and hemoglobin concentrations should both correlate with cytokine levels.

Erythropoietin regulator-hypothesis Dysregulation of the erythropoietin system results in anemia, which represses hepcidin. This leads to a negative correlation between hemoglobin and hepcidin in plasma.

Methods: 100 consecutive patients diagnosed with systolic CHF will be prospectively included in the study. Iron status will be assessed and hepcidin, erythropoietin as well as interleukin-1, interleukin-6 and soluble TNF alpha receptor levels will be measured by ELISA.

Patients will be followed up for one year and mortality, rehospitalization and worsening of CHF will be documented.


Eligibility criteria: Inclusion Criteria:

1. Systolic left ventricular dysfunction (LVEF\<45%)
2. Signed informed consent

Exclusion Criteria:

1. Women of child bearing potential
2. Pregnancy
3. Non cardiac illness limiting life expectancy to \<1 year
4. Renal disease of non-cardiac reason
5. Malignancy
6. Chronic inflammatory disease
7. Acute infection
8. Erythropoietin therapy or iron substitution within the last 6 months

Primary outcomes:
measure: Hemodilution
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
state: Vienna-Austria
Study officials:
affiliation: Medical University of Vienna
name: Martin Huelsmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adlbrecht C, Kommata S, Hulsmann M, Szekeres T, Bieglmayer C, Strunk G, Karanikas G, Berger R, Mortl D, Kletter K, Maurer G, Lang IM, Pacher R. Chronic heart failure leads to an expanded plasma volume and pseudoanaemia, but does not lead to a reduction in the body's red cell volume. Eur Heart J. 2008 Oct;29(19):2343-50. doi: 10.1093/eurheartj/ehn359. Epub 2008 Aug 12.
Clinical trial NCT00944866: Effects of Cox-II Inhibitor on Biochemical Markers in Cardiovascular-related Adverse Effects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis
Lead sponsor: National Chung Hsing University
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Arthritis

Brief summary: The selective cyclooxygenase-2 (COX-2) inhibitors have been associated with increased cardiovascular risk. The goal of the present study is to investigate the impacts of COX-2 inhibitors on biochemical indices in cardiovascular disease. As the reviewer suggested, the investigators propose to study the effects of Cox-II inhibitor using experimentally induced hyperlipidemic rats. Plasma total cholesterol, LDL and triglyceride concentrations will be determined before and after animals treated with cyclooxygenase-2 (COX-2) inhibitors. Biochemical markers related to cardiovascular events including prostaglandin I2, thromboxaneA2 and others will also be investigated. The investigators will also investigate these biochemical markers in patients taking Celecoxib and NSAIDs. The investigators hope these studies will reveal clinically useful biochemical markers for cardiovascular events in patients taking Cox-II inhibitor.


Eligibility criteria: Inclusion Criteria:

* Male/female age \>18
* Clinical diagnosed of arthritis

Exclusion Criteria:

* Must not be pregnant/breastfeeding
* Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitus, malignant melanoma, cardiac conduction disorders, hepatic/renal insufficiency.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chang HY, Tang FY, Chen DY, Chih HM, Huang ST, Cheng HD, Lan JL, Chiang EP. Clinical use of cyclooxygenase inhibitors impairs vitamin B-6 metabolism. Am J Clin Nutr. 2013 Dec;98(6):1440-9. doi: 10.3945/ajcn.113.064477. Epub 2013 Oct 23.