louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01375309: Bifidobacterium Supplementation for Very Low Birth Weight Infants
Official title: Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Keywords: probiotics
preterm infants
enteral feeding
Bifidobacterium on enteral feeding
Lead sponsor: Tokyo Women's Medical University
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 246
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.


Eligibility criteria: Inclusion Criteria:

* Infants with birth weight less than 1500g

Exclusion Criteria:

* Sever bacteremia
* Congenital anomaly
* Not suitable for the trial defined by an attending neonatologist

Primary outcomes:
measure: Postnatal day when enteral feeding exceeded at 100ml/kg/day
timeFrame: From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth
Secondary outcomes:
measure: standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)
timeFrame: For the duration of NICU stay, an expected average of 3 months
measure: Necrotizing enterocolitis or sepsis
timeFrame: For the duration of NICU stay, an expected average of 3 months
measure: Intestinal flora
timeFrame: For the duration of NICU stay, an expected average of 3 months
Other outcomes:
Locations:
city: Shinjuku
country: Japan
facility: Tokyo Women's Medical Unversity
state: Tokyo
Study officials:
affiliation: Tokyo Women's Medical University
name: Satoshi Kusuda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
Clinical trial NCT00051909: Efficacy and Safety of LY451395 in Patients With Probable Alzheimer's Disease
Official title: Efficacy and Safety of LY451395 in Patients With Probable Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2003-01-20
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of an investigational medication for the treatment of Alzheimer's Disease in patients who are not taking Aricept, Reminyl, Exelon.


Eligibility criteria: Inclusion Criteria:

* Must have a clinical diagnosis of Alzheimer's Disease
* Must be at least 50 years of age
* Must fluently read and speak English
* Must have a reliable caregiver

Exclusion Criteria:

* Has serious health problems other than Alzheimer's Disease
* Cannot swallow whole pills
* Has had a menstrual period in the last two years
* Takes insulin for diabetes
* Has taken Aricept, Reminyl, or Exelon in the last 5 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: Fresno
country: United States
state: California
city: Boca Raton
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Miami Beach
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Wichita Falls
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT00152009: Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17
Official title: A Phase III, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Safety and Efficacy Study of SPD503 in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 345
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged 6-17


Eligibility criteria: Inclusion Criteria:

* Subjects with a primary diagnosis of ADHD
* Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

* Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms
* History of seizure during the last 2 years
* Subject has any specific cardiac condition or family history of significant cardiac condition
* Subject is pregnant or lactating

Primary outcomes:
measure: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at Up to 5 Weeks
timeFrame: Baseline and up to 5 weeks
Secondary outcomes:
measure: Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at Up to 5 Weeks
timeFrame: Baseline and up to 5 weeks
measure: Change From Baseline in Conner's Teacher Rating Scale-revised Short Version (CTRS-R) Score at Up to 5 Weeks
timeFrame: Baseline and up to 5 weeks
measure: Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)
timeFrame: up to 5 weeks
measure: Number of Participants With Improvement in Parent Global Assessment (PGA)
timeFrame: up to 5 weeks
measure: Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 5 Weeks
timeFrame: Baseline and 5 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Biederman J, Melmed RD, Patel A, McBurnett K, Konow J, Lyne A, Scherer N; SPD503 Study Group. A randomized, double-blind, placebo-controlled study of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. Pediatrics. 2008 Jan;121(1):e73-84. doi: 10.1542/peds.2006-3695.
Clinical trial NCT04085809: This Was a Clinical Study Investigating the Moisturization and Desquamation Effect of AmLactin® Rapid Relief Restoring Lotion + Ceramides on Dry Skin in Healthy Female Volunteers. AmLactin® Rapid Relief is an Over-the-counter Cosmetic
Official title: A 14-Day, Single-Blind, Controlled Study to Assess the Qualitative Improvement in Skin Moisturization and Desquamation of AmLactin® Rapid Relief Treatment in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Skin
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2019-09-11
Enrollment: 56
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Upon enrollment, each subject received a randomization code, indicating which leg the study product had to be applied (the other leg received no study product). Each subject in this study served as her own control.
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to investigate if AmLactin® Rapid Relief improves the skin through desquamation and moisturization via D-SQUAME analysis. AmLactin® Rapid Relief is an over-the-counter cosmetic.


Eligibility criteria: Inclusion Criteria:

* healthy female (confirmed by medical history) with Fitzpatrick skin types I-VI
* dry, rough skin on the anterior shins (defined as Grade 3-4 on the dermatologist evaluation of the skin);

Exclusion Criteria:

- Had any visible skin disease at the assessment site which, in the opinion of the Investigator, would interfere with the evaluation of the test site

Primary outcomes:
measure: Change from baseline in D-SQUAME
timeFrame: Baseline, Day 2, Day 14
Secondary outcomes:
measure: Change from baseline in overall dry skin scale
timeFrame: Baseline, Day 2, Day 14
measure: Change from baseline in Skin Dryness assessed by Dry Skin Scale
timeFrame: Baseline, Day 2, Day 14
measure: Change from baseline in Skin Texture/Roughness (Tactile) assessed by Dry Skin Scale assessed by Dry Skin Scale
timeFrame: Baseline, Day 2, Day 14
measure: Change from baseline in Skin Texture/Roughness (Visual) assessed by Dry Skin Scale
timeFrame: Baseline, Day 2, Day 14
measure: Change from baseline in Desquamation/Flakiness assessed by Dry Skin Scale
timeFrame: Baseline, Day 2, Day 14
measure: Change from baseline in Luminosity/Radiance assessed by Dry Skin Scale
timeFrame: Baseline, Day 2, Day 14
measure: Change from baseline in Subject Self-Assessment Questionnaire
timeFrame: Baseline, Day 14
Other outcomes:
Locations:
city: High Point
country: United States
facility: Sandoz Investigational Site
state: North Carolina
Study officials:
References:
citation: Draelos ZD, Hall S, Munsick C. A 14-day Controlled Study Assessing Qualitative Improvement with 15% Lactic Acid and Ceramides in Skin Moisturization and Desquamation. J Clin Aesthet Dermatol. 2020 Aug;13(8):E54-E58. Epub 2020 Aug 1.
Clinical trial NCT05996809: PMCF Study for COSEAL® in Gynecologic Surgery
Official title: Post-Market Clinical Follow-up Study for COSEAL® in Gynecologic Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adhesion
Keywords: gynecological surgery, adhesion related morbidities
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2023-08-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data will be collected from adult female patient charts in whom COSEAL was used as an adjunct to good surgical technique to reduce the incidence, severity, and extent of post-surgical adhesion formation. Data will also be collected from the questionnaire responses, when necessary

Brief summary: The study is a single-arm, retrospective, chart review with a patient questionnaire intended to supplement the patient chart, when necessary. The population will consist of patients who underwent an index gynecologic surgery (performed at least 2 years prior to the start of the study) during which COSEAL was used as an adjunct to good surgical technique to reduce the incidence, severity, and extent of post-surgical adhesion formation. The purpose of the study is to detect the incidence of adhesion-related morbidities as measured by the proportion of adhesion-related readmissions, including reoperations in these patients.

Patient charts will be reviewed to collect the data on readmissions related to adhesions, If the patient chart has no record of adhesion related readmission within approximately 2 years of the index surgery, then a patient questionnaire will be sent. A questionnaire may still be sent if a patient chart has a record of adhesion related readmission within approximately 2 years of the index surgery and further clarification is needed. The questionnaire will collect information regarding readmission or reoperation directly or possibly related to adhesions following the index gynecologic surgical procedure at a hospital or outpatient clinic other than that of the index surgery.


Eligibility criteria: Inclusion Criteria:

1. Adult female patients who, at the time of surgery, were ≥18 years of age and who have undergone an index gynecologic surgery at least 2 years prior to the start of the study.
2. Patients in whom COSEAL was used for the reduction of post-surgical adhesion formation

Exclusion Criteria:

1. Patients who had frank infection in the abdominopelvic cavity at the time of the surgery

Primary outcomes:
measure: Incidence of hospital readmissions directly or possibly related to adhesions following the use of COSEAL in gynecologic surgery, approximately 2 years from the date of index surgery.
timeFrame: within 2 years of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Feinberg School of Medicine
state: Illinois
city: Rome
country: Italy
facility: Universita Campus Bio Medico di Roma
Study officials:
References:
Clinical trial NCT04456309: Brain MRI in Stroke Patients With Intracardiac Thrombus
Official title: Brain MRI Characteristics in Stroke Patients With Intracardiac Thrombus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Intracardiac Thrombus
Keywords: brain MRI
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2 groups of patients :

1 - Stroke patients with atrial fibrillation

2- Stroke patients with intracardiac thrombus

Brief summary: Acute infarction patterns have been described in cardioembolic stroke, mainly with atrial fibrillation (AF) or patent foramen ovale. We aimed to analyse acute infarction MRI characteristics in stroke patients with intracardiac thrombus (ICT) compared with stroke patients with AF.


Eligibility criteria: Inclusion Criteria:

* consecutive patients presenting with acute symptomatic cardioembolic infarction associated with ICT, recruited and registered in the stroke database between June 2018 and November 2019 of our centre (Nîmes University Hospital, France). These patients were compared with consecutive cardioembolic stroke patients with known or newly discovered AF (in the absence of ICT on echocardiography), recruited during the same time period.
* Brain MRI (including diffusion-weighted imaging \[DWI\]) performed within one week of symptom onset; complete etiological work-up including intracranial (time-of-flight \[TOF\], gadolinium-enhanced magnetic resonance angiography \[MRA\], or computed tomographic angiography \[CTA\]) and extracranial (gadolinium-enhanced MRA, CTA, or duplex ultrasound) vessel imaging; transthoracic or transoesophageal echocardiography; and ≥24h ECG monitoring (acute stroke unit monitoring and/or Holter ECG monitoring).

Exclusion Criteria:

* opt-out patient

Primary outcomes:
measure: Brain MRI characteristics
timeFrame: Day of inclusion (Day 1)
measure: Brain MRI characteristics
timeFrame: Day of inclusion (Day 1)
measure: Brain MRI characteristics
timeFrame: Day of inclusion (Day 1)
measure: Brain MRI characteristics
timeFrame: Day of inclusion (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Dimitri RENARD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trandafir C, Sandiramourty S, Laurent-Chabalier S, Ter Schiphorst A, Nguyen H, Wacongne A, Ricci JE, Pereira F, Thouvenot E, Renard D. Brain Infarction MRI Pattern in Stroke Patients with Intracardiac Thrombus. Cerebrovasc Dis. 2021;50(5):581-587. doi: 10.1159/000515707. Epub 2021 Jun 17.
Clinical trial NCT01661309: Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial
Official title: To Critically Investigate and Evaluate Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians, Who May Have a Resultant Susceptibility to Hyperhomocysteinemia Related Diseases.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin B12 Deficiency
Keywords: Hyperhomocysteinemia
Methylcobalamin
Cardiovascular disease
Plasma total homocysteine
Vegetarians
Lead sponsor: University of West London
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary animal produce, which can elevate homocysteine. There is strong evidence indicating that elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.


Eligibility criteria: Inclusion Criteria:

* Having a plasma tHcy \>10 micromol/L
* Not suffering from conditions as described in exclusion criteria.
* Vegetarian for at least one year.
* Not participating in a weight reducing diet.
* Not consuming regularly vitamin B12 supplements.
* Give written consent to participate in clinical trial and be fluent in English language.

Exclusion Criteria:

* Having a plasma tHcy less or equal to 10 micromol/L.
* Suffering from pernicious anemia or other vitamin B12 deficiency disease.
* Undergone bowel surgery or suffer from gastrointestinal disease.
* Pregnant, lactating or trying to conceive.
* Smoker.
* Alcohol intake regularly greater than official recommended daily units (i.e. 2 units female, 3 units male).
* Consume large amounts of caffeine (regular consumption of \>4 cups of strong tea or coffee per day).
* Use of medications known to influence nutritional status.
* Have genetic metabolic disease.
* Suffer from renal failure, diabetes, thyroid disease, cardiovascular disease, dementia or cancer.
* Have a known blood-borne infection (e.g. Hepatitis or HIV).

Primary outcomes:
measure: Reduction of plasma total homocysteine of vegetarians
timeFrame: 16 weeks per participant
Secondary outcomes:
measure: Improvement in systolic and diastolic blood pressure
timeFrame: 16 weeks per participant
Other outcomes:
measure: Improvement in body mass index
timeFrame: 16 weeks per participant
Locations:
city: London
country: United Kingdom
facility: University of West London
state: Middlesex
Study officials:
affiliation: University of West London
name: Amalia A Tsiami, PhD
role: STUDY_DIRECTOR
affiliation: University of West London
name: David C Chappell, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04110509: Fragility and Programmed Cardiovascular Surgery (EcoSarco)
Official title: Fragility and Programmed Cardiovascular Surgery: Development of Muscle Ultrasonographic Biomarkers of Sarcopenia and Post-surgical Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fragility
Intensive Care Unit Syndrome
Keywords: Imaging biomarkers
Ultrasonography
Fragility
Intensive Care Unit
Lead sponsor: Universidad Antonio de Nebrija
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are admitted to the Intensive Care Unit of the Hospital Clínico Universitario Virgen de la Arrixaca de Murcia (HCUVAM) and the Hospital Universitario del Vinalopó de Elche (HUVE) for surgery programmed cardiovascular, specifically aortic valve replacement.

Brief summary: Objectives: To characterize textural ultrasonographic biomarkers of the brachial biceps musculature, wrist flexors, quadriceps and anterior tibial muscle that allow the recognition of the muscular and functional status of patients undergoing programmed cardiovascular surgery and relate them to mortality, hospital stay and functionality results after the intervention.

Design: A first phase of cross-sectional observational study and a second phase of longitudinal observational prospective study. Participants: Patients with programmed cardiovascular surgery to aortic valve replacement Outcomes: Sociodemographic and anthropometric variables, severity and clinical risk scales, disability, fragility and quality of life scales, nutritional status and textural muscular biomarkers with ultrasonography.

Expected results: strong association between ultrasound muscle biomarkers and ICU and hospital stay, disability, fragility and quality of life after the surgery.


Eligibility criteria: Inclusion Criteria:

* Waiting list patients with cardiovascular surgery scheduled for aortic valve refill

Exclusion Criteria:

* Urgency while waiting list
* Patients with no evaluation by presurgery committee
* Previous diagnosis of neuropathies, radiculopathy, polyneuropathy congenital or acquired or pathologies with muscular affectation

Primary outcomes:
measure: Changes in muscle ultrasonography variation after surgery
timeFrame: 6 months
measure: Changes in muscle echointensity after surgery
timeFrame: 6 months
measure: Changes in muscle texture after surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Jose Rios-Diaz
Study officials:
References: