louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01600820: Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Spain)
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Clinical Study on the Effects of a Fermented Dairy Product Enriched With Phytosterols Over Blood Cholesterol Levels of Hypercholesterolemic Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Plant sterol
Hypercholesterolemia
diet
dairy
LDL-C
Mildly hypercholesterolemic subjects
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2012-05-17
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks in mildly hypercholesterolemic subjects treated or not by statins.


Eligibility criteria: Inclusion Criteria:

* male and female aged 18-75 years;
* BMI between 19 and 30 kg/m2 ,
* LDL-cholesterol higher than 130 mg/dl in individuals with a 10-year risk ≤ 20% without ischemic cardiopathy; or
* higher than 100 mg/dl in individuals with a 10-year risk \> 20% or with ischemic cardiopathy (according to NCEP ATPIII guidelines),
* with or without statin monotherapy,
* willing to respect the dietary advising delivered at the screening visit,
* agreeing to a written informed consent

Exclusion Criteria:

* subject with plasma triglycerides (TG) levels \> 400 mg/dL,
* with any cardiovascular event in the last 6 months,
* subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy,
* diabetic (type I and type II),
* presenting known allergy or hypersensitivity to milk proteins, soy or lactose,
* receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* with renal failure or any other metabolic disorder which could interfere with efficacy or safety assessment of the study,
* pregnant or breast feeding women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Hospital de Sant Joan
Study officials:
References:
Clinical trial NCT00594620: Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
Official title: A Prospective Trial of Soy Derivatives for Control of Hot Flashes in Men on Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2008-01-15
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of soy/isoflavone supplementation on hot flashes in men who are being treated with luteinizing hormone-releasing hormone (LHRH) agonist therapy for control of advanced prostate cancer

Detailed description: Literature has shown that low dose estrogens can control hot flashes in men on androgen deprivation but with a high risk of thromboembolic events. Soy derivatives that contain isoflavones, a type of phytoestrogen, have been evaluated in peri-menopausal women as a possible safer alternative to synthetic estrogens but there has not been a similar study performed on their effect in men on androgen deprivation therapy for prostate cancer.

Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma of prostate with treatment of prostate cancer (radical prostatectomy, radiation therapy, etc.)
* had biochemical/clinical relapse and started on antiandrogens
* have documented history of hot flashes

Exclusion Criteria:

* History of MI, DVT, CVA
* peanut allergy
* untreated hypothyroidism
* must be off other medical treatment for hot flashes for 2 weeks before enrollment in this study

Primary outcomes:
measure: Efficacy of Using Isoflavones as Safer Alternative to Synthetic Estrogens
timeFrame: 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jeffrey M. Holzbeierlein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02677220: Implantation With the Nucleus CI532 Cochlear Implant in Adults
Official title: Implantation With the Nucleus CI532 Cochlear Implant in Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: NYU Langone Health
First posted: 2016-02-09
Enrollment: 1
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: The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant.

The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.


Eligibility criteria: Inclusion Criteria:

* Meet current cochlear implant criteria at the implanting center
* 18 years or older with bilateral sensorineural hearing loss
* Limited benefit from appropriate binaural hearing aids
* Moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies
* Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz) and 500 Hz in the ear to be implanted
* Fluent speaker in the language used to assess clinical performance

Exclusion Criteria:

* Evidence of hearing loss prior to age 5
* Sensorineural severe to profound hearing loss greater than 20 years at and above 2000Hz
* Simultaneous bilateral implantation prior to the study
* Medical or psychological conditions that contraindicate undergoing general anesthesia or surgery
* Cochlear anomaly that might prevent complete insertion of the electrode array
* Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve, or central auditory pathway
* Active middle ear infection
* Tympanic membrane perforation
* Unrealistic expectations
* Unwillingness or inability co comply with all investigational requirements
* Patients with existing cerebral shunts or drains
* Recurrent episodes of bacterial meningitis

Primary outcomes:
measure: AzBio Sentence Recognition in Noise
timeFrame: 3 months post-activation
Secondary outcomes:
measure: Glasgow Benefit Inventory
timeFrame: 6 months post-activation
measure: Speech, Spatial, and Qualities of Hearing Scale
timeFrame: 6 months post-activation
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05586620: 3 Snip Punctoplasty With and Without Mitomycine C.
Official title: Comparative Study on 3 Snip Punctoplasty With and Without Mitomycine C in the Management of Punctual Stenosis or Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Punctal Stenosis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 18
Sex: ALL
Minimum age (years): 16
Maximum age (years): 63
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Punctal stenosis is a progressive constriction of the puncta with resultant epiphora. One of the most effective treatment options is 1- to 4-snip punctoplasty combined with or without Mitomycin-C.


Eligibility criteria: Inclusion Criteria:

* Patients with recurrence of punctal stenosis at the end of 1 month following punctal dilatation.

Exclusion Criteria:

* patients with associated lacrimal passage obstruction

Primary outcomes:
measure: Punctal patency
timeFrame: Baseline
measure: Punctal patency
timeFrame: 1 week postoperative
measure: Punctal patency
timeFrame: 1 month postoperative
measure: Punctal patency
timeFrame: 3 months postoperative
measure: Presence of Epiphora
timeFrame: Baseline
measure: Presence of Epiphora
timeFrame: 1 week postoperative
measure: Presence of Epiphora
timeFrame: 1 month postoperative
measure: Presence of Epiphora
timeFrame: 3 month postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Damieta
country: Egypt
facility: Ehab tharwat
state: New Damietta
Study officials:
References:
Clinical trial NCT04224220: Effectiveness of Nurse-based Care Coordination on Readmissions Among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial
Official title: Effectiveness of Nurse-based Care Coordination on Readmissions Among Primary Care Patients: a Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Activation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 1947
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial will evaluate the effectiveness of nurse-based care coordination and nurse-based remote patient monitoring on hospital readmissions among primary care patients.


Eligibility criteria: Inclusion Criteria:

* Discharged from the hospital in the past 7 days
* LACE+ score of 59 or greater and at least two chronic conditions
* Index hospitalization with discharge directly to community dwelling home (home, assisted living)
* English speaking
* Normal cognitive function - mild dementia or mild cognitive impairment is allowed if a caregiver is able to work with the care coordinator and patient during program enrollment
* Mayo Clinic or Mayo Clinic Health System provider managing the patient's care (e.g. primary care); patient is assigned to the panel of a Mayo Clinic Medical Doctor/Nurse Practitioner/Physician Assistant
* Access to and ability to communicate via telephone (either patient or caregiver)

Exclusion Criteria:

* Psychiatric hospital admission
* Patients with a serious and persistent mental health disorder or severe treatment interfering behavior that require a higher level of service than is available at the patient's clinic
* Untreated active substance or alcohol abuse
* Dementia or moderate to severe cognitive impairment
* Discharged to one of the following: rehabilitation unit, skilled nursing facility, assisted living memory unit, group home
* Pregnancy
* Active treatment for cancer
* Receiving dialysis or transplant services
* Life expectancy \< 6 months or enrolled in hospice or palliative care programs
* Patient is unwilling to sign a Release of Information (ROI); ROI allows those providing care, internal and external, to be actively involved in the patient's care coordination
* Patients with active tuberculosis (TB)
* Violent patient flag noted in Epic (for adult medical care coordination)
* Patient declines home visit (for adult medical care coordination)
* Patient is already enrolled in remote patient monitoring or the care transitions program

Primary outcomes:
measure: Rate of Readmission
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michelle Lampman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00420420: MK0249 for the Symptomatic Treatment of Alzheimer's Disease (MK0249-011)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Efficacy of MK0249 for the Symptomatic Treatment of Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 144
Sex: ALL
Minimum age (years): 55
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 test the efficacy and safety of an investigational medication for improving symptoms of Alzheimer's Disease. Subjects will receive either active medication or placebo for 28 days. Tests of memory, concentration will be included. Safety will be monitored using routine clinical and laboratory tests.


Eligibility criteria: Inclusion Criteria:

* Male or females
* Age at least 55 years or older
* Mild-to-moderate Alzheimer's Disease, with Mini Mental State Examination (MMSE) between 18 and 26, inclusive, Modified Hachinski Ischemic Scale (MHIS) score =/\<4, Global CDR score of 1 or 2, and who have a reliable informant/caregiver to accompany patient to all clinic visits
* If using symptomatic Alzheimer's Disease treatments, patients must be on the medication for 3 months and on a STABLE DOSE for at least 2 months

Exclusion Criteria:

* Patients cannot be living in a skilled nursing facility
* Patients cannot have poorly-controlled hypertension
* Patients cannot have the following conditions within 6 months of screening: significant cardiovascular disorders, active major depressive disorder, gastroesophageal reflux disease (GERD), or clinically significant sleep disorder
* Various concomitant therapy restrictions

Primary outcomes:
measure: Week 4 Change From Baseline in Computerized Neuropsychological Test Battery (CNTB): Short CNTB Summary Score.
timeFrame: Baseline and Week 4
measure: Week 4 Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog): ADAS-Cog Total Score
timeFrame: Baseline and Week 4
Secondary outcomes:
measure: Week 4 Change From Baseline in Cognition Summary Score (CSS)
timeFrame: Baseline and Week 4
Other outcomes:
measure: Baseline: Short CNTB Summary Score.
timeFrame: Baseline
measure: Baseline: ADAS-Cog Total Score
timeFrame: Baseline
measure: Baseline: Cognition Summary Score (CSS)
timeFrame: Baseline
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Egan M, Yaari R, Liu L, Ryan M, Peng Y, Lines C, Michelson D. Pilot randomized controlled study of a histamine receptor inverse agonist in the symptomatic treatment of AD. Curr Alzheimer Res. 2012 May;9(4):481-90. doi: 10.2174/156720512800492530.
Clinical trial NCT05204420: Spontaneous Gastric Intramural Hematoma: Case Report and Literature Review
Official title: Spontaneous Gastric Intramural Hematoma: Case Report and Literature Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Hemorrhage
Lead sponsor: University of Balamand
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients previously healthy presenting with bleeding gastric mass

Brief summary: Patient previously healthy found to have spontaneous gastric intramural hematoma

Detailed description: 28 year old male patient previously healthy presented with diarrhea and diffuse abdominal pain of 1 week duration that exacerbated 1 day prior to presentation. CT showed anterior abdominal mass possibly from the outer gastric wall. Gastroscopy suspected a submucosal tumor in the body and antrum. Patient's pain exacerbated and developed drop in hemoglobin. Urgent CT scan showed a bleeding gastric tumor. Urgent laparotomy identified a bleeding gastric lesion at greater curvature. Partial gastrectomy done with abutting mesocolon resection. Surgical specimen pathology showed gastric intramural hematoma that was considered spontaneous.

Eligibility criteria: Inclusion Criteria:

* any patient presenting with gastric bleeding tumors

Exclusion Criteria:

* patients on anticoagulants and patient with gastric medical history

Primary outcomes:
measure: Spontaneous gastric intramural hematoma
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: University of Balamand
Study officials:
affiliation: University of Balamand
name: Omar Tabbikha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05645120: Impact of Nutrition Education on Knowledge and Beliefs About Dietary Supplements/Herbal Foods
Official title: Impact of Nutrition Education on Knowledge and Beliefs About Dietary Supplements/Herbal Foods: A Pre - Post Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Keywords: nutrition education
dietary supplements
herbal supplements
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 226
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A two session nutrition education intervention was administered to health professionals and non-health professionals in separate sessions. Nutrition knowledge status was evaluated with comparing the pre-test and post-test values.

Detailed description: The purpose of this study is to evaluate the efficacy of nutrition education intervention of health professionals and non-health professionals about the effectiveness of dietary supplements/herbal foods (DS/HF) in COVID-19. Study design is a cross-sectional study with an education intervention. This study was conducted through online video communication application. Overall, 106 health professionals and 110 non-health professionals completed the study. The education intervention was administered in two sessions, one week apart for both health professionals and non-health professionals separately. Knowledge level of nutrition and COVID-19 and beliefs about DS/HF in the prevention/treatment of COVID-19 were evaluated with a pre-test and post-test setting. Comparison of the groups before and after the intervention was implemented with the McNemar's test.

Eligibility criteria: Inclusion Criteria:

* being 18 to 65 years old
* using social media
* being able to understand Turkish

Exclusion Criteria:

* regular supplement use prior to COVID-19 pandemic
* having a chronic disease that requires dietary supplementation

Primary outcomes:
measure: Knowledge Level
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Zeynep Goktas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04532320: Incidence of BRUE Among the Hospitalized Infants: Towards a Change in Medical Practices?
Official title: Incidence of BRUE Among the Hospitalized Infants: Towards a Change in Medical Practices?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brief Resolved Unexplained Events (BRUE)
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 31
Sex: ALL
Minimum age (years): 1
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infant less than one year old, admitted to the paediatric emergencies of the CHRU of Nancy between 11/01/2019 and 04/30/2020 for discomfort

Brief summary: The malaise of the infant represents a polymorphic pathology in its clinical presentation.

Due to the young age of the patients concerned and the parental anxiety generated, hospital management is necessary, for clinical and paraclinical evaluation and monitoring.

The practice of complementary examinations is guided by personal and family history, and the precise description of the discomfort as well as clinical examination of the child and assessment of his vital parameters.

However, in view of the particular terrain represented by infants under one year of age, a number of tests are carried out systematically, and therefore empirically, because they are not guided by the clinic.

These various tests can be invasive, anxiety-provoking for parents and generate a significant additional cost during hospital management.

An evaluation of the indication and interest of these tests is necessary in order to propose a homogeneous clinical and paraclinical management of the discomfort of the infant, in particular of discomforts of type BRUE (Brief Resolved Unexplained Events), as described in the 2016 American Academy of Pediatrics (AAP) recommendations.


Eligibility criteria: Inclusion Criteria:

* Infant less than one year old
* Admitted to the paediatric emergencies of the CHRU of Nancy between 11/01/2019 and 04/30/2020 for discomfort

Exclusion Criteria:

* Child over one year old
* Reasons for consultation in paediatric emergencies other than "malaise";

Primary outcomes:
measure: Measurement of the proportion of BRUE-type discomfort among infants hospitalized for discomfort between 11/01/2019 and 04/30/2020
timeFrame: From 11/01/2019 to 04/30/2020
Secondary outcomes:
measure: - Assessment of the number of additional tests performed, their nature and the results found - Assessment of the child's orientation following consultation in paediatric emergencies (return home / hospitalization) - Epidemiological analysis
timeFrame: From 11/01/2019 au 04/30/2020
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy, Hôpital d'Enfants
state: Lorraine
Study officials:
affiliation: CHRU Nancy
name: Myriam MANGIN, Interne
role: STUDY_CHAIR
References:
Clinical trial NCT05750420: Psychological Status and Self-care in Chronic Cardiovascular Disease
Official title: Psychological Status and Self-care: a Preliminary Study Involving Patients With Chronic Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Depression
Emotional Stress
Quality of Life
Self-care
Chronic Cardiovascular Disease
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with chronic cardiovascular disease

Brief summary: This is an observational study aimed at exploring the relationship between psychological status and self-care in patients with chronic cardiovascular disease

Detailed description: 400 patients with chronic cardiovascular disease were enrolled in this observational study aiming at exploring the relationship between their psychological status (anxiety, depression, emotional distress and quality of life) and their self-care.

Eligibility criteria: Inclusion Criteria:

* Being aged \> 18 years old and \> 85 years old
* Being diagnosed with a chronic cardiovascular disease
* Being able and willing to sign the Informed Consent Form

Exclusion Criteria:

* Having a cognitive dysfunction or psychotic disorder signaled in the clinical documentation
* Not speaking Italian

Primary outcomes:
measure: Psychological status and self-care
timeFrame: At the moment of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Monzino Cardiology Center
city: Monza
country: Italy
facility: IRCCS San Gerardo
Study officials:
References: